As Roundup cancer lawsuits surge, Monsanto fights to keep PR work secret

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As Monsanto continues to battle legal claims over alleged dangers of its widely used Roundup herbicides, the company is trying to block orders to turn over internal records about its work with public relations and strategic consulting contractors.

In a series of filings in St. Louis Circuit Court, Monsanto argues that it should not have to comply with discovery requests involving certain dealings between it and the global public relations firm FleishmanHillard, despite the fact that a special master has found Monsanto should hand those documents over. Monsanto is asserting that its communications with FleishmanHillard should be considered “privileged,” similar to attorney-client communications, and that Monsanto should not have to produce them as part of discovery to the lawyers representing the cancer patients suing Monsanto.

FleishmanHillard became the agency of record for Monsanto’s “corporate reputation work” in 2013, and its employees became deeply involved with the company, working “at Monsanto’s offices nearly every day” and gaining “access to online repositories of non-public confidential information,”  the company said. “The fact that some of these communications involve the creation of public messaging does not strip them of privilege,” Monsanto said in its court filing.

FleishmanHillard worked on two projects for Monsanto in Europe regarding re-registration of
glyphosate and worked with Monsanto lawyers on a “specific project for jury research.” The nature of the work done by the public relations firm “required privileged communications” with Monsanto’s legal counsel, the company said.

Earlier this year Monsanto owner Bayer AG said it was ending Monsanto’s relationship with FleishmanHillard after news broke that the public relations firm engaged in a Europe-wide data collection scheme for Monsanto, targeting journalists, politicians and other stakeholders to try to influence pesticide policy.

Monsanto has taken a similar position with respect to communications involving its work with corporate image management company FTI Consulting, which Monsanto hired in June 2016. “The absence of an attorney on a privileged document also does not automatically render that document susceptible to a privilege challenge,” Monsanto said in its filing.

Earlier this year, an FTI employee was caught impersonating a journalist at one of the Roundup cancer trials, trying to suggest story lines for other reporters to pursue that favored Monsanto.

The company also wants to avoid handing over documents involving its relationship with Scotts Miracle-Gro Company, which has been marketing and selling Monsanto’s Roundup lawn and garden products since 1998.

More than 40,000 cancer victims or their family members are now suing Monsanto blaming exposure to the company’s line of Roundup herbicides for their diseases, according to Bayer. The lawsuits allege that exposure to Monsanto’s herbicides caused the plaintiffs to develop non-Hodgkin lymphoma and that though Monsanto knew about the cancer risks, it intentionally did not warn consumers.

Bayer held a conference call with investors Wednesday to discuss its third quarter results and to update shareholders on the Roundup litigation.  Striking a reassuring tone, Bayer CEO Werner Baumann said that while investors might be surprised at the high number of lawsuits, it is “actually not that surprising.” He said plaintiffs’ attorneys in the United States have been spending tens of millions of dollars advertising for clients.

“This increase in the number of lawsuits does not change our conviction of the safety profile of glyphosate and is by no means a reflection of the merits of this litigation,” Baumann said. Appeals are underway after the company lost the first three trials, and the company is “constructively” engaging in mediation, according to Baumann. Bayer will only agree to a settlement that is “financially reasonable” and will bring “reasonable closure to the overall litigation,” he said.

Though the company refers to it as “glyphosate” litigation, the plaintiffs allege that their cancers were not caused by exposure to glyphosate alone, but by exposure to glyphosate-based formulated products made by Monsanto.

Many scientific studies have shown that the formulations are much more toxic than glyphosate by itself. The U.S. Environmental Protection Agency (EPA) has not required long-term safety studies on Roundup formulations throughout the 40-plus years the products have been on the market, and internal company  communications between Monsanto scientists have been obtained by plaintiffs’ attorneys in which the scientists discuss the lack of carcinogenicity testing for Roundup products.

Multiple trials that were scheduled for this fall in the St. Louis, Missouri area have been delayed until next year.

An Unappetizing Analysis from the FDA

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Last month the Food & Drug Administration published its latest annual analysis of the levels of pesticide residues that contaminate the fruits and veggies and other foods we Americans routinely put on our dinner plates. The fresh data adds to growing consumer concern and scientific debate over how pesticide residues in food may contribute – or not – to illness, disease and reproductive problems.

Over 55 pages of data, charts and graphs, the FDA’s “Pesticide Residue Monitoring Program” report also provides a rather unappetizing example of the degree to which U.S. farmers have come to rely on synthetic insecticides, fungicides and herbicides in growing our food.

We learn, for instance, in reading the latest report, that traces of pesticides were found in 84 percent of domestic samples of fruits, and 53 percent of vegetables, as well as 42 percent of grains and 73 percent of food samples simply listed as “other.” The samples were drawn from around the country, including from California, Texas, Kansas, New York and Wisconsin.

Roughly 94 percent of grapes, grape juice and raisins tested positive for pesticide residues as did 99 percent of strawberries, 88 percent of apples and apple juice, and 33 percent of rice products, according to the FDA data.

Imported fruits and vegetables actually showed a lower prevalence of pesticides, with 52 percent of fruits and 46 percent of vegetables from abroad testing positive for pesticides. Those samples came from more than 40 countries, including Mexico, China, India and Canada.

We also learn that for the most recently reported sampling, among the hundreds of different pesticides, the FDA found traces of the long-banned insecticide DDT in food samples, as well as chlorpyrifos, 2,4-D and glyphosate.  DDT is linked to breast cancer, infertility and miscarriage, while chlorpyrifos – another insecticide – has been scientifically shown to cause neurodevelopmental problems in young children.

Chlorpyrifos is so dangerous that the European Food Safety Authority has recommended a ban of the chemical in Europe, finding that there is no safe exposure level. The herbicides 2,4-D and glyphosate are both linked to cancers and other health problems as well.

Thailand recently said it was banning glyphosate and chlorpyrifos due to the scientifically established risks of these pesticides.

Despite the prevalence of pesticides found in U.S. foods, the FDA, along with the Environmental Protection Agency (EPA) and the U.S. Department of Agriculture (USDA), assert that pesticide residues in food are really nothing to worry about. Amid heavy lobbying by the agrichemical industry the EPA has actually supported continued use of glyphosate and chlorpyrifos in food production.

The regulators echo the words of Monsanto executives and others in the chemical industry by insisting that pesticide residues pose no threat to human health as long as the levels of each type of residue falls under a “tolerance” level set by the EPA.

In the most recent FDA analysis, only 3.8 percent of domestic foods had residue levels that were considered illegally high, or “violative.” For imported foods, 10.4 percent of the foods sampled were violative, according to the FDA.

What the FDA did not say, and what regulatory agencies routinely avoid saying publicly, is that the tolerance levels for certain pesticides have risen over the years as the companies that sell the pesticides request higher and higher legal limits. The EPA has approved several increases allowed for glyphosate residues in food, for instance. As well, the agency often makes the determination that it need not comply with a legal requirement that states the EPA  “shall apply an additional tenfold margin of safety for infants and children” in setting the legal levels for pesticide residues. The  EPA has overridden that requirement in the setting of many pesticide tolerances, saying no such extra margin of safety is needed to protect children.

The bottom line: The higher the EPA sets the “tolerance” allowed as the legal limit, the lower the possibility that regulators will have to report “violative” residues in our food.  As a result, the U.S. routinely allows higher levels of pesticide residues in food than other developed nations. For example, the legal limit for the weed killer glyphosate on an apple is 0.2 parts per million (ppm) in the United States but only half that level – 0.1 ppm – is allowed on an apple in the European Union. As well, the U.S. allows residues of glyphosate on corn at 5 ppm, while the EU allows only 1 ppm.

As legal limits rise for pesticide residues in food, many scientists have been increasingly raising alarms about the risks of regular consumption of the residues, and the lack of regulatory consideration of the potential cumulative impacts of consuming an array of bug and weed killers with every meal.

A team of Harvard scientists are calling for in-depth research about potential links between disease and consumption of pesticide as they estimate that more  than 90 percent of people in the United States have  pesticide residues in their urine and blood due to consumption of pesticide-laced foods.  A study connected to Harvard found that dietary pesticide exposure within a “typical” range was associated both with problems women had getting pregnant and delivering live babies.

Additional studies have found other health problems tied to dietary exposures to pesticides, including to glyphosate.  Glyphosate is the most widely used herbicide in the world and is the active ingredient in Monsanto’s branded Roundup and other weed killing products.

Pesticide Industry Push Back 

But as the concerns mount, agrichemical industry allies are pushing back. This month a group of three researchers with long-standing close ties to the companies that sell agricultural pesticides released a report seeking to soothe consumer worries and discount the scientific research.

The report, which was issued Oct. 21, stated that “there is no direct scientific or medical evidence indicating that typical exposure of consumers to pesticide residues poses any health risk. Pesticide residue data and exposure estimates typically demonstrate that food consumers are exposed to levels of pesticide residues that are several orders of magnitude below those of potential health concern.”

Not surprisingly, the three authors of the report are closely tied to the agrichemical industry. One of the report’s authors is Steve Savage, an agrichemical industry consultant and former DuPont employee. Another is Carol Burns, a former scientist for Dow Chemical and current consultant for Cortevia Agriscience, a spin-off of  DowDuPont. The third author is Carl Winter, Chair of the Department of Food Science and Technology at the University of California at Davis. The university has received approximately $2 million a year from the agrichemical industry, according to a university researcher, though the accuracy of that figure has not been established.

The authors took their report directly to Congress, holding three different presentations in Washington, D.C., designed to promote their message of pesticide safety for use in “media food safety stories, and consumer advice regarding which foods consumers should (or should not) consume.”

The pro-pesticide sessions were held at the office buildings for members of Congress and, appropriately it seems, at the headquarters for CropLife America, the lobbyist for the agrichemical industry. 

 

An Unappetizing Analysis from the FDA

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Last month the Food & Drug Administration published its latest annual analysis of the levels of pesticide residues that contaminate the fruits and veggies and other foods we Americans routinely put on our dinner plates. The fresh data adds to growing consumer concern and scientific debate over how pesticide residues in food may contribute – or not – to illness, disease and reproductive problems.

Over 55 pages of data, charts and graphs, the FDA’s “Pesticide Residue Monitoring Program” report also provides a rather unappetizing example of the degree to which U.S. farmers have come to rely on synthetic insecticides, fungicides and herbicides in growing our food.

We learn, for instance, in reading the latest report, that traces of pesticides were found in 84 percent of domestic samples of fruits, and 53 percent of vegetables, as well as 42 percent of grains and 73 percent of food samples simply listed as “other.” The samples were drawn from around the country, including from California, Texas, Kansas, New York and Wisconsin.

Roughly 94 percent of grapes, grape juice and raisins tested positive for pesticide residues as did 99 percent of strawberries, 88 percent of apples and apple juice, and 33 percent of rice products, according to the FDA data.

Imported fruits and vegetables actually showed a lower prevalence of pesticides, with 52 percent of fruits and 46 percent of vegetables from abroad testing positive for pesticides. Those samples came from more than 40 countries, including Mexico, China, India and Canada.

We also learn that for the most recently reported sampling, among the hundreds of different pesticides, the FDA found traces of the long-banned insecticide DDT in food samples, as well as chlorpyrifos, 2,4-D and glyphosate.  DDT is linked to breast cancer, infertility and miscarriage, while chlorpyrifos – another insecticide – has been scientifically shown to cause neurodevelopmental problems in young children.

Chlorpyrifos is so dangerous that the European Food Safety Authority has recommended a ban of the chemical in Europe, finding that there is no safe exposure level. The herbicides 2,4-D and glyphosate are both linked to cancers and other health problems as well.

Thailand recently said it was banning glyphosate and chlorpyrifos due to the scientifically established risks of these pesticides.

Despite the prevalence of pesticides found in U.S. foods, the FDA, along with the Environmental Protection Agency (EPA) and the U.S. Department of Agriculture (USDA), assert that pesticide residues in food are really nothing to worry about. Amid heavy lobbying by the agrichemical industry the EPA has actually supported continued use of glyphosate and chlorpyrifos in food production.

The regulators echo the words of Monsanto executives and others in the chemical industry by insisting that pesticide residues pose no threat to human health as long as the levels of each type of residue falls under a “tolerance” level set by the EPA.

In the most recent FDA analysis, only 3.8 percent of domestic foods had residue levels that were considered illegally high, or “violative.” For imported foods, 10.4 percent of the foods sampled were violative, according to the FDA.

What the FDA did not say, and what regulatory agencies routinely avoid saying publicly, is that the tolerance levels for certain pesticides have risen over the years as the companies that sell the pesticides request higher and higher legal limits. The EPA has approved several increases allowed for glyphosate residues in food, for instance. As well, the agency often makes the determination that it need not comply with a legal requirement that states the EPA  “shall apply an additional tenfold margin of safety for infants and children” in setting the legal levels for pesticide residues. The  EPA has overridden that requirement in the setting of many pesticide tolerances, saying no such extra margin of safety is needed to protect children.

The bottom line: The higher the EPA sets the “tolerance” allowed as the legal limit, the lower the possibility that regulators will have to report “violative” residues in our food.  As a result, the U.S. routinely allows higher levels of pesticide residues in food than other developed nations. For example, the legal limit for the weed killer glyphosate on an apple is 0.2 parts per million (ppm) in the United States but only half that level – 0.1 ppm – is allowed on an apple in the European Union. As well, the U.S. allows residues of glyphosate on corn at 5 ppm, while the EU allows only 1 ppm.

As legal limits rise for pesticide residues in food, many scientists have been increasingly raising alarms about the risks of regular consumption of the residues, and the lack of regulatory consideration of the potential cumulative impacts of consuming an array of bug and weed killers with every meal.

A team of Harvard scientists are calling for in-depth research about potential links between disease and consumption of pesticide as they estimate that more  than 90 percent of people in the United States have  pesticide residues in their urine and blood due to consumption of pesticide-laced foods.  A study connected to Harvard found that dietary pesticide exposure within a “typical” range was associated both with problems women had getting pregnant and delivering live babies.

Additional studies have found other health problems tied to dietary exposures to pesticides, including to glyphosate.  Glyphosate is the most widely used herbicide in the world and is the active ingredient in Monsanto’s branded Roundup and other weed killing products.

Pesticide Industry Push Back 

But as the concerns mount, agrichemical industry allies are pushing back. This month a group of three researchers with long-standing close ties to the companies that sell agricultural pesticides released a report seeking to soothe consumer worries and discount the scientific research.

The report, which was issued Oct. 21, stated that “there is no direct scientific or medical evidence indicating that typical exposure of consumers to pesticide residues poses any health risk. Pesticide residue data and exposure estimates typically demonstrate that food consumers are exposed to levels of pesticide residues that are several orders of magnitude below those of potential health concern.”

Not surprisingly, the three authors of the report are closely tied to the agrichemical industry. One of the report’s authors is Steve Savage, an agrichemical industry consultant and former DuPont employee. Another is Carol Burns, a former scientist for Dow Chemical and current consultant for Cortevia Agriscience, a spin-off of  DowDuPont. The third author is Carl Winter, Chair of the Department of Food Science and Technology at the University of California at Davis. The university has received approximately $2 million a year from the agrichemical industry, according to a university researcher, though the accuracy of that figure has not been established.

The authors took their report directly to Congress, holding three different presentations in Washington, D.C., designed to promote their message of pesticide safety for use in “media food safety stories, and consumer advice regarding which foods consumers should (or should not) consume.”

The pro-pesticide sessions were held at the office buildings for members of Congress and, appropriately it seems, at the headquarters for CropLife America, the lobbyist for the agrichemical industry. 

 

Gene Editing Mishaps Highlight Need for FDA Oversight

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A Midwestern company’s quest to genetically engineer the world’s first hornless dairy cows hit a snag this summer when the U.S. Food and Drug Administration found extra genes in the cows that weren’t supposed to be there. The mistakes that FDA caught – but the company missed – highlight the importance of government oversight of gene-edited foods at a time when industry groups are pushing for deregulation.

Cows without horns: a job for gene editing?

Pork producers, for example, “say the federal government should ease regulations on the use of gene editing in livestock,” which they claim is slowing down research and development, the Wall Street Journal reported last week. The producers want oversight moved from the FDA to the U.S. Department of Agriculture, which already allows gene-edited crops to be planted and sold with no regulatory oversight.

But the FDA plans to require pre-market safety assessments for gene-edited food animals, as they do for new animal drugs. The regulations will ensure that genetic changes are safe for animals and consumers, and help consumers get comfortable with the technology, an FDA spokeswoman told the Journal.

The FDA’s discovery of extra genes in the hornless cattle, and other recently reported mishaps involving new genetic engineering techniques, bolster the case for government scrutiny, and have industry groups scrambling to control the public relations fiasco.

The extra genes Recombinetics missed

Researchers at the Minnesota-based company Recombinetics, Inc., reported in a 2016 paper that they created the first polled (hornless) cows using a gene editing technique called TALENS to alter the gene sequence in the cows. The researchers reported finding no unintended impacts. They wrote, “our animals are free of off-target effects.”

But when FDA researchers reexamined the DNA this summer, using genome sequences that had been posted online by Recombinetics, they did find off-target effects. Two edited cows carried copies of the entire bacterial plasmid used in the editing process, including two antibiotic resistance genes in virtually every cell of their bodies. The genes don’t normally occur in cattle.

This “raises issues of biosafety given that there is a strong global push to limit the spread of genes conferring antibiotic resistance,” writes Jonathan Latham, PhD, in Independent Science News. It also raises questions about the lack of precision of gene editing techniques and gives weight to arguments for government oversight. Plans to breed the hornless cows in Brazil were scrapped after the off-target effects came to light, Wired reported, because regulators there could no longer consider the cows non-GMO.

The FDA researchers said their discovery “highlights a potential blind spot in standard genome editing screening methods,” and said they suspect integration errors are “underreported or overlooked” in genome editing experiments. They noted other examples of unexpected alterations – a 2017 mouse study that found complex deletions and insertions in an edited mouse genome, and a 2018 study that reported DNA damage in human cell lines.

So how did the Recombinetics researchers miss the unintended DNA integrations?

“we didn’t look”

“It was not something expected, and we didn’t look for it,” said Tad Sonstegard, CEO of Recombinetics’ agriculture subsidiary Acceligen, according to MIT Technology Review. A more complete check “should have been done,” he said. Wired magazine quoted Sonstegard explaining, “We weren’t looking for plasmid integrations. We should have.”

That should have been an obvious place to look, says Michael Hansen, PhD, Senior Scientist, Advocacy, of Consumers Reports. “Whether any DNA from the bacterial plasmid used in the gene editing process got picked up and transferred would be one of the first things you would look for if you were interested in finding off-target effects,” Hansen said.

In his view, the fact that Recombinetics missed the problem suggests that, “they didn’t do the necessary oversight. That’s why we need government oversight,” including requirements for pre-market safety assessments, he said.

Latham, a biologist and former genetic engineer, also points to recent findings from Japan that he believes may be more consequential than the FDA’s findings, and have greater implications for the regulatory landscape. In a 2019 study, Japanese researchers reported that edited mouse genomes had acquired DNA from the E. coli genome, as well as goat and bovine DNA. This stray DNA came from the gene editing reagents, the delivery method used to make the edits.

These findings “are very simple: cutting DNA inside cells, regardless of the precise type of gene editing, predisposes genomes to acquire unwanted DNA,” , Latham wrote in Independent Science News. He said the findings “imply, at the very least, the need for strong measures to prevent contamination by stray DNA, along with thorough scrutiny of gene-edited cells and gene-edited organisms. And, as the Recombinetics case suggests, these are needs that developers themselves may not meet.”

Next logical step

Recombinetics has “noisily objected” to FDA oversight all along and lobbied the Trump Administration to wrest oversight powers away from the food safety agency, according to MIT Technology Review. And when Recombinetics claimed in 2016 that its gene-edited hornless cows were “free of off-target effects,” that finding was immediately deployed as a lobby tool in the campaign against FDA scrutiny.

In a commentary that ran alongside the company’s study, five university researchers argued that pre-market safety assessments for gene-edited food animals are onerous and unnecessary. One of the authors, Alison Van Eenennaam PhD, an animal extension specialist at UC Davis and a leading advocate for deregulation, has described FDA’s plan to require pre-market safety assessments as “insane.”

“The effects of gene editing are largely identical to natural processes,” the researchers wrote in their commentary. Any “off-target effects can be minimized by careful design and extensive testing,” they said, noting that the researchers from Recombinetics “found none” in their gene-edited cattle.

They also claimed, inaccurately as it turned out, that the gene-edited cattle carried the same DNA “that has been consumed by humans for over 1,000 years.” The “next logical step,” they wrote, would be to spread the edited genome sequence “into global dairy populations.”

The disconnect between the rush to market genetically engineered foods, and the need for due diligence to understand off-target effects of gene manipulations and their possible impacts on health and the environment, has long been a sticky point in the GMO debate. For most GMO foods, the companies have been in charge of safety assessments all along, with little or no government oversight. But what incentive do companies have to look for problems?

Back in 1998, in an interview with Michael Pollan for the New York Times, Monsanto’s then director of communications was blunt in his assessment of where the industry’s interests lie: ”Monsanto should not have to vouchsafe the safety of biotech food. Our interest is in selling as much of it as possible. Assuring its safety is the FDA’s job.”

Further reading

Gene editing needs to become more precise to live up to its promise — by David Edgell, The Conversation (10.7.19)

Gene-editing unintentionally adds bovine DNA, goat DNA, and bacterial DNA, mouse researchers find — by Jonathan Latham, PhD, Independent ScienceNews (9.23.19)

Gene-edited cattle have a major screwup in their DNA — by Antonio Regalado, MIT Technology Review (8.28.19)

FDA finds unexpected antibiotic resistance genes in ‘gene-edited’ dehorned cattle — by Jonathan Latham, PhD, and Allison Wilson, PhD, Independent Science News (8.12.19)

Off-target mutations not the only concern in gene-edited plants — GM Watch (7.10.19)

Why the “molecular scissors” metaphor for CRISPR is misleading — by Elinor Hortle, The Conversation (7.4.19)

CRISPR causes unexpected outcomes even at the intended site of genetic modification — GM Watch (4.16.19)

CRISPR spin-off causes unintended mutations in DNA — GM Watch (3.13.19)

CRISPR base editing, known for precision, hits a snag with off-target mutations — by Sharon Begley, STAT (2.28.19)

Big tongues and extra vertebrae: The unintended consequences of animal gene editing — By Preetika Rana and Lucy Craymer, Wall Street Journal (12.14.18)

Potential DNA damage from CRISPR has been ‘seriously underestimated,’ study finds — by Sharon Begley, STAT (7.16.18)

Turns out CRISPR editing can also vandalize genomes — MIT Technology Review (7.16.2018)

A serious new hurdle for CRISPR: Edited cells might cause cancer, two studies find — by Sharon Begley, STAT (6.11.18)

Farmland gene editors want cows without horns, pigs without tails, and business without regulations — by Antonio Regalado, MIT Technology Review (3.12.18)

Report: Gene-edited animals will intensify factory farming and the climate crisis, could harm human health — Friends of the Earth (9.17.19)

Are you ready for the new wave of genetically engineered foods? — by Stacy Malkan, USRTK (3.16.18)

Monsanto Makes New Bid to Block St. Louis Trial

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Less than a month away from what would be the fourth Roundup cancer trial to pit cancer victims against the former agrochemical giant Monsanto Co., lawyers for the opposing sides continue to battle over how, when and where the case should – or should not – be heard.

Lawyers for Monsanto and for its German owner Bayer AG, sent a letter last week to the presiding judge in St. Louis County Circuit Court seeking action that would break up the group of plaintiffs into many smaller groups and delay the trial date of Oct. 15 that was previously set for 14 plaintiffs who had been grouped under the case Winston V. Monsanto.

Lead plaintiff Walter Winston and 13 others from around the country were set for trial in St. Louis City Court but Monsanto protested the venue for all the plaintiffs except Winston and after months of battling between the lawyers for both sides, St. Louis Circuit Court Judge Michael Mullen transferred all plaintiffs except Winston to St. Louis County in a Sept. 13 order.  A Missouri Supreme Court ruling early this year found it was improper for plaintiffs’ attorneys to anchor plaintiffs from outside the area to someone who had proper venue to bring a lawsuit in St. Louis.

Plaintiffs attorneys have been working to keep all 14 plaintiffs together and on track for an Oct. 15 trial, seeking approval for Judge Mullen to take a temporary assignment to the county for the purposes of trying the Roundup case. But Monsanto protested that effort, calling it an “extraordinary  proposal” in the company’s Sept. 19 letter to St. Louis County Judge Gloria Clark Reno.

The company said the plaintiffs’ attorneys “have only themselves to blame for the position they are now in. At the time they filed their claims, venue in the City of St. Louis was not proper… The Missouri Supreme Court’s decision… flatly confirmed that conclusion.”

Additionally, Monsanto’s lawyers argued in their letter that any trial should have no more than two plaintiffs: “A joint trial of the disparate claims of thirteen plaintiffs – claims arising under the law of three different states – would inevitably and impermissibly confuse the jury and deprive Monsanto of a fair trial.”

The Winston lawsuit, filed in March of 2018, would be the first trial to take place in the St. Louis area. Two trials that had been set to start in St. Louis in August and September have been delayed.

Before selling to Bayer last year, Monsanto was based in the suburb of Creve Coeur and was one of the largest St. Louis area-based employers.  Roundup cancer trials that had been set for St. Louis area in August and September have both already been delayed until next year. The back and forth battling over where and when the Winston trial may or may not take place has been ongoing for more than a year.

The plaintiffs in the Winston case are among more than 18,000 people in the United States suing Monsanto claiming that exposure to the company’s glyphosate-based herbicides caused them to develop non-Hodgkin lymphoma and that Monsanto hid the risks associated with its weed killers. Three juries in three trials over similar claims have found in favor of plaintiffs and ordered large punitive damages against Monsanto.

Bayer and lawyers for the plaintiffs are engaged in discussions about a potential global settlement  of the litigation. Bayer has been dealing with a depressed share price and disgruntled investors ever since the Aug. 10, 2018 jury decision in the first Roundup cancer trial. The jury awarded California groundskeeper Dewayne “Lee” Johnson $289 million and found that Monsanto acted with malice in suppressing information about the risks of its herbicides.

Emails Reveal Science Publisher Found Papers On Herbicide Safety Should Be Retracted Due to Monsanto Meddling

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Secretive influence by Monsanto in a set of papers published in the scientific journal Critical Reviews in Toxicology was so unethical that an investigation by the publisher found that at least three of the papers should be retracted, according to a series of internal journal communications. The journal editor refused to retract the papers, which declared no cancer concerns with the  company’s herbicides, saying a retraction could impact last summer’s first-ever Roundup trial and harm the authors’ reputations, the emails show.

The journal communications were obtained through discovery by lawyers representing several thousand people suing Monsanto over claims that the company’s glyphosate-based herbicides cause cancer and that Monsanto has covered up the evidence of the dangers.

Unlike the internal Monsanto emails that have thus far come to light revealing the agrochemical company’s manipulation of scientific literature about its herbicides, these emails detail the inner battle within a major scientific publishing house over how it should confront Monsanto’s covert meddling. They were obtained as part of a deposition of Roger McClellan, the longtime editor in chief of the peer-reviewed journal Critical Reviews in Toxicology (CRT.)

The papers in question were published by CRT in September 2016 as an “Independent Review” of the carcinogenic potential of the weed-killing agent glyphosate, the main ingredient in Monsanto’s Roundup herbicide and other brands. The five papers published as part of the review directly contradicted the findings of the World Health Organization’s International Agency for Research on Cancer (IARC), which in 2015 found glyphosate to be a probable human carcinogen. The 16 authors of the papers concluded that the weight of evidence showed the weed killer was unlikely to pose any carcinogenic risk to people.

At the end of the papers the authors stated that their conclusions were free of Monsanto’s intervention. Underscoring the supposed independence of the work, the declaration of interest section stated: “Neither any Monsanto company employees nor any attorneys reviewed any of the Expert Panel’s manuscripts prior to submission to the journal.”

That statement was proven false in the fall of 2017 after internal Monsanto records came to light showing extensive involvement by Monsanto scientists in the drafting and editing of the papers as well as company involvement in selecting the authors. Additionally, internal records showed direct payments to at least two of the so-called independent authors. Monsanto had a contract with author Larry Kier, for instance, paying him $27,400 to work on the papers.

In response to those revelations and questions from media outlets, CRT publisher  Taylor & Francis Group  launched an investigation in the fall of 2017. The newly released communications reveal that after spending months questioning the authors about how the papers came together,  a team of legal and ethics experts put together by Taylor & Francis concluded that the authors had hidden Monsanto’s direct  involvement in the papers, and had done so knowingly. Indeed, some of the authors did not even fully disclose Monsanto involvement in initial questioning by Taylor & Francis during the investigation, the emails show.

The “only tenable outcome is to retract 3 of the articles; specifically the summary, epidemiology and genotoxicity papers,” Taylor & Francis’ Charles Whalley wrote to McClellan on May 18, 2018. Whalley was managing editor of the publishing group’s medicine and health journals at the time.

The internal emails show McClellan refused to accept the idea of retraction, saying that he believed the papers were “scientifically sound” and produced “without external influence” from Monsanto. He said a retraction would tarnish the reputations of the authors, the journal and his own reputation.

“I can not agree to the proposal for retraction you have offered in your memo of May 18th, McClellan wrote in response.  In a series of emails McClellan laid out his arguments against retraction, saying   “Retractions of the papers would do irreparable harm to multiple parties including, most of all, the authors, the Journal , the publisher and key employees such as you and, in addition, me in my role as the Scientific Editor of CRT.”

In an email dated June 5, 2018, McClellan declared that he knew Monsanto had a “vested interest” in the publication of the papers and was personally aware of Monsanto’s relationships, including compensation agreements, with the authors, and still was satisfied that the papers were “scientifically sound.”

“In my professional opinion, the five Glyphosate papers are scholarly pieces of work clearly documenting the process used to critique the IARC report and provide an alternative hazard characterization,” McClellan wrote. “The five papers are scientifically sound. It would be a breach of scientific ethics and my own standards of scientific integrity to agree to retraction of any or all of the Glyphosate papers…”

Whalley pushed back, saying that the authors of the papers were clearly guilty of “misconduct and a breach of publishing ethics,” so severe as to warrant retraction. The “breaches of publication ethics that we have identified in this case are clear breaches of fundamental and clearly defined standards, and not attributable to misunderstandings of detail or nuance,” Whalley wrote to McClellan. He said the publisher had reviewed the guidelines from the Committee on Publication Ethics (COPE) before making the decision.  “Retractions are evidence that editorial policies are working, not that they have failed,” he wrote.

Whalley and McClellan argued over the retraction for months, the records show.  In one July 22, 2018 email McClellan pointed out that the first trial against Monsanto over the Roundup cancer claims was taking place at the time so the journal discussions of a retraction were “quite sensitive since the Johnson vs. Monsanto trial is underway in San Francisco.”  He suggested that instead of retracting the papers, they simply correct  the section at the end of the papers where the authors disclose potential conflicts.

“I urge you to agree to my recommendation to publish corrected and expanded Declaration of Interest statements and abandon the “we gotcha” approach with Retraction of the papers,” McClellan wrote to Whalley in a July 2018 email.  “I will not allow my well-earned reputation to be tarnished by arbitrary and capricious actions by others.”

“In this case, we need to collectively attempt to reach agreement on an equitable outcome that is FAIR to the authors, the publisher, CRT readers, the public and me as the Editor-in-Chief and the CRT Editorial board. We must not take an approach that determines winners and losers in legal cases based on what is allowed to appear in the peer reviewed literature,” McClellan wrote.

Neither McClellan nor Whalley responded to a request for comment regarding this article.

The CRT glyphosate series was considered so significant that its findings were widely reported by media outlets around the world and cast doubt upon the validity of the IARC classification. The papers were published at a critical time as Monsanto was facing doubts by European regulators about allowing glyphosate to remain on the market and growing unease in U.S. markets as well. The 2016 series was “widely accessed,” with one of the papers in the series accessed “over 13,000 time,” according to the internal journal correspondence.

The importance of the papers to Monsanto was laid out in a confidential document dated May 11, 2015, in which Monsanto scientists spoke of “ghost-writing” strategies that would lend credibility to the “independent” papers the company wanted to have created and then to be published by CRT.  Monsanto had announced in 2015 that it was hiring Intertek Scientific & Regulatory Consultancy to put together a panel of independent scientists who would review the IARC classification of glyphosate as a probable carcinogen. But the company had pledged that it would not be involved in the review.

Though Monsanto’s involvement was revealed in 2017 Taylor & Francis took no public action until September 2018 as the publisher and editor wrestled over the retraction issue. McClellan ultimately won the argument and no retractions were made. The internal emails show that Whalley notified the 16 authors of the glyphosate papers of the decision to merely publish corrections to the articles and update the declarations of interest at the end of the papers. That Aug. 31, 2018 email states:

            “We note that, despite requests for full disclosure, the original Acknowledgements and Declaration of Interest statements did not fully represent the involvement of Monsanto or its employees or contractors in the authorship of the articles. As referred to in our previous memos to you, this specifically relates to the statements that:

           ‘Neither any Monsanto company employees nor any attorneys reviewed any of the Expert Panel’s manuscripts prior to submission to the journal.’ and that ‘The Expert Panelists were engaged by, and acted as consultants to, lntertek, and were not directly contacted by the Monsanto Company.’ 

          “From information you have provided to us, we now believe that neither of these statements was accurate at time of submission. This is in contradiction to declarations you made on submission and to warranties you made in the Author Publishing Agreements regarding your compliance with Taylor & Francis’ policies. To provide the necessary transparency to our readers, we will publish corrections to your articles to update their respective Acknowledgements and Declaration of Interest statements as per the material you have provided.”

In September of 2018 the papers were updated to carry an “Expression of Concern” and updates to the acknowledgements and declaration of interests. But despite the findings of Monsanto’s involvement, the papers are still titled with the word “independent.”

Whalley left Taylor & Francis in October of 2018.

The journal’s handling of the matter has troubled some other scientists.

“McClellan’s comments about why he did not retract the paper was disingenuous, self-serving, and violate sound editorial practice,” said Sheldon Krimsky,  a Tufts University professor and a fellow of the Hastings Center, an independent bioethics research institution. Krimsky is also associate editor for a Taylor & Francis journal called “Accountability in Research.”

Nathan Donley, a senior scientist employed by the nonprofit Center for Biological Diversity said the journal’s failure to retract was a failure of transparency.  “This was one of the most disgraceful events in scientific publishing that I have ever witnessed,” Donley said. “What we’re left with is an expression of concern that no one will read and a blatant misrepresentation that this was somehow an ‘independent’ endeavor.  This was a win for the most powerful player in the pesticide industry, but it came at the expense of ethics in science.”

Click here to read 400-plus pages of the emails.  

Aspartame: Decades of Science Point to Serious Health Risks

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Long History of Concerns
Key Scientific Studies on Aspartame
Industry PR Efforts
Scientific References

Key Facts About Diet Soda Chemical 

What is Aspartame?

  • Aspartame is the world’s most widely used artificial sweetener. It is also marketed as NutraSweet, Equal, Sugar Twin and AminoSweet.
  • Aspartame is present in more than 6,000 products, including Diet Coke and Diet Pepsi, Kool Aid, Crystal Light, Tango and other artificially sweetened drinks; sugar-free Jell-O products; Trident, Dentyne and most other brands of sugar-free gum; sugar-free hard candies; low- or no-sugar sweet condiments such as ketchups and dressings; children’s medicines, vitamins and cough drops.
  • Aspartame is a synthetic chemical composed of the amino acids phenylalanine and aspartic acid, with a methyl ester. When consumed, the methyl ester breaks down into methanol, which may be converted into formaldehyde.

Decades of Studies Raise Concerns about Aspartame

Since aspartame was first approved in 1974, both FDA scientists and independent scientists have raised concerns about possible health effects and shortcomings in the science submitted to the FDA by the manufacturer, G.D. Searle. (Monsanto bought Searle in 1984).

In 1987, UPI published a series of investigative articles by Gregory Gordon reporting on these concerns, including early studies linking aspartame to health problems, the poor quality of industry-funded research that led to its approval, and the revolving-door relationships between FDA officials and the food industry. Gordon’s series is an invaluable resource for anyone seeking to understand the history of aspartame/NutraSweet:

Serious flaws in European Food Safety Authority safety assessment: In a July 2019 paper in the Archives of Public Health, researchers at the University of Sussex provided a detailed analysis of the EFSA’s 2013 safety assessment of aspartame and found that the panel discounted as unreliable every one of 73 studies that indicated harm, and used far more lax criteria to accept as reliable 84% of studies that found no evidence of harm. “Given the shortcomings of EFSA’s risk assessment of aspartame, and the shortcomings of all previous official toxicological risk assessments of aspartame, it would be premature to conclude that it is acceptably safe,” the study concluded. See also,

  • “‘Sales of aspartame should be suspended’: EFSA accused of bias in safety assessment,” by Katy Askew, Food Navigator (7.27.2019)

Health Effects and Key Studies on Aspartame 

While many studies, some of them industry sponsored, have reported no problems with aspartame, dozens of independent studies conducted over decades have linked aspartame to a long list of health problems, including:

Cancer

In the most comprehensive cancer research to date on aspartame, three lifespan studies conducted by the Cesare Maltoni Cancer Research Center of the Ramazzini Institute, provide consistent evidence of carcinogenicity in rodents exposed to the substance.

  • Aspartame “is a multipotential carcinogenic agent, even at a daily dose of … much less than the current acceptable daily intake,” according to a 2006 lifespan rat study in Environmental Health Perspectives.1
  • A follow-up study in 2007 found significant dose-related increases in malignant tumors in some of the rats. “The results … confirm and reinforce the first experimental demonstration of [aspartame’s] multipotential carcinogenicity at a dose level close to the acceptable daily intake for humans … when life-span exposure begins during fetal life, its carcinogenic effects are increased,” the researchers wrote in Environmental Health Perspectives.2
  • The results of a 2010 lifespan study “confirm that [aspartame] is a carcinogenic agent in multiple sites in rodents, and that this effect is induced in two species, rats (males and females) and mice (males),” the researchers reported in American Journal of Industrial Medicine.3

Harvard researchers in 2012 reported a positive association between aspartame intake and increased risk of non-Hodgkin lymphoma and multiple myeloma in men, and for leukemia in men and women. The findings “preserve the possibility of a detrimental effect … on select cancers” but “do not permit the ruling out of chance as an explanation,” the researchers wrote in the American Journal of Clinical Nutrition.4

In a 2014 commentary in American Journal of Industrial Medicine, the Maltoni Center researchers wrote that the studies submitted by G. D. Searle for market approval “do not provide adequate scientific support for [aspartame’s] safety. In contrast, recent results of life-span carcinogenicity bioassays on rats and mice published in peer-reviewed journals, and a prospective epidemiological study, provide consistent evidence of [aspartame’s] carcinogenic potential. On the basis of the evidence of the potential carcinogenic effects … a re-evaluation of the current position of international regulatory agencies must be considered an urgent matter of public health.”5

Brain Tumors

In 1996, researchers reported in the Journal of Neuropathology & Experimental Neurology on epidemiological evidence connecting the introduction of aspartame to an increase in an aggressive type of malignant brain tumors. “Compared to other environmental factors putatively linked to brain tumors, the artificial sweetener aspartame is a promising candidate to explain the recent increase in incidence and degree of malignancy of brain tumors … We conclude that there is need for reassessing the carcinogenic potential of aspartame.”6

  • Neuroscientist Dr. John Olney, lead author of the study, told 60 minutes in 1996: “there has been a striking increase in the incidence of malignant brain tumors (in the three to five years following the approval of aspartame) … there is enough basis to suspect aspartame that it needs to be reassessed. FDA needs to reassess it, and this time around, FDA should do it right.”

Early studies on aspartame in the 1970s found evidence of brain tumors in laboratory animals, but those studies were not followed up.

Cardiovascular Disease 

A 2017 meta-analysis of research on artificial sweeteners, published in the Canadian Medical Association Journal, found no clear evidence of weight loss benefits for artificial sweeteners in randomized clinical trials, and reported that cohort studies associate artificial sweeteners with “increases in weight and waist circumference, and higher incidence of obesity, hypertension, metabolic syndrome, type 2 diabetes and cardiovascular events.”7 See also:

  • “Artificial sweeteners don’t help with weight loss and may lead to gained pounds,” by Catherine Caruso, STAT (7.17.2017)
  • “Why one cardiologist has drunk his last diet soda,” by Harlan Krumholz, Wall Street Journal (9.14.2017)
  • “This cardiologist wants his family to cut back on diet soda. Should yours, too?” by David Becker, M.D., Philly Inquirer (9.12.2017)

 A 2016 paper in Physiology & Behavior reported, “there is a striking congruence between results from animal research and a number of large-scale, long-term observational studies in humans, in finding significantly increased weight gain, adiposity, incidence of obesity, cardiometabolic risk, and even total mortality among individuals with chronic, daily exposure to low-calorie sweeteners – and these results are troubling.”8

Women who consumed more than two diet drinks per day “had a higher risk of [cardiovascular disease] events … [cardiovascular disease] mortality … and overall mortality,” according to a 2014 study from the Women’s Health Initiative published in the Journal of General Internal Medicine.9

Stroke, Dementia and Alzheimer’s Disease

People drinking diet soda daily were almost three times as likely to develop stroke and dementia as those who consumed it weekly or less. This included a higher risk of ischemic stroke, where blood vessels in the brain become obstructed, and Alzheimer’s disease dementia, the most common form of dementia, reported a 2017 study in Stroke.10

In the body, the methyl ester in aspartame metabolizes into methanol and then it may be converted to formaldehyde, which has been linked to Alzheimer’s disease. A two-part study published in 2014 in the Journal of Alzheimer’s Disease linked chronic methanol exposure to memory loss and Alzheimer’s Disease symptoms in mice and monkeys.

  • “[M]ethanol-fed mice presented with partial AD-like symptoms … These findings add to a growing body of evidence that links formaldehyde to [Alzheimer’s disease] pathology.” (Part 1)11
  • “[M]ethanol feeding caused long-lasting and persistent pathological changes that were related to [Alzheimer’s disease] … these findings support a growing body of evidence that links methanol and its metabolite formaldehyde to [Alzheimer’s disease] pathology.” (Part 2)12

Seizures

“Aspartame appears to exacerbate the amount of EEG spike wave in children with absence seizures. Further studies are needed to establish if this effect occurs at lower doses and in other seizure types,” according to a 1992 study in Neurology.13

Aspartame “has seizure-promoting activity in animal models that are widely used to identify compounds affecting … seizure incidence,” according to a 1987 study in Environmental Health Perspectives.14

Very high aspartame doses “might also affect the likelihood of seizures in symptomless but susceptible people,” according to a 1985 study in The Lancet. The study describes three previously healthy adults who had grand mal seizures during periods when they were consuming high doses of aspartame.15

Neurotoxicity, Brain Damage and Mood Disorders

Aspartame has been linked to behavioral and cognitive problems including learning problems, headache, seizure, migraines, irritable moods, anxiety, depression, and insomnia, wrote the researchers of a 2017 study in Nutritional Neuroscience. “Aspartame consumption needs to be approached with caution due to the possible effects on neurobehavioral health.”16

“Oral aspartame significantly altered behavior, anti-oxidant status and morphology of the hippocampus in mice; also, it may probably trigger hippocampal adult neurogenesis,” reported a 2016 study in Neurobiology of Learning and Memory.17 

“Previously, it has been reported that consumption of aspartame could cause neurological and behavioural disturbances in sensitive individuals. Headaches, insomnia and seizures are also some of the neurological effects that have been encountered,” according to a 2008 study in the European Journal of Clinical Nutrition. “[W]e propose that excessive aspartame ingestion might be involved in the pathogenesis of certain mental disorders … and also in compromised learning and emotional functioning.”18 

“(N)eurological symptoms, including learning and memory processes, may be related to the high or toxic concentrations of the sweetener [aspartame] metabolites,” states a 2006 study in Pharmacological Research.19

Aspartame “could impair memory retention and damage hypothalamic neurons in adult mice,” according to a 2000 mice study published in Toxicology Letters.20

“(I)ndividuals with mood disorders are particularly sensitive to this artificial sweetener and its use in this population should be discouraged,” according to a 1993 study in the Journal of Biological Psychiatry.21

High doses of aspartame “can generate major neurochemical changes in rats,” reported a 1984 study in American Journal of Clinical Nutrition.22

Experiments indicated brain damage in infant mice following oral intake of aspartate, and showing that “aspartate [is] toxic to the infant mouse at relatively low levels of oral intake,” reported a 1970 study in Nature.23

Headaches and Migraines

“Aspartame, a popular dietetic sweetener, may provoke headache in some susceptible individuals. Herein, we describe three cases of young women with migraine who reported their headaches could be provoked by chewing sugarless gum containing aspartame,” according to a 1997 paper in Headache Journal.24

A crossover trial comparing aspartame and a placebo published in 1994 in Neurology, “provides evidence that, among individuals with self-reported headaches after ingestion of aspartame, a subset of this group report more headaches when tested under controlled conditions. It appears that some people are particularly susceptible to headaches caused by aspartame and may want to limit their consumption.”25

A survey of 171 patients at the Montefiore Medical Center Headache Unit found that patients with migraine “reported aspartame as a precipitant three times more often than those having other types of headache … We conclude aspartame may be an important dietary trigger of headache in some people,” 1989 study in Headache Journal.26

A crossover trial comparing aspartame and a placebo on the frequency and intensity of migraines “indicated that the ingestion of aspartame by migraineurs caused a significant increase in headache frequency for some subjects,” reported a 1988 study in Headache Journal.27

Kidney Function Decline

Consumption of more than two servings a day of artificially sweetened soda “is associated with a 2-fold increased odds for kidney function decline in women,” according to a 2011 study in the Clinical Journal of American Society of Nephrology.28

Weight Gain, Increased Appetite and Obesity Related Problems

Several studies link aspartame to weight gain, increased appetite, diabetes, metabolic derangement and obesity-related diseases. See our fact sheet: Diet Soda Chemical Tied to Weight Gain.

This science linking aspartame to weight gain and obesity-related diseases raises questions about the legality of marketing aspartame-containing products as “diet” or weight loss aids. In 2015, USRTK petitioned the Federal Trade Commission and FDA to investigate the marketing and advertising practices of “diet” products that contain a chemical linked to weight gain. See related news coverage, response from FTC, and response from FDA.

Diabetes and Metabolic Derangement

Aspartame breaks down in part into phenylalanine, which interferes with the action of an enzyme intestinal alkaline phosphatase (IAP) previously shown to prevent metabolic syndrome (a group of symptoms associated with type 2 diabetes and cardiovascular disease) according to a 2017 study in Applied Physiology, Nutrition and Metabolism. In this study, mice receiving aspartame in their drinking water gained more weight and developed other symptoms of metabolic syndrome than animals fed similar diets lacking aspartame. The study concludes, “IAP’s protective effects in regard to the metabolic syndrome may be inhibited by phenylalanine, a metabolite of aspartame, perhaps explaining the lack of expected weight loss and metabolic improvements associated with diet drinks.”29

People who regularly consume artificial sweeteners are at increased risk of “excessive weight gain, metabolic syndrome, type 2 diabetes, and cardiovascular disease,” according to a 2013 Purdue review over 40 years published in Trends in Endocrinology & Metabolism.30

In a study that followed 66,118 women over 14 years, both sugar-sweetened beverages and artificially sweetened beverages were associated with risk of Type 2 diabetes. “Strong positive trends in T2D risk were also observed across quartiles of consumption for both types of beverage … No association was observed for 100% fruit juice consumption,” reported the 2013 study published in American Journal of Clinical Nutrition.31

Intestinal Dysbiosis, Metabolic Derangement and Obesity

Artificial sweeteners can induce glucose intolerance by altering the gut microbiota, according to a 2014 study in Nature. The researchers wrote, “our results link NAS [non-caloric artificial sweetener] consumption, dysbiosis and metabolic abnormalities, thereby calling for a reassessment of massive NAS usage … Our findings suggest that NAS may have directly contributed to enhancing the exact epidemic [obesity] that they themselves were intended to fight.”32

A 2016 study in Applied Physiology Nutrition and Metabolism reported, “Aspartame intake significantly influenced the association between body mass index (BMI) and glucose tolerance… consumption of aspartame is associated with greater obesity-related impairments in glucose tolerance.”33

According to a 2014 rat study in PLOS ONE, “aspartame elevated fasting glucose levels and an insulin tolerance test showed aspartame to impair insulin-stimulated glucose disposal … Fecal analysis of gut bacterial composition showed aspartame to increase total bacteria…”34

 Pregnancy Abnormalities: Pre Term Birth 

According to a 2010 cohort study of 59,334 Danish pregnant women published in the American Journal of Clinical Nutrition, “There was an association between intake of artificially sweetened carbonated and noncarbonated soft drinks and an increased risk of preterm delivery.” The study concluded, “Daily intake of artificially sweetened soft drinks may increase the risk of preterm delivery.”35

  • See also: “Downing Diet Soda Tied to Premature Birth,” by Anne Harding, Reuters (7.23.2010)

Overweight Babies

Artificially sweetened beverage consumption during pregnancy is linked to higher body mass index for babies, according to a 2016 study in JAMA Pediatrics. “To our knowledge, we provide the first human evidence that maternal consumption of artificial sweeteners during pregnancy may influence infant BMI,” the researchers wrote.36

Early Menarche

The National Heart, Lung, and Blood Institute Growth and Health Study followed 1988 girls for 10 years to examine prospective associations between consumption of caffeinated and noncaffeinated sugar- and artificially sweetened soft drinks and early menarche. “Consumption of caffeinated and artificially sweetened soft drinks was positively associated with risk of early menarche in a US cohort of African American and Caucasian girls,” concluded the study published in 2015 in Journal of American Clinical Nutrition.37

Sperm Damage

“A significant decrease in sperm function of aspartame treated animals was observed when compared with the control and MTX control,” according to a 2017 study in the International Journal of Impotence Research. “… These findings demonstrate that aspartame metabolites could be a contributing factor for development of oxidative stress in the epididymal sperm.”38

Liver Damage and Glutathione Depletion

A mouse study published in 2017 in Redox Biology reported, “Chronic administration of aspartame … caused liver injury as well as marked decreased hepatic levels of reduced glutathione, oxidized glutathione, γ-glutamylcysteine, and most metabolites of the trans-sulphuration pathway…”39

A rat study published in 2017 in Nutrition Research found that, “Subchronic intake of soft drink or aspartame substantially induced hyperglycemia and hypertriacylglycerolemia… Several cytoarchitecture alterations were detected in the liver, including degeneration, infiltration, necrosis, and fibrosis, predominantly with aspartame. These data suggest that long-term intake of soft drink or aspartame-induced hepatic damage may be mediated by the induction of hyperglycemia, lipid accumulation, and oxidative stress with the involvement of adipocytokines.”40

Caution for Vulnerable Populations

A 2016 literature review on artificial sweeteners in the Indian Journal of Pharmacology reported, “there is inconclusive evidence to support most of their uses and some recent studies even hint that these earlier established benefits … might not be true.” Susceptible populations such as pregnant and lactating women, children, diabetics, migraine, and epilepsy patients “should use these products with utmost caution.”41

Industry PR Efforts and Front Groups 

From the start, G.D. Searle (later Monsanto and the NutraSweet Company) deployed aggressive PR tactics to market aspartame as a safe product. In October 1987, Gregory Gordon reported in UPI:

“The NutraSweet Co. also has paid up to $3 million a year for a 100-person public relations effort by the Chicago offices of Burson Marsteller, a former employee of the New York PR firm said. The employee said Burson Marsteller has hired numerous scientists and physicians, often at $1,000 a day, to defend the sweetener in media interviews and other public forums. Burson Marsteller declines to discuss such matters.”

Recent reporting based on internal industry documents reveals how beverage companies such as Coca-Cola also pay third party messengers, including doctors and scientists, to promote their products and shift the blame when science ties their products to serious health problems.

See reporting by Anahad O’Connor in the New York Times, Candice Choi in the Associated Press, and findings from the USRTK investigation about sugar industry propaganda and lobbying campaigns.

News articles about soda industry PR campaigns:

Overview news stories about aspartame:

USRTK Fact Sheets

Reports on Front Groups and PR Campaigns

Scientific References

[1] Soffritti M, Belpoggi F, Degli Esposti D, Lambertini L, Tibaldi E, Rigano A. “First experimental demonstration of the multipotential carcinogenic effects of aspartame administered in the feed to Sprague-Dawley rats.” Environ Health Perspect. 2006 Mar;114(3):379-85. PMID: 16507461. (article)

[2] Soffritti M, Belpoggi F, Tibaldi E, Esposti DD, Lauriola M. “Life-span exposure to low doses of aspartame beginning during prenatal life increases cancer effects in rats.” Environ Health Perspect. 2007 Sep;115(9):1293-7. PMID: 17805418. (article)

[3] Soffritti M et al. “Aspartame administered in feed, beginning prenatally through life span, induces cancers of the liver and lung in male Swiss mice.” Am J Ind Med. 2010 Dec; 53(12):1197-206. PMID: 20886530. (abstract / article)

[4] Schernhammer ES, Bertrand KA, Birmann BM, Sampson L, Willett WC, Feskanich D., “Consumption of artificial sweetener– and sugar-containing soda and risk of lymphoma and leukemia in men and women.” Am J Clin Nutr. 2012 Dec;96(6):1419-28. PMID: 23097267. (abstract / article)

[5] Soffritti M1, Padovani M, Tibaldi E, Falcioni L, Manservisi F, Belpoggi F., “The carcinogenic effects of aspartame: The urgent need for regulatory re-evaluation.” Am J Ind Med. 2014 Apr;57(4):383-97. doi: 10.1002/ajim.22296. Epub 2014 Jan 16. (abstract / article)

[6] Olney JW, Farber NB, Spitznagel E, Robins LN. “Increasing brain tumor rates: is there a link to aspartame?” J Neuropathol Exp Neurol. 1996 Nov;55(11):1115-23. PMID: 8939194. (abstract)

[7] Azad, Meghan B., et al. Nonnutritive sweeteners and cardiometabolic health: a systematic review and meta-analysis of randomized controlled trials and prospective cohort studies. CMAJ July 17, 2017 vol. 189 no. 28 doi: 10.1503/cmaj.161390 (abstract / article)

[8] Fowler SP. Low-calorie sweetener use and energy balance: Results from experimental studies in animals, and large-scale prospective studies in humans. Physiol Behav. 2016 Oct 1;164(Pt B):517-23. doi: 10.1016/j.physbeh.2016.04.047. Epub 2016 Apr 26. (abstract)

[9] Vyas A et al. “Diet Drink Consumption And The Risk of Cardiovascular Events: A Report from The Women’s Health Initiative.” J Gen Intern Med. 2015 Apr;30(4):462-8. doi: 10.1007/s11606-014-3098-0. Epub 2014 Dec 17. (abstract / article)

[10] Matthew P. Pase, PhD; Jayandra J. Himali, PhD; Alexa S. Beiser, PhD; Hugo J. Aparicio, MD; Claudia L. Satizabal, PhD; Ramachandran S. Vasan, MD; Sudha Seshadri, MD; Paul F. Jacques, DSc. “Sugar and Artificially Sweetened Beverages and the Risks of Incident Stroke and Dementia. A Prospective Cohort Study.” Stroke. 2017 April; STROKEAHA.116.016027 (abstract / article)

[11] Yang M et al. “Alzheimer’s Disease and Methanol Toxicity (Part 1): Chronic Methanol Feeding Led to Memory Impairments and Tau Hyperphosphorylation in Mice.” J Alzheimers Dis. 2014 Apr 30. (abstract)

[12] Yang M et al. “Alzheimer’s Disease and Methanol Toxicity (Part 2): Lessons from Four Rhesus Macaques (Macaca mulatta) Chronically Fed Methanol.” J Alzheimers Dis. 2014 Apr 30. (abstract)

[13] Camfield PR, Camfield CS, Dooley JM, Gordon K, Jollymore S, Weaver DF. “Aspartame exacerbates EEG spike-wave discharge in children with generalized absence epilepsy: a double-blind controlled study.” Neurology. 1992 May;42(5):1000-3. PMID: 1579221. (abstract)

[14] Maher TJ, Wurtman RJ. “Possible neurologic effects of aspartame, a widely used food additive.” Environ Health Perspect. 1987 Nov; 75:53-7. PMID: 3319565. (abstract / article)

[15] Wurtman RJ. “Aspartame: possible effect on seizure susceptibility.” Lancet. 1985 Nov 9;2(8463):1060. PMID: 2865529. (abstract)

[16] Choudhary AK, Lee YY. “Neurophysiological symptoms and aspartame: What is the connection?” Nutr Neurosci. 2017 Feb 15:1-11. doi: 10.1080/1028415X.2017.1288340. (abstract)

[17] Onaolapo AY, Onaolapo OJ, Nwoha PU. “Aspartame and the hippocampus: Revealing a bi-directional, dose/time-dependent behavioural and morphological shift in mice.” Neurobiol Learn Mem. 2017 Mar;139:76-88. doi: 10.1016/j.nlm.2016.12.021. Epub 2016 Dec 31. (abstract)

[18] Humphries P, Pretorius E, Naudé H. “Direct and indirect cellular effects of aspartame on the brain.” Eur J Clin Nutr. 2008 Apr;62(4):451-62. (abstract / article)

[19] Tsakiris S, Giannoulia-Karantana A, Simintzi I, Schulpis KH. “The effect of aspartame metabolites on human erythrocyte membrane acetylcholinesterase activity.” Pharmacol Res. 2006 Jan;53(1):1-5. PMID: 16129618. (abstract)

[20] Park CH et al. “Glutamate and aspartate impair memory retention and damage hypothalamic neurons in adult mice.” Toxicol Lett. 2000 May 19;115(2):117-25. PMID: 10802387. (abstract)

[21] Walton RG, Hudak R, Green-Waite R. “Adverse reactions to aspartame: double-blind challenge in patients from a vulnerable population.” J. Biol Psychiatry. 1993 Jul 1-15;34(1-2):13-7. PMID: 8373935. (abstract / article)

[22] Yokogoshi H, Roberts CH, Caballero B, Wurtman RJ. “Effects of aspartame and glucose administration on brain and plasma levels of large neutral amino acids and brain 5-hydroxyindoles.” Am J Clin Nutr. 1984 Jul;40(1):1-7. PMID: 6204522. (abstract)

[23] Olney JW, Ho OL. “Brain Damage in Infant Mice Following Oral Intake of Glutamate, Aspartate or Cysteine.” Nature. 1970 Aug 8;227(5258):609-11. PMID: 5464249. (abstract)

[24] Blumenthal HJ, Vance DA. “Chewing gum headaches.” Headache. 1997 Nov-Dec; 37(10):665-6. PMID: 9439090. (abstract/article)

[25] Van den Eeden SK, Koepsell TD, Longstreth WT Jr, van Belle G, Daling JR, McKnight B. “Aspartame ingestion and headaches: a randomized crossover trial.” Neurology. 1994 Oct;44(10):1787-93. PMID: 7936222. (abstract)

[26] Lipton RB, Newman LC, Cohen JS, Solomon S. “Aspartame as a dietary trigger of headache.” Headache. 1989 Feb;29(2):90-2. PMID: 2708042. (abstract)

[27] Koehler SM, Glaros A. “The effect of aspartame on migraine headache.” Headache. 1988 Feb;28(1):10-4. PMID: 3277925. (abstract)

[28] Julie Lin and Gary C. Curhan. “Associations of Sugar and Artificially Sweetened Soda with Albuminuria and Kidney Function Decline in Women.” Clin J Am Soc Nephrol. 2011 Jan; 6(1): 160–166. (abstract / article)

[29] Gul SS, Hamilton AR, Munoz AR, Phupitakphol T, Liu W, Hyoju SK, Economopoulos KP, Morrison S, Hu D, Zhang W, Gharedaghi MH, Huo H, Hamarneh SR, Hodin RA. “Inhibition of the gut enzyme intestinal alkaline phosphatase may explain how aspartame promotes glucose intolerance and obesity in mice.” Appl Physiol Nutr Metab. 2017 Jan;42(1):77-83. doi: 10.1139/apnm-2016-0346. Epub 2016 Nov 18. (abstract / article)

[30] Susan E. Swithers, “Artificial sweeteners produce the counterintuitive effect of inducing metabolic derangements.” Trends Endocrinol Metab. 2013 Sep; 24(9): 431–441. (article)

[31] Guy Fagherazzi, A Vilier, D Saes Sartorelli, M Lajous, B Balkau, F Clavel-Chapelon. “Consumption of artificially and sugar-sweetened beverages and incident type 2 diabetes in the Etude Epidémiologique auprès des femmes de la Mutuelle Générale de l’Education Nationale–European Prospective Investigation into Cancer and Nutrition cohort.” Am J Clin Nutr. 2013, Jan 30; doi: 10.3945/ ajcn.112.050997 ajcn.050997. (abstract/article)

[32] Suez J et al. “Artificial sweeteners induce glucose intolerance by altering the gut microbiota.” Nature. 2014 Oct 9;514(7521). PMID: 25231862. (abstract / article)

[33] Kuk JL, Brown RE. “Aspartame intake is associated with greater glucose intolerance in individuals with obesity.” Appl Physiol Nutr Metab. 2016 Jul;41(7):795-8. doi: 10.1139/apnm-2015-0675. Epub 2016 May 24. (abstract)

[34] Palmnäs MSA, Cowan TE, Bomhof MR, Su J, Reimer RA, Vogel HJ, et al. (2014) Low-Dose Aspartame Consumption Differentially Affects Gut Microbiota-Host Metabolic Interactions in the Diet-Induced Obese Rat. PLoS ONE 9(10): e109841. (article)

[35] Halldorsson TI, Strøm M, Petersen SB, Olsen SF. “Intake of artificially sweetened soft drinks and risk of preterm delivery: a prospective cohort study in 59,334 Danish pregnant women.” Am J Clin Nutr. 2010 Sep;92(3):626-33. PMID: 20592133. (abstract / article)

[36] Meghan B. Azad, PhD; Atul K. Sharma, MSc, MD; Russell J. de Souza, RD, ScD; et al. “Association Between Artificially Sweetened Beverage Consumption During Pregnancy and Infant Body Mass Index.” JAMA Pediatr. 2016;170(7):662-670. (abstract)

[37] Mueller NT, Jacobs DR Jr, MacLehose RF, Demerath EW, Kelly SP, Dreyfus JG, Pereira MA. “Consumption of caffeinated and artificially sweetened soft drinks is associated with risk of early menarche.” Am J Clin Nutr. 2015 Sep;102(3):648-54. doi: 10.3945/ajcn.114.100958. Epub 2015 Jul 15. (abstract)

[38] Ashok I, Poornima PS, Wankhar D, Ravindran R, Sheeladevi R. “Oxidative stress evoked damages on rat sperm and attenuated antioxidant status on consumption of aspartame.” Int J Impot Res. 2017 Apr 27. doi: 10.1038/ijir.2017.17. (abstract / article)

[39] Finamor I, Pérez S, Bressan CA, Brenner CE, Rius-Pérez S, Brittes PC, Cheiran G, Rocha MI, da Veiga M, Sastre J, Pavanato MA., “Chronic aspartame intake causes changes in the trans-sulphuration pathway, glutathione depletion and liver damage in mice.” Redox Biol. 2017 Apr;11:701-707. doi: 10.1016/j.redox.2017.01.019. Epub 2017 Feb 1. (abstract/article)

[40] Lebda MA, Tohamy HG, El-Sayed YS. “Long-term soft drink and aspartame intake induces hepatic damage via dysregulation of adipocytokines and alteration of the lipid profile and antioxidant status.” Nutr Res. 2017 Apr 19. pii: S0271-5317(17)30096-9. doi: 10.1016/j.nutres.2017.04.002. [Epub ahead of print] (abstract)

[41] Sharma A, Amarnath S, Thulasimani M, Ramaswamy S. “Artificial sweeteners as a sugar substitute: Are they really safe?” Indian J Pharmacol 2016;48:237-40 (article)

Aspartame is Tied to Weight Gain, Increased Appetite and Obesity

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Science on Weight Gain + Obesity Related Issues
Industry Science
Is “Diet” Deceptive Marketing?
Scientific References

Aspartame, the world’s most popular sugar substitute, is found in thousands of sugar-free, low-sugar and so-called “diet” drinks and foods. Yet the scientific evidence described in this fact sheet links aspartame to weight gain, increased appetite, diabetes, metabolic derangement and obesity-related diseases.

Please share this resource. See also our companion fact sheet, Aspartame: Decades of Science Point to Serious Health Risks, with information about the peer-reviewed studies linking aspartame to cancer, cardiovascular disease, Alzheimer’s disease, strokes, seizures, shortened pregnancies and headaches.

Quick Facts

  • Aspartame — also marketed as NutraSweet, Equal, Sugar Twin and AminoSweet — is the world’s most widely used artificial sweetener. The chemical is found in thousands of food and beverage products, including Diet Coke and Diet Pepsi, sugar-free gum, candy, condiments and vitamins.
  • The FDA has said aspartame is “safe for the general population under certain conditions.” Many scientists have said the FDA approval was based on suspect data and should be reconsidered.
  • Dozens of studies conducted over decades link aspartame to serious health problems.

Aspartame, Weight Gain + Obesity Related Issues 

Five reviews of the scientific literature on artificial sweeteners suggest that they do not contribute to weight loss, and instead may cause weight gain.

  • A 2017 meta analysis of research on artificial sweeteners, published in the Canadian Medical Association Journal, found no clear evidence of weight loss benefits for artificial sweeteners in randomized clinical trials, and reported that cohort studies associate artificial sweeteners with “increases in weight and waist circumference, and higher incidence of obesity, hypertension, metabolic syndrome, type 2 diabetes and cardiovascular events.”See also
    • “Artificial sweeteners don’t help with weight loss and may lead to gained pounds,” by Catherine Caruso, STAT (7.17.2017)
    • “Why one cardiologist has drunk his last diet soda,” by Harlan Krumholz, Wall Street Journal (9.14.2017)
    • “This cardiologist wants his family to cut back on diet soda. Should yours, too?” by David Becker, M.D., Philly Inquirer (9.12.2017)
  • A 2013 Trends in Endocrinology and Metabolism review article finds “accumulating evidence suggests that frequent consumers of these sugar substitutes may also be at increased risk of excessive weight gain, metabolic syndrome, type 2 diabetes, and cardiovascular disease,” and that “frequent consumption of high-intensity sweeteners may have the counterintuitive effect of inducing metabolic derangements.”2
  • A 2009 American Journal of Clinical Nutrition review article finds that the “addition of NNS [nonnutritive sweeteners] to diets poses no benefit for weight loss or reduced weight gain without energy restriction. There are long-standing and recent concerns that inclusion of NNS in the diet promotes energy intake and contributes to obesity.”3
  • A 2010 Yale Journal of Biology and Medicine review of the literature on artificial sweeteners concludes that, “research studies suggest that artificial sweeteners may contribute to weight gain.”4
  • A 2010 International Journal of Pediatric Obesity review article states, “Data from large, epidemiologic studies support the existence of an association between artificially-sweetened beverage consumption and weight gain in children.”5

Epidemiological evidence suggests that artificial sweeteners are implicated in weight gain. For example:

  • The San Antonio Heart Study “observed a classic, positive dose-response relationship between AS [artificially sweetened] beverage consumption and long-term weight gain.” Furthermore, it found that consuming more than 21 artificially sweetened beverages per week – compared to those who consumed none, “was associated with almost-doubled risk” of overweight or obesity.”6
  • A study of beverage consumption among children and adolescents aged 6-19 published in International Journal of Food Sciences and Nutrition found that “BMI is positively associated with consumption of diet carbonated beverages.”7
  • A two-year study in of 164 children published in the Journal of the American College of Nutrition found that “Increases in diet soda consumption were significantly greater for overweight and subjects who gained weight as compared to normal weight subjects. Baseline BMI Z-score and year 2 diet soda consumption predicted 83.1% of the variance in year 2 BMI Z-score.” It also found that “Diet soda consumption was the only type of beverage associated with year 2 BMI Z-score, and consumption was greater in overweight subjects and subjects who gained weight as compared to normal weight subjects at two years.”8
  • The U.S. Growing Up Today study of more than 10,000 children aged 9-14 found that, for boys, intakes of diet soda “were significantly associated with weight gains.”9
  • A 2016 study in the International Journal of Obesity reported finding seven tentatively replicated factors showing significant associations with abdominal obesity in women, including aspartame intake.10
  • People who regularly consume artificial sweeteners are at increased risk of “excessive weight gain, metabolic syndrome, type 2 diabetes, and cardiovascular disease,”11 according to a 2013 Purdue review over 40 years published in Trends in Endocrinology & Metabolism

Other types of studies similarly suggest that artificial sweeteners do not contribute to weight loss. For example, interventional studies do not support the notion that artificial sweeteners produce weight loss. According to the Yale Journal of Biology and Medicine review of the scientific literature, “consensus from interventional studies suggests that artificial sweeteners do not help reduce weight when used alone.”12

Some studies also suggest that artificial sweeteners increase appetite, which may promote weight gain. For example, the Yale Journal of Biology and Medicine review found that “Preload experiments generally have found that sweet taste, whether delivered by sugar or artificial sweeteners, enhanced human appetite.”13

Studies based on rodents suggest that consumption of artificial sweeteners can lead to consuming extra food. According to the Yale Journal of Biology and Medicine review, “ Inconsistent coupling between sweet taste and caloric content can lead to compensatory overeating and positive energy balance.” In addition, according to the same article, “artificial sweeteners, precisely because they are sweet, encourage sugar craving and sugar dependence.”14

A 2014 study in the American Journal of Public Health found that “Overweight and obese adults in the United States drink more diet beverages than healthy-weight adults, consume significantly more calories from solid food—at both meals and snacks—than overweight and obese adults who drink SSBs [sugar-sweetened beverages], and consume a comparable amount of total calories as overweight and obese adults who drink SSBs.”15

A 2015 study of older adults in the Journal of the American Geriatrics Society found “In a striking dose-response relationship,” that “increasing DSI [diet soda intake] was associated with escalating abdominal obesity…”16

An important 2014 study published in Nature found that “consumption of commonly used NAS [non-caloric artificial sweetener] formulations drives the development of glucose intolerance through induction of compositional and functional alterations to the intestinal microbiota … our results link NAS consumption, dysbiosis and metabolic abnormalities … Our findings suggest that NAS may have directly contributed to enhancing the exact epidemic that they themselves were intended to fight.”17

Diabetes and Metabolic Derangement

Aspartame breaks down in part into phenylalanine, which interferes with the action of an enzyme intestinal alkaline phosphatase (IAP) previously shown to prevent metabolic syndrome, which is a group of symptoms associated with type 2 diabetes and cardiovascular disease. According to a 2017 study in Applied Physiology, Nutrition and Metabolism, mice receiving aspartame in their drinking water gained more weight and developed other symptoms of metabolic syndrome than animals fed similar diets lacking aspartame. The study concludes, “IAP’s protective effects in regard to the metabolic syndrome may be inhibited by phenylalanine, a metabolite of aspartame, perhaps explaining the lack of expected weight loss and metabolic improvements associated with diet drinks.”18

  • See also: Mass General press release on the study, “Aspartame may prevent, not promote, weight loss by blocking intestinal enzyme’s activity”

People who regularly consume artificial sweeteners are at increased risk of “excessive weight gain, metabolic syndrome, type 2 diabetes, and cardiovascular disease,” according to a 2013 Purdue review over 40 years published in Trends in Endocrinology & Metabolism.19

In a study that followed 66,118 women over 14 years, both sugar sweetened beverages and artificially sweetened beverages were associated with risk of Type 2 diabetes. “Strong positive trends in T2D risk were also observed across quartiles of consumption for both types of beverage … No association was observed for 100% fruit juice consumption,” reported the 2013 study published in American Journal of Clinical Nutrition.20

Intestinal Dysbiosis, Metabolic Derangement and Obesity

Artificial sweeteners can induce glucose intolerance by altering the gut microbiota, according to a 2014 study in Nature. The researchers wrote, “our results link NAS [non-caloric artificial sweetener] consumption, dysbiosis and metabolic abnormalities, thereby calling for a reassessment of massive NAS usage … Our findings suggest that NAS may have directly contributed to enhancing the exact epidemic [obesity] that they themselves were intended to fight.”21

A 2016 study in Applied Physiology Nutrition and Metabolism reported, “Aspartame intake significantly influenced the association between body mass index (BMI) and glucose tolerance… consumption of aspartame is associated with greater obesity-related impairments in glucose tolerance.”22

According to a 2014 rat study in PLoS ONE, “aspartame elevated fasting glucose levels and an insulin tolerance test showed aspartame to impair insulin-stimulated glucose disposal … Fecal analysis of gut bacterial composition showed aspartame to increase total bacteria…”23

Industry Science

Not all recent studies find a link between artificial sweeteners and weight gain. Two industry-funded studies did not.

  • A 2014 American Journal of Clinical Nutrition meta-analysis concluded that “Findings from observational studies showed no association between LCS [low-calorie sweetener] intake and body weight or fat mass and a small positive association with BMI [body mass index]; however, data from RCTs [randomized controlled trials], which provide the highest quality of evidence for examining the potentially causal effects of LCS intake, indicate that substituting LCS options for their regular-calorie versions results in a modest weight loss and may be a useful dietary tool to improve compliance with weight loss or weight maintenance plans.” The authors “received funding to conduct this research from the North American Branch of the International Life Sciences Institute (ILSI).”24

The International Life Sciences Institute, a nonprofit that produces science for the food industry, is controversial among public health experts due to its funding from chemical, food and pharmaceutical companies and potential conflicts of interest, according to a 2010 article in Nature.25 See also: U.S. Right to Know fact sheet about the International Life Sciences Institute.

A series of stories published in UPI in 1987 by investigative reporter Greg Gordon describe ILSI’s involvement in directing research on aspartame toward studies likely to support the sweetener’s safety.

  • A 2014 study in the journal Obesity tested water against artificially sweetened beverages for a 12-week weight loss program, finding that “water is not superior to NNS [non-nutritive sweetened] beverages for weight loss during a comprehensive behavioral weight loss program.” The study was “fully funded by the American Beverage Association,”26 which is the main lobbying group for the soda industry.

There is strong evidence that industry-funded studies in biomedical research are less trustworthy than those funded independently. A 2016 study in PLOS One by Daniele Mandrioli, Cristin Kearns and Lisa Bero examined the relationship between research outcomes and risk of bias, study sponsorship and author financial conflicts of interest in reviews of the effects of artificially sweetened beverages on weight outcomes.27 The researchers concluded, “Artificial sweetener industry sponsored reviews were more likely to have favorable results than non-industry sponsored reviews … as well as favorable conclusions.” Financial conflicts of interest were not disclosed in 42% of the reviews, and reviews performed by authors with financial conflicts of interest with the food industry (whether disclosed or not) were more likely to have favorable conclusions for the industry than reviews performed by authors without financial conflicts of interest. 

A 2007 PLOS Medicine study on industry support for biomedical research found that “Industry funding of nutrition-related scientific articles may bias conclusions in favor of sponsors’ products, with potentially significant implications for public health … scientific articles about commonly consumed beverages funded entirely by industry were approximately four to eight times more likely to be favorable to the financial interests of the sponsors than articles without industry-related funding. Of particular interest, none of the interventional studies with all industry support had an unfavorable conclusion…”28

Is “Diet” Deceptive Marketing?

In April 2015, US Right to Know petitioned the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) to investigate the marketing and advertising practices of “diet” products that contain a chemical linked to weight gain.

We argued that the term “diet” appears to be deceptive, false and misleading in violation of section 5 of the Federal Trade Commission Act and section 403 of the Federal Food, Drug and Cosmetic Act. The agencies have so far declined to act citing lack of resources and other priorities (see FDA and FTC responses).

“It’s regrettable that the FTC won’t act to halt the deceptions of the ‘diet’ soda industry. Ample scientific evidence links artificial sweeteners to weight gain, not weight loss,” said Gary Ruskin, co-director of U.S. Right to Know. “I do believe that ‘diet’ soda will go down in U.S. history as one of the greatest consumer frauds ever.”

News coverage:

USRTK press releases and posts:

Scientific References 

[1] Azad, Meghan B., et al. Nonnutritive sweeteners and cardiometabolic health: a systematic review and meta-analysis of randomized controlled trials and prospective cohort studies. CMAJ July 17, 2017 vol. 189 no. 28 doi: 10.1503/cmaj.161390 (abstract / article)

[2] Swithers SE, “Artificial Sweeteners Produce the Counterintuitive Effect of Inducing Metabolic Derangements.” Trends in Endocrinology and Metabolism, July 10, 2013. 2013 Sep;24(9):431-41. PMID: 23850261. (abstract / article)

[3] Mattes RD, Popkin BM, “Nonnutritive Sweetener Consumption in Humans: Effects on Appetite and Food Intake and Their Putative Mechanisms.” American Journal of Clinical Nutrition, December 3, 2008. 2009 Jan;89(1):1-14. PMID: 19056571. (article)

[4] Yang Q, “Gain Weight by ‘Going Diet?’ Artificial Sweeteners and the Neurobiology of Sugar Cravings.” Yale Journal of Biology and Medicine, 2010 Jun;83(2):101-8. PMID: 20589192. (article)

[5] Brown RJ, de Banate MA, Rother KI, “Artificial Sweeteners: a Systematic Review of Metabolic Effects in Youth.” International Journal of Pediatric Obesity, 2010 Aug;5(4):305-12. PMID: 20078374. (abstract / article)

[6] Fowler SP, Williams K, Resendez RG, Hunt KJ, Hazuda HP, Stern MP. “Fueling the Obesity Epidemic? Artificially Sweetened Beverage Use and Long-Term Weight Gain.” Obesity, 2008 Aug;16(8):1894-900. PMID: 18535548. (abstract / article)

[7] Forshee RA, Storey ML, “Total Beverage Consumption and Beverage Choices Among Children and Adolescents.” International Journal of Food Sciences and Nutrition. 2003 Jul;54(4):297-307. PMID: 12850891. (abstract)

[8] Blum JW, Jacobsen DJ, Donnelly JE, “Beverage Consumption Patterns in Elementary School Aged Children Across a Two-Year Period.” Journal of the American College of Nutrition, 2005 Apr;24(2):93- 8. PMID: 15798075. (abstract)

[9] Berkey CS, Rockett HR, Field AE, Gillman MW, Colditz GA. “Sugar-Added Beverages and Adolescent Weight Change.”Obes Res. 2004 May;12(5):778-88. PMID: 15166298. (abstract / article)

[10] W Wulaningsih, M Van Hemelrijck, K K Tsilidis, I Tzoulaki, C Patel and S Rohrmann. “Investigating nutrition and lifestyle factors as determinants of abdominal obesity: an environment-wide study.” International Journal of Obesity (2017) 41, 340–347; doi:10.1038/ijo.2016.203; published online 6 December 2016 (abstract / article)

[11] Susan E. Swithers, “Artificial sweeteners produce the counterintuitive effect of inducing metabolic derangements.” Trends Endocrinol Metab. 2013 Sep; 24(9): 431–441.

[12] Yang Q, “Gain Weight by ‘Going Diet?’ Artificial Sweeteners and the Neurobiology of Sugar Cravings.” Yale Journal of Biology and Medicine, 2010 Jun;83(2):101-8. PMID: 20589192. (article)

[13] Yang Q, “Gain Weight by ‘Going Diet?’ Artificial Sweeteners and the Neurobiology of Sugar Cravings.” Yale Journal of Biology and Medicine, 2010 Jun;83(2):101-8. PMID: 20589192. (article)

[14] Yang Q, “Gain Weight by ‘Going Diet?’ Artificial Sweeteners and the Neurobiology of Sugar Cravings.” Yale Journal of Biology and Medicine, 2010 Jun;83(2):101-8. PMID: 20589192. (article)

[15] Bleich SN, Wolfson JA, Vine S, Wang YC, “Diet-Beverage Consumption and Caloric Intake Among US Adults, Overall and by Body Weight.” American Journal of Public Health, January 16, 2014. 2014 Mar;104(3):e72-8. PMID: 24432876. (abstract / article)

[16] Fowler S, Williams K, Hazuda H, “Diet Soda Intake Is Associated with Long-Term Increases in Waist Circumference in a Biethnic Cohort of Older Adults: The San Antonio Longitudinal Study of Aging.” Journal of the American Geriatrics Society, March 17, 2015. (abstract / article)

[17] Suez J. et al., “Artificial Sweeteners Induce Glucose Intolerance by Altering the Gut Microbiota.” Nature, September 17, 2014. 2014 Oct 9;514(7521):181-6. PMID: 25231862 (abstract)

[18] Gul SS, Hamilton AR, Munoz AR, Phupitakphol T, Liu W, Hyoju SK, Economopoulos KP, Morrison S, Hu D, Zhang W, Gharedaghi MH, Huo H, Hamarneh SR, Hodin RA. “Inhibition of the gut enzyme intestinal alkaline phosphatase may explain how aspartame promotes glucose intolerance and obesity in mice.” Appl Physiol Nutr Metab. 2017 Jan;42(1):77-83. doi: 10.1139/apnm-2016-0346. Epub 2016 Nov 18. (abstract / article)

[19] Susan E. Swithers, “Artificial sweeteners produce the counterintuitive effect of inducing metabolic derangements.” Trends Endocrinol Metab. 2013 Sep; 24(9): 431–441. (article)

[20] Guy Fagherazzi, A Vilier, D Saes Sartorelli, M Lajous, B Balkau, F Clavel-Chapelon. “Consumption of artificially and sugar-sweetened beverages and incident type 2 diabetes in the Etude Epidémiologique auprès des femmes de la Mutuelle Générale de l’Education Nationale–European Prospective Investigation into Cancer and Nutrition cohort.” Am J Clin Nutr. 2013, Jan 30; doi: 10.3945/ ajcn.112.050997 ajcn.050997. (abstract/article)

[21] Suez J et al. “Artificial sweeteners induce glucose intolerance by altering the gut microbiota.” Nature. 2014 Oct 9;514(7521). PMID: 25231862. (abstract / article)

[22] Kuk JL, Brown RE. “Aspartame intake is associated with greater glucose intolerance in individuals with obesity.” Appl Physiol Nutr Metab. 2016 Jul;41(7):795-8. doi: 10.1139/apnm-2015-0675. Epub 2016 May 24. (abstract)

[23] Palmnäs MSA, Cowan TE, Bomhof MR, Su J, Reimer RA, Vogel HJ, et al. (2014) Low-Dose Aspartame Consumption Differentially Affects Gut Microbiota-Host Metabolic Interactions in the Diet-Induced Obese Rat. PLoS ONE 9(10): e109841. (article)

[24] Miller PE, Perez V, “Low-Calorie Sweeteners and Body Weight and Composition: a Meta-Analysis of Randomized Controlled Trials and Prospective Cohort Studies.” American Journal of Clinical Nutrition, June 18, 2014. 2014 Sep;100(3):765-77. PMID: 24944060. (abstract / article)

[25] Declan Butler, “Food Agency Denies Conflict-of-Interest Claim.” Nature, October 5, 2010. (article)

[26] Peters JC et al., “The Effects of Water and Non-Nutritive Sweetened Beverages on Weight Loss During a 12-Week Weight Loss Treatment Program.” Obesity, 2014 Jun;22(6):1415-21. PMID: 24862170. (abstract / article)

[27] Mandrioli D, Kearns C, Bero L. “Relationship between Research Outcomes and Risk of Bias, Study Sponsorship, and Author Financial Conflicts of Interest in Reviews of the Effects of Artificially Sweetened Beverages on Weight Outcomes: A Systematic Review of Reviews.” PLOS One, September 8, 2016. https://doi.org/10.1371/journal.pone.0162198

[28] Lesser LI, Ebbeling CB, Goozner M, Wypij D, Ludwig DS. “Relationship Between Funding Source and Conclusion Among Nutrition-Related Scientific Articles.” PLOS Medicine, 2007 Jan;4(1):e5. PMID: 17214504. (abstract / article)

Weed Killer Residues Found in 98 Percent of Canadian Honey Samples

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Study is the latest evidence that glyphosate herbicides are so pervasive that residues can be found in foods not produced by farmers using glyphosate.

This article was originally published in Environmental Health News.

By Carey Gillam

As U.S. regulators continue to dance around the issue of testing foods for residues of glyphosate weed killers, government scientists in Canada have found the pesticide in 197 of 200 samples of honey they examined.

The authors of the study, all of whom work for Agri-Food Laboratories at the Alberta Ministry of Agriculture and Forestry, said the prevalence of glyphosate residues in honey samples – 98.5 percent – was higher than what was reported in several similar studies done over the last five years in other countries.

Glyphosate is the world’s most widely used herbicide and is the active ingredient in Roundup brands as well as hundreds of others sold around the world for agriculture and other purposes. Use has grown dramatically over the last 25 years and consumers have become concerned about residues of the herbicide in their food.

The data provides fresh evidence that glyphosate herbicides are so pervasive in the environment that residues can be found even in a food that is not produced by farmers using glyphosate. The researchers noted in their report that they ran into delays trying to calibrate their testing equipment “due to difficulties encountered in obtaining a honey sample which did not contain traces of glyphosate.”

Bees pick up traces of pesticides as they move from plant to plant, unintentionally transferring residues from crops or weeds sprayed with glyphosate back to their hives.

In a different study, researchers on the Hawaiian island of Kauai took honey directly from 59 bee hives and found glyphosate residues in 27 percent of them. The Hawaiian researchers said bee hives located near farming areas as well as golf courses where glyphosate is used had higher concentrations of the pesticide.

The Canadian report also comes amid growing evidence that glyphosate herbicides can cause cancer, specifically non-Hodgkin’s lymphoma. On Tuesday a jury in San Francisco unanimously found that Roundup, a glyphosate-based herbicide made popular by chemical manufacturer Monsanto Co., use was a “substantial factor” in causing non-Hodgkin’s lymphoma in a California man. That echoed a similar unanimous jury verdict handed down in August in a separate case in which a cancer victim also alleged his disease was due to exposure to Monsanto’s glyphosate-based herbicides.

Both verdicts came after plaintiffs’ lawyers presented evidence of multiple studies showing the cancer-causing potential of glyphosate herbicides, including one published last month in a journal whose editor is a senior scientist at the U.S. Environmental Protection Agency (EPA).

The Canadians’ decision to examine honey samples for glyphosate comes after a similar look at honey samples by a U.S. Food and Drug Administration chemist in 2017. That FDA scientist found all 28 honey samples he looked at had traces of glyphosate, with 61 percent of the samples having enough glyphosate to be measured. The other samples had residues of the herbicide too slight to measure.

“Safe” levels

The Canadian report, published in a journal called Food Additives & Contaminants: Part A, said that glyphosate is currently an active ingredient in 181 herbicides registered for use in Canada and its widespread use has made it commonly found in the environment.

The study authors pointed out that Canada, like the United States, does not have a legal standard for how much of the herbicide is considered safe in honey. Regulators in different countries set what are referred to as “maximum residue limits” (MRLs) and tell consumers their food is safe if pesticide residues remain below the MRLs. In Europe, the MRL for glyphosate in honey is 0.05 mg/kg, also expressed as 50 μg/kg.

The Canadian study authors said that all of the levels they found were below the European limit, though the highest was just barely within the legal limit. Because the residues did not exceed the MRL, they said, “the risk to consumer health appears to be quite low based on the residues detected.”

Several of the residue levels found by the FDA scientist in U.S. honey were above that so-called safe level that applies in the European Union. But the FDA, like the U.S. Department of Agriculture (USDA) and EPA, assert that as long as pesticide residues are below the legal MRLs, they are not harmful.

Many scientists do not agree that MRLs actually are protective of public health, however.

“People think the standards are protective of public health but they are not,” Dr. Philip Landrigan, director of the Global Public Health Program at Boston College, told EHN. “The optimal amount” of pesticide residues in food is “zero,” he said. “Remember, many of the people eating honey are children.”

A team of Harvard scientists published a commentary in October stating that more research about potential links between disease and consumption of pesticide residues is “urgently needed” as more than 90 percent of the U.S. population has pesticide residues in their urine and blood.

The United States has fallen behind Europe, Canada and other countries in testing foods for residues of glyphosate. Though both the FDA and the USDA annually test thousands of food samples for pesticide residues and report the data in reports, both agencies have not included glyphosate in their yearly testing programs.

In fact, the honey test data gathered by the FDA chemist was never published by the FDA and was not included in the agency’s first-ever glyphosate testing data that was released late last year as part of the annual test data report.

The USDA has similarly balked at testing foods for glyphosate residues for decades. The agency planned to start limited testing in 2017 but dropped the plan with little explanation only a couple of months before testing was to have started.

Legislative push for testing

Amid all the concerns about glyphosate and residues in food, U.S. Rep Rosa DeLauro of Connecticut this month introduced a measure called the “Keep Food Safe From Glyphosate Act.” The bill would require the USDA to routinely test food samples for glyphosate residues.

The bill would also ban the spraying of glyphosate as a desiccant on oats. The practice is employed by some farmers to dry their oats before harvesting. It makes harvest more efficient but leaves higher residues on finished oat-based foods.

Monsanto, now a unit of Bayer AG, has marketed glyphosate for use on oats as a desiccant for years, and the company also has successfully convinced the EPA to raise the MRL for glyphosate residues allowed in oat products. In 1993, for example, the EPA had a tolerance for glyphosate in oats at 0.1 parts per million (ppm) but in 1996 Monsanto asked EPA to raise the tolerance to 20 ppm and the EPA did as asked. In 2008, at Monsanto’s suggestion, the EPA again looked to raise the tolerance for glyphosate in oats, this time to 30 ppm.

In her bill, DeLauro is looking to slash the MRL for glyphosate residues in oats to 0.1 ppm.

Canadian farmers are among the world’s top producers of oats, and desiccation with glyphosate has been a common practice there.

Health Canada has rejected concerns about glyphosate safety, saying: “No pesticide regulatory authority in the world currently considers glyphosate to be a cancer risk to humans at the levels at which humans are currently exposed.”

In addition to testing for glyphosate residues, the Canadian scientists also tested for residues of glyphosate’s main degradation product, a metabolite called aminomethylphosphonic acid (AMPA). Like glyphosate, AMPA has long been considered to have low toxicity. AMPA was detected in 198 of the 200 samples up to a concentration of 50.1 μg/kg.

“The contribution of glyphosate and AMPA residues present in the ambient environment to contamination of plant nectar and subsequently honey itself is further complicated by the variations in the levels of these compounds in environmental matrices such as soil and surface water,” the scientists said in their report.

The scientists also looked for residues of the weed killer glufosinate and found residues of that herbicide in 125 of 200 samples, with the maximum concentration detected being 33 μg/kg.

Glufosinate is the active ingredient in BASF’s Liberty herbicide.

Chemicals on Our Food: When “Safe” May Not Really Be Safe

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Scientific scrutiny of pesticide residue in food grows; regulatory protections questioned

This article was originally published in Environmental Health News.

By Carey Gillam

Weed killers in wheat crackers and cereals, insecticides in apple juice and a mix of multiple pesticides in spinach, string beans and other veggies – all are part of the daily diets of many Americans. For decades, federal officials have declared tiny traces of these contaminants to be safe. But a new wave of scientific scrutiny is challenging those assertions.

Though many consumers might not be aware of it, every year, government scientists document how hundreds of chemicals used by farmers on their fields and crops leave residues in widely consumed foods. More than 75 percent of fruits and more than 50 percent of vegetables sampled carried pesticides residues in the latest sampling reported by the Food and Drug Administration. Even residues of the tightly restricted bug-killing chemical DDT are found in food, along with a range of other pesticides known by scientists to be linked to a range of illnesses and disease. The pesticide endosulfan, banned worldwide because of evidence that it can cause neurological and reproductive problems, was also found in food samples, the FDA report said.

U.S. regulators and the companies that sell the chemicals to farmers insist that the pesticide residues pose no threat to human health. Most residue levels found in food fall within legal “tolerance” levels set by the Environmental Protection Agency (EPA), regulators say.

“Americans depend on the FDA to ensure the safety of their families and the foods they eat,” FDA Commissioner Scott Gottlieb said in a press release accompanying the agency’s Oct. 1 release of its residue report. “Like other recent reports, the results show that overall levels of pesticide chemical residues are below the Environmental Protection Agency’s tolerances, and therefore don’t pose a risk to consumers.”

The EPA is so confident that traces of pesticides in food are safe that the agency has granted multiple chemical company requests for increases in the allowed tolerances, effectively providing a legal basis for higher levels of pesticide residues to be allowed in American food.

But recent scientific studies have prompted many scientists to warn that years of promises of safety may be wrong. While no one is expected to drop dead from eating a bowl of cereal containing pesticide residues, repeated low level exposures to trace amounts of pesticides in the diet could be contributing to a range of health problems, particularly for children, scientists say.

“There are probably many other health effects; we just haven’t studied them”

A team of Harvard scientists published a commentary in October stating that more research about potential links between disease and consumption of pesticide residues is “urgently needed” as more than 90 percent of the U.S. population has pesticide residues in their urine and blood. The primary route of exposure to these pesticides is through the food people eat, the Harvard research team said.

Several additional Harvard-affiliated scientists published a study earlier this year of women who were trying to get pregnant. The findings suggested that dietary pesticide exposure within a “typical” range was associated both with problems women had getting pregnant and delivering live babies, the scientists said.

“Clearly the current tolerance levels protect us from acute toxicity. The problem is that it is not clear to what extent long-term low-level exposure to pesticide residues through food may or may not be health hazards,” said Dr. Jorge Chavarro, associate professor of the Departments of Nutrition and Epidemiology at the Harvard T.H. Chan School of Public Health, and one of the study authors.

“Exposure to pesticide residues through diet is associated [with] some reproductive outcomes including semen quality and greater risk of pregnancy loss among women undergoing infertility treatments. There are probably many other health effects; we just haven’t studied them sufficiently to make an adequate risk assessment,” Chavarro said.

Toxicologist Linda Birnbaum, who directs the U.S. National Institute of Environmental Health Sciences (NIEHS), has also raised concerns about pesticide dangers through exposures once assumed to be safe. Last year she called for “an overall reduction in the use of agricultural pesticides” due to multiple concerns for human health, stating that “existing US regulations have not kept pace with scientific advances showing that widely used chemicals cause serious health problems at levels previously assumed to be safe.”

In an interview Birnbaum said that pesticide residues in food and water are among the types of exposures that need greater regulatory scrutiny.

“Do I think that levels that are currently set are safe? Probably not,” said Birnbaum. “We have people of different susceptibility, whether because of their own genetics, or their age, whatever may make them more susceptible to these things,” she said.

“While we look at chemicals one at a time, there is a lot of evidence for things acting in a synergistic fashion. A lot of our standard testing protocols, many that were developed 40 to 50 years ago, are not asking the questions we should be asking,” she added.

Legal doesn’t mean safe

Other recent scientific papers also point to troubling findings. One by a group of international scientists published in May found glyphosate herbicide at doses currently considered “safe” are capable of causing health problems before the onset of puberty. More research is needed to understand potential risks to children, the study authors said.

And in a paper published Oct. 22 in JAMA Internal Medicine, French researchers said that when looking at pesticide residue links to cancer in a study of the diets of more than 68,000 people, they found indications that consumption of organic foods, which are less likely to carry synthetic pesticide residues than foods made with conventionally grown crops, was associated with a reduced risk of cancer.

A 2009 paper published by a Harvard researcher and two FDA scientists found 19 out of 100 food samples that children commonly consumed contained at least one insecticide known to be a neurotoxin. The foods the researchers looked at were fresh vegetables, fruits and juices. Since then, evidence has grown about the harmful human health impacts of insecticides, in particular.

Unacceptable levels

“A number of current legal standards for pesticides in food and water do not fully protect public health, and do not reflect the latest science,” said Olga Naidenko, senior science advisor to the non-profit Environmental Working Group, which has issued several reports looking at potential dangers of pesticides in food and water. “Legal does not necessarily reflect ‘safe,'” she said.

One example of how regulatory assurances of safety have been found lacking when it comes to pesticide residues is the case of an insecticide known as chlorpyrifos. Marketed by Dow Chemical, which became the DowDuPont company in 2017, chlorpyrifos is applied to more than 30 percent of apples, asparagus, walnuts, onions, grapes, broccoli, cherries and cauliflower grown in the U.S. and is commonly found on foods consumed by children. The EPA has said for years that exposures below the legal tolerances it set were nothing to worry about.

Yet scientific research in recent years has demonstrated an association between chlorpyrifos exposure and cognitive deficits in children. The evidence of harm to young developing brains is so strong that the EPA in 2015 said that it “cannot find that any current tolerances are safe.”

The EPA said that because of unacceptable levels of the insecticide in food and drinking water it planned to ban the pesticide from agricultural use. But pressure from Dow and chemical industry lobbyists have kept the chemical in wide use on American farms. The FDA’s recent report found it the 11th most prevalent pesticides in U.S. foods out of hundreds included in the testing.

A federal court in August said that the Trump Administration was endangering public health by keeping chlorpyrifos in use for agricultural food production. The court cited “scientific evidence that its residue on food causes neurodevelopmental damage to children” and ordered the EPA to revoke all tolerances and ban the chemical from the market. The EPA has yet to act on that order, and is seeking a rehearing before the full 9th Circuit Court of Appeals.

When asked how to explain its changing positions on chlorpyrifos, an agency spokesman said that the EPA “plans to continue to review the science addressing neurodevelopmental effects” of the chemical.

The fact that it is still in wide use frustrates and angers physicians who specialize in child health and leaves them wondering what other pesticide exposures in food might be doing to people.

“The bottom line is that the biggest public health concerns for chlorpyrifos are from its presence in foods,” said Dr. Bradley Peterson director of the Institute for the Developing Mind at the Children’s Hospital of Los Angeles. “Even small exposures can potentially have harmful effects.”

The EPA decision to continue to allow chlorpyrifos into American diets is “emblematic of a broader dismissal of scientific evidence” that challenges human health as well as scientific integrity, according to Dr. Leonardo Trasande, who directs the Division of Environmental Pediatrics within the Department of Pediatrics at New York University’s Langone Health.

Epidemiologist Philip Landrigan, director of Boston College’s Global Public Health initiative, and a former scientist with the U.S. Centers for Disease Control, is advocating for a ban on all organophosphates, a class of insecticides that includes chlorpyrifos, because of the danger they pose to children.

“Children are exquisitely vulnerable to these chemicals,” said Landrigan. “This is about protecting kids.”

Increased tolerances at industry request

The Federal Food, Drug, and Cosmetic Act authorizes the EPA to regulate the use of pesticides on foods according to specific statutory standards and grants the EPA a limited authority to establish tolerances for pesticides meeting statutory qualifications.

Tolerances vary from food to food and pesticide to pesticide, so an apple might legally carry more of a certain type of insecticide residue than a plum, for instance. The tolerances also vary from country to country, so what the U.S. sets as a legal tolerance for residues of a pesticide on a particular food can – and often is – much different than limits set in other countries. As part of the setting of those tolerances, regulators examine data showing how much residue persists after a pesticide is used as intended on a crop, and they undertake the dietary risk assessments to confirm that the levels of pesticide residues don’t pose human health concerns.

The agency says that it accounts for the fact that the diets of infants and children may be quite different from those of adults and that they consume more food for their size than adults. The EPA also says it combines information about routes of pesticide exposure – food, drinking water residential uses – with information about the toxicity of each pesticide to determine the potential risks posed by the pesticide residues. The agency says if the risks are “unacceptable,” it will not approve the tolerances.

The EPA also says that when it makes tolerance decisions, it “seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices.”

Monsanto, which became of unit of Bayer AG earlier this year, has successfully asked the EPA to expand the levels of glyphosate residues allowed in several foods, including in wheat and oats.

In 1993, for example, the EPA had a tolerance for glyphosate in oats at 0.1 parts per million (ppm) but in 1996 Monsanto asked EPA to raise the tolerance to 20 ppm and the EPA did as asked. In 2008, at Monsanto’s suggestion, the EPA again looked to raise the tolerance for glyphosate in oats, this time to 30 ppm.

At that time, it also said it would raise the tolerance for glyphosate in barley from 20 ppm to 30 ppm, raise the tolerance in field corn from 1 to 5 ppm and raise the tolerance of glyphosate residue in wheat from 5 ppm to 30 ppm, a 500 percent increase. The 30 ppm for wheat is matched by more than 60 other countries, but is well above the tolerances allowed in more than 50 countries, according to an international tolerance database established with EPA funding and maintained now by a private government affairs consulting group.

“The Agency has determined that the increased tolerances are safe, i.e, there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue,” the EPA stated in the May 21, 2008 Federal Register.

“All these statements from EPA – trust us it’s safe. But the truth is we have no idea if it actually is safe,” said Dr. Bruce Lanphear, a clinician scientist at the Child & Family Research Institute, BC Children’s Hospital, and a professor in the faculty of health sciences at Simon Fraser University in Vancouver, British Columbia. Lanphear said that while regulators assume toxic effects increase with dose, scientific evidence shows that some chemicals are most toxic at the lowest levels of exposure. Protecting public health will require rethinking basic assumptions about how agencies regulate chemicals, he argued in a paper published last year.

In recent years both Monsanto and Dow have received new tolerance levels for the pesticides dicamba and 2,4-D on food as well.

Raising tolerances allows farmers to use pesticides in various ways that may leave more residues, but that doesn’t threaten human health, according to Monsanto. In a blog posted last year, Monsanto scientist Dan Goldstein asserted the safety of pesticide residues in food generally and of glyphosate in particular. Even when they exceed the regulatory legal limits, pesticide residues are so minuscule they pose no danger, according to Goldstein, who posted the blog before he retired from Monsanto this year.

About half of foods sampled contained traces of pesticides

Amid the scientific concerns, the most recent FDA data on pesticide residues in food found that roughly half of the foods the agency sampled contained traces of insecticides, herbicides, fungicides and other toxic chemicals used by farmers in growing hundreds of different foods.

More than 90 percent of apple juices sampled were found to contain pesticides. The FDA also reported that more than 60 percent of cantaloupe carried residues. Overall, 79 percent of American fruits and 52 percent of vegetables contained residues of various pesticides – many known by scientists to be linked to a range of illnesses and disease. Pesticides were also found in soy, corn, oat and wheat products, and finished foods like cereals, crackers and macaroni.

The FDA analysis “almost exclusively” is focused on products that are not labeled as organic, according to FDA spokesman Peter Cassell.

The FDA downplays the percentage of foods containing pesticide residues and focuses on the percentage of samples for which there is no violation of the tolerance levels. In its most recent report, the FDA said that more than “99% of domestic and 90% of import human foods were compliant with federal standards.”

The report marked the agency’s launch of testing for the weed killer glyphosate in foods. The Government Accountability Office said in 2014 that both the FDA and the U.S. Department of Agriculture should start regularly testing foods for glyphosate. The FDA did only limited tests looking for glyphosate residues, however, sampling corn and soy and milk and eggs for the weed killer, the agency said. No residues of glyphosate were found in milk or eggs, but residues were found in 63.1 percent of the corn samples and 67 percent of the soybean samples, according to FDA data.

The agency did not disclose findings by one of its chemists of glyphosate in oatmeal and honey products, even though the FDA chemist made his findings known to supervisors and other scientists outside the agency.

Cassell said the honey and oatmeal findings were not part of the agency’s assignment.

Overall, the new FDA report covered sampling done from Oct. 1, 2015, through Sept. 30, 2016, and included analysis of 7,413 samples of food examined as part of the FDA’s “pesticide monitoring program.” Most of the samples were of food to be eaten by people, but 467 samples were of animal food. The agency said that pesticide residues were found in 47.1 percent of the samples of food for people produced domestically and 49.3 percent of food imported from other countries destined for consumer meals. Animal food products were similar, with pesticide residues found in 57 percent of the domestic samples and 45.3 percent of imported foods for animals.

Many imported food samples showed residues of pesticides high enough to break the legal limits, the FDA said. Nearly 20 percent of imported grain and grain product samples showed illegally high levels of pesticides, for example.