Pursuing Truth and Transparency in America's Food System

The FDA and food companies have been wrong before: they have assured us of the safety of products that were not safe

The following is an excerpt from Chapter 14, “Seedy Business: What Big Food is hiding with its slick PR campaign on GMOs,” by Gary Ruskin, co-director of the public watchdog group US Right to Know.

Many people believe that if a food is sold in the U.S. market, it must be safe. This impression is false.

On food safety, the U.S. Food and Drug Administration and food companies have been wrong before – many times. The FDA and food companies have often allowed food products or additives on the market, later to discover they were, in fact, unsafe.

This is important, because it suggests that since the FDA and food companies have been wrong before, they could be wrong again, this time about genetically engineered foods.

(It is curious that many Republicans – who are inclined to distrust the federal agencies, including the FDA — should so readily accept the idea that a food is safe because the FDA allows it on the market.)

What follows is a list of food additives, artificial flavors and sweeteners that were sold in the United States and later removed from the market because they were unsafe.

One could make a parallel list of FDA-approved pharmaceuticals that were subsequently pulled from the market, such as Vioxx, Bextra, Baycol, Propulsid, Rezulin, Lotronex, Trasylol and many others.[1] But this is a report about food, so we will keep our focus there. 

Agene (nitrogen trichloride) was a widely used bleaching agent for wheat flour between 1924-49.[2] In 1948, according to the New York Times, 90% of all white flour was agenized.[3] Agene was banned in 1949,[4] after it was discovered to have caused “running fits” and “hysteria” in dogs.[5]

Cinnamyl anthranilate was an artificial flavor. It produces an imitation grape or cherry flavor. It was found to cause liver in mice,[6] and was banned in 1985.[7]

Cobalt salts were added to beer as a foam stabilizer. In 1966, cobalt salts were linked to thirty-seven deaths due to cardiomyopathy,[8] and later that year the FDA banned them.[9]

Coumarin is a vanilla flavoring, a product of the tonka bean. According to the New York Times, it was “widely used in ice creams, candy, baked goods, soft drinks and products using chocolate, for many years.”[10] It is toxic to the liver, and was banned by the FDA in 1954.[11]

Cyclamates are a class of artificial sweeteners. They were popular; about 15 million pounds were used in 1967, mostly in soft drinks.[12] The FDA banned them in 1969, following evidence that they caused bladder tumors in rats.[13]

Diethyl pyrocarbonate (DEPC) was a fermentation inhibitor and preservative used in wine, beer and fruit drinks. Researchers discovered that it reacts with ammonia to create urethane, a well-known carcinogen.[14] The FDA banned it in 1972.[15]

Dulcin was an artificial sweetener. The FDA banned it in 1950,[16] because of evidence that it caused liver and bladder cancer in rats.[17]

Green 1 was an artificial color approved for food use in 1922. It was delisted in 1966.[18]

Monochloroacetic acid was a preservative for alcoholic and nonalcoholic beverages. It was banned in 1941[19] because it is highly toxic.

Nordihydroguaiaretic acid (NDGA) is an antioxidant. The FDA banned it in 1968[20] because it caused renal cysts and other kidney damage.

Oil of Calamus is a flavoring agent. The FDA banned it in 1968.[21]

Orange 1 was an artificial color approved for food use in 1907. According to the FDA, in 1953 it was “probably the most widely used of all food colors, going into soft drinks, confectionary and baking.”[22] According to the New York Times, “In 1950, many children became ill after eating Halloween candy containing Orange No. 1 dye, and the F.D.A. banned it after more rigorous testing suggested that it was toxic.”[23] It was delisted (banned) in 1956.

Orange 2 was an artificial color. It was delisted (banned) in 1956.[24]

Orange B was an artificial color approved for food use in 1966, for dying hot dog and sausage casings. It was found to be toxic in rats. The FDA proposed banning it in 1978, but the manufacturer stopped producing it, and the ban was never finalized.[25]

P-4000 is an artificial sweetener about 4,000 times sweeter than sucrose. The FDA banned it in 1950[26] due to toxicity in rats.

Red 1 was an artificial color approved for use in food by the Pure Food and Drug Act of 1906. It was delisted in 1961, because it is a liver carcinogen.[27]

Red 2 was an artificial color approved for use in food by the Pure Food and Drug Act of 1906. It was delisted in 1976, after studies showed that it is a probable carcinogen in rats.[28]

Red 4 was an artificial color approved in 1929 for dyeing butter and margarine. It was delisted in 1976 after it was found to be toxic to dogs.[29]

Red 32 was an artificial color approved for food use in 1939. It was delisted in 1956, after it was shown to be toxic to rats.[30]

Safrole was a flavoring derived from sassafras used in foods and beverages such as root beer. The FDA banned it in 1960 because it causes liver cancer in rats.[31]

Thiourea was an antimycotic preservative. The FDA banned it because it causes liver cancer in rats.[32]

Violet 1 was an artificial color approved for food use in 1950. It was delisted in 1973 because it was a suspected carcinogen in rats.[33]

Yellow 1 was an artificial color approved for food use in 1907. It was delisted in 1959.[34]

Yellow 2 was an artificial color approved for food use in 1939. It was delisted in 1959.[35]

Yellow 3 and 4 were artificial colors approved for food use in 1918 for coloring margarine. They were found to be toxic to the livers of rats and dogs. They were delisted in 1959.[36]

Footnotes

[1] See, for example, “Update on Withdrawals of Dangerous Drugs in the U.S.” Worst Pills, Best Pills, Public Citizen Health Research Group, January 2011.

[2] Clyde E. Stauffer, Functional Additives for Bakery Foods. (New York: Van Nostrand Reinhold, 1990) p. 7.

[3] Jane Nickerson, “News of Food.” New York Times, March 18, 1948.

[4]Stop Order Is Put on Bleaching Flour.” New York Times, November 3, 1948.

[5] Edward Mellanby, “Diet and Canine Hysteria: Experimental Production by Treated Flour.” British Medical Journal, December 14, 1946; 2(4484): 885–887.

[6] International Agency for Research on Cancer, monograph on cinnamyl anthranilate.

[7] 21 CFR 189.113.

[8] Jane E. Brody, “A Heart Ailment is Linked to Beer.” New York Times, July 26, 1966.

[9] 21 CFR 189.120.

[10]Coumarin Withheld as a Danger in Foods.” New York Times, May 23, 1953.

[11] 21 CFR 189.130.

[12] Douglas W. Cray, “Battle Over Sweeteners Turns Bitter.” New York Times, June 1, 1969.

[13] Harold M. Schmeck, “Government Officially Announces Cyclamate Sweeteners Will Be Taken Off Market Early Next Year.” New York Times, October 19, 1969.

[14] Jane E. Brody, “Drink Preservative Found to Produce a Carcinogen.” New York Times, December 21, 1971.

[15] 21 CFR 189.140.

[16] 21 CFR 189.145.

[17] A. Wallace Hayes, ed. Principles and Methods of Toxicology. (New York: Informa, 2008), p. 669.

[18] S. S. Deshpande, Handbook of Food Toxicology. (New York: Marcel Dekker, 2002), p. 227.

[19] 21 CFR 189.155.

[20] 21 CFR 189.165.

[21] 21 CFR 189.110.

[22]U.S. Orders Hearings on 3 Food Colorings.” Associated Press/New York Times, December 19, 1953.

[23] Gardiner Harris, “F.D.A. Panel to Consider Warnings for Artificial Food Colorings.” New York Times, March 29, 2011. See also Deborah Blum, “A Poisoner’s Tale of Halloween.” Wired, October 31, 2012.

[24] Deborah Blum, “A Poisoner’s Tale of Halloween.” Wired, October 31, 2012.

[25] Sarah Kobylewski and Michael F. Jacobson, “Toxicology of Food Dyes.” International Journal of Occupational and Environmental Health, July-September 2012, 18(3):220-46. doi: 10.1179/1077352512Z.00000000034. S. S. Deshpande, Handbook of Food Toxicology. (New York: Marcel Dekker, 2002). p. 227.

[26] 21 CFR 189.175.

[27] S. S. Deshpande, Handbook of Food Toxicology. (New York: Marcel Dekker, 2002). p. 231.

[28] S. S. Deshpande, Handbook of Food Toxicology. (New York: Marcel Dekker, 2002). p. 231.

[29] S. S. Deshpande, Handbook of Food Toxicology. (New York: Marcel Dekker, 2002). p. 234.

[30] S. S. Deshpande, Handbook of Food Toxicology. (New York: Marcel Dekker, 2002). p. 234.

[31]U.S. Food Unit Bars Safrol Flavoring.” New York Times, December 2, 1960. 21 CFR 189.180.

[32] 21 CFR 189.190.

[33] Richard J. Lewis, Sr., Food Additives Handbook. (New York: Chapman & Hall, 1989). p. 16.

[34] S. S. Deshpande, Handbook of Food Toxicology. (New York: Marcel Dekker, 2002). p. 227.

[35] S. S. Deshpande, Handbook of Food Toxicology. (New York: Marcel Dekker, 2002). p. 227.

[36] S. S. Deshpande, Handbook of Food Toxicology. (New York: Marcel Dekker, 2002). p. 238.