Reviewed by Hansa D. Bhargava, MD on October 05, 2018
From the WebMD Archives

Oct. 5, 2018 -- The FDA has banned the use of seven synthetic substances used to flavor or enhance flavor in baked goods, ice cream, candy, beverages, and chewing gum.

Environmental and health advocacy groups sent data to the agency that showed that 6 of the substances cause cancer in lab animals, the FDA says, and the seventh flavor is being removed from approved additives as it is no longer used by industry.

On a label, the substances are listed as ''artificial flavors," rather than their specific names, according to the Environmental Defense Fund, one of the organizations that petitioned to get the flavors outlawed. The substances are typically added to simulate mint, cinnamon, and citrus.

The 6 are:

  • Benzophenone
  • Ethyl acrylate
  • Eugenyl methyl ether
  • Myrcene
  • Pulegone
  • Pyridine

The FDA also removed its approval for styrene, which has been abandoned by industry, the agency says.

The Petitioning

In 2015, several organizations petitioned the FDA to ban the substances, pointing to data showing they cause cancer in lab animals. Under the Food, Drug, and Cosmetic Act's Delaney Clause, enacted in 1958, the FDA cannot allow the legal use of any food additive found to induce cancer in humans or animals at any dose.

In its statement announcing the decision on Oct. 5, the FDA notes that its ''rigorous scientific analysis has determined that they do not pose a risk to public health under the conditions of their intended use. The synthetic flavoring substances that are the subject of this petition are typically used in foods available in the U.S. marketplace in very small amounts and their use results in very low levels of exposure and low risk."

But, the agency says, the groups calling for the ban proved the “substances caused cancer in animals who were exposed to much higher doses. As such, the FDA is only revoking the listing of these six synthetic flavorings as a matter of law.”

The decision, the FDA says, does not affect the legal status of foods that contain the natural counterparts of the substances used to flavor foods and drink.

The FDA will give companies 24 months to identify suitable replacement ingredients and change the formula for their products.

Petitioners Applaud Decision

"The evidence is really clear that these are carcinogens," says Tom Neltner, a chemical engineer and attorney who is the chemicals policy director of the Environmental Defense Fund.

The data they submitted, he says, links the flavorings to a variety of cancers, including urinary cancer and those of the kidney, blood, and liver.

Jaydee Hanson, senior policy analyst at the Center for Food Safety, another of the petitioners, said in this case, the system worked.

“This is the kind of thing that is supposed to happen,” he says “You’re supposed to petition the government, they’re supposed to pay attention and do something about it, and they did.”

Other petitioners included the Breast Cancer Fund, Center for Environmental Health, Consumers Union, Environmental Working Group, Improving Kids’ Environments, Natural Resources Defense Council, WE ACT for Environmental Justice, and James Huff, former associate director for chemical carcinogenesis at the National Institute of Environmental Health Sciences.

In a statement, the Flavor and Extract Manufacturers Association of the U.S., an industry group, says the FDA action shows the limitations of the law, as it fails “to address risk or relevance in humans. It limits FDA's scientific discretion and requires the FDA to ban any food additive found to induce cancer in laboratory animals."

Show Sources

FDA: "FDA Removes 7 Synthetic Flavoring Substances from Food Additives List," Oct. 5, 2018.

Statement, Center for Science in the Public Interest, Oct. 5, 2018.

Tom Neltner, chemicals policy director, Environmental Defense Fund.

Jaydee Hanson, senior policy analyst, Center for Food Safety.

Flavor and Extract Manufacturers Association statement, Oct. 5, 2018.

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