By Ingrid Mezo, Food Chemical News

Several advocacy groups have asked the U.S. Court of Appeals for the Ninth Circuit for a writ of mandamus to force FDA to act on a petition to prohibit seven artificial flavors used in beverages, baked goods, candy, chewing gum and ice cream that they say cause cancer.

The seven chemicals at issue include benzophenone (also known as diphenylketone), ethyl acrylate, eugenyl methyl ether (also known as 4-allylveratrole or methyl eugenol), myrcene (also known as 7-methyl-3-methylene-1,6-octadiene), pulegone (also known as p-menth-4(8)-en-3-one), pyridine, and styrene.

After FDA approved six of the seven chemicals as safe for use as synthetic food flavors in 1964, and approved the seventh, styrene, in 1967, the U.S. Department of Health and Human Services’ National Toxicology Program concluded that all seven flavors cause cancer in animals, and that methyleugenol and styrene are also “reasonably anticipated to be human carcinogens,” said the lawsuit filed Wednesday (May 2).

The Federal Food, Drug, and Cosmetics Act prohibits the use of any food additive found to induce cancer in humans or animals. “Accordingly, the flavors cannot be deemed safe under the law and cannot lawfully be approved for use in food,” Earthjustice said in a May 2 statement.

The flavors are added to many common foods, according to evidence collected by the International Agency for Research on Cancer (IARC), a division of the World Health Organization, and the European Food Safety Authority’s Scientific Panel on Food Additives and Flavorings.

Benzophenone, methyleugenol, and pulegone are used to add floral, cinnamon, or mint flavor to baked goods, beverages, candy, chewing gum and ice cream, according to the groups. Mycrene is described as adding a “picnic-inspired … citrus, fruity mango note” or a “sweet woody note” to beer and other beverages. And ethyl acrylate is advertised for its “irritating brown ethereal character reminiscent of ripe pineapple, rum and whiskey, roasted onion and garlic” to enhance beverages, butterscotch, and savory dishes.

While these chemicals are widely used, they are likely unfamiliar to consumers because, under food labeling rules, they would all appear only as “artificial flavor” on food ingredient lists, the groups said.

“The use of these carcinogens in food is not only contrary to the law – it is entirely unnecessary. There are thousands of other flavor chemicals available on the market that can be used to add similar flavors,” said Tom Neltner, chemicals policy director for Environmental Defense Fund (EDF). “FDA should take immediate action to prohibit intentional use of these carcinogens and better protect consumers.”

“The use of these carcinogens in food is not only contrary to the law – it is entirely unnecessary. There are thousands of other flavor chemicals available on the market that can be used to add similar flavors.” – Tom Neltner, chemicals policy director for Environmental Defense Fund

After FDA accepted an earlier petition from advocacy groups to prohibit the flavors on safety grounds, the agency formally accepted a revised and expanded petition in February 2016, which presented extensive scientific evidence and highlighted the dangers of these chemicals, Earthjustice noted.

But FDA has yet to act on the petition, although the agency’s final decision on it was due in August 2016. The agency has also failed to take any other steps to prevent these chemicals from being used in food. “FDA’s unlawful delay defies a congressional mandate requiring prompt action in assessing the safety of chemicals added to food and puts public health and welfare at risk,” Earthjustice said.

“The federal agency charged with studying toxics found that these chemicals cause cancer,” said Peter Lehner, Earthjustice senior attorney. “Congress clearly told FDA that known carcinogens cannot be used as food additives. What more does FDA need? It is time for FDA to take seriously its responsibility to keep cancer-causing chemicals out of food. Consumers cannot identify every ingredient in processed food and they shouldn’t have to; we need FDA to do its job and protect our health and welfare.”

The petitioners include Breast Cancer Prevention Partners, Center for Environmental Health, Center for Food Safety (CFS), Center for Science in the Public Interest (CSPI), Environmental Defense Fund, Environmental Working Group, Natural Resources Defense Council (NRDC), Inc., and WE ACT for Environmental Justice.

Industry says flavors are also naturally occurring

Christie Harman, scientific director for the Flavor and Extract Manufacturers Association of the United States (FEMA), noted in an email to IEG Policy that while the advocacy groups’ petition characterizes the chemicals as purely synthetic, “it’s important to keep in mind that these flavorings are naturally occurring in foods such as basil, passionfruit, pineapples, apples, and asparagus, to name just a few.”

The studies cited in the petition have been reviewed by several risk assessment authorities including the World Health Organization Joint Expert Committee on Food Additives, the European Food Safety Authority, the FEMA Expert Panel and/or other scientific and regulatory bodies, she noted.

“In fact, the European Food Safety Authority re-evaluated the safety of three of the substances in the petition in just the last three years and have concluded that these flavoring substances are safe and pose no risk to public health,” Harman said. “We recognize that the FDA has a difficult task and believe that it should be given the time necessary to make an informed, careful decision.”

In addition, one of the chemicals noted in the advocacy groups’ petition and lawsuit is no longer used as a food flavoring in the United States, according to an abandonment petition filed with FDA in May 2016 by the law firm Keller and Heckman on behalf of the Styrene Information and Research Center (SIRC). The petition asked FDA to amend the food additive regulations to no longer provide for the use of styrene as a synthetic flavoring substance and adjuvant in food.

When FDA amends the additive regulations based on abandonment, the agency does not consider safety, and the advocacy groups that filed the food additive petition to prohibit the seven synthetic flavors on safety grounds had asked FDA to not consider the industry petition ahead of their own, citing concerns that foreign manufacturers could still use styrene as a flavoring if FDA did not prohibit it for safety reasons.

FDA will likely respond to the abandonment petition at the same time it responds the advocacy groups’ food additive petition, Devon Hill, a partner at Keller & Heckman, told IEG Policy.