EDF and Health Advocates Prevail: FDA Bans Seven Cancer-Causing Flavorings

New legal strategy deployed to compel agency action

October 5, 2018
Keith Gaby, kgaby@edf.org, (703) 625-8218

Today, in response to a 2015 food additive petition by Environmental Defense Fund and other public health advocates, the Food and Drug Administration (FDA) removed its approval of seven artificial flavors because they have been shown to cause cancer in animal studies.

These chemicals are believed to be used in foods like candy, chewing gum, baked goods, ice cream and beverages to simulate flavors like mint, cinnamon, and citrus. They would appear on the label as "artificial flavors."

The chemicals losing approval are: benzophenone, ethyl acrylate, eugenyl methyl ether, myrcene, pulegone, and pyridine. The FDA also removed approval for styrene without ruling on its status as a carcinogen. For one of the chemicals, benzophenone, FDA went a step further and removed approval for use as a plasticizer in flexible plastics.

The decision is effective immediately after the notice is published in the Federal Register unless industry objects. The FDA has said it will begin enforcement of these decisions in two years, allowing industry time to reformulate products.

"This is an important win for American families, who were consuming these cancer-causing "flavors" without even knowing it," said Tom Neltner, Chemicals Policy Director at EDF. "While these FDA decisions were long overdue, we applaud the agency for following the law and taking these actions. Now it's time for FDA to rule on overdue petitions including the use of toxic ortho-phthalates in food manufacturing and packaging, cancer-causing perchlorate in dry food plastic packaging, and lead acetate in hair dyes like Grecian Formula."

The petition by EDF and the other organizations represents a new legal strategy. For the first time, public health advocates used a process formerly only deployed by industry to gain approval for chemicals in food. Under this approach, the law required FDA to come to a decision by August 2016.

In May of this year, the petitioners, represented by Earthjustice, asked a court to order FDA to make a final decision.

"While it's unfortunate that we had to go to court to get FDA to act, we are glad they here took the right decision to protect public health," said Carrie Apfel, Senior Attorney, Earthjustice.

FDA agreed to make a decision in response to the court filing.

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