- The U.S. Food and Drug Administration announced Oct. 5 it will no longer allow seven synthetic flavoring substances and enhancers to be used in foods and beverages. The action came in response to a 2016 citizen petition from consumer and environmental groups showing the substances induce cancer in laboratory animals, the agency said. The groups sued the FDA earlier this year to force a decision.
- Six of the flavoring substances are synthetically derived benzophenone, ethyl acrylate, eugenyl methyl ether (methyl eugenol), myrcene, pulegone and pyridine. Companies have two years to find suitable replacements and reformulate products, the FDA said in a release. The seventh, styrene, has already been permanently abandoned by the industry, according to the agency.
- The FDA will accept electronic or written comments on the final rule, or requests for a hearing, within 30 days after the Federal Register publication scheduled for Oct. 9.
The seven synthetic substances probably won't sound familiar to most consumers because they're usually lumped under "artificial flavors" on product labels. First approved by the FDA in 1964, the substances are said to mimic or enhance natural flavors and are often used to impart mint, floral, cinnamon and other flavors in baked goods, beer, ice cream, candy, beverages and chewing gum. But for those petitioning to get the substances banned, this is a big move.
Both the FDA and the flavoring industry said there is no risk to the public at the low levels these substances are used. Still, a growing number of consumers have said they would rather not have synthetic or artificial substances in their foods and beverages — particularly when there are often natural alternatives that can be used instead.
In a statement, the Flavor and Extract Manufacturers Association emphasized the FDA's action was required by the "the rigid language" in the Delaney Clause of the Federal Food, Drug and Cosmetic Act, which says the agency cannot approve the use of any food additive found to induce cancer in humans or animals at any dose. The association signaled an effort to overturn the Delaney Clause could be forthcoming.
"The delisting of these six flavoring substances — despite the conclusions by the FDA that these materials are safe both for use as flavorings and when they are consumed via the variety of foods that contain them (e.g. grapes, pineapples, oranges) — confirms the need for FDA to be given the latitude to assess actual risk, rather than be boxed in by an antiquated, 60-year-old statutory provision," the association's statement said.
Getting the FDA to approve a petition isn't easy. The agency receives about 200 petitions each year, with each one taking several weeks to more than a year to be evaluated before a decision is made. The FDA has previously denied petitions asking for mandatory labeling of GMOs in food products and for limited uses of partially hydrogenated oils in foods. Most petitions aren't approved unless the FDA substantiates all the claims for a ban.
The coalition that filed the petitions to ban the seven synthetic flavoring substances included the Natural Resources Defense Council, the Center for Food Safety and the Center for Science in the Public Interest, among others. They initially approached the agency on the matter in 2016 and then sued in May to force the FDA to act.
Erik Olson, director of health, food and agriculture initiatives for the Natural Resources Defense Council, told National Public Radio the FDA decision is a "win for consumers."
Manufacturers will likely be looking around for substitutes and determining how to change recipes now that these substances will no longer be permitted. They have two years to get the job done, a process that will take time and money. One positive is that advertising a switch to natural flavoring substances on packaging could draw a positive consumer response and lend a competitive boost to impacted products.