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FDA Bans 6 Flavor Chemicals Because of the Delaney Clause against Carcinogens, yet Ignores Petitions to Ban Aspartame

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A short film about Carcinogens, produced by Vassar College

On October 5, 2018, the United States Food and Drug Administration very recently removed six artificial flavors from America's food supply after a serious legal challenge concerning their safety. This dispute results from complicated rules that govern what goes in our food, juxtaposed with how little the public actually knows about it. These six are all a part of this class of ingredients which evolved over the past fifty years. On food packages, hundreds of ingredients are listed simply as natural flavor or artificial flavor, and in those ubiquitous miniscule levels, they impart onion tastes to potato chips, etc., ad nauseum.

In what to me sounds like one of those "balanced" corporate soothing palliative, which of course misses the entire panorama of facts about these additives being carcinogens, Nadia Berenstein, a New York "Flavor Historian," stated in a response used in the sanguine Associated Press article that "the food system we have is unimaginable without flavor additives." She stated that in practice these flavor ingredients do not have to be specified because regulators decided long ago that listing the names of compounds on packages might just confuse people. She emphasized that the flavors are used in very small amounts. Berenstein said a "more robust regulatory system might inspire greater public confidence about flavors."

FDA has "graciously" given the companies that are involved a big two years to remove these chemicals from their products, yet while opening the door to further litigation and court action by acknowledging their flawed scientific finding that the ingredients are safe in the miniscule amounts in which they are used. The six artificial flavors include methyl eugenol, benzophenone, ethyl acrylate and pyridine, and are used to create cinnamon or spicy notes, fruity or minty flavors, or a taste of balsamic vinegar.

Both the FDA and the Flavor and Extract Manufacturers Association, an industry group, declined to respond when asked for examples of products the six ingredients are used in. but dutifully and predictably noted that these six chemicals have naturally occurring counterparts in foods like basil, coffee, grapes and peppermint.

The FDA said it had no choice but to remove the artificial versions out of the food supply because of a consumer advocacy group lawsuit that was based on the Delaney Amendment from 1958, a rule disallowing additives that have been shown to have caused cancer in animals, even if the chemicals were tested at doses higher than what a person would consume. In the press release by the flavor industry group, they stated that the Delaney Clause doesn't allow regulators to assess an ingredient's risk based on modern scientific understanding, and that changing it would require an act of Congress. (As early as 1981, the Government Accountability Office issued its own report that stated that Delaney should be re-examined because of its inflexibility.

Christopher Kemp, a professor of cancer biology at the Fred Hutchinson Cancer Research Center, doesn't think the rule is necessarily too strict a threshold, that animal studies provide the most conclusive evidence regarding human cancers, and that it is "better to err on the side of caution."

The Natural Resources Defense Council is one of the groups that sued over the six ingredients, and their representative Erik Olson stated that it would be completely unknown what effect they might have when used in combination with other ingredients. Because they're listed only as "artificial flavor," people don't know in what concentrations they're used in particular products. "It's all secret. You can't pick up an ice cream or chewing gum or a baked good and have any idea what chemicals are in there," he said.

FDA faces major challenges in a different lawsuit regarding its oversight of the ingredients companies can put into foods, including artificial flavors.

New flavors, sweeteners and other ingredients go through an FDA petition process to be approved as food additives. However, another option lets manufacturers deem their own ingredients to be GRAS, or "generally recognized as safe." The flavor industry group regularly declares other ingredients like them to be GRAS, without formal review by the FDA.

There's no clear statute or administrative practice to determine whether ingredients should take one path or the other. The artificial sweetener Splenda is an approved food additive. Another sweetener, stevia, was declared GRAS by manufacturers. The six artificial flavors in question were approved food additives, along with scores of synthetic flavors. FDA's critics and activists clearly maintain that GRAS determinations were meant for basic ingredients like salt and vinegar, not highly engineered complex chemicals produced by industry and added as ingredients.

The advocacy groups suing the FDA say the GRAS option has turned into a loophole that lets companies approve all sorts of ingredients without public scrutiny, including artificial flavors. In September, a judge allowed the legal challenge to move forward.

See also:

No accounting for these tastes: Artificial flavors a mystery

Candice Choi's excellent Associated Press article from November 13, 2018


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