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OpEdNews Op Eds    H2'ed 11/19/18

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

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FDA law says a petition to ban must be answered in 180 days. Instead they send out notices saying they have more important things to do. In 2009 the FDA called me after some FDA employees contacted Obama and said that the FDA was broken; they discussed not only corruption but some refuse to speak out because of fear of reprisals.

The man seemed angry and said Obama said they had to answer petitions back from 2007. I mentioned that my petition was dated 2002; I was told: "It won't happen". When I said people were sick and dying all over the world from this poison I was told by an FDA scientist (coincidentally named Delaney) "So what? We need to depopulate!"

The petition was finally answered in 2014 along with Dr. Stoller's. They wrote a letter to me and Dr. Stoller but neither one of us got it because the FDA knew we would appeal the decision and show aspartame to be what Dr. Monte called in his book - "a killing machine" and according to FDA's own records should never have been marketed for human conception.

The only reason Dr. Stoller and I found out the FDA answered the petition is their responses were published by the National Law Review years later. When I mentioned this, the letters disappeared from the net but we had already printed them out. They were not sent to us because we would have obviously appealed with real and factual information from the FDA's own records.

In a discussion with Dr. Joseph Thomas of the FDA he said I could refile with articles after 2002. Of course, he hasn't answered the questions from the original. When I mentioned the FDA has already admitted aspartame causes cancer and violates the Delaney Amendment, he replied that "we've addressed that." Yet he refused to tell me how you address the admission that aspartame causes cancer and violates the Delaney Amendment.

I have constantly sent the FDA petitions to ban aspartame by certified mail. The FDA has refused to acknowledge the petitions.

>>>>>

Back to this recent FDA decision to take 6 flavor chemicals off the market, how did these consumer advocate activists force FDA to blacklist and then order the removal of "carcinogenic" flavor chemicals the agency previously maintained as safe?

Key points excerpted from Nadia Berenstein's own brilliant article:

First, a class-action lawsuit filed in Chicago by Beaumont Costales accused the Natural Beverage Corporation, makers of LaCroix, of deceiving consumers by using "artificial chemicals" in its supposedly "100% natural" flavored fizzy waters. Although all the chemicals mentioned in the lawsuit are naturally occurring, found in common citrus fruits and herbs, and widely recognized as safe, the plaintiffs raised the specter of fear by associating them with cancer drugs, kidney tumors, and "cockroach insecticide."

Then, on October 5, the Food and Drug Administration (FDA) announced it was taking the rare step of amending its regulations to remove six synthetic flavor chemicals from its list of approved food additives. This action came in response to a food additive petition, originally filed in 2016 by a coalition of eight consumer, environment, and public health NGOs. The petition claimed that the chemicals were known carcinogens and should be banned from the food supply.

The activist coalition--which included the Center for Science in the Public Interest (CSPI), the National Resources Defense Council (NRDC), and the Environmental Defense Fund (EDF)--was quick to claim victory for consumer health and safety, but the actual language of FDA's ruling was murkier. While revoking its approval for these synthetic additives, FDA nonetheless insisted that they were "safe for human consumption" and "unlikely to pose a potential or significant carcinogenic risk for humans."

We are exposed to far higher levels of these substances from natural sources in the food supply than from synthetic additives.

The FDA decision concerns different chemicals than those invoked in the lawsuit against LaCroix, and the two events are unrelated. Taken together, however, they highlight growing public concern around the safety of the largely anonymous compounds that are added to foods and beverages. Although the LaCroix lawsuit has received far more attention in the media, FDA's decision is more consequential--and illuminates some of the complications and confusion around regulating the safety of food additives, and particularly of flavor chemicals.

The six chemicals named by the FDA (benzophenone, ethyl acrylate, methyl eugenol, myrcene, pulegone, and pyridine) are not by any means new to the food supply. These synthetic compounds have been approved as food additives since 1964, and some have been in use for decades longer than that, in flavorings for ice cream, baked goods, candy, and other foods. All of these chemicals are also found naturally in familiar foods. In most cases, we are exposed to far higher levels of these substances from natural sources in the food supply than from synthetic additives.

The evidence that these substances might cause cancer comes from National Toxicology Program (NTP), a sister agency of FDA, and was obtained using scientific guidelines for carcinogenicity. In these studies, mice and rats were given large doses of these chemicals--orders of magnitude larger than any likely human exposure--and then surveilled for tumors. None of the testing used human subjects, and there are no known cases of cancer in humans associated with any of these chemicals. FDA concludes that "none of the data" supports a finding that [these six synthetic substances] are human carcinogens when consumed at the levels of intended use." FDA's decision only applies to synthetic forms of these chemicals. So even if we don't consume these chemicals as food additives, we'll still be ingesting them in foods.

In an absolute sense, it would be difficult to argue that this decision will make American eaters any safer. So how should we make sense of its meaning? In order to understand the coalition's petition, and FDA's response to it, we have to turn back the clock 60 years to the law that continues to serve as a cornerstone of food safety regulation in the United States: the 1958 Food Additives Amendment.

In the 1950s, legislators were confronting a food system that was being transformed by synthetic chemistry. Advances in post-war food technology brought an explosion of new chemical additives, making possible many of the supermarket innovations of the time: the fluffiness of Wonder Bread, the extended shelf-life of potato chips, and a kaleidoscope of alluring flavors in beverages, snacks, and other treats. The problem was that FDA had no effective way of ensuring the safety of these chemicals before they reached our plates. Existing law, the 1938 Food, Drugs, & Cosmetics Act, only gave the federal government the power to act after the fact--to issue a recall only if and when a food additive had been shown to cause harm.

The Food Additives Amendment changed the rules of the game entirely. It gave FDA pre-market approval over food additives--the same kind of authority the agency already had to regulate pharmaceuticals. Manufacturers were required to submit scientific evidence showing, in the words of the statute, "reasonable certainty in the minds of competent scientists that the substance is not harmful under intended conditions of use." For the first time, the food industry had to prove to FDA that a synthetic chemical presented negligible danger to human health before it could be used in food.

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