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FDA Loophole Allows Possibly Dangerous Chemicals in Food

A recent expose by the Natural Resources Defense Council (NRDC) about GRAS, in which it refers to the program as "Generally Recognized as Secret," reveals a don't ask/don't tell system in which as many as 1,000 additives have been self-declared "safe" by the companies that make them.
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Don't Ask/Don't Tell Food Additive System Puts Many At Risk

Since 1958, the FDA has allowed everyday ingredients in food without requiring a lengthy approval process for them. Food companies and their suppliers have never had to prove, for example, that vinegar, vegetable oil or sugar are safe; they are allowed in food under the Generally Recognized as Safe (GRAS) program.

Since the late 1990s, however, the GRAS program has become a dangerous "honor system" in which food makers can simply declare their additives and chemicals safe and put them in the food supply, neither petitioning the FDA for a GRAS designation or sometimes informing the FDA the additives are being used. In the 1950s, there were only a few hundred GRAS ingredients; now there are thousands and neither consumers or the FDA know what foods they are added to because they are unlabeled.

A recent expose by the Natural Resources Defense Council (NRDC) about GRAS in which it refers to the program as "Generally Recognized as Secret," reveals a don't ask/don't tell system in which as many as 1,000 additives have been self-declared "safe" by the companies that make them but not the FDA. In many cases, neither the FDA or consumers know the ingredients are in the food; in other cases, ingredients the FDA has specifically rejected as GRAS still appear in food -- sometimes, ironically on the label.

And it gets worse. Many of the companies making the additives are headquartered overseas like the China-based Hanzhong TRG Biotech, which makes at least 40 of the chemicals NRDC says have undisclosed GRAS safety determinations. In 2007, tainted pet food from China killed many U.S. dogs and cats and in 2010 Whole Foods was found to be selling foods from China as "organic" (including its "California blend" vegetables) when no such designation is even possible. Many China imports are rejected because of "pesticides, bacteria and filth," say officials.

Such imported additives are "triply difficult" for the FDA when the companies self-declare them as safe, Erik Olsen, senior strategic director for health and food at the Natural Resources Defense Council told me. The FDA does not realize the additive is being used, has not, itself, evaluated the additive and it lacks a mechanism for assessing the safety of imported products. Buyer beware.

Rules for what proves "safety" are also vague, Dr. Olsen told me. It is largely assumed that if a company self-declares its product "GRAS" and markets it, there exists corroborating scientific or clinical evidence somewhere if the FDA should want to see it. But NRDC investigations found that sometimes the proof of safety boils down one paltry published study. Almost none of the companies NRDC contacted would provide information about their GRAS determination -- often citing "propriety" reasons -- though several assured NRDC their products were safe and some provided supporting studies. Four companies said they would provide safety information about five additives if NRDC swore to keep it confidential. We're eating it but it's a secret?

Who are the additive companies? A quick glance shows a roster of chemical and drug companies as opposed to well known food names like Kraft or ConAgra like Merck eprova AG, located in Switzerland and BASF Cognis Nutrition and Health, part of BASF, the world's largest chemical company, based in Germany with 66 U.S. subsidiaries.

Almost 100 additives with "undisclosed GRAS safety determinations" are made by NutraMax, whose website advertises products for "your heath," "for your pet," and "for your horse." When we asked Dr. Olsen what Nutramax products the additives are found in, he said that information is not known yet. (After all, the additives are not labeled.)

Many are made by chemical/food companies not in the U.S. like Hanzhong TRG Biotech, located in China and Jungbunzlauer and Merck eprova AG located in Switzerland.

If additive makers can "self-declare" an ingredient safe why would they ever petition the FDA for a GRAS determination, I asked Dr. Olsen, especially if the FDA determination results in a delay and a possible online "rejection letter" if the ingredient doesn't make it? He said the answer was that an FDA determination could help the additive makers in sales to food companies, even though it is not clear if the food company or the additive maker would be liable an ingredient proves harmful. Sadly, the "harm" is often not known until a consumer suffers adverse reactions.