FDA Loophole Allows Unlabeled and Possibly Dangerous Chemicals in Food
FDA Loophole Allows Unlabeled and Possibly Dangerous Chemicals in Food

Since 1958, the FDA has allowed ingredients in foods 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 nor 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 nor the FDA know to which foods they are added because they are unlabeled.

As many as 1,000 food additives have been self-declared ‘safe’ by the companies that make them but not by the FDA.

A recent exposé by the Natural Resources Defense Council (NRDC) about GRAS—that 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 by the FDA.

In many cases, neither the FDA nor consumers know the ingredients that are in the food. In other cases, ingredients the FDA has specifically rejected as GRAS still appear in food—sometimes, ironically on the label.

Many of the companies making the additives are headquartered overseas—in China, for example, which makes exports often rejected due to ‘pesticides, bacteria, and filth.’

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 FDA inspectors.

Such imported additives are triply difficult for the FDA when the companies self-declare them as safe.

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

A vendor picks up rice at her stall in a market in Beijing on Dec. 2, 2009. For decades, high levels of cadmium and other toxic heavy metals have polluted China's waterways and through irrigation they have ended up in village rice paddies. (Peter Parks/Getty Images)

A vendor picks up rice at her stall in a market in Beijing on Dec. 2, 2009. For decades, high levels of cadmium and other toxic heavy metals have polluted China’s waterways, and through irrigation they have ended up in village rice paddies. (Peter Parks/Getty Images)

Rules for what proves “safety” are also vague, Olsen said. 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 doesn’t show companies you’d expect like Kraft or ConAgra, but instead chemical and drug companies. Some companies on the roster are 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 Olsen what Nutramax products the additives are found in, he said that information is not known yet. (After all, the additives are not labeled.)

If additive makers can “self-declare” an ingredient safe, why would they ever petition the FDA for a GRAS determination, especially if the FDA determination results in a delay and a possible online “rejection letter” if the ingredient doesn’t make it?

Olsen said there is still some benefit to petitioning the FDA. 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 if an ingredient proves harmful.

Sadly, the “harm” is often not known until a consumer suffers adverse reactions.

Martha Rosenberg is author of the award-cited food exposé “Born With a Junk Food Deficiency.” A nationally known muckraker, she has lectured at the university and medical school level and appeared on radio and television.

Top