Federal protections to keep potentially unsafe chemicals out of the nation’s foods are inadequate and may be putting the health of Americans at risk, according to the Natural Resources Defense Council, an environmental action organization.
The food safety protection system is minimal supervised by the U.S. Food and Drug Administration, has conflicts of interest in safety evaluations, and is ineffective due to a gaping loophole that allows companies to declare as safe hundreds of chemicals added to foods – without any notification to the FDA or the public, the council’s report released Monday said.
“Americans should expect that their food is safe to eat, but sadly today there’s no guarantee because safety oversight from federal agencies and food manufacturers is shockingly weak and hidden from public scrutiny,” said Tom Neltner, the council’s health scientist and report co-author.
“Congress should close the loophole responsible for this failing now,” Neltner said. “Until it does, FDA should strictly limit companies’ conflicts of interest and require them to disclose to the agency when they self-approve the safety of a chemical. And consumers should demand that their grocery stores and their favorite brands sell only food with ingredients deemed safe by federal food safety experts.”
The findings in council’s report, “Generally Recognized as Secret: Chemicals Added to Food in the United States,” focus on what it calls a loophole in a federal law known as “generally recognized as safe,” or GRAS.
The report shows:
- 275 chemicals used by 56 companies appear to be marketed as GRAS and used in many food products based on companies’ safety determinations that, under current regulations, didn’t need to be reported to the FDA or the public.
- Information obtained under the federal Freedom of Information Act shows that when the FDA does learn of a chemical proposed to be used in food, the agency often asks tough questions, but because of the GRAS loophole a company isn’t required to answer them and isn’t prohibited from continuing to sell the chemical for use in food.
- Based on information from notices submitted to the FDA, but later withdrawn, companies have sometimes certified their chemicals as safe for use in food despite potentially serious allergic reactions or adverse reactions in combination with common drugs. And, the companies have proposed using amounts of the chemicals in food at much higher levels than company-established safe levels.
- When companies seek the FDA’s voluntary review of their GRAS safety determination, the agency rejects or triggers withdrawal of that determination in one out of five cases. In some cases, companies may have withdrawn their notices to avoid having an FDA rejection made public.
- The public and the FDA don’t know about hundreds of chemicals found in food because companies aren’t required to submit the safety determination to the FDA for its review.
The council said these problems are the result of a 1958 law that included an exemption for common ingredients such as vinegar and vegetable oil. The exemption avoided a lengthily FDA approval process because there was a consensus in the scientific community that a chemical’s use was generally recognized as safe to eat or drink.
In following years, however, companies have heavily used this GRAS exemption to self-approve hundreds, if not thousands, of ingredients added to food, council’s report said.
In addition, companies are allowed to hire their own experts, which may be their own employees, to determine the safety of chemicals used in food. This can present a conflict of interest, especially when the FDA doesn’t review the GRAS decision, because the evaluators may have a financial incentive to provide positive results, according to the council’s report.
In four case studies, the council found that chemicals which were subject to a withdrawn GRAS notice have been listed as an ingredient in foods marketed to the public, despite FDA’s serious concerns about their safety. According to the council report, companies determined the following are safe:
- Epigallocatechin-3-gallate or EGCG: For use in beverages including teas, sport drinks, and juices, despite the FDA’s citation of evidence it may cause leukemia in fetuses in human cells tests and animal studies showing it affected the thyroid, testis, spleen, pituitary, liver, and gastrointestinal tract.
- Gamma-amino butyric acid or GABA: For use in beverages, chewing gum, coffee, tea, and candy, despite FDA concerns that estimated exposure was well in excess of what the company itself considered safe.
- Sweet lupin protein, fiber, and flour: For use in baked goods, dairy products, gelatin, meats, and candy, despite FDA-raised questions about whether or not the chemicals would cause serious allergic reactions in those with peanut allergies.
- Theobromine: For use in bread, cereal, beverages, chewing gum, tea, soy milk, gelatin, candy, and yogurt and fruit smoothies, despite FDA’s question about the estimated consumption being five times higher than the safe consumption level reported by the company.
