WASHINGTON (April 7, 2014) – Federal protections to keep potentially unsafe chemicals out of our foods are woefully inadequate and may be putting the health of Americans at risk, a Natural Resources Defense Council investigation found.
The food safety protection system is marred by minimal supervision by the U.S. Food and Drug Administration, rife with apparent conflicts of interest in safety evaluations, and rendered all but toothless by a gaping loophole that allows companies to simply declare as safe hundreds of chemicals added to our foods—without any notification to the FDA or the public, according to an NRDC report released today.
“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, NRDC health scientist and report co-author. “Congress should close the loophole responsible for this failing now. 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 NRDC’s report, “Generally Recognized as Secret: Chemicals Added to Food in the United States,” focus on a key shortcoming in the safety oversight of chemicals in food, 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, pursuant to current regulations, did not need to be reported to the FDA or the public. This is probably just the tip of the iceberg.
- Information obtained under the federal Freedom of Information Act shows that when 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 is not bound to answer them and not 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- Based on information from notices submitted to the FDA, but later withdrawn, companies have sometimes certified their chemicals as safe for use in food despite potentially serious allergic reactions, or adverse reactions in combination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, or have proposed using amounts of the chemicals in food at much higher levels than company-established safe levels.
- When companies seek FDA’s voluntary review of their GRAS safety determination, the agency rejects or triggers withdrawal of that determination in one out of every 5 cases. At least in some instances, companies may have withdrawn their notices in order to avoid having an FDA rejection made public.
- The public and FDA are in the dark about hundreds of chemicals found in our food because companies aren’t required to submit the safety determination to FDA for its review.
These problems are rooted in a 1958 law which included an exemption designed for common ingredients such as vinegar and vegetable oil. The exemption avoided an extended FDA approval process because there was a consensus in the scientific community that a chemical’s use was generally recognized as safe to consume. In the ensuing years, however, companies have heavily used this GRAS exemption to self-approve hundreds, if not thousands, of ingredients added to food, NRDC’s report says.
More troubling, 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 serious conflict of interest, especially when FDA does not review the GRAS decision, because the evaluators may have a financial incentive to provide positive results, according to NRDC’s report.
In four case studies, NRDC found that chemicals that 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. They are:
- Epigallocatechin-3-gallate (EGCG): A company determined as safe for use in beverages including teas, sport drinks, and juices, despite 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 (GABA): A company determined as safe 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: A company determined as safe 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: A company determined as safe 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.
“The law places responsibility on FDA to ensure food Americans consume is safe. If the FDA is in the dark about the identity and safety of hundreds of chemicals, it cannot do its job. The “generally recognized as secret” loophole undermines public health,” said NRDC health scientist Maricel Maffini, the report’s coauthor.
A link to NRDC’s report, FOIA documents and a video about the GRAS issue is here: