Potentially Harmful Chemicals Find Their Way Into Our Food Thanks To 56-Year-Old FDA Rule

There are a number of federal protections to keep unsafe chemicals out of our favorite foods. But more often than not, those protections fail consumers. A new report by the Natural Resources Defense Council explores one of those failures: Generally Recognized As Safe (GRAS) designation.

Here’s how it works: the designation allows companies to use their own scientists or contractors to determine if a food additive is safe for consumption. Through use of that loophole a number of potentially dangerous chemicals are being poured into products such as cereal bars, chewing gum and sports drinks.

On Monday, the NRDC released a report [PDF], “Generally Recognized as Secret: Chemicals Added to Food in the United States,” highlighting the inadequacies and minimal Food & Drug Administration supervision found in the United States food safety protection system.

“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.

One of those inadequacies is the use of the Food Additives Amendment of 1958 which exempted from the formal, extended FDA approval process common food ingredients like vinegar and vegetable oil that are “generally recognized as safe” (GRAS).

Today, the Act has evolved to become a loophole that allows manufacturers to make safety determinations about the newest chemicals used in food without notifying the FDA. The chemicals are deemed safe by the manufacture’s in-house scientists or employees, a clear conflict of interest, the NRDC says.

Further, the safety of a chemical is usually determined without taking into consideration the potentially serious allergic reactions, interactions with common drugs, or proposed uses much greater than company-established safe doses.

In an attempt to limit these undisclosed GRAS determinations the FDA allows companies to voluntarily inform the the agency about their chemicals. However, when the FDA begins to ask tough questions the companies often withdraw their information, Neltner says.

Because of the frequency at which companies make GRAS safety determinations, the NRDC decided to explore the companies’ rationale for not participating in the voluntary notification program.

The NRDC identified chemicals that appear to be marketed in the U.S. pursuant to an undisclosed GRAS determination. In all, the report found 275 chemicals from 56 companies that are marketed for use in food based on GRAS.

Using a Freedom of Information Act request, the NRDC identified four case studies in which a company withdrew its voluntary GRAS notice to the FDA after the agency brought forward concerns about the chemical’s safety.

A company determined the use of Epigallocatechin-3-gallate (EGCG) was safe in the production of 25 products including teas, sports drinks, and juices. However, documentation shows the FDA cited evidence the chemical may cause leukemia in fetuses in human cell tests and animal studies showing it affected the thyroid, testis, spleen, pituitary, liver and gastrointestinal tract.

Gamma-amino butyric acid (GABA) is currently used in five products marketed in the U.S. including beverages, chewing gum, coffee, tea, and candy despite the FDA’s concerns that estimated exposure was well in excess of what the company itself deemed safe.

Sweet lupin protein, fiber, and flour is found 20 products in the U.S. including baked goods, dairy products, gelatin, meats and candy despite the FDA-raised questions about whether or not the chemical would cause serious allergic reactions in those with peanut allergies. The chemical is found in a plant related to the peanut family.

A company determined Theobromine was safe to be used 20 products including bread, cereal, beverages, chewing gum, tea, soy milk, gelatin, candy and yogurt despite the FDA’s questions about the estimated consumption being five times higher than the safe consumption level reported by the company.

Neltner said the NRDC could not name specific companies using the chemicals in their products, citing an agreement the organization made in order to gain access to a commercial database for their investigation.

Asked whether consumers would be able to connect any health issues with the consumption of the chemicals, Neltner says there wouldn’t have been enough time to completely explore the effects.

The NRDC concludes that a chemical additive cannot be “generally recognized as safe” if its identify, chemical composition and safety determination are not publicly disclosed to the FDA.

“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,” Neltner says. “And consumers should demand that their grocery stores and their favorite brands sell only food with ingredients deemed safe by federal food safety experts.”

NRDC Report: Potentially Unsafe Chemicals in Food Threaten Public Health [Natural Resources Defense Council]