FDA Food Ingredient Approval Process Violates Law, Says CSPI

Consumers are being exposed to potentially dangerous chemicals that industry self-certifies as safe for use in foods, with little or no scrutiny from the Food and Drug Administration, according to the Center for Science in the Public Interest, Consumers Union, Environmental Working Group and Natural Resources Defense Council. In an 80-page regulatory comment filed today, the four organizations told the FDA that its process for determining what substances are generally recognized as safe—or “GRAS” in agency parlance—violates the 1958 law that requires FDA oversight of whether ingredients are safe before they can be used in food.

That law acknowledged that the FDA need not require pre-market testing of substances that had long been used in foods or that were well-recognized as safe by scientists. But in a rulemaking opened by the agency in 1997—but never finalized—FDA weakened the standards for what could be considered GRAS and proposed making permanent what the groups say is an illegal program of GRAS determinations by the food industry, often done in secret.

“Congress sensibly intended that certain common ingredients already in wide use, like vinegar or baking soda, would be exempt from the pre-market testing requirements it set up for food additives,” said CSPI regulatory affairs attorney Laura MacCleery. “But FDA has let companies completely abuse that limited exemption and hide the use of new food chemicals from regulators and the public.”

“The FDA’s job is to ensure the safety of our food supply; it should be doing much more to protect our health—not outsourcing decisions on the safety of thousands of chemicals in our food to industry,” said Erik D. Olson, director of NRDC’s health program.

Manufacturers are able withdraw their GRAS notifications if the FDA raises questions about the substances. But that hasn’t prevented other companies from going ahead and using the substances in food anyway. Epigallocatechin-3-gallate is one such chemical, used in beverages, even though its manufacturer had submitted and withdrawn GRAS notifications twice in response to FDA questions. A Japanese company withdrew its notification that the neurotransmitter gamma-aminobutyric acid was GRAS after the FDA expressed concerns. Nevertheless, the NRDC found GABA in bottled tea and nutrition bars.

“The GRAS loophole gives industry the upper hand,” said Maricel V. Maffini, co-author of an important 2014 report from NRDC on problems with the GRAS system. “If FDA asks for additional or more current toxicology or exposure information, a company may choose to withdraw its GRAS notice, effectively leaving the agency in the dark.”

The FDA also allows GRAS determinations to be made by a trade association of chemical manufacturers, the Flavor and Extract Manufacturers Association. For instance, FEMA certified as GRAS a chemical, trans-6-octenal, said by one company to have a “green melon character.” FEMA could not provide any published safety data on trans-6-octenal or three other chemicals it certified as GRAS when CSPI and NRDC asked for such data last year.

“It’s quite extraordinary for a federal agency to basically subcontract its regulatory work to a trade group designed to protect the business interests of its member companies,” MacCleery said. “It’s a process that does not inspire consumer confidence in these chemicals, and it’s certainly not what Congress intended when it required the FDA to issue pre-market approvals of novel and inadequately tested food additives.”

FEMA is declaring chemicals as GRAS even in cases where the scientific literature raises questions about their safety. The chemical o-phenylphenol was determined by FEMA to be GRAS even though the state of California considers it a carcinogen. Another chemical, trans, trans-2,4-hexadienal is GRAS for use as a flavoring, despite classification as a possible carcinogen by the International Association for Research on Cancer.

“The FDA must provide better oversight over all of the substances that are put in our food, especially those whose safety is in question,” said EWG research director Renee Sharp. “Any safety determination should be based on publicly available scientific data, not the opinions of ‘expert panels’ that likely have conflicts of interest with food additive regulation.”

The same trade association is also certifying as GRAS new chemical taste modifiers, which manufacturers describe only as “artificial flavors” on ingredient lists, even though the substances have no flavor. Those chemicals may prove to be beneficial, enabling manufacturers to use less salt or sugar in certain foods. But companies can, and in some cases are, adding them to foods and drinks without submitting any information on the substances to FDA for evaluation.

“Any substance added to food created by using new science or technology, including nanomaterials, should be required to undergo a safety assessment prior to marketing and so should categorically be denied GRAS status,” said Consumers Union senior scientist Michael Hansen.

Ingredients created through nanotechnology can be used in food without FDA oversight, although tiny nanomaterials have novel properties that may have unpredictable effects on the body. The FDA issued guidance to industry that nanomaterials are ineligible for GRAS certification, but that guidance is nonbinding.

Another relatively new entrant to the food supply is Quorn-brand mycoprotein, a vat-fermented soil mold that gets processed into imitation chicken patties and other products. Quorn’s manufacturer informed the FDA in 2001 that the product was GRAS after the agency failed to act on an earlier company petition to accept mycoprotein as a food additive. A significant percentage of people experience nausea, violent vomiting, diarrhea, or life-threatening anaphylactic reactions after eating Quorn. At least one death has been linked to the product in the United States.

The FDA is required to publish a final rule on GRAS substances by August 2016 as part of a consent decree it reached with the Center for Food Safety, an advocacy organization that sued the agency last year.

The nonprofit groups’ filing makes a number of recommendations that it says would bring FDA’s pending proposal on GRAS in line with the 1958 food additives law. GRAS designations should not be used for novel chemical ingredients, the groups say, or for substances flagged as risks by authoritative scientific bodies. GRAS notifications shouldn’t be based on unpublished studies and should be made by experts without a conflict of interest. And FDA must make GRAS notifications mandatory and public, not voluntary and secret, the groups say.

“By reasserting its legitimate power over the scope and substance of safety determinations with reasonable definitions and requirements, FDA could restore the rightful position of GRAS in the statutory scheme and reestablish public confidence in the agency’s oversight,” the filing states.