In a study released earlier this year by the Natural Resources Defense Council (NRDC), concerns were raised about a loophole in the Food Additives Amendment of 1958 for substances designated by food manufacturers as generally recognized as safe. The report, Generally Recognized as Secret: Chemicals Added to Food in the US, identified 56 companies that appeared to market 275 chemicals for use in food, based on an undisclosed GRAS safety determination. NRDC did not find evidence FDA had cleared any of the chemicals identified in this study for use in food.

Now, both FDA and at least one industry group are set to make some changes designed to take the “secret” out of GRAS. FDA has completed a review of how the agency evaluates the harmful effects of chemicals in foods, cosmetics, dietary supplements, animal food/feed and veterinary drugs. Based on the findings, FDA will take further steps to strengthen its internal processes.

At the same time, the Grocery Manufacturers Association (GMA) announced a five-part initiative that will advance the procedures used to assess the safety of ingredients used in food products. “Our industry is committed to providing consumers with safe, quality, affordable and innovative products,” says Dr. Leon Burner, GMA chief science officer. “In the spirit of that ongoing commitment, today we are launching a modernization initiative that will improve the process and increase the transparency for making GRAS determinations of ingredients added to food.”

GMA’s five-part initiative includes the following actions:

• GMA will take the lead in defining a standard that will provide clear guidance on how to conduct transparent, state-of-the-art ingredient safety assessments. These advanced procedures will be documented in a Publicly Available Standard (PAS) for GRAS determinations.
• GMA is establishing a program to ensure FDA has increased visibility to the ingredients assessed as GRAS by members of the food industry.
• GMA will expand its curriculum of GRAS education and training programs to increase the capability of scientists who assess the GRAS status of ingredients.
• GMA members committed to drive improvement in the GRAS assessment process by adopting a Code of Practice at the recent GMA board of directors meeting.
• GMA will execute a communications outreach program to inform stakeholders and consumers of steps being taken to increase the integrity of procedures used to assess ingredient safety.

FDA’s chemical safety assessment review (Report of the CFSAN Chemical Safety Review Working Group) is the first of three planned strategic reviews being conducted under the direction of FDA’s Office of Foods and Veterinary Medicine. Two others are focusing on nutrition and microbiological laboratory programs.

Among the first review’s most significant outcomes are:

• Led by CFSAN, FDA will develop a process for updating the agency’s Toxicological Principles for the Safety Assessment of Food Ingredients (aka Redbook) so that it reflects current science.
• FDA’s CFSAN and CVM will develop a process to ensure the consistency of the methodologies used for safety and risk assessments within and across offices at CFSAN and between CFSAN and CVM.

While the original GRAS determination applied to chemicals/ingredients such as oil and vinegar, since 1958, manufacturers have determined an estimated 1,000 chemicals are GRAS and used them in the food industry without any FDA approval or review, says Tom Neltner, an attorney in NRDC’s health program. Because these ingredients/chemicals are often undisclosed on food labels, consumers have no idea what the cumulative effects of these chemicals may be over a period of time, nor do they know what interactions these chemicals may cause with medications they may be taking or even with other food, beverages and/or nutraceuticals, according to Neltner.

GMA will work for more transparency in the self-approval evaluation process and provide more guidance for processors on how to conduct research to help ensure safe chemicals are added to food. “This is a good first step, but it doesn’t require disclosing all the information to the public, as it should,” says Neltner. He adds that FDA must have the opportunity to review and have final say in all safety assessments that allow the use of a chemical in food, and FDA should seek authority from Congress to require fees [from manufacturers] to review the safety of chemicals added to food. “There is no reason taxpayers should pay to have FDA to review the latest new chemical,” says Neltner.