WASHINGTON — An article that appeared Sept. 12 in The New England Journal of Medicine urged the US Food and Drug Administration (FDA) to take a more active role in food safety, specifically in the generally recognized as safe (GRAS) status of ingredients. An FDA spokesperson responded that the Federal, Food, Drug and Cosmetic Act does not give the FDA authority to follow through on some of the recommendations mentioned in the article.

The article, written by Pieter A. Cohen, MD, an associate professor of medicine at Cambridge Health Alliance, Somerville, Mass., and Emily M. Broad Leib, a clinical professor of law at Harvard Law School, said the FDA should require that manufacturers share all new GRAS determinations with the FDA. The FDA, according to the article, also could require that manufacturers base GRAS decisions on the results of multiple “high-quality” studies and to publicly post a summary of the evidence they used to determine an ingredient’s safety.

The FDA should reconsider the safety of previously introduced GRAS substances, including determining whether new evidence suggests that limits on the amount of the substance are required, according to the article, which added that the FDA should consider creating an expert advisory committee to meet periodically to review updated safety guidance. The authors compared the idea to the Dietary Guidelines Advisory Committee meeting every five years to give advice on the Dietary Guidelines for Americans.

Under current rules, manufacturers may determine for themselves that a substance is GRAS and send a notice to the FDA. If the FDA requests additional safety data, the company may comply or withdraw the notification. If the company withdraws its GRAS notification, it still may introduce the new ingredient into the food supply, according to the article.

“The FDA prioritizes its review of chemicals in food based on risk, science, safety and the FDA’s legal authority,” the FDA spokesperson said. “However, under the Federal Food, Drug and Cosmetic Act (FD&C Act), the law enacted by Congress that governs food additives, ingredients that meet the criteria for GRAS do not require the FDA’s pre-market review nor does the FD&C Act provide the FDA with specific authority to compel ingredient or food manufacturers to post their GRAS conclusions.”

Under FDA regulations, for a substance’s use to be considered GRAS, its safety data must be available publicly, the FDA spokesperson said.

“Food manufacturers are responsible for marketing safe foods, including ensuring the safety and regulatory status of the ingredients they use in foods before they are available to consumers,” the FDA spokesperson said. “The FDA currently reviews GRAS conclusions under the voluntary GRAS notification program. The FDA encourages industry to engage with our GRAS notification program in which FDA experts evaluate the publicly available safety data to see if the use of the ingredient raises any regulatory or safety questions.”

The article noted a recent food safety issue with tara flour. The FDA in May ruled tara flour is an unapproved additive in human food because it does not meet the GRAS standard. The ruling came after Daily Harvest in 2022 used tara flour in a leak and lentil crumble product that was associated with about 400 adverse event reports, including gastrointestinal distress, hepatotoxicity (liver damage) and hospitalization.

“The FDA can and does take action when it determines that a substance is not GRAS and is an unapproved food additive,” the FDA spokesperson said.