Report finds over 100 food chemicals companies declared safe without notifying FDA

A new report has identified over 100 food chemicals that companies have declared are safe for consumption without notifying the Food and Drug Administration (FDA), leveraging what critics say is a legal loophole that prevents federal regulators from making sure food ingredients are safe.

The report, published March 3 by the Environmental Working Group (EWG), sheds light on chemicals added to popular food products under the FDA’s decades-old Generally Recognized as Safe (GRAS) designation, which exempts some food chemicals from the standard review process additives undergo before they are approved for the market.

While companies can choose to notify the FDA that they are designating a chemical as GRAS, they are not required to – the 111 GRAS chemicals in the EWG report were not disclosed to the agency.

“I think people should be concerned that the FDA doesn’t know what’s in food and that we have a regulatory process that allows companies to bypass the FDA’s safety review process and not even bother telling the regulator who’s in charge of making sure our food is safe,” said Melanie Benesh, EWG’s vice president of government affairs. Benesh co-authored the report with Maricel Maffini, an independent researcher.

The findings come after the FDA proposed a rule in December that would make GRAS submission notices mandatory and would require federal regulators to maintain a publicly available inventory of GRAS notices.

The proposal is currently under review by the Office of Management and Budget and the FDA is expected to issue it for public comment in late spring or early summer, Mark Hartman, director of the agency’s Office of Food Chemical Safety, Dietary Supplements, and Innovation, said at a recent chemical industry conference in Washington, DC.

Hartman did not respond when asked on a panel at the conference if the proposed rule would apply to GRAS chemicals already on the market in addition to new GRAS designations.

The “secret” GRAS chemicals Benesh and Maffini identified were acknowledged in an industry consulting database, trade publications or company press releases.

A chemical’s presence on the list in the report doesn’t necessarily mean it’s harmful, said Benesh, and some may have undergone internal company safety reviews.

“The problem is, we don’t really have access to that information,” she said.

Some substances on the list sound harmless and familiar, including mushroom and green tea extracts. But while certain foods may be safe in their whole form, they may have potentially harmful effects on the body when highly concentrated, said Benesh.

There are likely thousands of total GRAS substances on the market, she said, including those that have been disclosed to regulators and those that have not. However, it’s not possible to know the exact number, since not every company that decides its chemical is “generally recognized as safe” makes any sort of public announcement.

An FDA database contains 1,290 records of GRAS notices that companies have voluntarily filed since 1998, but these include multiples notices for the same substances that companies plan to use in different ways, said Benesh.

Food is a major source of toxic chemicals impacting young children’s health, and GRAS is “one important regulatory loophole” by which these chemicals are ending up in foods, Ami Zota, an environmental health researcher at Columbia University, said at a recent legislative briefing in Washington, DC.

“There’s really no transparency,” she said. “There’s very little accountability, too.”

The new EWG report echoes the findings of a 2014 report by the Natural Resources Defense Council (NRDC) that identified 275 food chemicals from 56 companies that appeared to have been given undisclosed GRAS determinations.

“This is likely the tip of the iceberg,” the authors wrote, noting that in a previous analysis they estimated that there had been 1,000 “secret” GRAS determinations at that time.

The number of GRAS chemicals in the EWG report is smaller because the NRDC report included substances that were submitted to the FDA’s voluntary GRAS notice inventory and later withdrawn, said Benesh while the new report includes only substances for which no notifications were sent to regulators.

At the American Chemistry Council (ACC)’s conference last week in Washington, DC, industry leaders defended their use of GRAS designations.

Deborah Attwood, who works in global regulatory compliance at the chemicals company WR Grace, said industry must evaluate its approach to GRAS moving forward to make sure people have trust in the designation.

“I think we have earned it, but I don’t know that we’ve communicated it,” said Atwood.

Joseph Dages, a lawyer with Steptoe LLP who counsels food and chemical companies, said at the conference that making a GRAS determination “actually requires a higher standard as opposed to the amount of information you would need to submit if you were going to put that same substance through pre-market review.”

Changing the GRAS system could potentially have economic consequences if companies are required to disclose confidential information, he added.

“If you’re now required to notify the agency about a GRAS determination for truly minimal exposure, single parts per billion or less, that’s a big deal to companies because all their competitors are going to see they’re using that substance in that way,” said Dages.

(Featured image by matthew Feeney on Unsplash.)