A wave of state laws aiming to ban certain chemicals from the food supply and create greater transparency in how additives are approved is reshaping the regulatory landscape and placing new scrutiny on FDA’s GRAS (Generally Recognized as Safe) system.
But a new survey by the International Food Information Council (IFIC) shows that nearly two-thirds of respondents (65%) who have heard of the self-affirmed GRAS pathway for ingredients consider it very effective (25%) or somewhat effective (40%).
IFIC released the results in its webinar “Generally Recognized As Safe or Generally Misunderstood? Understanding GRAS & Food Additive Safety” on Thursday, where the industry group sought to dispel what it said are common misperceptions about GRAS and make the case for maintaining federal control of the program.
The webinar comes at a time when legislatures across the nation are following the lead of California, where in 2023 Gov. Gavin Newsom signed the California Food Safety Act (AB 418) – landmark legislation that bans the use of brominated vegetable oil, potassium bromate, propyl paraben and Red Dye No. 3, effective January 2027.
Meanwhile, GRAS has also come under fire from Health and Human Services Secretary Robert F. Kennedy, Jr., who in March directed FDA to explore eliminating the self-approved GRAS system.
Legislatures following California’s new standard
Legislatures across the country have introduced over 100 bills that aim to reform the GRAS system and in some cases replace it entirely.
Tony Pavel, an attorney with Keller and Heckman, LLP said in the webinar that he is seeing an “unprecedented level of state legislative activity” across the country, and three states – New York, New Jersey and Pennsylvania – are considering bills that would implement a state GRAS program.
Pavel also offered a sample of other states – including Arizona (HB 2164), Arkansas (SB 9), Delaware (SB 69), Louisiana (HR 3, HR 4 and SB 14), Tennessee (HB 134), Texas (SB 314 and SB 25), Utah (HB 402), Virginia (SB 1289) and West Virginia (HB 2354) – that have already signed bills banning food dyes and other chemicals, restricting food additives in schools and requiring warning labels on products that contain certain chemicals.
Like in California, New York’s proposed Food Safety and Disclosure Act prohibits Red Dye No. 3, potassium bromate and propylparaben, but the proposal goes a step further by establishing a mandatory GRAS disclosure program, requiring companies to report to a public database publishing the safety data for additives now eligible for self-certification under GRAS.
Pennsylvania’s Show Us Your Science Act is a package of proposed bills that require GRAS disclosures, impose new labeling requirements and ban certain chemicals in public schools.
One of the bills, HB 1130, requires manufacturers to disclose use of GRAS substances and document them in a public database. HB1131 prohibits the sale of products containing Red 40, Yellow 5, Yellow 6, Blue 1, Blue 2 and Green 3 in public schools, and HB 1133 requires warning labels on products containing Butylated Hydroxyanisole (BHA).
New Jersey’s A4640 bill similarly requires disclosure of new food additives in products that are not reported to the FDA and establishes a public database that includes reports on the chemicals and their safety.
“We know that there are a number of legislative proposals on the hill at the moment, and we know that the agency is working on rulemaking, but what I want folks to keep in mind is some of these legislative proposals would eliminate GRAS entirely, and that would not put us at an equal footing with Europe or anywhere else in the world,” Pavel said. “It would put us behind, and it would create incredible challenges to innovation, as well as producing an abundant and safe food supply.”
Misperceptions and pitfalls?
Legislation establishing state review aims to close what critics refer to as the “GRAS loophole” that enables manufacturers to self-affirm the safety of chemicals that make it into the food supply.
Critics often point to the recall of tara flour in June 2022, when Daily Harvest Inc.’s French Lentils and Leek Crumbles sickened some 400 people and hospitalized more than 130. Daily Harvest identified tara flour as the culprit, and GRAS took much of the blame, according to Pavel.
He noted, however, that the manufacturer never engaged in a self-determination process before making the product available to the public.
“It’s been said, ‘Well, this got to market because of self-determination,’ – that is not accurate. This was a breaking-the-law issue, and FDA investigated. There was no self-determination ever made,” he said.
Pavel added that there have been few examples of companies including ingredients that have been subject to a secret determination.
“Companies are not hiding ingredients within their food that have been secretly determined to be GRAS – that would be a violation of law,” he said. “They would be misbranding those products as they enter the marketplace.
He continued: “I’d also note as a practical matter, food companies, and the companies that are producing those consumer products, they want to see the FDA no questions letter that the agency has reviewed those ingredients, and they rarely are relying on self-determinations for new ingredients.”
