Industry groups have urged the US Food and Drug Administration (FDA) to tread cautiously in its post‑market review of butylated hydroxyanisole (BHA), warning that regulatory action could be disproportionate to health risks posed by the long‑authorised preservative used in food and as a food contact substance (FCS).
The comments come amid a broader effort by the FDA to revamp its process for post-market reviews of food chemicals, including generally recognised as safe (GRAS) substances. The review of BHA could serve as a bellwether for the agency’s ongoing reset of its post-market oversight of food chemicals.
In February, the FDA launched its review of BHA – a preservative used in food processing and packaging materials to prevent fats and oils from oxidising and maintain product stability and shelf life – and released a request for information (RFI) about its uses and safety profile.
Data received in the RFI could help inform an assessment of whether the preservative remains safe under current conditions of use (COUs) in food and food contact materials (FCMs), the FDA said at the time.
In response, a cross‑section of food industry and consumer goods groups pushed back against any potential move to revoke or restrict the preservative’s authorised uses in food and FCMs absent new evidence of risk.
While business groups generally welcomed the FDA’s efforts to modernise oversight of food chemicals, they said scientific evaluations do not support removing BHA from the food supply, adding that an overly aggressive post-market review could set a regrettable precedent for future assessments.
Many environmental groups, on the other hand, urged the FDA to "take decisive action" to remove BHA from the food supply, citing evidence of its carcinogenicity.
‘Lack of transparency’
While industry groups voiced support for post‑market reviews, they asked the FDA to clarify how it will interpret prior assessments, particularly since the outcome of the BHA review is likely to be an indicator of how far the agency may go in revisiting other legacy authorisations.
The Consumer Brands Association (CBA), for example, said the post‑market review process is essential to ensure a safe food supply "while also promoting a more predictable regulatory landscape for industry".
However, it said there is "a lack of transparency" around what a post-market review will entail, adding that the FDA should clarify how information collected through RFIs will be used in that process.
That is particularly important for assessing substances such as BHA that have authorised uses for food and FCMs across the regulatory landscape, the CBA said.
"We continue to encourage the FDA to provide the public with additional transparency and a final approach to the post-market assessment process," the group said. "Without this information, it is unclear how the information collected in this RFI will be utilised."
‘Well-documented history of safe use’
Other industry groups focused on scientific precedent supporting the safety of BHA.
The Food & Beverage Issue Alliance (FBIA) said BHA has a "long and well‑documented history of safe use" under existing conditions, and that scientific evidence continues to support the ingredient’s use in both food and packaging.
The National Pork Producers Council (NPPC) agreed, saying BHA remains "scientifically evaluated, internationally approved, technologically necessary, and economically important" in the food production process.
The NPPC also said that exposure assessments show the amount of BHA leaching from FCMs into food "is low and remains well within established safety thresholds".
Meanwhile, groups such as the American Feed Industry Association (AFIA) warned that the FDA’s actions on BHA "will likely have implications, whether intended or not" for the availability of other preservatives used in food, feed and FCMs.
Environmental groups urge ‘decisive action’
On the other hand, environmental groups urged the FDA to restrict or remove BHA from food and related applications.
The Environmental Working Group (EWG) said the FDA already has sufficient evidence to act on BHA due to the preservative’s classification as a carcinogen by both the US National Toxicology Program and California’s Proposition 65. On that basis, the FDA should "take decisive action to remove" BHA from the food supply, the group said.
The Food Packaging Forum (FPF) said restricting BHA’s food contact uses is warranted, citing evidence that the substance migrates from FCMs into food under realistic COUs. It is "reasonable to assume that human exposure is widespread" and that plastic FCMs containing BHA contribute to exposures, the group said.
And the Center for Science in the Public Interest (CSPI) said the FDA should restrict BHA under the Delaney Clause, a 1958 amendment to the Federal Food, Drug, and Cosmetic (FD&C) Act that prohibits the agency from approving food additives found to ‘induce cancer’ in humans or animals. Since BHA is listed as a carcinogen by multiple authoritative bodies, the agency should prohibit its use and revoke its GRAS status, CSPI said.
The FDA has not yet indicated its next steps in the BHA post-market review process.