CSPI's comments to FDA on butylated hydroxytoluene (BHT)
CSPI respectfully submits these comments in response to Docket No. FDA-2026-N-2526-0001. We appreciate the agency’s ongoing commitment to reforming the post-market assessment system for evaluating food chemical safety. CSPI is encouraged to see the agency initiate a post-market evaluation of butylated hydroxytoluene (BHT) following its inclusion in the FDA’s List of Select Chemicals in the Food Supply Under FDA Review.
Serious concerns about the safety of BHT have emerged over the past several decades, including from the FDA itself, yet it remains legal for use in food in the US. BHT is approved for use as an antioxidant, flavor enhancer, and flavoring agent or adjuvant. There is evidence that BHT causes cancer in animals, which should preclude the agency from approving its use in food under the Delany Clause, which prohibits the FDA from approving the use of additives that induce cancer in humans or animals.
Uses of BHT are regulated under the agency’s “Generally Recognized as Safe” regulations as GRAS substances. Courts have not ruled on the question of whether the Delaney Clause applies to GRAS substances, though at least one lower-level court has rejected the argument that GRAS self-certification inherently runs afoul of the Delaney Clause, and FDA’s finalized framework for post-market assessment adopts that interpretation as well. Appellate courts have not considered the question. We argue that this interpretation defies legislative intent; Congress clearly intended for novel food substances to come to market via the FDA pre-market approval process, not the GRAS process, and therefore, through the Delaney Clause, clearly intended for carcinogenic substances to be prohibited from use in food. It defies common sense for substances not reviewed by FDA (secret GRAS substances) to be subject to a lower standard than the ones FDA actually reviews. Therefore, FDA should declare that BHT is not GRAS on the basis of the cancer evidence.