- with readers working within the Automotive and Utilities industries
The U.S. Food and Drug Administration (FDA) continues to advance the Trump administration's Make America Healthy Again (MAHA) priorities by increasing scrutiny of chemicals in the food supply and accelerating the shift away from FD&C-certified (synthetic) colors and other food chemicals. Recent actions include a new request for information (RFI) supporting FDA's reassessment of butylated hydroxyanisole (BHA), a new enforcement discretion posture for "no artificial colors" claims, expanded permitted uses for certain naturally derived color additives, and preparation of a proposed rule that could require GRAS notification for all GRAS substances.
Key Takeaways
- BHA reassessment underway: FDA has launched a post-market reassessment of BHA and indicated it will seek information this year on other preservatives, including BHT and azodicarbonamide.
- "No artificial colors" enforcement discretion: FDA will generally refrain from enforcement action against certain "no artificial colors" claims when a product contains no FD&C-certified colors, even if it uses approved, naturally derived color additives exempt from certification.
- Color additive compliance still required: "Natural" color additives still require FDA authorization via color additive listing (i.e., approval following a color additive petition); enforcement discretion on labeling does not change that baseline rule.
- GRAS reform may be imminent: FDA's proposed rule reportedly requiring mandatory GRAS notification is under OIRA review and could be released at any time.
Post-Market Assessments of BHA and Other Preservatives
On February 10, 2026, FDA announced a comprehensive reassessment for butylated hydroxyanisole (BHA), a widely used preservative in human food and food-contact applications. FDA stated it will evaluate whether BHA remains safe under its current conditions of use based on the latest scientific information. It issued an RFI seeking information on current uses and relevant safety data. RFI responses are due April 13, 2026.
BHA has a long regulatory history. FDA listed BHA as Generally Recognized as Safe (GRAS) in 1958 and approved it as a food additive in 1961. However, since then, concerns periodically resurfaced about potential carcinogenicity. For example, a longstanding citizen petition submitted in 1990 alleged that BHA was associated with forestomach tumors in certain animal studies. However, FDA raised questions about human relevance in its Federal Register notice of the petition. BHA has also appeared in the National Toxicology Program's Report on Carcinogens since 1991 and has been classified by IARC as Group 2B ("possibly carcinogenic to humans").
FDA has indicated that it plans to issue additional RFIs this year, including for butylated hydroxytoluene (BHT) and azodicarbonamide.
See here for more information on FDA's post-market chemical review program, through which the agency evaluates emerging safety data, conducts targeted research, monitors contaminants, and, where justified, can amend or revoke prior approvals.
Enforcement Discretion for "No Artificial Colors" Claims
On February 5, 2026, FDA issued a letter to food manufacturers describing a revised enforcement posture for label statements such as "no artificial colors." Historically, FDA could view "no artificial colors" claims as potentially misleading if a food contained any color additive—even one derived from a natural source—because FDA's regulations define "artificial color" broadly to include "color additives," whether produced synthetically or derived from natural sources. 21 C.F.R. § 101.22(a)(4); 21 C.F.R. § 70.3(f).
Under the new approach, FDA intends to focus enforcement on products that make "no artificial colors" claims while using FD&C-certified colors (i.e., synthetic colors subject to certification). FDA stated it will generally decline enforcement where a product uses only approved color additives exempt from certification (i.e., certain non-certified colors), and contains no FD&C-certified colors.
FDA framed this change as part of a broader effort to accelerate industry transition away from certified colors. See here and here for more information on the MAHA agenda.
FDA indicated it will generally refrain from enforcement action for foods that contain no FD&C-certified colors and use only approved, non-certified color additives where the label bears claims such as:
- "Made without artificial food colors/colorings,"
- "No artificial color/colors/coloring," and
- "No added artificial color/colors/coloring."
This enforcement discretion is not legally binding. FDA has not amended the regulatory definitions of "artificial color" or "color additive," and the letter does not state that FDA intends to do so. Companies relying on the policy should also plan for continued exposure to state or private consumer litigation under consumer protection and other theories, even where FDA is unlikely to prioritize federal enforcement.
Separately, FDA has reminded industry that color additives exempt from certification must still meet applicable identity and specification requirements and comply with all other legal requirements. As manufacturers shift toward naturally derived color additives, they should ensure controls are in place to manage impurities (e.g., heavy metals, residual solvents, microbial contaminants). FDA has advised manufacturers to consult Appendix XXI of the U.S. Pharmacopeia's Food Chemicals Codex (FCC) for contaminant-control guidance for food colors derived from natural materials.
Expanded Uses of Certain Naturally Derived Color Additives
FDA also recently amended color additive regulations to expand permitted uses for two naturally derived color additives:
Beetroot Red
FDA amended its listing to allow beetroot red for coloring human food generally at levels consistent with current good manufacturing practice (GMP), with exceptions including certain U.S. Department of Agriculture (USDA)-jurisdiction foods, infant formula, and foods subject to standards of identity unless the standard authorizes the user.
Spirulina Extract
FDA also amended its listing for spirulina extract (Arthrospira platensis) to allow coloring human food generally at GMP levels and to update specifications, including lowering heavy metal limits for lead, arsenic, and mercury, and adding a cadmium specification. As with beetroot red, the expanded authorization does not extend to certain USDA- jurisdiction foods, infant formula, or foods subject to standards of identity that do not permit the use of spirulina extract.
Major Changes on the Horizon for GRAS Substances
On December 1, 2025, FDA submitted its proposed rule on GRAS ingredients to the Office of Management and Budget's (OMB) Office of Information and Regulatory Affairs (OIRA) for review. The proposed rule could be released at any time.
The proposal is expected to require submission of GRAS notices for all substances that companies have self-affirmed as GRAS, whereas GRAS notification is currently voluntary. The proposal may signal a reversal of FDA's long-standing position that mandatory GRAS notifications would be too resource-intensive for the agency to administer and that post-market enforcement could adequately support its public health mission. This would be a dramatic shift in FDA and industry practices, potentially increasing both transparency and scrutiny of ingredients widely used across the U.S. food supply.
For more information on GRAS affirmation and notification, see here, here, and here.
Practical Implications for Food and Chemical Manufacturers
- Engage early on RFIs: Companies that manufacture, use, or rely on BHA (and potentially BHT or azodicarbonamide) should consider whether to submit information and safety data in response to FDA's current and anticipated RFIs.
- Audit "no artificial colors" claims: Confirm products contain no FD&C-certified colors, including from sub-ingredients and carry-through components, and document the basis for any "no artificial colors" claims (supplier representations, specifications, change-control records).
- Confirm color additive authorization: "Natural" does not equal exempt. Verify that any non-certified color additive used is authorized for the intended use under FDA's color additive regulations (i.e., listed following a color additive petition).
- Strengthen impurity controls: Anticipate increased scrutiny of naturally derived colors and review supplier qualification, specifications, and risk-based testing plans for contaminants.
- Plan for litigation risk: FDA's enforcement discretion may reduce federal risk, but state and private litigation exposure remains.
- Prepare for GRAS reform: If FDA moves to mandatory GRAS notification, companies should anticipate new compliance costs and increased public scrutiny and consider building internal workflows now for notice preparation and governance.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
