Regulatory Roundup

Regulatory Roundup February 24, 2026

AWG Regulatory Roundup — February 24, 2026

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FDA to Reassess BHA

On February 10, 2026, FDA announced that it is re-evaluating the preservative butylated hydroxyanisole (“BHA”) as a food additive. FDA listed BHA as GRAS in 1958 and approved it as a food additive in 1961. The reassessment will focus on whether BHA is safe for its current uses in food and as a food contact substance, based on the latest scientific information. As part of the reassessment, FDA has issued a Request for Information on the use and safety of BHA, with written comments and scientific data and information due by April 13, 2026. The assessment of BHA is one of several post-market assessments as part of the agency’s ongoing review of chemicals in the food supply.

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FDA Announces Enforcement Discretion For “No Artificial Colors” Claims

FDA recently published a press release and sent a letter to industry explaining that it intends to exercise enforcement discretion with respect to “No Artificial Colors” and similar claims that appear on products that contain non-petroleum-based colors. Currently, FDA considers any added color, regardless of source, to be an “artificial” color additive. In the February 5, 2026 press release, the agency also announced that it has approved beetroot red as a new color additive and expanded uses for spirulina extract, a previously approved color additive. On the same day, FDA sent a second letter to manufacturers to remind them “that, while certain color additives do not require FDA batch certification, all authorized color additives must meet the identity and specifications (including purity specifications) described in their listing regulations.”

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Federal Legislation Seeks to Preempt State-Based Dietary Supplement Laws

On February 4, 2026, Representative Nick Langworthy (R-NY) introduced the Dietary Supplement Regulatory Uniformity Act (H.R. 7366), which would prohibit states from enacting or continuing to enforce “any requirement concerning a dietary supplement which is different from, or in addition to, or that is not otherwise identical with, a requirement applicable to a dietary supplement under” the FD&C Act. The bill allows states to petition FDA if local conditions require a dietary supplement law or regulation that differs from the federal law.

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GRAS Oversight and Transparency Act Introduced in Congress 

On February 3, 2026, Representative Mike Lawler (R-NY) introduced the GRAS Oversight and Transparency Act (H.R.7291), which would establish an interagency GRAS Review Board “to review the validity of covered GRAS designations,” led by FDA and HHS, with participation from USDA and EPA. The bill defines “covered GRAS designations” as substances designated as GRAS by a manufacturer prior to 2000 and that have not been notified to FDA (i.e., substances that were self-affirmed as GRAS prior to 2000). The bill would require food manufacturers to provide the Board, not later than 90 days after the enactment of the law, a notice that identifies each covered GRAS designation attributable to such manufacturer together with any other information the Board requires. Non-compliance would result in civil penalties or the Board treating the GRAS substances as unapproved food additives. The Board would then prioritize and review the validity of each designation, based on a tiered system, and, not later than 90 days after completing the review of a covered GRAS designation, would notify the Secretary of HHS and Congress of any determination that a substance is not safe and recommend that the Secretary revoke the GRAS designation. Depending on the priority of the substance’s review, the recommendations would be made public either two, four, or ten years after the bill’s enactment.

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Virginia Considers Dietary Supplement Disclosure and Gluten Disclaimer Bill

The Virginia Senate has introduced Senate Bill 486, which, if signed into law, would require all dietary supplements manufactured, distributed, sold, or offered for sale in the state to include a clear, legible, and conspicuous label that lists all active ingredients and inactive ingredients contained in the product, effective July 1, 2027. “Inactive ingredient” is defined as “any component of a dietary supplement other than an active ingredient, including excipients, fillers, binders, flavorings, colorings, preservatives, coatings, or processing aids.” For products that contain gluten, the label must also include a clear, legible, and conspicuous disclaimer separate from the list of active ingredients and inactive ingredients that states “contains gluten.” The bill passed the Senate on February 9, 2026, and is currently in committee in the House.

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Court Pauses Texas Food Warning Law

The Western District of Texas issued a preliminary injunction blocking enforcement of Section 9 of Texas Senate Bill 25, which requires foods containing one of 44 listed ingredients to bear the following warning statement, effective January 1, 2027:

“WARNING: This product contains an ingredient that is not recommended for human consumption by the appropriate authority in Australia, Canada, the European Union, or the United Kingdom.”

In December, four food and beverage trade associations filed a lawsuit challenging the constitutionality of the warning requirement. On February 11, 2026, the court held that the plaintiffs showed substantial likelihood of success on the merits of their First Amendment claim and that the state failed to show the law is narrowly tailored to the state’s interest of providing information on the possible dangers of food products. However, the court found the plaintiffs’ arguments that the law is unconstitutionally vague and that the warning requirement is preempted by federal law were not likely to succeed. Of note, the injunction only applies to the plaintiff trade associations and their members while the lawsuit is ongoing.

As previously reported, in December a federal court in West Virginia issued a preliminary injunction temporarily blocking enforcement of West Virginia House Bill 2354, which bans the use of certain color additives in food.

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What’s Trending in Litigation?

There is no sign that plaintiffs’ claims against food companies making “no artificial flavors or preservatives” claims on products that contain citric acid, DL-malic acid, or similar ingredients alleged to be artificial are abating. Plaintiffs also arguing that the presence of these acid ingredients renders “With Other Natural Flavors” declarations deceptive, and dietary supplements are also a growing target for these suits. Protein content claims are another area of focus for plaintiffs, with numerous demand letters and complaints alleging that the stated protein Percent Daily Value was not properly adjusted using the Protein Digestibility-Corrected Amino Acid Score (PDCAAS), or that the Percent Daily Value is missing from the Nutrition or Supplements Facts panel. Complaints and demand letters are also piling up for products – especially protein powders – that allegedly contain undisclosed and unsafe levels of heavy metals. Finally, for companies offering online subscription services, there are a growing number of lawsuits targeting those services due to technical violations of California’s Auto-Renewal Law.

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