Regulatory Roundup

Regulatory Roundup March 10, 2026

AWG Regulatory Roundup — March 10, 2026

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FDA to Host Dietary Supplement Ingredients Public Meeting

On March 3, 2026, FDA announced that it will host a public meeting (in person and virtually) entitled “Exploring the Scope of Dietary Supplement Ingredients.” The March 27, 2026 meeting will include presentations on the following topics:

  • The scope of the phrase “dietary substance for use by man to supplement the diet by increasing the total dietary intake” as used in DSHEA (Section 201(ff)(1)(E) of the FD&C Act);
  • New methodologies to produce existing dietary ingredients; and
  • Specific ingredient types, including proteins, enzymes, and microbials.

Meeting participants will have the opportunity to provide feedback during the meeting and submit comments for the agency to review. Please reach out to us if you’d like assistance with preparing comments.

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Amazon’s DSHEA Disclaimer Stay Request Denied

The U.S. District Court for the Western District of Washington denied Amazon’s motion for a stay in Li et al. v. Amazon.com Services LLC, a class action alleging that the retailer promoted and sold dietary supplements in its online marketplace with structure/function claims that failed to include the mandatory DSHEA disclaimers. In its motion, Amazon cited FDA’s December 2025 letter to the dietary supplement industry, which stated that the agency is considering a regulatory amendment to 21 C.F.R. § 101.93(d) regarding the requirement for the DSHEA disclaimer to appear on each panel of a product label where an applicable claim is made.

Applying the Syntek factors to determine whether FDA has primary jurisdiction over the issue, the court found that the primary jurisdiction doctrine does not apply because Amazon failed to show, beyond mere speculation, that FDA will amend the regulation in a manner that applies retroactively.

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California Takes Aim at GRAS

On February 17, 2026, California Assembly Member Addis introduced Assembly Bill 2034, which would require packaged food manufacturers selling products in California to provide evidence to the California Department of Public Health (CDPH) that each color additive, food additive, and dietary ingredient in their products is safe. If an ingredient was introduced prior to 1958 or has undergone pre-market review by FDA, the safety is presumed; however, if an ingredient is self-affirmed GRAS, the manufacturer must provide such evidence to CDPH. For ingredients introduced prior to July 1, 2027, manufacturers will be required to submit a notice through an online database, and CDPH will review the submitted notices and either publicly publish the notice and issue a license to the manufacturer stating that the ingredient can be used as outlined in the notice or issue a rejection letter to the manufacturer. For ingredients introduced after July 1, 2027, the public will have 45 days to file objections to any new ingredient notice prior to CDPH making its decision on whether to issue a license. The bill also includes a provision requiring CDPH, starting July 1, 2030, to review 10 food additives, color additives, prior-sanctioned substances, and dietary ingredients every three years.

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ICYMI – IN DEPTH: Extended Producer Responsibility (EPR) for Packaging: New Year, New Regulatory Burden

Speaking of the states, in case you missed it, please check out our in-depth coverage of state Extended Producer Responsibility (EPR) laws – a growing trend in state law that will affect business operations throughout the CPG supply chain.

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AWG in the News

Could 2026 Be the Biggest Year for Dietary Supplements Since the Introduction of GMPs?

FDA Sets Meeting to Clarify DSHEA Definitions

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Where We’ll Be

Please say hello or reach out to schedule a meeting!

Rend Al-Mondhiry, Personal Care Products Council 2026 Beauty Collective Summit, March 23-25, 2026

Rend Al-Mondhiry and Ivan Wasserman, SupplySide Connect, April 14-15, 2026

Rebecca Lee, Food Protein Summit, April 15-16, 2026

Evan Phelps, Medical Device Manufacturers Association Annual Meeting, April 29-May 1, 2026

Ryan Kaiser and Ashley Rovner-Watson, International Trademark Association Annual Meeting, May 2-6, 2026

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