AWG Regulatory Roundup — September 22, 2026
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- FDA Clarifies Cosmetic Registration and Product Listing Do Not Mean FDA Approval
- FDA Now Accepting Applications for its Expedited IND Pilot
- FDA Seeks Public Input to Advance Development of Botanical Drug Products
- PABA and Trolamine Salicylate Removed From Sunscreen Monograph
- FTC Launches New Rule Guidance Program
- New Legislation Seeks to Reform Drug Preclusion
FDA Clarifies Cosmetic Registration and Product Listing Do Not Mean FDA Approval
FDA issued a Constituent Update clarifying that it does not provide certificates or other documents verifying compliance with cosmetic facility registration or product listing requirements under the Modernization of Cosmetics Regulation Act (MoCRA). FDA also emphasized that a cosmetic facility registration number or product listing number does not constitute FDA approval of the facility or its products. The clarification comes in response to inquiries, including from e-commerce platforms, requesting documentation of FDA registration or exemption.
FDA Now Accepting Applications for its Expedited IND Pilot
On September 15, 2026, FDA published the final design of its Expedited Investigational New Drug (IND) Pilot Program. The program seeks to “accelerate the time it takes from identifying a drug to initiating a first-in-human clinical trial by partnering drug companies with qualified research institutions (QRI) that have scientific expertise to support efficient development of IND applications.” Applications to participate are due October 30, 2026. FDA expects that 8–10 Sponsor-QRI pairs will be selected to join the initial pilot cohort.
FDA Seeks Public Input to Advance Development of Botanical Drug Products
FDA has issued a request for information (RFI) to gather public input on ways to further advance the development of botanical drug products. To date, four botanical products have been approved for marketing as prescription drugs through FDA’s new drug application and biologics license application pathways. Additionally, botanical ingredients such as psyllium and witch hazel may be marketed under certain over-the-counter monographs. Through the RFI, FDA aims to build on its experience with these products and other botanical drug development programs. Comments, data, and information may be submitted through November 3, 2026.
PABA and Trolamine Salicylate Removed From Sunscreen Monograph
On September 10, 2026, FDA issued a final administrative order amending OTC Monograph M020 to remove aminobenzoic acid (PABA) and trolamine salicylate as sunscreen active ingredients. FDA determined that sunscreen drug products containing either ingredient are not generally recognized as safe and effective (GRASE), based on its review of available safety data and its determination that the risks associated with their use outweigh their benefits. FDA notes that it will address other aspects of its proposed amendments to the sunscreen monograph in future order(s).
FTC Launches New Rule Guidance Program
The FTC’s Bureau of Consumer Protection (BCP) announced a new BCP Rule Guidance Program through which businesses and other stakeholders can raise questions about ambiguities, conflicts with existing statutes or other FTC rules, and other significant issues involving Commission rules. The program is not intended to interpret established requirements or take on businesses’ own legal or compliance responsibilities. For example, BCP will not interpret performance-based standards such as “clear and conspicuous,” which have established meaning in case law, or address questions the FTC’s existing plain-language guidance can answer.
New Legislation Seeks to Reform Drug Preclusion
On September 10, 2026, Representative Diana Harshbarger (R-TN) introduced H.R. 10336, the Dietary Supplement Innovation Act, which would amend the FD&C Act’s drug preclusion provisions for dietary supplements. Among other things, the bill would protect ingredients that were marketed in food or dietary supplements before relevant drug approval or clinical development milestones, allow preclusion to expire when Phase 2 or 3 clinical investigations have been inactive or withdrawn for at least seven years or when drug development has been publicly discontinued, and authorize FDA to permit otherwise-precluded ingredients through an administrative order. The bill would also require FDA to consider factors such as route of administration, dosage, concentration or composition, and safety when determining whether a drug and dietary supplement contain the same “article,” and would provide for judicial review of certain FDA preclusion determinations.
