Unpacking OMUFA

Unpacking OMUFA – FDA Watch

Wayne chats with Meredith Petillo, Vice President of Technical and Regulatory Affairs at the Independent Beauty Association. You'll hear her thoughts on recent FDA warning letters to sunscreen brands; the mention of sunscreens in the new MAHA report; "foodification" risks in beauty and the personal care products space; how companies can prepare for potentially increased agency focus on non-traditional product formats; OMUFA, how it could impact innovation and competition in the OTC space, and its effect on small businesses; and much more. Check out IBA's Cosmetics Convergence Fall 2025: Indie Beauty Compliance Edition, a two-day virtual conference happening Nov. 12–13, for further updates and practical guidance on beauty and personal care industry compliance. FDA Watch listeners get 10% off registration with discount code IBAFDA10. In our headlines segment, Wayne delves into these major developments: HHS issues new MAHA report President Trump signs executive order regarding DTC advertising; FDA Commissioner Makary sends letters to pharma companies saying new rules and stricter enforcement coming Pharma and Devices: OMB releases Spring 2025 regulatory agenda Food: FDA launches new Nationalized Entry Review program Cosmetics: EU bans gel nail polishes that continue to be sold in U.S. In our Resource Links segment, we list key documents in our four core areas. To view these links, subscribe, or find out more information about our podcast, visit FDAWatch.net. Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at info@fdawatch.net.  Music by Dvir Silver from Pixabay.   

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Wayne chats with Meredith Petillo, Vice President of Technical and Regulatory Affairs at the Independent Beauty Association. You’ll hear her thoughts on recent FDA warning letters to sunscreen brands; the mention of sunscreens in the new MAHA report; “foodification” risks in beauty and the personal care products space; how companies can prepare for potentially increased agency focus on non-traditional product formats; OMUFA, how it could impact innovation and competition in the OTC space, and its effect on small businesses; and much more.

Check out IBA’s Cosmetics Convergence Fall 2025: Indie Beauty Compliance Edition, a two-day virtual conference happening Nov. 12–13, for further updates and practical guidance on beauty and personal care industry compliance. FDA Watch listeners get 10% off registration with discount code IBAFDA10.

Headlines

HHS issues new MAHA report

President Trump signs executive order regarding DTC advertising; FDA Commissioner Makary sends letters to pharma companies saying new rules and stricter enforcement coming

Pharma and Devices: OMB releases Spring 2025 regulatory agenda

Food: FDA launches new Nationalized Entry Review program

Cosmetics: EU bans gel nail polishes that continue to be sold in U.S.

Resource Links

Pharma: FDA announced the “CDER/CBER Rare Disease Evidence Principles” process

Devices: According to Healthcare Brew and FDA, the number of agency-cleared AI-enabled medical devices nearly doubled from less than 700 in 2023 to 1,247 as of Aug. 28

Food: FDA amends food additive regulation for safe use of hydrogen peroxide as an antimicrobial agent, oxidizing and reducing agent, and bleaching agent

• Federal Register rule
• Food and Safety Magazine article

Cosmetics: IBA holding Cosmetics Convergence Fall 2025: Indie Beauty Compliance Edition in November

About Our Guest

Meredith Petillo

Meredith Petillo is the Vice President of Technical and Regulatory Affairs at the non-profit trade association, the Independent Beauty Association (IBA). Meredith leverages 20 years of experience in cosmetic regulatory affairs, legal advertising, product testing, and product development to support IBA member companies with practical regulatory and technical education and solutions.

Prior to joining IBA, Meredith established an in-house Regulatory Department at Bare Escentuals for bareMinerals, BUXOM and MDFormulations.  She then moved to Energizer (now Edgewell) to support Banana Boat, Hawaiian Tropic and Schick North American Regulatory Affairs. She then joined Reckitt Benckiser’s Legal team overseeing advertising claims substantiation for RB’s Health & Hygiene portfolios including Mucinex, Delsym, Air Wick, Lysol, Veet, Clearasil, Durex, among many others. Meredith also provided regulatory consulting services at Product Integrity Laboratory. 

She holds a B.S. in Biochemistry & Molecular Biology from the University of Richmond and an M.S. in Regulatory Affairs for Drugs, Biologics & Medical Devices from Northeastern University.