Life Sciences Blog

Over-the-Counter Drug Product Monographs: Cosmetics and Other Combination Focus

by | Aug 21, 2021


We recently hosted the sixth in a series of OTC-focused webinars featuring Reed Tech subject-matter experts and some of our industry friends and colleagues. The series has taken place throughout this summer. For more fundamental information on OTC drug monographs, provided in the first webinar of the Reed Tech OTC series, read the blog or view the webinar.


This sixth webinar featured speakers Katelyn (Zumpino) Clark of Reed Tech and Shelly Garg and Jennifer Adams of Amin Talati Wasserman LLP. In this webinar, the speakers provided FDA regulatory guidance for companies who produce cosmetic and drug combination products, including moisturizers marketed with sun-protection claims, anti-dandruff shampoos marketed to both cleanse and treat dandruff, toothpaste marketed with fluoride, etc.

The speakers began by explaining the parameters the FDA has put in place to determine if a product is a cosmetic. By definition, cosmetics are for cleansing, beautifying, promoting attractiveness or altering appearance. Cosmetics cannot affect the structure or function of the body or treat, cure, mitigate or prevent any disease. If a product falls into this ‘cosmetic’ category, the FDA has relaxed regulatory standards, even compared to most over-the-counter drug products. Sometimes, a cosmetic can contain drug claims, for instance, a shampoo that cleans hair and helps to treat or prevent dandruff. This type product is subject to stricter FDA requirements as an OTC + Cosmetic Product. OTC + Cosmetic Products must be labeled and registered as drugs.

Key Learning

Determining if a product is a cosmetic or an OTC + cosmetic product, as such a drug, comes down to intended use, marketing claims and consumer perception. Consumer reception often relates to advertising claims. Advertisers are responsible for express and implied claims. Advertisers must ensure they are only advertising active ingredients and not inactive ingredients within the formula.

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