Correctly determining whether a product is regulated as a cosmetic, drug, or OTC hybrid is one of the most critical steps for companies entering the U.S. market. Misclassification can lead to FDA enforcement actions, product recalls, detentions at ports, and costly re-labeling or reformulation.

The U.S. FDA defines cosmetics as products intended to cleanse, beautify, or alter appearance without affecting body structure or function. Examples include skin creams, makeup, perfumes, and shampoos. However, when a product makes a therapeutic or medical claim—such as “heals acne,” “treats dandruff,” or “prevents sunburn”—it may fall under OTC drug regulations, requiring compliance with 21 CFR monographs, drug listing, and additional testing.

Some products fall into hybrid categories, often referred to as cosmetic-drug combinations. For example:

• Sunscreen lotions – cosmetic for beautification but drug for UV protection.
• Anti-dandruff shampoos – cosmetic for cleansing, drug for scalp treatment.
• Acne creams – cosmetic for moisturizing, drug for acne claims.

Key considerations for FDA product classification:

• Intended Use & Marketing Claims – Claims drive classification more than ingredients alone.
• Ingredient Restrictions – Certain active ingredients automatically fall under drug regulations.
• Labeling Requirements – Cosmetic vs. drug labeling differ significantly, especially regarding warnings and directions.
• Regulatory Pathways – Cosmetics require VCRP listing, while OTC drugs require compliance with monographs or New Drug Applications (NDA).

At XPRO America, we guide businesses through this complex classification process. Our experts analyze your formulations, intended use, and labeling to determine the correct FDA regulatory pathway. We also help with label compliance, OTC monograph alignment, and hybrid product strategy to ensure smooth U.S. market entry.

With the FDA increasing scrutiny under the Modernization of Cosmetics Regulation Act (MoCRA) 2022, accurate product classification is more important than ever. By partnering with XPRO America, companies minimize risks, avoid misbranding, and ensure their products are positioned for long-term success in the U.S. marketplace.

XPRO America provides expert FDA product classification services, guiding companies on cosmetic, drug, and OTC hybrid pathways for U.S. market compliance.