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MoCRA or OTC: which applies to your product?
With the implementation of the Modernization of Cosmetics Regulation Act (MoCRA) and existing requirements for Over-the-Counter (OTC) drugs, understanding whether your product falls under MoCRA or OTC regulations is more critical than ever for businesses aiming to sell cosmetic products in the United States.
If your product is marketed in the U.S., you may be wondering:
Is my product subject to MoCRA, OTC or both?
This article will help you determine the correct regulatory pathway, understand borderline cases, and identify the specific compliance requirements your company must meet.
What is covered by FDA MoCRA?
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is a major reform of U.S. cosmetic regulations under the Federal Food, Drug, and Cosmetic Act (FD&C Act). It introduces new mandatory requirements for companies selling cosmetic products in the U.S. market.
MoCRA compliance applies to products intended to cleanse, beautify, promote attractiveness, or alter appearance, provided they do not affect the body’s structure or function.
Key MoCRA requirements:
- FDA facility registration
- FDA cosmetic product listing
- Adverse event reporting and maintenance of safety records
- Safety substantiation to ensure the product is safe under labeled conditions of use
- Labeling updates, including mandatory allergens disclosure
- Compliance with Good Manufacturing Practices (GMP) (enforced by FDA in future rules)
MoCRA applies to all cosmetic products, including skincare, makeup, fragrances, and personal hygiene products, that are not classified as drugs.
What are OTC drug products?
Over-the-Counter (OTC) products are non-prescription drug products regulated under separate FDA drug regulations. These are intended to treat, prevent, or mitigate medical conditions.
OTC products are commonly found in personal care categories, such as:
- Acne treatments (benzoyl peroxide, salicylic acid)
- Sunscreens (SPF claims)
- Anti-dandruff shampoos
- Antiperspirants (vs. deodorants, which are cosmetics)
Key OTC regulatory requirements:
- Compliance with an FDA monograph or submission of a New Drug Application (NDA)
- Drug establishment registration and product listing in FDA’s database
- Detailed drug labeling, including active ingredients, dosage, and warnings
- GMP compliance at the level of pharmaceutical manufacturing
OTC products must make therapeutic claims, which are not allowed under MoCRA unless the product is also compliant with drug regulations.
Borderline products: Dual compliance may apply
Some products sit at the intersection of cosmetics and drugs—known as borderline products. These items may be regulated under both MoCRA and OTC frameworks depending on their intended use, labeling, and claims.
Common examples of borderline products:
- A facial moisturizer with SPF → OTC drug + cosmetic
- A shampoo with anti-dandruff claims → OTC drug + cosmetic
- A facial cleanser with anti-acne claims → OTC drug + cosmetic
- A body lotion that claims to relieve eczema symptoms → OTC drug
Borderline classification is not based solely on ingredients, but primarily on marketing claims and product functionality. Companies must be careful in how they present their product on labels, websites, and promotional materials.
How Cosmeservice supports your FDA compliance
Cosmeservice helps companies worldwide meet FDA cosmetic and drug regulations for entering the U.S. market. Whether your product falls under MoCRA or OTC compliance, or both, we provide:
- FDA facility registration and product listing services
- Review of borderline product classifications and regulatory strategy
- Guidance on labeling, safety documentation, and claims assessment
- Support with OTC monograph compliance and U.S. market entry steps
- Ongoing regulatory updates and advisory for your compliance needs
If you’re looking to market your OTC product in the U.S., visit our OTC page to start the compliance process with Cosmeservice. Contact us to assess your product and streamline your FDA compliance process: info@cosmeservice.com
