of America.cosmeticsIn the United States, a product can be both cosmetic and non-prescription drugs (OTC). This unique regulatory environment puts higher compliance requirements on relevant U.S. carriers. This article will explore the regulatory mechanisms of OTC products for U.S. cosmetic use and provide practical compliance guidance for relevant companies.

Definition and classification of OTC products

Although the definitions of cosmetics and medicines in the United States overlap, they still have their unique features.

(1) Cosmetics: According to the U.S. Food, Drug & Cosmetic Act (FD&C Act), cosmetics are primarily used for cleansing, beautifying, enhancing attractiveness or improving appearance. The U.S. market offers diverse cosmetic categories ranging from makeup to personal cleansing products.
Medicines involve a wider range of uses, including diagnosis, treatment and prevention of diseases, and affecting body structure or function.
(3) OTC products: OTC products are a special class of medicines that are strictly regulated by the U.S. Food and Drug Administration (FDA). These products include not only common non-prescription medicines, but also some cosmetics with specific effects, such as sunscreen and antiperspirant.

Determining whether products are subject to OTC regulation

Determining whether a product falls within the scope of OTC regulation is not easy, but a clear judgment can be made through the following ways.

(1) Product Statements: Statements in product labels, advertisements and other promotional materials may classify them as OTC products. For example, if a mouthwash claims to inhibit bacterial proliferation, it may need to be regulated according to the drug.
(2) Product Ingredients: Certain ingredients may be considered to have pharmaceutical effects, or are widely recognized and used in the industry for treatment.
(3) OTC Opinion: The OTC Opinion provides a practical reference approach, listing the active ingredient standards with specific drug effects. If the active ingredients and effectiveness in the product claim to meet the requirements of the Opinion, then this product is likely to be considered an OTC product.

U.S. regulatory requirements for OTC products

U.S. regulations on OTC products are extremely strict, ensuring their quality, effectiveness and safety.

(1) Compliance with OTC Advisory: If an active ingredient is listed in the FDA’s OTC Advisory and the product meets all the requirements of the Advisory, then the product is generally considered to be safe and effective.
(2) Applications for new drugs: For products that do not comply with OTC expertise, may need to take the path of applying for new drugs, which often involves more complex and time-consuming processes.
(3) Registration and compliance: Even with OTC-compliant products, enterprises still need to complete a range of registration and compliance tasks, including factory registration, product listing, compliance with GMP standards, etc. In addition, product labels also need to meet special requirements for OTC products.