Introduction
The regulatory framework in the United States presents a unique blend of rules for cosmetics and over‐the‐counter (OTC) drug products. Unlike China and the European Union, where the boundaries between cosmetics and drugs are distinctly drawn, the U.S. landscape allows for some products to be classified under both categories. This article explores the definitions, regulatory approaches, and compliance pathways that govern U.S. cosmetics and OTC products.
Understanding U.S. Cosmetics Regulation
According to the Federal Food, Drug, and Cosmetic (FD&C) Act, cosmetics is defined as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance” – excluding soaps. In the United States, cosmetics cover a wide range of products including makeup, hair styling and coloring preparations, oral care products, deodorants, baby care items, personal cleansers, and tanning products among others.
Defining Drugs and OTC Products
Different from the definition of cosmetics, drugs are defined as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals”. Over-the-counter (OTC) products, a subset of drug products, are regulated by the U.S. Food and Drug Administration (FDA) to ensure quality, efficacy, and safety. Common examples include pain relievers, antipyretics, decongestants, sunscreens, as well as certain deodorants and oral hygiene products.
The Overlap: OTC Cosmetics
Unique to the U.S. market is the categorization of certain products that fall into both cosmetic and OTC drug classes. A prominent example is anti-dandruff shampoo: while its primary function as a cleanser categorizes it as a cosmetic, its therapeutic claim for treating dandruff qualifies it as an OTC drug. Other products that might straddle these categories include fluoride toothpastes, specific deodorants with antiperspirant properties, and sunscreens.
Compliance and Regulatory Pathways
For OTC cosmetic products, federal compliance is governed by specific standards:
• Active ingredients listed in the OTC monograph are generally recognized as safe and effective (GRASE), allowing for a streamlined marketing process without the need for premarket approval from the FDA – provided all labeling and formulation requirements are met.
• Both OTC and cosmetic manufacturing facilities must complete factory registration and adhere to FDA Good Manufacturing Practices (GMP).
• Products must obtain a National Drug Code (NDC) as a unique 11-digit identifier for packaging and listing purposes, with sales products required to complete product listing within five business days.
Extra Considerations: The Impact of Modernization
Updates under the Modernization of Cosmetics Regulation Act (MoCRA) require cosmetics to register their manufacturing facilities and product listings. However, if a product is also classified as an OTC drug, compliance via the OTC pathway becomes the priority, avoiding duplicate registration and listings on cosmetics direct.
How Can REACH24H Help You?
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Securing DUNS Number
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Facility Registration
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Formulation and Label Review
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Product Listing
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Product Annual Renewal
Why Choose REACH24H?
Expert Team: Comprises multiple seasoned safety assessors with extensive knowledge of UK cosmetics regulations and cosmetic product safety assessments.
Strong Collaborations: Benefit from our extensive network and partnerships with prominent organizations around the globe.
Regulatory Information Platform: We own a dedicated platform for real-time regulatory tracking, in-depth analysis, and reliable database support, keeping you up-to-date with the latest requirements in the industry.
Trusted by Global Brands: We have successfully served over 1000 cosmetic companies worldwide, including well-known Fortune Global 500 companies, earning their trust and satisfaction through our reliable services.
Global Reach: With our global branches and multilingual capabilities, we offer efficient international services, ensuring effective communication and comprehensive support throughout the compliance process.
Conclusion
Understanding the complex interplay between cosmetics and OTC drug regulations in the U.S. is essential for market success. By aligning product claims, ingredient lists, and manufacturing practices with FDA requirements, manufacturers can effectively position their products in a competitive market while ensuring consumer safety and regulatory compliance. This guide aims to assist stakeholders in navigating these regulatory challenges and seizing growth opportunities within North America.
