When we think of FDA regulations, pharmaceuticals and medical devices usually come to mind. However, the U.S. Food and Drug Administration (FDA) also plays a critical role in overseeing cosmetics—an industry that touches nearly every consumer. From moisturizers and makeup to shampoos and perfumes, cosmetics are regulated by the FDA to ensure they are safe, properly labeled, and not adulterated or misbranded.
The basis for FDA oversight of cosmetics comes from the Federal Food, Drug, and Cosmetic Act (FD&C Act) of 1938, which granted the agency authority to regulate the safety and labeling of cosmetic products. Unlike drugs, cosmetics do not require FDA pre-approval before entering the market. However, manufacturers are legally responsible for ensuring their products are safe for consumer use and properly labeled (FDA, 2023).
The FDA defines cosmetics as “articles intended to be rubbed, poured, sprinkled, or sprayed on…the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance” (FDA, 2023). This definition excludes products that claim to affect the structure or function of the body, such as anti-aging creams that claim to treat wrinkles as these may be classified as drugs, thus subject to stricter regulatory requirements.
Safety is a major concern in cosmetic regulation. Adulterated or contaminated products can cause serious health risks, such as allergic reactions, infections, or long-term skin damage. Recent recalls of talc-based powders due to asbestos contamination underscore the critical need for regulatory oversight (Brewington, 2022). Although cosmetic ingredients do not require FDA approval (with the exception of color additives), the FDA can take action against products found to be unsafe or misbranded under sections 601 and 602 of the FD&C Act.
Labeling is another key area of focus. Cosmetics must include ingredient declarations, usage instructions, and any necessary warnings. Labels that are misleading or lack proper ingredient disclosure are considered misbranded and can lead to enforcement actions (CTFA, 2021). The Modernization of Cosmetics Regulation Act (MoCRA) of 2022 has further strengthened FDA authority, requiring mandatory adverse event reporting and facility registration, which aligns cosmetic oversight more closely with drug and device regulations (Goldstein, 2023).
Importantly, as the cosmetic industry continues to globalize and grow—with U.S. sales expected to surpass $90 billion in the coming years—regulatory consistency and enforcement become even more crucial. The FDA also partners with international agencies and monitors imported cosmetic products to prevent the entry of unsafe or counterfeit goods into the U.S. market.
In conclusion, while cosmetics may seem low risk, their wide usage and potential for harm demand regulatory scrutiny. The FDA plays a vital role in protecting consumers by enforcing standards that promote product safety, truthful labeling, and industry accountability. As regulations continue to evolve, both consumers and manufacturers benefit from a system designed to ensure that beauty doesn’t come at the cost of health.
EMMA International is here to assist at any point in the lifecycle of a product, contact us today at (248) 987-4497 or info@emmainternational.com to speak with our highly qualified and motivated team.
References:
Goldstein, S. (2023). MoCRA: A New Era in Cosmetics Regulation. Regulatory Affairs Journal.
FDA. (2023). FDA Authority Over Cosmetics. Retrieved from https://www.fda.gov/cosmetics/cosmetics-laws-regulations/fda-authority-over-cosmetics
Brewington, K. (2022). Talc in cosmetics: A health hazard hiding in plain sight. Consumer Reports.
CTFA (Cosmetic, Toiletry and Fragrance Association). (2021). Labeling Requirements for Cosmetics.
