US FDA to impose stricter regulation on cosmetics

The US Congress recently introduced the Personal Care Products Safety Act, which will authorize the US Food and Drug Administration (FDA) to regulate cosmetics more proactively and actively, including requiring cosmetic companies to register, submit ingredient statements and adverse event reports, comply with good manufacturing practices and ingredient reviews.

Currently, FDA's regulation of cosmetics is passive, usually resolving compliance issues after products enter US distribution. FDA can issue warning letters and refuse entry of cosmetics at ports, but the Federal Food, Drug, and Cosmetic Act (FD&C Act) does not authorize FDA to order mandatory recalls of cosmetics. Other products regulated by FDA, such as food, medical devices and drugs, are subject to more proactive and active regulation.

The new bill will require companies that manufacture, process or (in some cases) distribute cosmetics for use in the United States to register with FDA and submit a statement to FDA for each cosmetic they intend to sell in the United States, containing information such as the ingredients and warnings applicable to the cosmetic. In addition, the bill will also require cosmetic companies to submit serious adverse event reports to FDA, such as health events that result from or require medical intervention due to the use of cosmetics.

The bill will also authorize FDA to review at least five cosmetic ingredients each year for safety and use restrictions, and require cosmetic companies to comply with good manufacturing practices to ensure the quality and purity of cosmetics. In addition, the bill will also allow FDA to impose fines on cosmetic companies that violate regulations and order recalls of unsafe cosmetics when necessary.

The bill was introduced by Senators Dianne Feinstein and Susan Collins and is supported by several industry and consumer organizations, such as the Personal Care Products Council (PCPC) and Consumer Union (CU). The bill aims to protect consumer health and rights while increasing transparency and trust in the cosmetics industry.