FDA Regulation News|U.S. cosmetics regulations will usher in a huge change!

The flourishing multi-billion dollar US cosmetics industry continues to thrive. According to data analysis reports from the U.S. Food and Drug Administration (FDA), which is tasked with overseeing the nation’s cosmetics sector, more than 2.3 million distinct cosmetic products entered U.S. ports during the 2020 fiscal year (FY). Nevertheless, the sheer volume of imported cosmetics presents significant challenges, as extant regulations and resources hinder the agency’s capacity to effectively preclude potentially harmful cosmetics from permeating the United States market for distribution.

In the 2020 fiscal year, a mere 2,823 cosmetic products (less than 1%) were inspected by the FDA, with 538 (19%) of these inspected items being denied entry into the United States due to regulatory infringements. It is highly probable that a considerable quantity of non-compliant and potentially harmful products evaded detection and subsequently infiltrated the US market.

Simultaneously, domestically manufactured products in the United States are not subject to any evaluations before market entry, further exacerbating the issue. In April 2018, a fraudulent scheme in Los Angeles involved the unauthorized use of celebrity Kylie Jenner’s brand name to promote a cosmetics line, which was later discovered to contain a cosmetic bag laden with fecal matter. This incident prompted Jenner’s sister, Kourtney Kardashian, to advocate for the implementation of more stringent cosmetics regulations among US legislators.

Proactive regulatory solutions


The FDA’s existing regulations for cosmetics are predominantly reactive, addressing compliance concerns post-distribution within the United States. While the FDA can issue warning letters for violations and deny entry of cosmetics at ports, the Federal Food, Drug, and Cosmetic (FD&C) Act does not empower the FDA to enforce mandatory recalls of cosmetics.

Other FDA-regulated commodities, such as food, medical devices, and pharmaceuticals, are subjected to more proactive and comprehensive oversight. These products must adhere to pre-market submission protocols and product registration mandates, which not only assist the FDA in preventing non-compliant products from entering the United States but also facilitate more effective enforcement actions once these products arrive.

In an effort to establish analogous regulations for cosmetics, the US Congress recently introduced the “Personal Care Product Safety Act.” Although this bill is not without precedent, similar legislation, such as the “FDA Cosmetic Safety and Modernization Act (S.2003)” and the more recent “Safe Cosmetics and Personal Care Products Act of 2018 (HR6903),” has yet to secure congressional approval. These legislative proposals share common features and provide insights into the potential trajectory of US cosmetics regulations over the next decade. This article will explore the transformative impact on the cosmetics industry should the new “Personal Care Product Safety Act” or comparable laws be enacted.

Mandatory registration for cosmetics companies:

The FDA mandates that companies within the majority of its regulated industries register or report to the FDA before their products are marketed in the United States. However, current regulations do not obligate cosmetic companies to register, instead permitting voluntary registration.

The proposed legislation would require companies engaged in the production, processing, or (in certain instances) distribution of cosmetics for use within the United States to register with the FDA. Earlier proposed bills stipulated varying annual or biennial registration renewal obligations. The recently introduced “Personal Care Product Safety Act” necessitates annual renewal of cosmetics company registration. Mirroring prior legislation, the bill would mandate that entities located outside the United States designate a representative physically situated within the United States to liaise with the FDA on the company’s behalf.

Regulatory enforcement would compel cosmetics companies to register with the FDA, thereby informing the FDA of the companies responsible for marketing cosmetics in the US. This would grant regulatory authorities the authority to detain or refuse entry to products from unregistered companies. Should the bill be enacted, the FDA would possess the power to suspend the registration of non-compliant companies, effectively prohibiting them from selling their products within the United States. Additionally, similar to past legislation, the Personal Care Product Safety Act proposes that, as part of the registration process, cosmetics companies with average annual sales exceeding $10 million should pay annual fees.

This new bill would necessitate that cosmetic companies submit separate declarations to the FDA regarding the cosmetics they anticipate selling in the United States. These declarations should encompass information pertaining to the cosmetics manufacturer, warnings about the ingredients and suitability of the cosmetics, and any other relevant stipulations. The FDA would require these declarations to be submitted within 60 days of the product’s market launch or after a product upgrade, followed by an annual review (akin to the recommendations made by S.1113).

The cosmetic ingredient declarations would serve to notify the FDA of the products being processed by specific companies, thereby enabling the FDA to prohibit the listing of cosmetics without valid declarations. This heightened regulatory framework aims to enhance the safety of cosmetic products, minimize the risk of non-compliant or harmful products entering the market, and ultimately protect the well-being of consumers. By implementing these measures, the cosmetics industry will undergo a significant transformation, characterized by increased accountability and a more stringent adherence to safety standards.

Cosmetic ingredient declaration

This new bill will require cosmetic companies to submit a separate statement to the FDA regarding the cosmetics they expect to sell in the United States. The statement should include information about the cosmetics manufacturer, warnings on the ingredients and applicability of the cosmetics, and other relevant requirements. The FDA will require that these declarations must be submitted within 60 days after the product is on the market or after the product is upgraded, and an annual review (this is similar to the recommendation made by S.1113).

The cosmetic ingredient declaration will notify the FDA which products are processed by specific companies and allow the FDA to prohibit the cosmetics from being listed without a valid declaration.


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