All You Need to Know About FDA Cosmetics Regulations

The multi-billion dollar U.S. cosmetics industry is booming. The U.S. Food and Drug Administration (FDA), which regulates cosmetics in the United States, reports through its data dashboard that more than 2.4 million cosmetic products enter U.S. ports in fiscal year (FY) 2021. However, such a large number of cosmetic imports presents certain challenges, as current regulations and resources limit what the agency can do to effectively prevent potentially harmful cosmetic products from entering the U.S. for sale. Here’s what we brand owners need to know

Cosmetic FDA Registration

The solution to aggressive regulation.
Current FDA regulation of cosmetics is reactive, and compliance issues are usually resolved after the product enters the U.S. FDA can issue warning letters for violations and reject cosmetics at ports of entry, but the Federal Food, Drug, and Cosmetic Act (FD&C) does not authorize FDA to order mandatory recalls of cosmetics.

Other products authorized by the FDA, such as food, medical devices, and drugs, are more aggressively regulated. These products are subject to premarket documentation and facility requirements, which not only help the FDA prevent more non-compliant products from entering the U.S. but also better enable it to take action against these products when they do enter the country.

To provide similar regulation of cosmetics, the U.S. Congress recently introduced the Personal Care Products Safety Act. This bill is not the first of its kind, but similar bills, such as the FDA’s Cosmetic Safety and Modernization Act (S. 2003) and the more recent Safe Cosmetics and Personal Care Products Act of 2018 (HR 6903), have yet to make it out of congressional committees. They have some commonalities that illustrate where U.S. cosmetic regulations are likely to go in the next decade. This article will discuss the key changes the industry should expect if the new Personal Care Products Safety Act or a similar bill becomes law.

Mandatory FDA registration of cosmetic facilities.
The FDA requires companies in most industries under its jurisdiction to register or report their products to the FDA before they can be sold in the United States. Under current regulations, the FDA does not require cosmetic companies to register but allows them to do so voluntarily.

The proposed bill would require facilities that manufacture, process, or (in some cases) distribute cosmetic products for use in the United States to register with the FDA. Previously proposed bills provided for different annual or biennial registration renewal requirements. The recently introduced Personal Care Products Safety Act would require cosmetic facilities to renew their registrations annually. Similar to past bills, the bill would require facilities located outside the United States to designate an agent physically located in the United States to communicate with the FDA on behalf of the facility.

Mandatory cosmetic facility registration would provide the FDA with a written record of who is selling cosmetics in the U.S. and give the agency the authority to withhold or reject products from unregistered facilities. If passed, the FDA could suspend the registration of facilities that violate the regulations, effectively barring them from selling products in the United States.

In addition, as with past bills, as part of the registration process, the Personal Care Products Safety Act proposes to charge an annual fee to cosmetic companies with annual sales averaging more than $10 million.

1.Cosmetic ingredient declarations

The new bill would require cosmetic facilities to file a declaration with the FDA for each cosmetic product that they intend to sell in the United States. Among other requirements, the declaration would contain information about the cosmetic manufacturing facility, as well as the cosmetic ingredients and applicable warnings. the FDA would require these declarations to be submitted within 60 days after the product is marketed or reformulated, and then annually (similar to what is proposed in S. 1113).

A cosmetic ingredient statement would inform the FDA which products are processed in a specific facility and would allow the FDA to prohibit the sale of cosmetics without a valid statement.

2. Serious Adverse Event Reporting

The Personal Care Products Safety Act would require cosmetic companies to submit serious adverse event reports to the FDA. The Act defines a “serious adverse event” generally as a health-related event associated with the use of a cosmetic that results in or requires medical intervention. It would also require annual reporting of adverse health events, such as skin rashes.

Like S. 1113 and S. 2003, the Personal Care Products Safety Act would require that labels for cosmetic products include contact information for entities located in the United States to receive notification of adverse events from consumers. Products that do not contain this information would be considered mislabeled and detained or rejected at the U.S. border.

3. Good Manufacturing Practices

The Personal Care Products Safety Act would authorize the FDA to establish Good Manufacturing Practices (GMPs) for cosmetic products based on “current industry standards”. In other FDA-regulated industries, GMPs regulate manufacturing aspects such as sanitary conditions, hazard control, and record keeping. For cosmetics, GMPs will provide enforceable standards that the FDA can refer to during inspections. GMP violations may result in regulatory actions such as warning letters, import alerts, and import rejections.

GMPs for cosmetic products will be determined through FDA rulemaking. During the rulemaking process, the FDA proposes rules and allows industry and consumer comments. Depending on the comments received by FDA, FDA may issue additional proposed rules for further comment, discontinue the rulemaking, or issue a final rule.

The final rule contains compliance deadlines for the industry, which usually depend on the size of the businesses covered by the rule. As FDA prepares guidance and provides time for companies to process and comply with the requirements, it may take several years for the industry to see full implementation of the rule.

4. Ingredient Review

The Personal Care Products Safety Act will also require the FDA to conduct an annual review of cosmetic ingredients. the FDA will analyze safety data surrounding certain cosmetic ingredients to determine whether they are safe for unrestricted use, safe under certain conditions or uses, or not safe at all. The FDA will then use these decisions to develop regulations that allow or prohibit the use of certain ingredients in cosmetics.
The bill would even immediately ban products containing products that use harmful poly-fluoroalkyl substances.

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