The U.S. Food and Drug Administration (FDA), which regulates cosmetics in the United States, reports through its data dashboard that over 2.3 million cosmetic line-items entered U.S. ports in 2020. However, this immense volume of cosmetic imports poses certain challenges as current regulations and resources limit what the Agency can do to effectively prevent potentially harmful cosmetics from entering U.S. distribution.
FDA was only able to examine less than 1% cosmetic line-items in 2020. It is probable that, in the unexamined shipments, many non-compliant and potentially harmful products evaded enforcement and made their way to shelves.
Meanwhile, domestically produced goods, which are not subject to any screening before entering the market, present a different issue.
Solutions For Proactive Regulations Current FDA regulations for cosmetics are reactive, often addressing compliance issues after a product has already entered U.S. distribution. FDA can issue Warning Letters for non-compliance and refuse cosmetics in port, but the Federal Food, Drug, and Cosmetics (FD&C) Act does not give the Agency authority to order a mandatory recall of a cosmetic. Other products under FDA’s authority such as food, medical devices, and drugs are more proactively regulated. These products are subject to pre-market submissions and facility requirements that not only help the Agency prevent significantly more non-compliant products from entering the U.S., but also better enforce action against them when they do. In order to provide comparable regulations for cosmetics, the U.S. Congress has recently introduced The Personal Care Products Safety Act. This act is not the first of its kind, but similar bills like the FDA Cosmetic Safety and Modernization Act (S.2003) and the recent Safe Cosmetics and Personal Care Products Act of 2018 (H.R.6903) have not made it past Congress committees.
Mandatory Registration of Cosmetic Facilities
FDA requires businesses in most industries under its authority to register or report to the Agency prior to marketing their products in the United States. Under current regulations, FDA does not require cosmetic establishments to register, but allows them to do so voluntarily.
The proposed bills would require facilities that manufacture, process, or (in some cases) distribute cosmetics for use in the United States to register with FDA. The Act would require facilities located outside of the United States to designate an agent physically located in the United States to communicate with FDA on the facility’s behalf.
Cosmetic Ingredient Statements
This new bill would require cosmetic facilities to submit a statement to FDA for each cosmetic intended to be marketed in the United States. The statement would contain, among other requirements, information on the facility manufacturing a cosmetic as well as the cosmetic’s ingredients and applicable warnings. FDA would require these statements be submitted within 60 days of marketing or reformulating the product and then annually (this is similar to a proposal under S.1113).
Serious Adverse Event Reporting
The Personal Care Products Safety Act would require cosmetics businesses to submit serious adverse event reports to FDA. The bill’s definition for “serious adverse events” are generally health-related events associated with the use of a cosmetic that result in or require medical intervention. It also requires annual reporting of adverse health events such as rashes.
The Personal Care Products Safety Act would require the label of a cosmetic product to bear contact information for an entity located in the U.S. to receive notification of adverse events from consumers. A product not containing this information would be considered misbranded, subjecting it to detention or refusal at the U.S. border.
Good Manufacturing Practices The Personal Care Products Safety Act would give FDA the authority to establish good manufacturing practices (GMPs) for cosmetics based on “current industry standards.”
Ingredient Review The Personal Care Products Safety Act would also establish an annual review of cosmetic ingredients by FDA. As more resources would be allocated to evaluating cosmetics’ safety, FDA may forbid or restrict the use of certain ingredients currently used in cosmetics. Businesses using these ingredients would need to reformulate their product to remain compliant.
In Conclusion
While the Personal Care Product Safety Act is not yet close to being passed, the push for the above requirements is supported by congressional Democrats and Republicans, and the proposed regulations bear significant resemblance to existing requirements in other FDA-regulated industries.
Based on the consistency of proposed cosmetics safety bills, it is likely that one may be enacted within the next several years. If this change is realized, industry will need to adapt and adjust to continue business in the United States. Companies that need assistance with FDA requirements can contact Belab Services, an expert FDA compliance consultant. Our Regulatory Specialists can review your labeling for compliance, register your cosmetics establishment with FDA, assist with reporting under the California Safe Cosmetics Act, and more.