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 over 3 million cosmetic line-items entered U.S. ports in Fiscal Year (FY) 2021.   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.

It is probable that, in the unexamined shipments, many non-compliant and potentially harmful products evaded enforcement and made their way to shelves.

Sometimes companies will recall these harmful products, but by then, the cosmetics have already fallen into the hands of consumers. In December 2021, Proctor and Gamble (P&G) recalled more than 30 aerosol hair products due to the presence of benzene, a chemical that can cause cancer. More brands initiated recalls for the same reason in the following months. Despite the recalls, independent lab testing performed in October 2022 revealed that 70% of tested dry shampoos still contained benzene.

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 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. They share some commonalties that illustrate the direction U.S. cosmetics regulations may take in the next decade.

In May 2022, FDA released a discussion draft of the FDA Safety and Landmark Advancements (FDASLA) Act, which includes steps to strengthen oversight of cosmetics based on provisions laid out in the Personal Care Products Safety Act. This article will discuss major changes industry should expect if the  Personal Care Products Safety Act or a similar bill becomes a law.

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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.  Previously proposed bills have specified differing annual or biennial registration renewal requirements. The 2022 discussion draft included a provision for requiring cosmetics facilities to renew their registration annually..  Similar to past bills, 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.

Mandatory registration of cosmetics facilities would provide FDA a paper trail of who is marketing cosmetics in the United States and would grant the Agency authority to detain or refuse products from unregistered establishments.  If this bill passes, FDA could suspend the registrations of facilities that violate regulations, effectively prohibiting them from marketing their products in the United States.

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).

Cosmetic ingredient statements would notify FDA which products a particular facility processes and would allow the Agency to prohibit a cosmetic from being marketed without a valid statement.

Currently, cosmetics companies only need to report ingredients under certain circumstances. The California Safe Cosmetics Act of 2005 lists ingredients suspected to cause cancer or reproductive harm and requires companies that market products in California containing any of these ingredients to report the products to the state.

Another act that only applies to cosmetics marketed in California is the Cosmetic Fragrance and Flavor Ingredient Right to Know Act of 2020 (CFFIRKA), which went into effect on January 1, 2022. CFFIRKA designates a subset of ingredients called “fragrance allergens” and specific ingredients that companies must report if being used as a fragrance ingredient (regardless of their function). The company named on the label must report these ingredients when present at a concentration of 0.01% (rinse-off cosmetics) or 0.001% (leave-on cosmetics).

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.

Like both S.1113 and S.2003, 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.” In other FDA-regulated industries, GMPs regulate production aspects such as sanitary conditions, hazard controls, and record-keeping. For cosmetics, GMPs would provide enforceable standards for FDA to reference during inspections. Violation of GMPs could result in regulatory actions such as Warning Letters, Import Alerts, and Import Refusals.

GMPs for cosmetics would be determined through FDA rulemaking. During rulemaking, FDA proposes a rule and allows industry and consumers to provide comment. Depending on the comments FDA receives, the Agency may issue an additional proposed rule for further comments, cease rulemaking, or issue a final rule.

A final rule contains compliance deadlines for industry, which are often determined by the size of businesses covered under the rule. It may take years for industry to see a rule’s full implementation as FDA prepares guidance and provides businesses time to process and comply with requirements.

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Ingredient Review

The Personal Care Products Safety Act would also establish an annual review of cosmetic ingredients by FDA.  FDA would analyze safety data surrounding certain cosmetic ingredients to determine whether they are safe for use without restriction, safe under certain conditions or uses, or not safe for use at all.  FDA would then use these determinations to establish regulations that either permit or prohibit the use of certain ingredients in cosmetics.

The bill would even immediately prohibit products containing products that use harmful polyfluoroalkyl substances.

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. Not only is reform supported by many elected representatives, but some cosmetic companies are also arguing for increased regulation of their own products. The Personal Care Product Safety Act has received support from several major cosmetic manufacturers, including Burt’s Bees Company, Johnson and Johnson, L’Oreal, and more.

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.

Get Assistance with Cosmetics Compliance

For assistance with FDA’s cosmetics regulations, contact leading FDA compliance consultant, Registrar Corp. 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

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