Activist beauty brands and NGOs in the clean beauty movement, along with industry trade organizations, have been actively lobbying Congress regarding regulatory reform of the cosmetics industry for over a decade. While most of us were heading off for the holidays, Congress passed a bill modifying the Food and Drug Administration's (FDA) authority to collect specific fees and expanding its power to regulate certain products, including cosmetics. The Modernization of Cosmetics Regulation Act of 2022 (MoCRA), as it has been titled, has been included in the 4,155-page Omnibus government funding bill.
MoCRA passed the Senate HELP Committee with bipartisan support earlier this year, led by HELP Chair Patty Murray (D-WA) and Ranking Member Richard Burr (R-NC) as part of the broader committee efforts to reauthorize FDA's medical product user fee programs.
While this is the first major amendment to the FDA's cosmetics regulations since 1938, an FDA official told Congress in 2019, according to the Wall Street Journal, "We believe that most cosmetics on the market in the United States are indeed safe, and in our experience, most firms are responsible actors—they care about consumer safety and the reputations of their brands, and in those rare cases when safety issues do arise, many firms work with us cooperatively to address them."
Over the past decade, Beautycounter has been one of the most vocal brands advocating for safety and transparency, activating a collective community effort to send 236,000 emails, making over 16,000 calls, and holding over 2,200 meetings with Members of Congress. Jen Lee, Chief Impact Officer, believes MoCRA marks a meaningful step in the right direction, "Consumers are demanding safety and transparency, and it is because of this community that we can celebrate this progress. Beautycounter was founded because we believed we could raise the standard for the beauty industry. There is still work to do, but we are one step closer toward achieving our mission of getting safer products into the hands of everyone."
Since 2015, Senators Dianne Feinstein (D-CA) and Susan Collins (R-ME) have introduced the Personal Care Products Safety Act. MoCRA includes many of the reforms sought by the senators.
"Although more is needed to ensure the safety of chemicals used in cosmetics, this update is a welcome step in the right direction. We are grateful that many of the reforms sought by Senators Feinstein and Collins are included in the end-of-year spending bill," said Scott Faber, Environmental Working Group Senior Vice President for Government Affairs. "The FDA will now have many of the same commonsense, basic tools the FDA already has for oversight of other product categories."
The FDA can already enforce adulterated or misbranded cosmetics, and its cosmetic regulations preclude or limit certain ingredients. However, once signed into law by President Biden, MoCRA will add significant new authorities to chapter VI of the Federal Food, Drug, and Cosmetic Act.
IBA, a trade organization comprised of hundreds of small businesses across the country, commented on the legislation saying, "While beauty and personal care products have an excellent safety record, given how long it has been since the regulations have been updated, we support modernizing cosmetics regulation so that FDA has the authority and resources it needs to oversee our products for decades to come."
Regulatory Reform Outlined in the Bill
Covington & Burling LLP, an international law firm that provides corporate, litigation, and regulatory expertise, summarized the key provisions of MoCRA.
Adverse Event Recordkeeping and Serious Adverse Event Reporting (Section 605): Similar to the FDA's existing authorities for dietary supplements and OTC drugs—that a responsible person (i) maintain records of any health-related adverse events associated with the use of its product for six years (or three years for some small businesses) and, (ii) report to FDA any serious adverse events no later than 15 days after learning about the issue. A responsible person also must provide any new and material medical information it learns of related to the serious adverse event for one year following the initial submission.
MoCRA broadens the scope of what constitutes a serious adverse event to account for particular considerations relevant to the cosmetics sector. In addition to the existing definition of a serious adverse event for dietary supplements and OTC drugs, a reportable event for cosmetics also includes an infection or "significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance), other than as intended, under conditions of use that are customary or usual."
Mandatory Facility Registration, Product and Ingredient Listing (Section 607): Facilities that manufacture or process cosmetic products for US distribution, whether the facility is located in the US or abroad, must register with the FDA. The MoCRA definition of facility includes a number of carve-outs; most notably, an establishment that solely performs labeling, relabeling, packaging, repackaging, holding, and/or distributing of cosmetic products is not a facility subject to the new requirements. Other carve-outs include establishments that manufacture or process cosmetic products solely for use in research or evaluation, including for production testing, and not offered for retail sale, and establishments that manufacture cosmetic ingredients but not cosmetic products. Existing facilities must register within one year after the date of enactment of MoCRA, whereas any new facilities must register within 60 days after beginning to manufacture cosmetics or 60 days after the deadline for existing facilities, whichever is later. All registrations must be renewed biennially.
Responsible persons must also list each cosmetic product, including its ingredients and information about where it is manufactured, with the FDA. For products marketed before the enactment of MoCRA, a responsible person must submit product listings no later than one year after enactment; for products first marketed after enactment, a responsible person must submit product listings within 120 days of marketing. Responsible persons must update product listings annually. Importantly, a single listing submission for a cosmetic product may include multiple cosmetic products with identical formulations or formulations that differ only with respect to colors, fragrances, flavors, or quantity of contents.
Cosmetic Safety Substantiation (Section 608): Responsible persons must ensure and maintain records supporting "adequate substantiation" showing that a cosmetic product is "safe," and establishes a safety standard that products must meet to be marketed in the US. Cosmetic products that do not have adequate safety substantiation will be considered adulterated under section 601 of the FDCA.
Cosmetic Labeling and Fragrance Allergen Transparency (Section 609): This section builds on the FDA's current cosmetic product labeling requirements in three ways. First, MoCRA requires cosmetic product labels to include contact information through which the responsible person can receive adverse event reports; this requirement takes effect two years after the date of enactment of MoCRA. Second, MoCRA requires professional cosmetics products labels to include the same information required of cosmetic products intended for sale to consumers and state that only licensed professionals may use the product; this requirement takes effect one year after the date of enactment of MoCRA. With the third cosmetic product labeling requirement, MoCRA requires labels to identify each fragrance allergen in a product once FDA issues the fragrance allergen rule discussed in Part IV below.
Facility Suspension (Section 607): This section gives the FDA authority to suspend a facility's registration if it determines that a cosmetic product manufactured by that facility has a reasonable probability of causing serious adverse health consequences and other products manufactured by the facility may be similarly affected. Once suspended, a facility may not introduce any cosmetic products into commerce until its registration is reinstated. This authority is very similar to FDA's authority to suspend a food facility's registration, which was added to the FDCA in 2011.
Records Access (Section 610): The FDA has the authority to access records relating to a cosmetic product if it reasonably believes that a product or its ingredients are adulterated and present a threat of serious adverse health consequences. This authority does not extend to cosmetic formulas/recipes or to financial, pricing, sales, personnel, or research data (other than safety substantiation data). In addition, newly added section 605 provides that the FDA may request a list of ingredients in the fragrances or flavors in a product if it has reason to believe that a fragrance or flavor contributed to a serious adverse event.
Recall Authority (Section 611): This section gives the FDA mandatory recall authority if it determines a reasonable probability that a cosmetic is adulterated or misbranded within the meaning of FDCA sections 601 and 602 and exposure to the product will cause serious adverse health consequences or death.
Preemption (Section 614): This section preempts any state or local laws that differ from the federal framework on registration, product listing, good manufacturing practice, records, recalls, adverse event reporting, or safety substantiation. Newly added section 614 also includes a limitation clause and savings clause, which may apply in certain circumstances.
OTC Drug-Cosmetic Clarity (Section 613): For products that are both a drug and a cosmetic under the FDCA and related operations, newly added section 613 makes clear that the drug requirements of chapter V of the FDCA apply instead of the cosmetic requirements of chapter VI, except concerning fragrance allergen disclosure and professional use labeling.
Animal Testing: MoCRA did not adopt any requirements specific to testing involving animals, but instead provided a sense from Congress that animal testing should not be used for the purposes of safety testing on cosmetic products and should be phased out with the exception of appropriate allowances. The industry had advocated for inclusion of the Humane Cosmetics Act (S. 3357) in MoCRA.
Small Business Accommodations: MoCRA makes a number of accommodations for small businesses. First, the CGMP regulations issued by FDA under newly added section 606 must offer flexibility, simplified requirements, and a longer compliance period for small businesses. Second, very small businesses (as defined by MoCRA) are exempt from newly added section 606 (for CGMP) and 607 (registration and listing) and, concerning newly added section 605, must maintain records of any health-related adverse events associated with the use of a product for three years, rather than six years.
Resources for FDA: The bill authorizes appropriations for the FDA to support activities related to MoCRA. The legislation does not impose industry user fees.
The new legislation will not change much in terms of process for most beauty manufacturers. Brands exporting to international markets or selling wholesale already adhere to many proposed changes like GMP and safety testing. However, if the FDA doesn't attempt to homogenize its requirements with those of the EU, there is the potential for duplicative documentation, which could be burdensome for independent beauty brands.
Based on the framework of the bill, the FDA will begin the rulemaking process, which includes opportunities for public comment and feedback. The IBA shared, "As we move forward toward implementation, some of our other goals include aligning the new regulations so that manufacturers can have a single set of manufacturing standards for US and EU products; align safety requirements; potentially follow the Toxicology Risk Assessments already used in other countries that would allow many companies to comply with few to no changes; and harmonize label requirements to the degree possible with other geographies."
Rhonda Marshall, MA, a trained chemist and founder and CEO of Inahsi LLC, a manufacturer and seller of haircare products, said, "As a trained chemist who was involved in the development of several groundbreaking personal care products, safety is the top priority for me as it is for my customers, so I support this plan. But as a small business owner, I must keep a close eye on our bottom line, and therefore I look forward to working with IBA as it engages with the FDA on the development and implementation of these new rules."
On the other end of the legislative spectrum, some segments of the industry will continue pushing for additional reforms to cosmetic legislation. EWG President and co-founder Ken Cook said, "The hard work of banning or restricting chemicals will now fall to the states. The cosmetics provisions in the end-of-year spending bill preserve the ability of states to ban toxic chemicals from cosmetics, as California, Colorado and Maryland have recently done."
The elephant in the room remains the Etsy-style small businesses exempt from the new legislation. Beauty brands with revenues under a million dollars can continue to whip products up in their kitchen and sell them online without testing, quality control, and often only a rudimentary understanding of cosmetic chemistry.
January 12, 2023 at 3pm ET: Independent Beauty Association (IBA) is conducting a virtual Town Hall. Association leadership and the Government & Public Relations Committee will discuss legislative updates.
January 25, 2023 at 12pm ET: Covington & Burling LLP and the Personal Care Products Council (PCPC) will co-host a webinar to discuss the reforms and assess key implications for cosmetics industry stakeholders.
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