Raqiyyah Pippins and Danait Mengist, Arnold & Porter03.10.23
Notably, MoCRA’s long-awaited updates to US cosmetics regulations have been welcomed by the personal care products industry. The Personal Care Products Council, for instance, applauded Congress for passing the legislation stating in a press release that “[t]he long-awaited legislation advances product safety and innovation for the science-driven beauty and personal care industry and reinforces consumer confidence.”4 While the new legislation will likely provide the consistent and modernized regulations desired by industry, MoCRA will also usher in a new regulatory landscape in which the personal care product industry will not only be subject to more requirements but also greater scrutiny from FDA—changes that companies should prepare for as soon as possible. In fact, as a sign that FDA is already gearing up to implement the new cosmetics requirements, FDA recently announced that it is moving cosmetic regulation and color certification out of the Center for Food Safety and Applied Nutrition (CFSAN) and into the Office of the Chief Scientist—a move that, according to the agency, “will leverage the FDA’s areas of expertise across the agency as it works to implement [MoCRA].”5
MoCRA dramatically expands FDA’s authority with respect to cosmetics, including, among other things, allowing for mandatory recalls, inspection of records, suspension of facility registrations and promulgation of regulations to establish cosmetic good manufacturing practices. Importantly, the legislation also significantly expands the legal obligations of cosmetic companies. This article highlights key new regulatory requirements impacting personal care product companies and then closes with steps companies can take to prepare for the brave new world of MoCRA.
Regulatory Obligations
MoCRA establishes notable reporting, listing and recordkeeping obligations related to cosmetic products. In particular, key new requirements companies should prepare for include obligations to:- Report Serious Adverse Events—Under MoCRA, “responsible persons;” i.e., companies which manufacture, pack or distribute cosmetic products and whose name appears on the label, will be required to submit to FDA reports of any serious adverse events involving the use of their cosmetic products within 15 days of receiving any such report. Companies should particularly be aware that the definition of “serious adverse event” in MoCRA is broader than existing definitions of “serious adverse event” applied in the context of over-the-counter drugs and dietary supplements. Specifically, the new definition adds infections and significant disfigurement (including “serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance”) to the list of events that would need to be reported to FDA. MoCRA will also require companies to maintain records related to each adverse event report for a period of six years and to permit FDA access to such records. Notably, the new law allows FDA to request a list of ingredients or categories of ingredients in a fragrance or flavor if FDA has reasonable grounds to believe they caused or contributed to a serious adverse event. Like most provisions in MoCRA, this requirement will go into effect in December 2023, one year from enactment of the bill.
- Register Cosmetics Facilities and Submit Product Listings—Before passage of MoCRA, cosmetics were the only FDA-regulated products without some sort of registration and product listing requirement. MoCRA changes this by requiring all persons who own or operate a facility that manufactures or processes cosmetics products for distribution in the US to register each facility with FDA. Responsible persons are also required to submit a product listing for each cosmetic product, which includes a list of ingredients in the cosmetic product, including fragrances, flavors or colors, with each ingredient identified by name. Personal care companies that already operate facilities will be required to register by December 2023 and to renew their registration biennially. New facilities will need to register within 60 days of beginning their manufacturing or processing operations. Likewise, the requirement to submit product listings will also go into effect by December 2023 and companies will need to submit updates to their product listings on an annual basis. For new cosmetics, companies must submit their product listing within 120 days of marketing the product.
- Maintain Adequate Safety Substantiation—Under current law, personal care companies already have a legal responsibility to ensure the safety of their cosmetic products; however, the law does not explicitly require that they substantiate the safety of their products.6 Rather, if a company has not substantiated the safety of its product, it is required to include a warning on the product’s label, stating “Warning—The safety of this product has not been determined.”7 Starting in December 2023, MoCRA will require that companies ensure, and maintain records supporting, there is adequate substantiation of safety for each cosmetic product sold in the US. The new law defines “adequate substantiation of safety” as “tests or studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a cosmetic product is safe.”
- Adhere to New Labeling Requirements—MoCRA also introduces three new cosmetic labeling requirements. Under the new law, cosmetics product labels must:
- Include contact information through which the “responsible person” for the product can receive adverse event reports;
- Disclose each fragrance allergen included in the cosmetic product; and
- For products intended to be used by a licensed professional, bear a clear and prominent statement that the product may only be administered or used by licensed professionals and include all information currently required for cosmetics intended to be sold to consumers.
How Should Companies Prepare?
For more than eight decades, FDA’s regulatory authority over cosmetics has been fairly limited, particularly in comparison to other regulated products like food and OTC drugs. Under the existing regulatory regime, FDA’s cosmetics program has operated under a limited budget (approximately $10 million per year in or around 2018)8 with limited enforcement tools primarily consisting of FDA’s inspection authority, import refusals for cosmetics manufactured abroad and warning letters. In contrast, MoCRA authorizes significant increase in funding during the next few years, with $25,960,000 allocated for fiscal year 2024, and $41,890,000 a year for fiscal years 2025, 2026 and 2027. Compared to the previous annual budget of approximately $10 million, this funding is a significant jump and will almost certainly result in increased cosmetics-related inspections and other enforcement activities by the agency.9 No doubt, with FDA’s increased budget, personal care companies can expect to see the agency wield its inspection authority at a much higher level than seen to date.With this in mind, personal care companies should take this time to review their current procedures with respect to manufacturing and marketing their cosmetic products and reassess the risk profile for their products in light of the upcoming regulations and increased scrutiny. Specifically, we recommend that companies:
- Conduct a gap analysis with respect to adverse event reporting procedures. Many personal care companies likely have procedures in place to collect adverse event reports and generally monitor the safety of their products post-marketing. In light of MoCRA’s mandatory reporting requirement and expanded definition of “serious adverse events,” companies should revisit their current practices and procedures to ensure they adequately capture all events that must be reported to FDA, including incidents of infection and “significant disfigurement.” Personal care companies that do not have any adverse event reporting procedures in place should either begin to implement such procedures internally or consider contracting with third-parties that specialize in adverse event reporting.
- Reassess product labels and formulations for compliance with existing and new cosmetic requirements. In light of FDA’s expanded resources to inspect cosmetic facilities, personal care companies should review their current labels and formulations to ensure the risk of being deemed unsafe or unapproved drugs is reduced. A reassessment of the materials and components of cosmetic products is particularly important to confirm products do not include pharmaceutical active ingredients that may increase the risk of FDA deeming the products as unapproved drugs; and
- Develop (or update) a plan for FDA inspections. For years, FDA has devoted limited resources to inspecting cosmetic facilities, focusing instead on other regulated products. As a result, many personal care companies have not been routinely exposed to FDA inspections and may not have a plan in place for when such inspections occur. With enactment of MoCRA, companies should anticipate a lot more FDA inspections and develop a plan to successfully host such an inspection. The plan should ensure that personnel are sufficiently trained and that procedures are in place to demonstrate the company’s compliance with US cosmetics laws and—once they are in effect—with good manufacturing practices.
About the Authors
Raqiyyah Pippins is a partner with Arnold & Porter, a Washington, DC law firm. She co-leads the firm’s Consumer Products Practice Group and the Consumer Products & Retail Industry Team. She has extensive experience representing companies that are engaged in the development, marketing, import, and export of consumer products, including FDA-regulated consumer products, apparel, appliances, and devices.Danait Mengist is an associate with Arnold & Porter. She focuses on FTC and state regulation of the marketing and sale of consumer products. She regularly counsels food, cosmetic and consumer products companies on issues related to advertising and marketing claims, and provides guidance regarding FDA, FTC, NAD, and litigation considerations and risks.
More info www.arnoldporter.com
References
- MoCRA was passed as part of the 2023 Consolidated Appropriations Act. Full text available at: https://www.congress.gov/bill/117th-congress/house-bill/2617/text?s=1&r=2&q=%7B%22search%22%3A%5B%22%5C%22modernization+of+cosmetic+regulations%5C%22%22%5D%7D
- Full text available at: https://www.congress.gov/bill/114th-congress/senate-bill/1014/text
- See, e.g., “FDA Advises Consumers to Stop Using Certain Cosmetics Products,” available at: https://www.fda.gov/cosmetics/cosmetics-recalls-alerts/fda-advises-consumers-stop-using-certain-cosmetic-products; “Is Your Long-Lasting Makeup Toxic? Study Raises Concerns about PFAS in Cosmetics.” Washington Post, Aug. 11, 2021. Available at: https://www.washingtonpost.com/lifestyle/wellness/pfas-cosmetics-forever-chemicals-toxic/2021/08/11/f6475ab4-f9f3-11eb-8a67-f14cd1d28e47_story.html
- December 21, 2022 Press Release, available at: https://www.personalcarecouncil.org/news-release/personal-care-products-council-applauds-inclusion-of-cosmetics-regulatory-reform-in-consolidated-appropriations-act-of-2023/
- “FDA Provides Update on Proposed Human Foods Program and Office of Regulatory Affairs Restructuring,” available at: https://www.fda.gov/news-events/press-announcements/fda-provides-update-proposed-human-foods-program-and-office-regulatory-affairs-restructuring
- 21 U.S.C.A. § 361.
- 21 CFR § 740.10.
- In December 2019, the Director of FDA’s Center for Food Safety and Applied Nutrition testified “In recent years, our program for cosmetics is approximately $10 million and has represented about three percent of CFSAN’s total $327 million budget.” See “FDA Regulation of Cosmetics and Personal Care Products,” Congressional Research Service. March 9, 2022. Available at: https://crsreports.congress.gov/product/pdf/R/R42594/4
- While FDA already has existing authority to inspect cosmetics facilities, the agency’s use of this enforcement tool has been limited. For instance, out of the more than 10,000 domestic inspections the agency conducted in fiscal year 2022, only 15 were for cosmetics establishments. See “FDA Fiscal Year 2023 Justification of Estimates for Appropriations Committees” for number of cosmetics, available at: https://www.fda.gov/about-fda/reports/budgets and FDA’s Data Dashboard for total number of inspections, available at: https://datadashboard.fda.gov/ora/cd/inspections.htm