A year has passed since Congress enacted the Modernization of Cosmetics Regulation Act (MoCRA) and enhanced the Food and Drug Administration’s (FDA) authority to regulate the cosmetics industry. Although MoCRA implementation efforts steadily increased throughout the calendar year, as the December 29, 2023 compliance date for most MoCRA provisions approached, FDA’s release of information and deployment of new systems for the industry came to a climax. Several recent MoCRA-related developments will influence how cosmetic industry stakeholders, consumers, and even the FDA will approach and navigate the law’s requirements over the next year. In this blog post, we will discuss each of these developments and forecast the law’s future as we move into 2024.

FDA Updates Cosmetics Constituents on Mandatory Reporting of Serious Adverse Events

On December 14, 2023, FDA took its first public actions related to serious adverse event reporting under MoCRA. First, the agency issued a Cosmetics Constituent Update regarding the reporting of serious adverse events – a brand new mandatory obligation that came into effect with the law’s one-year anniversary. Other statutory requirements that become enforceable on December 29 include those related to adverse event recordkeeping, documentation of safety substantiation for cosmetic products, and specific labeling for professional use products. 

Under MoCRA, a “responsible person” (defined as “manufacturer, packer, or distributor of a cosmetic whose name appears on the label of that product”) is required to report a serious adverse event to FDA within 15 business days of its occurrence. A “serious adverse event” is an adverse health-related event associated with the use of a cosmetic product that results in: 

• death; 
• a life-threatening experience; 
• inpatient hospitalization; 
• a persistent or significant disability or incapacity; 
• a congenital anomaly or birth defect; 
• an infection; or 
• significant disfigurement. 

A “serious adverse event” is also one that requires, based on reasonable medical judgment, a medical or surgical intervention to prevent one of the above-described outcomes. 

After previewing this implementation plan earlier in the year as part of its educational MoCRA webinar (available on the main MoCRA webpage here and as mentioned in our April 2023 blog post), FDA is now formally requesting that responsible persons use the MedWatch Form 3500A to report serious adverse events to the agency. It also announced that the instructions for how to fill out Form 3500A – which is used for safety reports associated with drugs, biologics, and medical devices – have been updated to reflect cosmetic-specific guidance for completing various sections of the lengthy form. Responsible persons’ MedWatch forms and supporting documentation can be submitted via email at CosmeticAERS@fda.hhs.gov or by regular mail using the address listed in the December 14 Constituent Update. Additionally, FDA simultaneously updated its webpage for consumers and health care professionals on how to report adverse events and other safety complaints related to cosmetic products.

Finally, the Cosmetics Constituent Update notes that FDA is developing an electronic submissions process for responsible persons to utilize when reporting serious adverse events; the agency will provide more information regarding the launch date for this planned upgrade “in the coming months.” Once the electronic submissions process is available, FDA will strongly encourage its use “to facilitate efficiency and timeliness of data submission and management for the agency.” 

FDA Launches “Cosmetics Direct” Electronic Submissions Portal for Registration and Listing & Finalizes Guidance for Industry 

In our November blog post, we provided an overview of FDA’s decision to delay enforcement of the cosmetic product listing and cosmetic facility registration requirements, which also became effective on the one-year anniversary of December 29, 2023. The enforcement delay was due, in part, to FDA’s setback in launching the Cosmetics Direct electronic submissions portal and in finalizing new paper-based registration and listing forms for cosmetics. Then, on December 18, FDA announced that Cosmetics Direct is now live and can be accessed at https://direct.fda.gov/. Although FDA expects paper forms for cosmetic facility registration and cosmetic product listing to “be available soon” for use “as an alternative submission tool,” it emphasized in the December 18 Constituent Update that electronic submissions are highly encouraged. 

To further facilitate the adoption and successful submission of electronic submissions via Cosmetics Direct, FDA concurrently released an updated version of its technical guidance for industry titled Structured Product Labeling (SPL) Implementation Guide with Validation Procedures. SPL is a document type sanctioned by health level seven (HL7) for the exchange of product and facility-related information, and FDA mandated the use of files compliant with the SPL standard for all electronic submissions back in 2005. Cosmetic stakeholders therefore have a large number of SPL publication resources available to them and can learn from the prior experiences of drug, device, and food companies that have been submitting facility registrations in the language for many years.

FDA does not intend to enforce MoCRA’s facility registration and cosmetic product listing requirements until July 1, 2024, but it is encouraging companies to comply before then to the extent possible. As a reminder, these requirements apply to entities that engage in manufacturing or processing cosmetic products that were marketed on or before December 29, 2022 (the enactment date of MoCRA), as well as those that entered into the U.S. cosmetic market after that date, subject to the statute’s requirement that new companies register and list within 60 days and 120 days, respectively. 

On the same day as its launch of Cosmetics Direct, FDA also published its Final Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products (Final Guidance), which finalizes the draft guidance issued in August 2023 and discussed in our previous blog post.

Although the Final Guidance is substantially the same as the draft version, there are a few key changes to note in the Final Guidance. First, the Final Guidance revises the definition of “Contract Manufacturer” to a “facility that manufactures or processes a cosmetic product on behalf of another entity.” The previous definition captured facilities that engage “in one or more steps in manufacturing or processing a cosmetic product on behalf of another company.” FDA also more clearly explains that “FEI” stands for “FDA Establishment Identifier” and that the agency will use the FEI number as the cosmetic product facility’s registration number. If an entity does not already have an FEI number, it must obtain one from FDA before submitting the facility registration. 

Draft “FAQ” Guidance on Registration and Listing Open for Comment 

Notably, the Final Guidance includes a new draft “Appendix B: Frequently Asked Questions and Answers” on which the agency has solicited stakeholder comments. The draft Appendix B contains 19 questions and answers covering a variety of topics related to the cosmetic registration and product listing. Some of the topics addressed in the FAQs are whether a consultant or a company located outside of the United States can be considered a “responsible person” under MoCRA; which types of products do not qualify facilities for the small business exemption from registration and compliance with good manufacturing regulations; and whether certain persons or entities, such as importers or laboratories that perform batch release testing, need to register as cosmetic facilities. FDA is accepting electronic or written comments on Appendix B to be submitted by January 18, 2024 (see relevant Federal Register notice and also Docket No. FDA-2023-D-1716). 

Government Accountability Office Releases Report on MoCRA’s Implementation

Separately from the year-end flurry of FDA activity in the cosmetics space, on December 6, 2023, the Government Accountability Office (GAO) released Report No. GAO-24-105542, entitled Cosmetic Safety: Better Planning Would Enhance FDA Efforts to Implement New Law (Report). The Report details FDA’s work to date implementing MoCRA and its oversight of cosmetic products more generally. To prepare the Report, GAO examined FDA’s activities from November 2021 through December 2023 and interviewed senior FDA officials, such as the agency’s Chief Scientist. It also reviewed relevant scientific literature, applicable laws, and agency documents. GAO then used the information derived from its review to highlight critical steps FDA has taken thus far and its future plans for cosmetic-related programs, as well as to point out current gaps and areas where the agency’s activities are lagging. 

More specifically, the Report found that FDA has been successful in the following efforts: 

• Designating leadership in charge of MoCRA's implementation (i.e., Office of the Chief Scientist);
• Imposing leadership accountability and oversight; 
• Establishing an internal MoCRA-specific implementation team; 
• Holding various meetings and communications with agency staff; 
• Hiring three new one-year contractors, including two epidemiologists, to begin work on MoCRA requirements; 
• Tracking the number and cost of contractors supporting implementation efforts; 
• Establishing MoCRA working groups to engage FDA employees; and 
• Beginning steps in strategic workforce planning. 

However, the Report also found that the agency could be engaging in strategic planning for the long term to ensure the law’s continued incorporation into all relevant aspects of FDA operations. GAO identified several gaps in FDA’s efforts to date that relate to management and monitoring of key MoCRA milestones and strategic workforce planning. For example, GAO reported that FDA has not yet taken adequate steps to track and manage MoCRA-related developments; strategically plan for agency workforce needs including identification of personnel skills and capacity; or establish processes to measure effectiveness of its ongoing efforts. Additionally, the Report referenced FDA’s partial reporting of its activities under the MoCRA authorities. For instance, FDA has not updated the public about its plans for issuing a proposed regulation governing the labeling of fragrance allergens – a task that is due to be completed by June 29, 2024.

Finally, GAO made seven recommendations to FDA to address cosmetic safety under MoCRA effectively in the long term. The oversight office is recommending that FDA: 

• Develop a timeline, with interim agency steps, for meeting MoCRA deadlines; 
• Plan for and incorporate public reporting into the timeline; 
• Conduct data collection to measure MoCRA-related efforts; 
• Determine effects of implementing MoCRA provisions on current and future workforce; 
• Create a multi-year strategic workforce plan; 
• Adopt a plan to strengthen diversity, equity, inclusion, and accessibility in hiring efforts; and 
• Develop strategies for effective recruitment, focusing on recruitment of highly specialized and hard-to-fill positions. 

Perhaps coincidentally, on December 19 the agency’s lead for MoCRA implementation – the Office of the Chief Scientist – updated the list of guidance documents it intends to publish by the end of 2024. This updated list includes guidance documents on mandatory recall for cosmetics and records access, both areas that were expanded under the cosmetic modernization law. The only other two guidances related to cosmetics appearing on the list at this time are the Final Guidance on registration and listing (see above) and guidance on “Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination,” which was issued in draft form in June 2023.

Conclusion

December 2023 was an eventful month for FDA activity in the cosmetic safety space. These end-of-year activities foreshadow developments that are sure to take place in the new year. The GAO Report identified successes, as well at pitfalls, of implementation that FDA can set as benchmarks for the next year. In addition to the launch of the electronic registration and listing submissions process, we can also anticipate updates on and the impending launch of a companion serious adverse event e-reporting process in 2024. We will continue to monitor developments from FDA that are critical for industry stakeholders to be aware of, including any potential inspectional or enforcement activity related to new MoCRA recordkeeping and other requirements.