Hello, dear readers. Before we retreat to our couches and pajamas to rewatch “Nobody Wants This,” and count the days until another Beyonce halftime show, let’s take stock of the year that was and wonder what we can expect in the coming year.
Caveat—I don’t have a crystal ball and cannot say for certain what will happen next year, nor can I speak for any regulatory agency or incoming administration. Any views expressed are entirely my own.
Here are some of the top stories of 2024, and what can we expect in 2025?
A new administration
Any discussion of 2024 must start with the election of Donald J. Trump in November and his selection of Robert F. Kennedy Jr. to serve as Secretary of the U.S. Department of Health and Human Services. HHS oversees approximately 80,000 employees across 13 federal agencies, including the Food & Drug Administration.
If confirmed, Kennedy could have a significant impact on the beauty and wellness industry, as well as consumer product safety. While many of his proposed policies to date have focused on food and pharmaceuticals, and in particular vaccines, Kennedy has accused the government of aggressively suppressing wellness products and treatments, including various nutritional supplements or hyperbaric oxygen or stem cell treatments.
At the same time, Kennedy has been a vocal critic of certain ingredients such as phthalates, which have been found in personal care products, and bisphenol-A (BPA), which may be found in certain cosmetic packaging, as well as voicing skepticism of certain chemical-based sun protections.
FDA reorganization
On October 1, 2024, FDA implemented the single largest reorganization in the agency’s history. First announced in January 2023, the reorganization created a unified Human Foods Program and restructure FDA’s field operations.
As a result of the reorganization, FDA’s Office of Cosmetics and Colors organization, functions, and resources has been moved from the Center for Food Safety and Applied Nutrition (CFSAN) to the Office of the Chief Scientist (OSC), which will better align expertise of FDA’s cosmetics subject‐matter experts with those of the Chief Scientist, and allow for streamlined decision-making and enhanced collaboration with organizational stakeholders, including women and minority health.
Additionally, FDA’s Office of Regulatory Affairs has been streamlined into the Office of Inspections and Investigations or OII, which will narrow its focus to inspections, investigations, and import operations–including with respect to cosmetics that may be adulterated and pose risks to the public.
MoCRA: Year 2
The Modernization of Cosmetics Regulation Act, or MoCRA, as it has come to be known, continued its rollout into 2024.
As of July 1, 2024, owners and operators of facilities that manufacture or process cosmetic products distributed for sale in the United States are required to register their facilities with FDA.
Additionally, as of July 1, 2024, MoCRA requires that a responsible person—the manufacturer, packer or distributor of a cosmetic product whose name appears on the product’s label—must list each marketed cosmetic product with FDA within 120 days of first marketing, including ingredients, and provide annual updates.
On December 12, 2024, FDA announced the availability of a final guidance for industry entitled “Registration and Listing of Cosmetic Product Facilities and Products,” intended to assist persons submitting facility registrations and product listing submissions. This guidance also includes three new draft frequently asked questions and answers for comment purposes only:
- Defining the responsibilities of a US agent;
- Can multiple buildings that are in close proximity (within 3 miles of each other) be associated with one FEI number, or are two FEI numbers needed; and
- Whether a product listing must be submitted for free samples or gifts.
With respect to MoCRA’s new rulemaking obligations, on December 14, 2024, the Office of Information and Regulatory Affairs (OIRA) published its Fall 2024 Unified Agenda of Federal Regulatory and Deregulatory activities, pushing back target dates for proposed regulations required under MoCRA. These include:
- Identifying fragrance allergens that must be disclosed on cosmetics labels and the format for disclosure, in line with EU and other international requirements (now slated for January 2025; updated from its prior target date of October 2024);
- Standardizing testing methods for detecting and identifying asbestos in talc-containing cosmetic products (now slated for December 2024, as opposed to July 2024)
- Mandating good manufacturing practices for cosmetic product facilities consistent with national and international standards (now slated for October 2025).
Although not required by MoCRA, in 2023, FDA issued a notice of proposed rulemaking with respect to banning the use of formaldehyde and formaldehyde-releasing chemicals, such as methylene glycol, as ingredients in hair smoothing or straightening products. As of the Fall Unified Agenda, the target date for this NPRM has been moved to March 2025 as opposed to 2024.
Additionally, as of December 29, 2024, MoCRA will require responsible persons to update cosmetic product labeling to list contact information for the reporting of serious adverse events on the product label by December 29, 2024. The labeling must include a domestic address and telephone number, website or other electronic contact information where the responsible person can receive reports of adverse events.
Finally, MoCRA requires FDA to issue a report assessing the use of perfluoroalkyl and polyfluoroalkyl substances in cosmetics, including the scientific evidence regarding their safety and any human health risks posed by its use in cosmetics, due no later than December 29, 2025.
In addition, Senate appropriators have directed FDA “to develop a plan outlining research needed to inform regulatory decision-making, including potential development of a proposed rule to ban intentionally added PFAS substances in cosmetics.” To date, FDA has not issued any announcements regarding those proposed rules or reports.
#BeautyTok no more?
In a blow to American tweenagers (and the Millennials struggling to catch up), in April 2024 Congress passed a law requiring the social media giant TikTok to divest itself of its US operations, and sell to an American company before January 19, 2025, or be banned from US app stores. The United States Supreme Court is expected to hear arguments on January 10, 2025, over whether the law forcing the sale is constitutional.
TikTok maintains around 170 million users in the United States alone, many of them teenagers and young adults. However, US lawmakers have long expressed national security concerns over the app so long as it is owned by a Chinese parent company, including the possible spread of misinformation or espionage.
It’s important to remember that any ban won’t take place immediately—existing versions of apps will continue to work until phone software updates. Nevertheless, beauty and wellness companies who depend on influencer-led campaigns or sales through TikTok’s in-app e-commerce feature, TikTopShop, should be prepared for significant legal upheaval.
State legislative activity
Since MoCRA’s enactment in 2022, we’ve seen a new wave of state legislative activity that limits or restricts the use of cosmetic ingredients, or requires additional reporting obligations. While we can’t identify all of them here, it’s important to remember that any of those new laws will take effect in January 2025:
As of January 1, 2025, Washington’s Toxic Free Cosmetics Act will ban the manufacture, sale, and distribution of cosmetic products containing certain added chemicals, including, but not limited to, ortho-phthalates; PFAS, methylene glycol, and formaldehyde.
As of January 1, 2025, California’s Toxic Free Cosmetics Act, approved in 2020, will ban the manufacture, sale, delivery, or offer for delivery any cosmetic product that contains the following intentionally added ingredients: dibutyl phthalate; diethylhexyl phthalate; formaldehyde; paraformaldehyde; methylene glycol; quaternium-15; mercury; isobutylparaben; isopropylparaben; and certain PFAS and their salts.
As of January 1, 2025, California’s PFAS-Free Cosmetic Act bans all intentionally added PFAS from personal care products sold in California.
As of January 1, 2025, Colorado’s Perfluoroalkyl and Polyfluoroalkyl Chemicals Consumer Protection Act will prohibit the sale or distribution of any cosmetic products containing intentionally added PFAS chemicals.
As of January 1, 2025, Oregon’s Toxic Free Cosmetic Act will require manufacturers to disclose all ingredients on their product websites.
Thank you so much for joining me in 2024 as we covered everything from the origins of the Food, Drug, and Cosmetics Act of 1938 to anti-aging treatments to “Sephora” tweens, to “clean” beauty. Looking forward to discussing what unfolds in 2025!
Kelly
Questions or suggestions? Reach out to Kelly at kabonner@duanemorris.com.
