“The cannabis industry will need to closely monitor both FDA, as it rolls out implementing regulations, and state marijuana and hemp laws as state lawmakers consider whether and how to establish laws consistent with MOCRA.”
By Andrea A. Golan, Vicente Sederberg LLP
Tucked away deep into the 1,600-plus page omnibus appropriations bill signed by President Joe Biden at the end of December 2022 is the “Modernization of Cosmetics Regulation Act of 2022,” otherwise known as “MOCRA.” The MOCRA legislation is significant for a number of reasons—including its potential implications for the expanding cannabis cosmetics market.
This is the first time Congress has updated the cosmetic regulations included in the Federal Food, Drug, & Cosmetics Act (“FDCA”) since 1938 when the FDCA was first enacted. To compare, over the course of the last eight decades, other provisions of the FDCA have been updated and amended dozens of times—and in significant ways—to account for advances in science, technology, product development and, as relevant to this discussion, the discovery of ingredients that could cause harm if placed in food, drugs or dietary supplements. None of those amendments touched on cosmetic regulation until now.
Pre-MOCRA, cosmetic companies were not required to test their products or individual ingredients for safety. Companies were not required to register their facilities with the Food and Drug Administration (FDA), manufacture in adherence to good manufacturing practice regulations (“GMPs”) or report adverse events. And prior to MOCRA, FDA had no authority to recall a product, even if life-threatening. MOCRA addresses these shortcomings and expands FDA’s oversight and authority to regulate cosmetic products.
Highlights of the major changes include the following:
Substantiation of Safety. A “responsible person” must ensure and maintain records supporting adequate substantiation of the cosmetic product’s safety.
New labeling requirements, including contact details for adverse event reporting and identification of fragrance allergens (once the FDA issues the fragrance allergen rule)
Record keeping and reporting to the FDA of serious adverse events
Mandatory facility registration and product and ingredient listing for anyone who manufactures cosmetics distributed in the U.S., including importers
Good manufacturing practice regulations
Authority to FDA for mandatory recalls
Small businesses are exempt from certain of the above requirements subject to certain exceptions
Cosmetics with CBD or other hemp-derived cannabinoids must comply with MOCRA
Companies marketing cosmetics with hemp-derived CBD or other cannabinoids must comply with MOCRA requirements with respect to the following items: registration and product listing, good manufacturing practices, records, recalls, adverse event reporting and safety substantiation.
This is so because MOCRA contains a preemption clause that overrules any state or local law that differs from MOCRA with respect to those specific items. In all other areas, states can establish or keep in effect its own respective laws affecting cosmetics that differ from MOCRA. This expanded federal regulatory framework makes manufacturing more costly now that companies must have adequate data substantiating the safety of the cosmetic product and its ingredients.
MOCRA’s requirement for “adequate substantiation of safety” is defined to mean “…tests or studies, research, analyses or other evidence or information that is considered, among [qualified experts], to be sufficient to support a reasonable certainty that a cosmetic product is safe.”
It is a positive development that companies will be able to represent to consumers that their cannabinoid cosmetic products have been tested for safety. Moreover, having a substantiated cosmetic use for CBD, in particular, may actually decrease the risk of FDA objection (and potentially lawsuits by private parties) because it provides a legitimate reason for CBD to be included in the cosmetic product.
On the other hand, the requirement that responsible persons must list with FDA each cosmetic product, including its ingredients and information about where the product is manufactured, could draw additional scrutiny, particularly where the products contain CBD as an ingredient.
The mandatory product listing likely makes it easier for the FDA to track companies to ensure they stick to claims permissible for cosmetic products. Because “cosmetics” are defined in the FDCA as articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness or altering the appearance, companies are limited to claims about cleansing, promoting attractiveness or altering the appearance.
If the product is marketed with claims that its intended use is to treat or prevent a disease or condition or affect the structure or function of the body, it is considered a “drug” as far as FDA is concerned, even if the product also affects the appearance and is used for cleansing, beautifying, etc. Hence, the FDA’s focus on issuing warning letters to CBD companies making therapeutic or disease claims.
Will MOCRA Impact State-Licensed Manufacturers of Marijuana-Based Topical Products?
Perhaps in some ways. Given that marijuana topicals are frequently marketed as balms, salves or oils intended to alleviate pain, they would not be classified as cosmetics under federal law for the reasons noted above; they would be considered drugs.
Nonetheless, it is possible that states with medicinal and/or adult-use marijuana programs will adopt some provisions of MOCRA and require marijuana manufacturers to comply even though their topical products would not qualify as cosmetics outside of the regulated marijuana market. Mandatory facility registration and mandatory product listing with FDA wouldn’t be possible due to marijuana’s federal illegality, but states could enact their own facility and product listing requirements and enact requirements that are identical or consistent with MOCRA.
Some of MOCRA’s requirements do not take effect immediately. The labeling requirements take effect in December 2024. The FDA has two years to issue a proposed rule for GMP regulations, and manufacturers of products already on the market have one year to register their facility and submit a product listing to FDA. How FDA will implement MOCRA and whether states will impose MOCRA requirements on licensed marijuana manufacturers remains to be seen.
The cannabis industry will need to closely monitor both FDA, as it rolls out implementing regulations, and state marijuana and hemp laws as state lawmakers consider whether and how to establish laws consistent with MOCRA.
Andrea A. Golan serves as counsel in Vicente Sederberg’s Los Angeles office and a member of the firm’s Regulatory Compliance and Hemp and Cannabinoids Departments. Her practice focuses on advising businesses in ensuring compliance with regulatory requirements for cultivating, processing, testing, marketing, and selling cannabis products—including advising businesses with respect to the intersection of federal, state and local laws.
(Disclosure: Vicente Sederberg supports Marijuana Moment’s work with a monthly pledge on Patreon.)
Photo courtesy of Kimzy Nanney.