Although it didn’t get a lot of splashy coverage when it first passed, the gargantuan appropriations bill signed by the president at the end of last year contained a piece of legislation that has some significant potential for expansion of the cannabis cosmetics industry.
The Modernization of Cosmetics Regulation Act of 2022 (better known as MOCRA), it’s the first time cosmetic rules have been updated by Congress through the Federal Food, Drug, & Cosmetics Act since it was passed in 1938. Other aspects of the law have been updated many times over as we’ve seen evolutions of technology, science, product safety, and responsible resourcing advocacy. Still, none of those expressly addressed makeup laws until MOCRA.
Prior to these changes, makeup companies didn’t legally have to test their products or the individual ingredients to ensure safety. Businesses didn’t have to register their production facilities with the FDA, abide by good manufacturing practice rules, or notify the government when there are adverse reactions (even life-threatening ones). Additionally, the FDA didn’t have the power to recall cosmetic products – even those that could be deadly. MOCRA rectifies all this and grants the FDA authority to oversee regulation of makeup products. (Small businesses may be exempt from certain requirements, depending on the specific circumstances.)
Cosmetics are defined not just as makeup, but those products intended for application to human bodies for cleaning, beautifying, altering appearance, or promoting attractiveness. Any product that promises to treat or prevent a condition or disease or alters some bodily function is classified as a “drug” by the FDA. It’s worth noting that CBD products can fall into both categories, but we’re specifically here just talking about CBD-infused cosmetics – though many do promise anti-inflammatory properties. These can include products like:
- Lip balm and lip gloss
- Under eye serums
- Hair creams
- Scalp oil
- Skin cleansers
- Face masks
- Concealer/color corrector
What Does This Mean for CBD Cosmetics Companies?
Companies that produce makeup or other cosmetic products with CBD (hemp-derived) or other cannabinoids are now bound by MOCRA requirements with respect to the following practices:
- Product listing.
- Product registration.
- Facility registration.
- Good manufacturing practices.
- Product recalls.
- Safety substantiation.
- Adverse event reporting to the government.
While states might have their own laws pertaining to cosmetics, MOCRA supersedes those.
It’s worth noting that federal prohibition on cannabis could make complying with certain provisions tricky. For example, if CBD cosmetic products are sourced from a larger cannabis producer, those facilities might not be able to be registered with the FDA due to marijuana’s ongoing classification as a Schedule I narcotic. That said, states are free to pass their own requirements for product and facility listing that align with MOCRA. We suggest companies consult with an attorney to ensure they are in compliance with the law.
As our Los Angeles CBD lawyers can explain, manufacturing CBD cosmetic products may ultimately be more expensive because they’ll have to acquire and maintain proof of their safety and ingredients. On the other hand, the ability to bolster consumer confidence in product safety is important for just about every product maker – particularly those in newer markets like CBD cosmetics. Beyond that, a “substantiated cosmetic use” for CBD products could go a long way in reducing the odds the FDA will object to these products – and possibly even reduce the risk of product liability litigation. It establishes a legitimate, legal reason for CBD to be included in makeup and cosmetic products.
Certain provisions of MOCRA don’t go into effect until the end of next year, and we expect there will be some state-level rules developed in the meantime.
If you have questions about how to make sure your production, record-keeping, registration, reporting, and sales of CBD products are aligned with state and federal rules, contact an experienced cannabis business lawyer for insight.
The Los Angeles CANNABIS LAW Group represents growers, dispensaries, ancillary companies, patients, doctors and those facing marijuana charges. Call us at 714-937-2050.
Modernization of Cosmetics Regulation Act of 2022, March 27, 2023, U.S. Food & Drug Administration