According to statistics, it’s estimated that the U.S. beauty market nets just under $100 billion within a global market valuation of $571.1 billion at the start of 2023. In many countries around the world (e.g., EU, Canada, China) the cosmetic industry is tightly regulated by the government. You might be surprised to learn that up until recently, legislation for the production, sale, and distribution of cosmetics in the U.S. hadn’t been updated since President Franklin D. Roosevelt signed the Federal Food, Drug, and Cosmetic Act (FDCA) in 1938. Quite the history lesson! Surely, a law enacted 85 years ago isn’t quite up to snuff, which is why reform has taken place at the state level over the last several decades.
After a long-awaited overhaul, President Biden signed the Modernization of Cosmetics Regulation Act (MoCRA) in December 2022, which grants the FDA increased supervision and oversight of cosmetic products. It’s important to note that although MoCRA will initiate sweeping change across the beauty industry, this will not happen overnight. The bill outlines each directive, with associating dates and deadlines for compliance that the FDA will work towards disseminating. So, what does this mean for cosmetic manufacturers and brands? Below, we’ve highlighted the major provisions of MoCRA to help break down some of the legal jargon and prepare you for the implementation of this new law.
First things first, what does the FDA consider a cosmetic?
The FDA defines a cosmetic as a product (excluding pure soap) intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance. The classification of product types, such as a soap vs. a cosmetic, has not been modified. A true soap made from saponified oils that does not make any claim beyond cleansing is not subject to FDA regulations or MoCRA.
Okay, back to MoCRA. What will the FDA enforce under this new legislation?
- Facility and product registrations
- Adverse event reporting
- Product safety substantiation
- Required Good Manufacturing Practices for all manufacturers
- Authority to request a mandatory product recall
- Asbestos testing method for talc-containing products
- Safety and use assessments of PFAS (per- and polyfluoroalkyl) chemicals
Who does MoCRA place these responsibilities on, specifically?
The majority of these statutes pertain to a responsible person, which is defined as “the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of [the FDCA] or section 4(a) of the Fair Packaging and Labeling Act.” Put differently, the responsibility for most of the new requirements falls primarily on the brand. See below for detail.
For Twincraft as a contract manufacturer, we are responsible for:
- Registering all three of our facilities with the FDA by the end of December 2023.
- Manufacturing cosmetics according to GMP guidelines. This is a practice we already have in place.
For our brand partners, you are responsible for making the following changes if you haven't done so already:
- Registering cosmetic product(s) with the FDA by the end of 2023
- Listing a complete U.S. address with street name or U.S. phone number and website on product artwork and labels for the reporting of adverse events by the end of 2023
- Reporting adverse events to the FDA within 15 days and keeping adverse events records by the end of 2023
- Maintaining substantiation of cosmetic product safety through raw material documentation review and product testing by the end of 2023
- Including cosmetic allergens in product artwork and labels by the end of 2024
In accordance with MoCRA’s requirements, our manufacturing facilities are registered with the FDA as “OTC Facilities” and will be registered as “Cosmetic Facilities” by the end of 2023. Moreover, all Twincraft-made products are currently manufactured under GMP guidelines. We recognize that although MoCRA is instituting necessary change within the industry, there are certain adjustments that will take time and energy to execute. Our valued customers can count on us to support them through this process by providing documentation, testing, and any additional resources to ensure that they are compliant with the new regulations under MoCRA. Let us know how we can help.