New FDA regulations: the latest guide for UK and European businesses post-MoCRA
Navigating the American market for handmade cosmetics involves understanding key regulatory differences, particularly those governed by the Food and Drug Administration (FDA) in the USA. The regulations can differ significantly from those in the EU and UK. With the Modernisation of Cosmetics Regulation Act of 2022 (MoCRA), the FDA has introduced new guidelines that further differentiate the American market from its European counterparts. Here is the latest guide to help you navigate these newly instated complexities.
Ingredients and formulation: simpler but still critical
Although the FDA does not require a formal safety assessment for each cosmetic product, MoCRA mandates that product manufacturers and processors register their facilities and list marketed products, including ingredients. This makes accurate labelling of all ingredients, in descending order of concentration, even more critical for compliance.
Clear and compliant labelling: a universal requirement
Label requirements remain less rigorous in the USA compared to the EU and the UK. Still, they are essential for compliance, particularly in light of MoCRA. Labels must feature accurate and comprehensive information including the product's name, weight or volume, directions for safe use, a complete list of ingredients, and the name and address of the manufacturer or distributor.
Facility registration and product listing: new mandates under MoCRA
One of the most significant changes under MoCRA is the mandatory registration of cosmetic product facilities. If you're a manufacturer or processor, you'll have to register your facilities with the FDA and update content within 60 days of any changes. You'll also need to renew this registration every two years. Additionally, a responsible person must list each marketed cosmetic product with the FDA, providing updates annually.
Exemptions to MoCRA: opportunities for small businesses
MoCRA does offer exemptions for certain small businesses, which is good news for small, handmade soap and cosmetics businesses. However, these exemptions do not apply to products that have specific application methods like injection or are intended for internal use.
Voluntary registration no more: VCRP discontinued
The FDA has stopped accepting submissions to the Voluntary Cosmetic Registration Program (VCRP), rendering it defunct as a result of the new registration and listing authorities mandated by MoCRA.
Electronic submissions and FEI numbers: prepare in advance
The FDA will be introducing a new electronic registration and listing submission portal in October 2023. Stakeholders are strongly encouraged to use this portal for efficiency and timeliness. Moreover, facilities will now need to obtain an FDA Establishment Identifier (FEI) number before submitting for registration. This FEI number will also be required for product listing.
Pilot programme for user acceptance testing: an invitation for stakeholders
If you're looking to be on the forefront of adapting to these new changes, the FDA is inviting applications for a voluntary pilot programme to conduct User Acceptance Testing (UAT) for the new electronic submission portal.
Worldwide insurance: a safety net
Given the evolving landscape of international regulations, investing in worldwide insurance coverage for your products can offer you added protection against legal claims and show that you take customer safety seriously.
Consult legal advice: an essential step
Given these significant changes and the complexity of navigating both U.S. and EU/UK regulations, consulting a legal advisor who specialises in international trade and cosmetics laws remains strongly advised.
Armed with this updated knowledge on the latest FDA guidelines, your UK or European handmade soap or cosmetic business will be better equipped for a successful venture into the American market.
Useful links and sources
https://www.fda.gov/cosmetics
https://www.fda.gov/cosmetics/cosmetics-news-events/fda-issues-draft-guidance-registration-and-listing-cosmetic-product-facilities-and-products