The U.S. Food and Drug Administration (FDA) plays a crucial role in regulating products that impact public health, including hand hygiene products, which generally fall into two categories:
- Over-the-counter (OTC) drugs: Hand sanitizers and antibacterial hand soaps
- Cosmetics: Non-antibacterial hand soaps
With the introduction of the Modernization of Cosmetics Regulation Act (MoCRA), significant changes are coming into effect that will substantially impact the cosmetics portion of the skin care product category.
What Is MoCRA?
MoCRA represents an extensive expansion of the FDA's authority over cosmetics, marking the most considerable changes since the 1938 Federal Food, Drug, and Cosmetic Act. The new legislation tightens regulations for cosmetics to align more closely
with those for OTC drugs.
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Key Provisions of MoCRA
- Registration and Compliance: All cosmetics manufacturers should have registered their facilities with the FDA by the end of 2024 and need to comply with Good Manufacturing Practices (GMPs) by end of 2025. Registrations must be
renewed every two years, and facilities must report any changes within 60 days.
- FDA Oversight: The FDA has the authority to inspect facilities, conduct audits, and suspend registrations if manufacturers fail to meet compliance requirements.
- Product Listing: Each cosmetic product must be individually listed with the FDA, including detailed information about ingredients, labeling, and intended use.
- Safety Substantiation: Manufacturers are required to maintain records that substantiate the safety of their products, using data derived from scientifically robust methods.
- Adverse Event Reporting: Companies must report any adverse events within 15 business days and continue to submit any new related information for one year.
- Mandatory Recalls: The FDA now has the power to institute mandatory recalls for products that do not meet safety standards.
Implications for Manufacturers & Customers
At this time, there is no tool supplied by the FDA to determine which manufacturers comply with MoCRA. This means that customers must rely on suppliers to be forthcoming about the status* of their operations and products, as well as potential ramifications
of newly establishing or forgoing compliance. This potentially includes supply disruptions, price increases, reformulation, or changes to claims.
Because we already strictly follow GMP guidelines for the manufacture, fill, and shipment of all hand hygiene products, the December 2025 deadline will not affect the availability of our products.
At Betco®, we prioritize the health and safety of our customers and transparent, proactive communication. Having long been registered with the FDA for OTC products, we are well-positioned to meet these new regulations for cosmetics.
Betco has already registered our facility for cosmetics manufacturing and all relevant products well ahead of the MoCRA enforcement deadlines. Because we already strictly follow GMP guidelines for the manufacture, fill, and shipment of all hand hygiene
products, the December 2025 deadline will not affect the availability of our products. Betco is in good standing with the FDA.
*While certain small businesses and activities like labeling or repackaging may be exempt from some of the stringent requirements under MoCRA, the vast majority of manufacturers in the jan-san industry are affected
Contact Us
The introduction of MoCRA is set to bring more rigorous standards to cosmetics suppliers in jan-san and other industries. If you have any questions or concerns about how these changes might affect your business, please fill out the form below to contact
a knowledgeable expert on Betco’s dedicated regulatory team.