U.S FDA COMPLIANCE: NEW MODERNIZATION OF COSMETIC REGULATION ACT

What is MoCRA?

MoCRA defines cosmetic products as formulations intended for finished product use. It grants the FDA authority to set standards for cosmetic facilities, emphasizing quality control and sanitary conditions.

The objective is to prevent any instances of adulteration or contamination of personal care products, and facilitate FDA inspections to ensure product integrity.  However, it doesn’t regulate over-the-counter (OTC) drugs, like sunscreens that make cosmetic claims.

benzophenone-4

Do you need to comply with MoCRA regulation?

  • FEI number 
  • Facility Registration
  • US Agent.

  • Safety Substantiation 
  • California’s Proposition 65 & California Safe Cosmetic Program (CSCP)
  • Cosmetic Direct Product Listing
  • Responsible Person 

U.S. Small Businesses: Defined by average annual sales under $1M, enjoy specific exemptions.

Manufacturers

Brand owners

Small businesses

Delay in enforcing cosmetic facility and product registration requirements.

The FDA has extended the deadline for cosmetic facility registration and product listing requirements under MoCRA by six months. This gives the industry more time to submit the necessary information. Additionally, the FDA will not enforce these MoCRA requirements for an additional six months, until July 1, 2024, while still requiring safety and adverse event reporting.

Tell us about your project

FAQS

The 2022 Modernization of the Cosmetics Regulation Act (MoCRA) is the FDA’s first major cosmetics regulatory update in 85 years, focusing on product safety and manufacturing standards. Non-US cosmetic facilities need a US Agent for representation. Cosmeservice offers US Agent services, ensuring compliance and liaising with the FDA.

While there’s no guarantee, given the vast number of companies needing to register, it’s advisable to prepare your data early to avoid potential business interruptions. manufacturing facility with the FDA and the Responsible Person to list (register) each cosmetic product sold in the American market.

It’s recommended to start early. The FDA has outlined many requirements, and starting now ensures you stay ahead and prevent business disruptions due to non-compliance.

All products and facilities must be registered by December 29, 2023.

Every company responsible for a cosmetic product sold in the US must comply. Share your manufacturer’s contact details with experts like us to ensure they’re educated and compliant.

While the FDA hasn’t provided explicit guidelines, MoCRA suggests aligning with international standards. A Cosmetic Product Safety Report (CPSR) used in the European Union is a recognized standard that can be adapted for the US.

Labels must include contact details for Adverse Event Reports and disclose identified fragrance allergens. Products for professionals should be clearly labeled as such by December 29, 2023.

Facility registrations under Modernization of the Cosmetics Regulation Act (MoCRA) must be renewed every two years.

Small US businesses with cosmetic sales under $1M in the last three years are exempt from Good Manufacturing Practices, Facility Registration, and Product Listing. However, exemptions don’t apply to businesses producing cosmetics for eye contact, injectable products, internally consumed products, or products that modify appearance for over 24 hours.

The Responsible Person introduces products to the market and ensures compliance with safety regulations. They don’t have to be located in the US. The US Agent, on the other hand, must be based in the US and plays a crucial role in reporting adverse events, answering queries, and facilitating communication between the FDA and the product introducer. Cosmeservice is excited to offer its expertise as a US Agent for international brands and also provides guidance and support to US Responsible Persons. Let us assist you in achieving compliance and success under the new MoCRA guidelines.

Do you want to know FDA compliance?

Start selling your products in the USA

Join Our Newsletter and Stay Up-to-Date!

Subscribe to our newsletter for exclusive offers, industry news, and the latest in cosmetics right to your inbox. Stay informed and ahead of the curve—join now!

By subscribing to Cosmeservice newsletter, you agree to receive promotional and informational emails from us. You can unsusbcribe at any time by clicking the ‘unsubscribe’ link at the bottom of out emails.

×