The beauty industry just experienced its biggest regulatory shift in over 80 years. 

If your brand sells cosmetics in the U.S.—whether online or in retail—you need to understand what the Modernization of Cosmetics Regulation Act (MoCRA) means for your business. 

And more importantly, how to stay compliant before deadlines catch up with you. 

“MoCRA is the FDA’s message to the global cosmetics industry: the U.S. market is no longer a free pass,” says Tim Forrest, FDA Compliance Consultant and founder of Tim Forrest Consulting. “For the first time, brands must meet serious documentation, registration, and safety standards to sell legally.” 

What is MoCRA?

MoCRA, signed into law in late 2022, modernizes how the FDA oversees cosmetic products. It introduces mandatory regulations for manufacturers and processors—especially international brands entering the U.S. market. 

In the past, cosmetic compliance was largely voluntary. That era is over. 

Who Must Comply?

MoCRA applies to: 

• U.S. and foreign cosmetic manufacturers and processors 

• Brand owners, even if using contract manufacturers 

• Businesses of all sizes including Amazon sellers. (with limited exemptions for very small businesses) 

If your facility makes, fills, or repackages cosmetic products sold in the U.S.—you are subject to MoCRA. 

Key FDA Requirements Under MoCRA

1. FDA Facility Registration 

All facilities must register with the FDA and obtain an FEI number. A D-U-N-S® number is required to validate registration. Registrations renew every two years. 

“Even small brands with contract manufacturers must ensure their partners are registered—or risk delays and detentions,” says Forrest. 

2. Product Listings 

Each marketed product must be listed with the FDA, including full ingredient disclosure. Changes in formulation require an update. 

3. Safety Substantiation 

You must maintain documentation that your product is safe for intended use, including toxicological profiles and supporting evidence. 

4. Good Manufacturing Practices (GMP) 

The FDA will release enforceable GMP rules soon. In the meantime, ISO 22716 is the standard to follow. 

5. Adverse Event Reporting 

Serious adverse events (e.g., reactions requiring medical attention) must be reported to the FDA within 15 business days. All adverse event records must be kept for 6 years. 

6. Labeling Requirements 

Product labels must include the responsible party’s contact information and meet all FDA labeling rules. Fragrance allergen disclosure rules are expected soon. 

Common Misconceptions 

Many small and indie brands assume MoCRA doesn’t apply to them. That’s a dangerous assumption. 

“We’ve spoken to several founders who believed MoCRA didn’t apply because they sell direct-to-consumer or make small batches,” Forrest explains. “That’s a costly mistake. Registration and documentation are still required.” 

How Tim Forrest Consulting Can Help 

With over 30 years in FDA compliance and food & cosmetic strategy, we provide: 

• Cosmetic facility registration 

• FEI and D-U-N-S® support 

• Label and claim compliance reviews 

• Safety documentation consulting 

• U.S. Agent services for international brands 

“MoCRA has changed the game,” says Forrest. “The brands that prepare early will move ahead. The ones who wait? They may find their shipments stuck at the port.” 

Ready to Comply with MoCRA? 

Don’t risk delays, detentions, or enforcement. 

 Let our team simplify and manage your FDA compliance process from start to finish. 

📧 Email: [email protected] 

 🌐 Website: www.timforrest.com 

 📅 Book a Call: www.timforrestmarkets.com