FDA Regulations for the Cosmetic Industry: What You Need to Know

In today’s competitive beauty market, understanding and complying with FDA regulations is not just a legal necessity—it’s a strategic advantage. Whether you're a contract manufacturer, a brand owner, or an influencer launching a private label, navigating the regulatory landscape is essential to protect your business and build consumer trust.

Why FDA Compliance Matters

The U.S. Food and Drug Administration (FDA) oversees the safety and labeling of cosmetic products under the Federal Food, Drug, and Cosmetic Act (FD&C Act). While cosmetics do not require premarket approval, the FDA has the authority to take action against products that are misbranded or adulterated.

Non-compliance can lead to warning letters, product recalls, import refusals, and reputational damage. With the rise of consumer awareness and regulatory scrutiny, ensuring your products meet FDA standards is more important than ever.

Key Regulatory Updates: MoCRA

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) introduced the most significant changes to cosmetic regulation in over 80 years 1. Here are the key requirements now in effect:

• Facility Registration: Manufacturers and processors must register their facilities with the FDA and renew every two years.

• Product Listing: Each marketed cosmetic product must be listed with the FDA, including ingredients and updates submitted annually.

• Adverse Event Reporting: Companies must report serious adverse events and maintain records for six years.

• Safety Substantiation: Responsible persons must ensure and document that products are safe for use.

• Labeling Requirements: Labels must include contact information for adverse event reporting and disclose fragrance allergens (pending further FDA rulemaking).

Who Needs to Comply?

• Contract Manufacturers: Must ensure facility registration and collaborate with brand owners on product listings.

• Brand Owners: Are considered the “responsible person” under MoCRA and bear primary responsibility for compliance.

• Influencers with Private Labels: If you market products under your name, you may be legally responsible for compliance—even if you outsource manufacturing.

Common Pitfalls to Avoid

• Assuming small-scale or online-only operations are exempt.

• Failing to update product listings annually.

• Overlooking the need for safety substantiation documentation.

• Mislabeling products with drug claims (e.g., “treats acne” or “anti-aging”).

How an FDA Attorney Can Help

As an attorney focused on FDA regulatory compliance, I help clients:

• Navigate MoCRA requirements

• Draft compliant labels and marketing claims

• Prepare for FDA inspections

• Respond to enforcement actions

• Structure contracts between brand owners and manufacturers

Whether you're launching a new product or scaling your operations, proactive legal guidance can save you time, money, and risk.

Need help with FDA compliance for your cosmetic brand or manufacturing business?

Let’s talk. I offer consultations tailored to your business model and regulatory needs.