Compliance 101: Decoding Key FDA Terms and Requirements
June 3, 2025
Navigating FDA regulations can feel overwhelming—especially for newcomers in the cosmetics industry. Whether you're a contract manufacturer or a brand owner, understanding the language of compliance is the first step toward protecting your business and building consumer trust.
As an attorney practicing in FDA regulatory compliance, I’ve broken down the most important terms and concepts you need to know.
1. FDA (Food and Drug Administration)
The federal agency responsible for protecting public health by regulating food, drugs, medical devices, and cosmetics. While cosmetics don’t require pre-approval, the FDA can take action against unsafe or misbranded products.
2. MoCRA (Modernization of Cosmetics Regulation Act of 2022)
MoCRA is the most significant update to U.S. cosmetic law in over 80 years. It introduced new requirements for:
Facility Registration: Manufacturers and processors must register with the FDA and renew every two years.
Product Listing: Each cosmetic product must be listed with the FDA, including ingredients.
Adverse Event Reporting: Serious adverse events must be reported within 15 business days.
Safety Substantiation: Companies must ensure and document that products are safe for use
3. Responsible Person
Under MoCRA, the “responsible person” is the entity listed on the product label—typically the brand owner. This person is legally accountable for ensuring compliance with FDA regulations.
4. Adulterated vs. Misbranded Products
Adulterated: A product is considered adulterated if it contains harmful substances or is manufactured under unsanitary conditions.
Misbranded: A product is misbranded if its labeling is false or misleading, or if it lacks required information (like ingredient lists or warnings).
5. Good Manufacturing Practices (GMPs)
GMPs are standards the FDA is developing for cosmetics under MoCRA. These will ensure products are consistently produced and controlled to quality standards
6. Serious Adverse Event
Defined as an adverse health effect that results in death, hospitalization, significant disability, or requires medical intervention. These must be reported to the FDA and documented for six years.
7. Cosmetic vs. Drug Claims
Cosmetics are intended to cleanse or beautify. If a product claims to treat or prevent disease (e.g., “heals acne” or “reduces wrinkles”), it may be classified as a drug—triggering stricter FDA oversight.
Why This Matters
Understanding these terms isn’t just academic—it’s essential for avoiding costly enforcement actions, recalls, or import refusals. Compliance is not optional; it’s a business imperative.
Need Help Navigating FDA Compliance?
As an attorney focused on FDA regulatory law, I help brands and manufacturers:
Interpret MoCRA requirements
Draft compliant labels and marketing claims
Prepare for FDA inspections
Respond to warning letters or enforcement actions
📩 Contact me today for a consultation tailored to your business.