Tackling FDA Compliance: Tips for Private Labelers and Brand Owners
June 17, 2025
Private labeling offers a fast track to launching a cosmetic brand—but it also comes with regulatory responsibilities that many new brand owners overlook. Whether you're an influencer launching a skincare line or a contract manufacturer supporting multiple brands, understanding FDA compliance is essential for long-term success.
As an attorney focused on FDA regulatory compliance, I’ve outlined key tips and common pitfalls to help private labelers stay compliant and competitive.
1. Understand Your Role as the “Responsible Person”
Under the Modernization of Cosmetics Regulation Act (MoCRA), the “responsible person” is the entity listed on the product label—typically the brand owner. This person is legally accountable for:
Ensuring product safety
Submitting product listings to the FDA
Reporting serious adverse events
Maintaining records for six years
Even if you outsource manufacturing, you are still responsible for compliance.
2. Avoid Drug Claims on Cosmetic Products
One of the most common pitfalls is making marketing claims that classify your product as a drug. For example:
❌ “Treats acne”
❌ “Heals eczema”
❌ “Reduces inflammation”
These claims imply therapeutic use and may trigger FDA enforcement unless the product is approved as an over-the-counter (OTC) drug.
Stick to cosmetic claims like:
✅ “Improves the appearance of skin”
✅ “Moisturizes and softens”
✅ “Enhances natural glow”
3. Labeling Must Be Clear, Accurate, and Compliant
FDA labeling requirements include:
Product identity and net quantity on the front (Principal Display Panel)
Ingredient list in descending order of predominance
Name and address of the responsible person
Warning statements where applicable
Labels must be legible and not misleading. Avoid vague or exaggerated claims that could be interpreted as deceptive.
4. Vet Your Contract Manufacturer
Even though you’re not producing the product yourself, you’re still liable for its safety and compliance. Make sure your manufacturer:
Follows Good Manufacturing Practices (GMPs)
Provides Certificates of Analysis (COAs)
Has a track record of FDA compliance
Consider using a Quality Agreement to define roles and responsibilities clearly.
5. Keep Documentation Ready
MoCRA requires that you maintain:
Safety substantiation for each product
Adverse event records
Product listing updates
Having this documentation organized and accessible is critical in the event of an FDA inspection or inquiry.
How I Can Help
As an attorney specializing in FDA regulatory compliance, I help private labelers and brand owners:
Draft compliant labels and marketing claims
Navigate MoCRA registration and reporting
Review contracts with manufacturers
Respond to FDA enforcement actions
📩 Need help launching or scaling your private label brand with confidence?
Let’s talk. I offer tailored legal support to help you stay compliant and competitive.