February 07, 2025
When selling personal care products in the U.S., it’s crucial to determine whether your product falls under the FDA’s definition of cosmetics. The Modernization of Cosmetics Regulation Act (MoCRA) has reinforced regulatory oversight, making proper classification more important than ever. Misclassifying a product can lead to compliance issues, unnecessary regulatory burdens, or even legal consequences.
How Does the FDA Define Cosmetics?
The Federal Food, Drug, and Cosmetic Act (FD&C Act), defines cosmetics as products intended for cleansing, beautifying, promoting attractiveness, or altering appearance. This includes, but is not limited to:
✅ Skincare products (moisturizers, serums, toners)
✅ Makeup (foundation, lipstick, mascara)
✅ Haircare products (shampoo, conditioner, styling gels)
✅ Fragrances (perfumes, colognes)
✅ Body care products (lotions, deodorants)
Cosmetics do not include products intended to treat or prevent disease, which would classify them as drugs under FDA regulations.
Cosmetic vs. Drug: Key Differences
Some products blur the line between cosmetics and drugs. If a product claims to affect the structure or function of the body, it may be classified as a drug and require FDA approval.
Examples of Cosmetic vs. Drug Classification:
✅ Cosmetic: "Moisturizes and smooths skin."
⚠️ Drug: "Treats eczema and reduces inflammation."
✅ Cosmetic: "Reduces the appearance of fine lines."
⚠️ Drug: "Increases collagen production to reduce wrinkles."
✅ Cosmetic: "Soothes and refreshes the skin."
⚠️ Drug: "Heals damaged skin and treats acne."
If your product makes therapeutic claims, it may also require FDA approval as a drug rather than a cosmetic. Provision Consulting Group can help review your product labels with our Label Compliance Review Service to avoid making drug claims.
MoCRA’s Impact on Cosmetic Classification
Under MoCRA, cosmetic companies must:
📌 Ensure product safety through adequate testing.
📌 Register manufacturing facilities with the FDA.
📌 List all marketed products with the FDA.
📌 Adhere to Good Manufacturing Practices (GMPs).
📌 Provide adverse event reporting for consumer safety.
If your product contains active ingredients typically found in drugs or makes medical claims, it may be subject to additional regulations beyond MoCRA.
How to Ensure Proper Classification
To avoid misclassification:
✅ Review product claims to ensure they align with cosmetic definitions.
✅ Analyze ingredient lists for active substances regulated as drugs.
✅ Consult regulatory experts for guidance on compliance.
✅ Label your product correctly to meet FDA requirements.
Understanding whether your product is a cosmetic is essential for regulatory compliance under MoCRA.
Need Help Navigating MoCRA Regulations?
At Provision Consulting Group, we specialize in FDA compliance and can help you determine whether your product qualifies as a cosmetic under MoCRA.
📞 Contact Us Today to ensure compliance and avoid regulatory pitfalls!
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We will streamline the regulatory processes so that our clients can utilize their time
and money most efficiently.
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