Why Accurate Cosmetic Product Classification Matters?
Legal background
Classification is the first step in FDA cosmetic compliance and sets the foundation for your product’s regulatory strategy. Proper classification of the cosmetics ensures that your product follows the correct regulatory pathway, preventing enforcement actions and helping you enter the U.S. market efficiently.
Misclassified products may face:
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- Refused entry at customs
- Product recalls or market withdrawals
- Delays in product launch or distribution
- FDA warning letters or inspections
- Risk to consumer trust and brand reputation
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Our services
How Obelis Supports Your Classification Process
Obelis provides expert Cosmetic Classification Support tailored to the U.S. regulatory framework. At Obelis, we specialize in FDA product classification for cosmetics and related categories. Our regulatory experts analyze your product’s formula, claims, and intended use to determine its correct classification under U.S. law. We offer:
- Review of your product’s formula and intended function
- Assessment of product claims for cosmetic or therapeutic implications
- Guidance on the applicable regulations (Cosmetics vs OTC Drug)
- Regulatory pathway recommendations (e.g., FDA listing, MoCRA compliance, OTC monograph or NDA/510(k))
- Ongoing support as you develop and position your product
With Obelis, you avoid costly missteps and start your U.S. market journey on a strong, compliant foundation.
