Cosmetic labeling and claims: Is your product ready for the shelf?

Jason Sapsin of Faegre, Baker & Daniels LLP and Michelle Zerbib, standards director at New Hope Network, break down cosmetic regulations so you can ensure your product is beautiful in the eye of regulators.

New Hope Network staff

January 3, 2018

1 Min Read
Cosmetic labeling and claims: Is your product ready for the shelf?

"It's the threatened convergence of drugs and cosmetics that mostly create the regulatory problems that young companies have."
—Jason Sapsin of Faegre, Baker & Daniels LLP

Part 1: Statutory framework 


  • Products are regulated by what they claim they can do, more so than what is actually in the product.

  • Know who is looking at your labels by understanding agency structure.


Part 2: Product development 


  • The FDA does not look at products before they go on shelf. All scrutiny happens after the fact.  

  • Understand the issues of misbranding and adulteration.  

  • A look at the Color Additives Amendment Act; Fair Packaging and Labeling Act; and Microbead-free Waters Act.


Part 3: Ways to violate the Food, Drug & Cosmetic Act


  • The language on the label is important.

  • Physical adulteration tends to be handled differently than misbranding claims.

  • What defines a cosmetic vs. drug?


Part 4: How do we bring it to market?


  • Begin the process with premarket approval and product demonstration. 

  • The principle display panel, info panel and color additives are important labeling properties.

  • A look at post-market issues.


Part 5: What the Natural Products Expo standards team looks for on labels 


  • Michelle Zerbib shows examples of unacceptable structure-function claims and drug claims.

  • Hear how to correctly describe the use of ingredients.

  • What is the difference between a drug and cosmetic?


Part 6: Q&A


  • What regulates what you can and can’t say in a retail store?

  • What precautions can retailers take to protect themselves from misbranded products?

  • How does this all manifest in reality when you see so much adulteration?

This session—Cosmetic Labeling & Claims: Understanding Regulations to Ensure your Product is Beautiful on the Inside & Out—was recorded at Natural Products Expo East 2017. Click "download" to access the presentation slides. 

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