"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.