"The No. 1 thing the FDA is going to look at is the product name and how you are talking about the product on the label."
—Justin Prochnow, lawyer
Part 1: The process of analysis for marketing and selling new product
- How do you determine if a product is a food/beverage or supplement?
- What is the difference between nutrition facts versus supplement facts?
- The factors to review when deciding.
Part 2: Food ingredient regulation
- Typically, companies label products as food rather than supplements.
- How do you define food ingredients versus approved food additives?
- What is GRAS?
Part 3: Supplement ingredient regulation
Dietary ingredients differ from dietary supplements.
- The scope of permissible dietary ingredients is larger than those that have been approved as food additives or GRAS.
Part 4: Ingredient differences
- Caffeine is an example of an ingredient with labeling issues.
- The major differences between supplement facts and nutrition facts.
- "You don't register as a dietary supplement. There's no registration of supplements or foods and beverages. What you put out on the market and your labeling is basically your statement of what you are."
Part 5: Food/beverages vs. supplements
- Key factors to consider, other than regulations of ingredients, are manufacturing, labeling and claims.
- The FDA regulations covering structure-function claims are less regulated for foods than supplements.
- Companies are selling products as supplements because of the difference in treatment of ingredients.
Part 6: Liquid product regulation
- The growth of "energy drinks," labeled as both beverage and supplement, spurred FDA's concern for how products are sold.
- The product name is perhaps the most important factor to FDA.
- The labeling and advertising of how a product will be used is highly scrutinized.
Part 7: Risk assessment
- Some examples of FDA case files.
- Tips for success: long-term intentions and target customers.
- The threat of litigation does not mean a requirement to pay.
Part 8: Q&A
- If you settle a class-action lawsuit, is there a public record and is that an admission of guilt?
- What is the Jelly-Bean Rule?
- What is the FDA's standard of substantiation?
This session—Supplement or food? Products labeling opportunities & limitations—was recorded at Natural Products Expo East 2017. Click "download" to access the presentation slides.