Supplement or food? Product labeling opportunities and limitations

"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

Highlights:

• 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. 

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Part 2: Food ingredient regulation

Highlights:

• Typically, companies label products as food rather than supplements.  
• How do you define food ingredients versus approved food additives?  
• What is GRAS?

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Part 3: Supplement ingredient regulation

Highlights:

• 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.

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Part 4: Ingredient differences 

Highlights:

• 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."

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Part 5: Food/beverages vs. supplements 

Highlights:

• 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.

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Part 6: Liquid product regulation 

Highlights:

• 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.  

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Part 7: Risk assessment 

Highlights:

• 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. 

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Part 8: Q&A 

Highlights:

• 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.