Supplement or food? Product labeling opportunities and limitations

Lawyer Justin Prochnow outlines regulatory issues and considerations for claims and whether to label a product as a food, beverage or supplement. Here’s what you need to know as you formulate your product and plan your packaging.

New Hope Network staff

December 15, 2017

2 Min Read
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


  • 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. 

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