Supplement or food? Product labeling opportunities and limitations

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. 

Typically, companies label products as food rather than supplements.  

How do you define food ingredients versus approved food additives?  

What is GRAS?

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.

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."

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.

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.  

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. 

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?