Time for a Third Regulatory Category?

U.S. Food and Drug Administration (FDA)

“For example, garlic could be a food if you put it on pizza, a food additive when added as a powder, a drug when used for cholesterol control, or a device if inserted into the ear to prevent swimmer’s ear,” said Dr. Hoffman. “And then what happens if you extract components from the garlic and bottle that as a distinct product?”

Doterra's FDA Claims Guide
Doterra’s FDA Claims Guide

The current regulatory framework recognizes the following different types of claims:

Drug claims: for controlled substances prescribed by healthcare professionals and used to treat a specific disease state.

Over-the-Counter Drug or Supplement claims: for products generally considered safe and with efficacy in treatment of minor ailments or physiologic states.

Medicinal Food claims: used in the marketing of specialty food items to meet specific dietary needs.

Structure/Function claims: widely used by the supplement industry for products which affect a particular physical structure or bodily function. Structure/Function claims can posit “well-being,” but cannot state benefits in treating disease.

Nutrient claims: seen most commonly with meal replacement products.

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