“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?”
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.