If a food product claims to cure a disease, how does the FDA respond?

When a food product claims to cure a disease, the FDA responds by regulating it as a drug. This is based on the premise that claims of curing, treating, or preventing disease elevate the product from merely being considered food to being classified as a drug under the Food, Drug, and Cosmetic Act. Drugs are subject to stricter regulatory controls, including demonstrating safety and efficacy through clinical trials before they can be marketed.

The FDA's role is to ensure that any product making such claims is supported by adequate evidence and meets the necessary standards for consumer safety and effectiveness. This regulatory oversight exists to protect consumers from products that may not be safe or effective for their intended use. The classification as a drug requires the manufacturer to adhere to stringent requirements that food products typically do not face, such as labeling requirements, manufacturing practices, and pre-market approval processes.