01.14.14
FDA has issued guidance for industry on distinguishing liquid dietary supplements from beverages. The guidance is available on the FDA website here.
The guidance was designed to help dietary supplement and beverage manufacturers and distributors determine whether a product in liquid form is properly classified as a dietary supplement or as a beverage.
The guidance describes the factors that distinguish liquid products that are dietary supplements from those that are conventional foods. Further, this guidance reminds manufacturers and distributors of dietary supplements and beverages about the requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) regarding their respective ingredients and labeling.
According to the guidance, “The most obvious representations about a product’s use are claims made for the product in its labeling and advertising. However, a product’s name, packaging, serving size, recommended daily intake and other recommended conditions of use, and composition, as well as marketing practices and representations about the product outside its labeling and advertising, can also be important determinants of whether the product is represented as a conventional food (and, thus, may not be marketed as a dietary supplement).”
The guidance was designed to help dietary supplement and beverage manufacturers and distributors determine whether a product in liquid form is properly classified as a dietary supplement or as a beverage.
The guidance describes the factors that distinguish liquid products that are dietary supplements from those that are conventional foods. Further, this guidance reminds manufacturers and distributors of dietary supplements and beverages about the requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) regarding their respective ingredients and labeling.
According to the guidance, “The most obvious representations about a product’s use are claims made for the product in its labeling and advertising. However, a product’s name, packaging, serving size, recommended daily intake and other recommended conditions of use, and composition, as well as marketing practices and representations about the product outside its labeling and advertising, can also be important determinants of whether the product is represented as a conventional food (and, thus, may not be marketed as a dietary supplement).”
