Novel Ingredients Letter Goes to Food Industry

February 7, 2001

The Food and Drug Administration (FDA) has sent a letter to the food industry restating the requirements of the Federal Food, Drug, and Cosmetic Act regarding the marketing of conventional foods containing novel ingredients, including botanicals. FDA issued the letter because of the significant growth in the marketing of foods containing these ingredients.

FDA said it is concerned that some botanical and other novel ingredients that are being added to conventional foods are neither approved food additives nor generally recognized as being safe for these uses. The letter is to serve as a reminder to the industry of the longstanding legal requirements governing conventional food products.

The agency also reminded manufacturers about the legal requirements regarding claims on conventional foods. The Food Drug and Cosmetic Act allows for certain claims such as: health claims -- a claim characterizing the relationship between a food substance and a disease or health related condition; nutrient content claims -- a claim characterizing the level of a nutrient in a food; and structure/function claims -- a claim characterizing the effect of a food on the structure or function of the body.

FDA must review health claims and nutrient content claims prior to marketing, unless the claim has been authorized by regulation or by statute under the authoritative statement notification procedure. Manufacturers were encouraged to contact the agency regarding the regulatory status of ingredients and claims they intend to use for foods.