The Food and Drug Administration (FDA) recently issued 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 is issuing this letter because of the significant growth in the marketing of foods containing these ingredients.
FDA 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. This letter serves as a reminder to
the industry of the longstanding legal requirements governing conventional food
In issuing this letter, FDA is also reminding 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 are encouraged to contact the agency regarding the regulatory
status of ingredients and claims they intend to use for foods.