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FDA Cautions Industry Against Mislabeling Foods That Contain Novel Ingredients

Date: May 01, 2001


The Food and Drug Administration (FDA) has issued a letter to manufacturers regarding the use of botanicals and other novel ingredients in conventional foods. The letter expresses the Agency's concern that many of these ingredients are being added to foods in violation of the Federal Food, Drug and Cosmetic Act because they are neither approved for use as food additives nor generally recognized as safe (GRAS). In particular, the letter reminds industry that the Act requires pre-market approval of food additives and that the Agency has a specific set of criteria that must be heeded to determine  whether an ingredient is GRAS.

FDA's letter also addresses labels for foods containing botanicals and other novel ingredients, noting specifically that the labels on these products should avoid making unauthorized health and nutrient content claims. Health and nutrient content claims can only be made if cleared by FDA by way of a petition or through a notification procedure. 

The letter does point out, however, that labels may contain statements about a substance's effect on the "structure or function" of the body, provided that the statements are not false or misleading and do not claim to diagnose, mitigate, treat, cure or prevent disease. Additionally, the claimed "structure or function" effect must be achieved through nutritive value.

FDA's letter to industry is available on the Internet at www.cfsan.fda.gov/~dms/ds-ltr15.html.

Used with permission. Copyright FOOD & DRUG PACKAGING, May, 2001.

For further information about this article, please contact George G. Misko at 202-434-4170 or by e-mail at misko@khlaw.com.