Editor's Note: Companies likely need to submit a new dietary ingredient (NDI) notification before introducing an isolated botanical substance to the market, according to Daniel Fabricant, director of the Food and Drug Administration's (FDA's) Division of Dietary Supplements. Fabricant noted that compounds found in botanicals aren't automatically considered part of the food supply and FDA is likely to consider products adulterated if they include isolated botanical compounds for which NDI notifications have not been submitted.

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FDA: Botanical Compounds May Not be Legal Dietary Ingredients

Just because a compound is found in a botanical doesn't mean FDA considers it a part of the food supply, according to Daniel Fabricant, Ph.D., Director, Division of Dietary Supplements, FDA, during his featured presentation at SupplySide West. Thus, if a supplement company introduces an isolated botanical substance to the market without submitting a new dietary ingredient (NDI) notification, the agency is likely to consider it an adulterated product.

Fabricant said FDA recently encountered a product with aegeline, a substance originally isolated from the Indian bael tree. FDA said it did not receive an NDI notification for aegeline, and the substance has not been proven to be safe. ...