FDA Releases Draft Guidance on New Dietary Ingredients

The FDA released its updated draft guidance on new dietary ingredients (NDIs) on July 5, 2011. The draft guidance is intended to assist industry in deciding when a pre-market safety notification for a dietary supplement containing an NDI is necessary. The draft guidance provides the FDA’s interpretation of what qualifies as an NDI, advises when an NDI notification is necessary, and explains the procedures for submitting an NDI notification—the types of data and information manufacturers and distributors should consider when evaluating the safety of a supplement containing an NDI.

Upon initial review, the nutritional supplement industry generally believes the draft guidance is overly burdensome and plans to submit comments to the FDA during the 90-day public comment period (July 5-Oct. 3, 2011). After taking those comments under review, the draft guidance could be revised and then will be finalized. Should the draft guidance as it stands become official guidance from the FDA, every other nutritional supplement company in the United States would likely incur added costs and spend more time bringing new products to market.

Generally, Supplement manufacturers, the good and the not so good, are considering that the intent of the draft guidance is not to ban or make illegal existing dietary supplement products that contain recognized dietary ingredients. It’s still early in the FDA’s typically long process for creating official industry guidance documents. Much could still change during the next few months. FDA guidance documents do not have the force of law. On the contrary, the FDA states that guidance documents only “represent the FDA’s current thinking on a particular subject. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public.”

MyAchingKnees comment: I believe most Nutritional Supplement companies are sweating bullets over this (FDA regulations) as any new regulations and requirements by the FDA will shoot up their costs of manufacturing not just significantly but exponentially. Some of you may be paying three times as much for a bed pan pill! The only companies that are not sweating it are the ones who already make pharmaceutical grade products at FDA registered facilities. Still, I think the makers of high quality products still prefer not to have over regulation as this would force the vast list of food grade supplement makers to up their quality and this would greatly diminish the heretofore great differences between food grade and pharmaceutical grade nutritional supplements.

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