Compliance with FDA’s Premarket NDI Requirements

Guidance Through the NDI Process for Manufacturers, Importers and Distributors of Dietary Ingredients and Dietary Supplements

The term “new dietary ingredient” refers to a dietary ingredient that was not marketed in the United States in a dietary supplement prior to October 15, 1994. Manufacturers, importers and distributors who intend to market a dietary supplement containing a new dietary ingredient, as well as those who intend to market a new dietary ingredient for use in dietary supplements, generally must provide a New Dietary Ingredient Notification (NDI) to FDA prior to bringing the product to market. This premarket notification must inform FDA of the basis for the manufacturer, importer or distributor’s conclusion that the new dietary ingredient is reasonably expected to be safe under the conditions of use indicated on the dietary supplement product’s labeling.

The attorneys of Ullman, Shapiro & Ullman have extensive experience in guiding manufacturers, importers and distributors of dietary ingredients and dietary supplements through the NDI process. This process may include putting together a team of qualified experts to review and compile the scientific evidence, studies and data needed to substantiate a determination that the ingredient satisfies the reasonable expectation of safety standard. Companies that submit data to FDA with the assistance of qualified experts and counsel historically have a significantly greater rate of success when dealing with FDA on NDI issues.

For specific advice about compliance with FDA’s premarket NDI requirements, contact Ullman, Shapiro & Ullman.