Dietary Supplements | New Dietary Ingredients

The Food Drug and Cosmetic Act (FDCA) and FDA regulations define the term “new dietary ingredient” as a dietary ingredient that was not in the United States food supply in a chemically unaltered form before October 15, 1994. If you wish to market dietary supplements that contain new dietary ingredients, you are required to notify the FDA about these ingredients and provide scientific data and support documenting your conclusion that the dietary ingredient or a dietary supplement bearing the ingredient is reasonably expected to be safe under the labeled conditions of use.

Because there is no authoritative list of dietary ingredients that were in the food supply in the United States prior to October 15, 1994, manufacturers and distributors look to FDAImports.com, LLC to help them assess whether the new dietary ingredient notification requirements apply or to help them prepare, file and prosecute such notifications. FDA regulations place the responsibility for determining if an ingredient is a new dietary ingredient upon you, the company making or selling it. If the ingredient is not a new dietary ingredient, you should maintain documentary evidence establishing the ingredient was in the food supply before the relevant date and in a chemically unaltered form.

FDAImports.com, LLC can help you determine whether the new dietary ingredient notification requirements apply to your dietary supplements and dietary ingredients and can help identify the risks associated with importing such products. We provide The Way Through the FDA regulatory requirements enabling our clients to reduce business and compliance risks in making, marketing and distributing dietary supplements and dietary ingredients. Let us help you, too.