UNDERSTANDING NDI COMPLIANCE: A KEY REQUIREMENT FOR DIETARY SUPPLEMENT SAFETY

Understanding NDI Compliance: A Key Requirement for Dietary Supplement Safety

Understanding NDI Compliance: A Key Requirement for Dietary Supplement Safety

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In the U.S., dietary supplement manufacturers and distributors must adhere to the FDA's New Dietary Ingredient (NDI) compliance requirements to ensure product safety and regulatory adherence.



What Is an NDI?


A New Dietary Ingredient (NDI) refers to a dietary ingredient not marketed in the U.S. before October 15, 1994. Examples include new botanical extracts, novel amino acids, or synthetic compounds intended for dietary supplements.



When Is NDI Notification Required?


If a dietary supplement contains an NDI that hasn't been present in the food supply in a chemically unaltered form, the manufacturer or distributor must submit a premarket notification to the FDA at least 75 days before marketing the product. This notification should provide evidence that the NDI is reasonably expected to be safe under the recommended conditions of use.



Key Components of an NDI Notification


An NDI notification must include:





  • The name and address of the manufacturer or distributor.The name of the NDI, including its Latin binomial name for botanicals.





  • A description of the dietary supplement containing the NDI, including the level of the NDI and the conditions of use.




  • Evidence of safety, such as history of use or other scientific data.




  • The signature of an authorized individual responsible for the notification.




Consequences of Non-Compliance


Failing to submit a required NDI notification can result in the product being deemed adulterated under the Federal Food, Drug, and Cosmetic Act, leading to potential enforcement actions by the FDA.



Staying Compliant


To maintain NDI compliance, companies should:





  • Determine if their ingredient qualifies as an NDI.




  • Prepare and submit a comprehensive NDI notification to the FDA.




  • Monitor FDA guidance and updates related to dietary supplements.




For detailed information on the NDI notification process, refer to the FDA's official guidance.

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