U.S. New Dietary Ingredients (NDI) Notification

Background of New Dietary Ingredients (NDI) Notification

The U.S. Food and Drug Administration (FDA) has established regulations governing the introduction of new dietary ingredients (NDIs) into the U.S. market to ensure the safety of ingredients used in dietary supplements under specified and recommended conditions. In order to legally market a new dietary ingredient in the United States, the manufacturer or distributor must submit a premarket safety notification to the FDA. This notification must include information about the identity and composition of the ingredient, its intended conditions of use, and any potential safety concerns. In addition, safety studies may be required as part of the notification process. However, according to the NDI Draft Guidance, if the ingredient was marketed as a dietary supplement in the United States prior to October 15, 1994, it is not subject to NDI notification requirements.

About Us

Our team of experts can help ensure that your NDI notification meets all regulatory requirements and is submitted in a timely and efficient manner.

As a leading provider of regulatory compliance services for the food, beverage, and supplement industries, our company has extensive experience in assisting manufacturers with the preparation and submission of NDI notifications to the FDA. Our experts in NDI identity (chemistry) and safety (toxicology) can assist you with the submission of components or the entire paperwork and provide you with customized, integrated solutions to successfully meet NDI compliance. Our comprehensive range of services and deep understanding of NDI regulatory requirements make us a reliable partner for companies seeking to introduce NDIs into the U.S. market.

Information Required for NDI Notification

• Name and full address of the manufacturer/distributor of the NDI or dietary supplement containing the NDI.
• The name of the premarket NDI, including the Latin binomial name of any herb or other botanical.
• Description of the dietary supplement or dietary supplements containing the NDI, including the level of the NDI in the dietary supplement and the recommended or suggested conditions of use in the dietary supplement's labeling.
• A history of use or other safety evidence indicating that the dietary ingredient can reasonably be expected to be safe when used under the conditions recommended or suggested in the dietary supplement labeling. Where published information is provided in support of a notification, a copy of the reference should be included. If any part of the submission is in a foreign language, it should be accompanied by an accurate and complete English translation.
• The signature of the person designated by the manufacturer/distributor of the dietary supplement containing the NDI.

Our NDI Notification Services

Our extensive experience in the regulatory compliance field gives us a unique advantage in assisting companies with NDI notifications. Our team of experts has a deep understanding of the regulatory requirements governing NDIs and can provide guidance on all aspects of the notification process. Our services include, but are not limited to:

• NDI general investigation determination
• NDI complete survey determination
• Strategy for submitting NDI notifications
• Technical review of identity specifications
• Recommendations for preclinical safety research (animal toxicology)
• Document gap analysis and outline any additional data needed
• Request and prepare for the FDA pre-submission meeting
• Prepare a full dossier for a New Dietary Ingredient Notification (NDIN) to meet federal regulatory requirements
• Organization of raw data
• Organization of all identity and safety information
• Complete copies of all cited references
• Drafting of written narratives
• Address any FDA questions or clarification requests during the notification process

If you need help or have a question, please feel free to contact us for more details.