3 min read
Are you a manufacturer or distributor of New Dietary Ingredients (NDIs) and dietary supplements? If so, you may be required to submit a premarket safety notification to the United States Food and Drug Administration (US FDA) under section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act. This process, commonly known as the New Dietary Ingredient Notifications (NDINs), is crucial for ensuring the safety and efficacy of dietary supplements entering the market. In fact, the US FDA has provided comprehensive guidance for industry stakeholders on the NDIN submission and review process.
Understanding the US FDA’s Dietary Supplements
Dietary supplements are products intended to supplement your diet and provide additional nutrients, vitamins, minerals, herbs, botanicals, amino acids, or other substances. They are available in various forms, such as pills, capsules, tablets, gummies, powders, and liquids. Dietary supplements can help fill your nutritional gaps, support specific health conditions, and promote overall wellness.
An Overview of New Dietary Ingredient Notification Procedures
A “New Dietary Ingredient” or NDI is defined as a dietary ingredient that had not been marketed in the US before October 15, 1994. If a dietary supplement contains an NDI, the manufacturer or distributor must notify the US FDA about this specific ingredient at least seventy-five (75) days before introducing the product into interstate commerce.
Key Components of the US FDA Guidance for the Industry
Content Requirements for NDINs
- The guidelines specify that New Dietary Ingredient Notifications (NDINs) must include a detailed description of the NDI, the dietary supplement containing it, and the conditions of use.
- This description encompasses the level of the NDI, other dietary ingredients, manufacturing process details, and critical safety attributes.
- Identification of any trade secret or confidential commercial information is also required.
Submission of Safety Narratives and Evidence
- A New Dietary Ingredient Notification (NDIN) should include safety narratives that provide an objective evaluation of the NDI’s history of use or other safety evidence.
- Submission of toxicology studies and other safety evidence supporting the conclusion that the dietary supplement will be safe under its recommended conditions of use is necessary.
Electronic Submissions
- Electronic submission streamlines the US FDA’s review process by ensuring completeness and facilitating efficient processing.
- It enhances the US FDA’s ability to review NDINs promptly, thereby enabling timely feedback to notifiers and promoting overall efficiency.
Addressing Materials in Languages Other Than English
- The guidelines allow the inclusion of foreign language materials to support the safe use of NDIs but require accurate English translations for the US FDA’s evaluation.
- This provision broadens the scientific evidence considered, aiding in a comprehensive safety assessment.
Notification Procedures
The US FDA guidance outlines the detailed steps for preparing and submitting an NDIN. It emphasizes the importance of a well-organized notification for facilitating efficient review by the US FDA. Manufacturers or distributors of dietary supplements containing NDIs are required to submit a New Dietary Ingredient Notification (NDIN), which must include specific information such as:
- The identity of the NDI, including the Latin name for botanicals.
- The description of the dietary supplement.
- The level of the NDI in the dietary supplement.
- Recommended or suggested conditions of use for labeling.
- Ordinary conditions of use of the supplement if there are no recommended conditions.
- History of use or other evidence supporting the safety of the dietary ingredient.
- Authorized signature of the manufacturer or distributor.
Required Information and Documentation
The US FDA guidance specifies the information required in the notification:
- Specifications and analytical methods for the new dietary ingredient.
- Safety data, including studies and information demonstrating that the NDI is expected to be reasonably safe under the conditions of use recommended or suggested in the labeling.
- Copies of any literature reports and other data relating to the NDI.
Timeframes and Deadlines
The US FDA guidance outlines the timeframes and deadlines for submitting an NDIN. As mentioned earlier, manufacturers or distributors must submit the notification at least seventy-five (75) days before introducing the product into interstate commerce. The US FDA has seventy-five (75) days to review the notification and respond accordingly. If additional substantive information is submitted, the date of receipt becomes the new notification filing date, and the seventy-five (75)-day period restarts. The US FDA will not disclose the existence of, or the information contained in, an NDIN for ninety (90) days after the filing date. After the 90th day, the entire notification, except trade secrets and confidential commercial information, will be placed on public display.
Compliance and Implications
Adhering to the New Dietary Ingredient Notifications (NDIN) procedures and timeframe guidance is essential for ensuring the safety and efficacy of dietary supplements entering the market. Complying with the regulations demonstrates a commitment to consumer safety and responsible product development. However, non-compliance can lead to enforcement actions, product recalls, and potential legal consequences.
Thus, the New Dietary Ingredient Notifications (NDIN) procedures and timeframe guidance are crucial for maintaining the dietary supplement industry’s integrity and reputation. The US FDA New Dietary Ingredients (NDIs) guidelines emphasize compliance with Regulatory requirements and providing accurate information to ensure the safety and efficacy of new NDIs. Our Regulatory experts can assist you in understanding these requirements, in turn, aiding you in responsibly introducing new dietary ingredients. Contact Freyr now!
