When introducing a new dietary ingredient (NDI) into the market, businesses must submit a FDA New Dietary Ingredient Notification (NDIN) to ensure full compliance with regulatory requirements. In this article, UCC will provide a detailed guide on the NDIN requirements and the process for submitting a notification. By following these steps, businesses can ensure the safety and legality of their products.
1. Overview of FDA New Dietary Ingredient Notification
On September 23, 1997, the FDA published its final rule in the Federal Register, outlining the requirements for submitting a New Dietary Ingredient Notification (NDIN) prior to product marketing, as codified under 21 CFR §190.6. According to the Federal Food, Drug, and Cosmetic Act (FD&C Act), a New Dietary Ingredient (NDI) is defined as “a dietary ingredient not marketed in the United States before October 15, 1994.” The FD&C Act further mandates that manufacturers and distributors who wish to market dietary supplements containing a new dietary ingredient must notify the Food and Drug Administration (FDA) about these ingredients.
2. Required Information for Submitting FDA New Dietary Ingredient Notification
2.1. Submission Timeline
If you plan to introduce a dietary supplement containing a new ingredient, you must submit the NDIN to the FDA at least 75 days before introducing or commercially distributing the product. This allows the FDA ample time to review and assess the safety of the product.
2.2. Information to Include
Your NDIN submission should include the original notification, two copies, all necessary attachments, and the following information:
- Your name and address.
- The name of the new dietary ingredient, including the scientific name if it is an herb or plant.
- A detailed description of the dietary supplement, including the level of the new dietary ingredient and the product’s usage conditions as stated on the label.
- History of use or safety evidence for the dietary ingredient when used according to the label instructions.
- Copies of published references supporting the ingredient’s safety.
- Any foreign-language documents translated into English.
- The signature of the person designated as the FDA contact representative.
2.3. Submission Methods
- Electronic Submission
The FDA provides an electronic portal (CFSAN Online Submission Module or COSM) for submitting NDIN, which allows for receipt confirmation, progress tracking, and email updates on submission status. Once a COSM account is created, it can be used for future submissions. Electronic submission is encouraged for faster and more convenient processing. Detailed instructions are available on COSM.
- Written Submission
If electronic submission is not possible, submissions can be sent by mail. However, the FDA recommends electronic submission to avoid delays. If submitting by mail, you must send an email with the subject line “NDIN Written Submission” to NDITeam@fda.hhs.gov to prevent delays. Send written submissions to: Office of Dietary Supplement Programs (HFS-810), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Drive, College Park, MD 20740-3835.
3. Vital Points for FDA New Dietary Ingredient Notification
FDA may consider the information in your NDIN submission as confidential commercial information (CCI) and may exempt it from public disclosure under the Freedom of Information Act (FOIA) and FDA regulations. However, there is no automatic presumption that any information in your submission is CCI. You must clearly identify confidential information, either by marking it directly in the submission or by providing a separate explanation. If no such information exists, you should explicitly state this in your submission. The FDA will maintain and update a list of NDIN submissions referenced in public NDIN notifications on its website.
Additionally, the FDA encourages using the ePortal to receive quick acknowledgment of receipt and to streamline the review process. The portal also sends email updates about the submission’s status, providing convenience and transparency.
Properly following the NDIN submission process is crucial for ensuring product safety and compliance. By adhering to the FDA’s guidelines, businesses not only ensure their products are safe but also build consumer trust and credibility with regulatory authorities. If you have any questions regarding FDA regulations or the NDIN process, feel free to contact UCC for expert guidance.
