New Dietary Ingredient Applications
What is a New Dietary Ingredient (NDI)?
A “new dietary ingredient” (NDI) refers to a dietary ingredient or finished product that was not marketed in the United States before October 15, 1994. According to US FDA regulations, manufacturers must submit New Dietary Ingredient Notifications (NDINs) to legally market these ingredients in the US.
Our NDI Services
Navigating the pre-market notification process can be complex, but we are here to guide you every step of the way. We offer comprehensive regulatory guidance, consulting, and submission services for your NDIN application to the US FDA. Our services include:
- Qualifying Your Ingredient: We begin by conducting a thorough feasibility assessment of your dietary ingredient to ensure it meets all necessary criteria to qualify as an NDI. Our team performs a comprehensive gap analysis to identify any additional information needed for a successful submission.
- Compiling Pertinent Information: We will work with you to gather all relevant research, publications, and data required for the pre-market notification.
- Authoring and Submission: We expertly draft your NDIN and submit it on your behalf.
- Correspondence with the FDA: We handle all communications with the FDA regarding your NDIN.
Our team has a proven track record of success, consistently securing FDA “letters of no objection” for our clients’ NDINs. Trust us to help you bring your new dietary ingredient to market with confidence.
What if my ingredient is an Old Dietary Ingredient (ODI)?
In some cases, your ingredient may qualify for an NDIN exemption. We can help you maintain robust records of the regulatory status of your products and ingredients. BCI will provide the necessary documentation to demonstrate that your ingredient does not require an NDI notification. We offer comprehensive consulting, research, and administrative services to develop an Old Dietary Ingredient dossier with substantiating evidence, ensuring your organization’s compliance and peace of mind.