New Dietary Ingredient (NDI) Notification – Ensure Compliance, Protect Consumers

If you're planning to introduce a dietary supplement with a New Dietary Ingredient (NDI) into the U.S. market, FDA compliance is not optional—it’s essential.

Under the Federal Food, Drug, and Cosmetic Act, manufacturers and distributors must notify the U.S. Food and Drug Administration (FDA) at least 75 days before marketing any dietary supplement that contains an NDI. This process helps ensure that your product is safe, legal, and ready for interstate commerce.

What is a "Dietary Ingredient"?

Before submitting an NDI notification, you must first confirm that your ingredient qualifies as a "dietary ingredient" under section 201(ff)(1) of the FD&C Act. According to the FDA, a dietary ingredient must be one of the following:

• A vitamin
• A mineral
• An herb or other botanical
• An amino acid
• A dietary substance for use by humans to supplement the diet by increasing total dietary intake
• A concentrate, metabolite, constituent, extract, or combination of any of the above

Important: If your substance does not meet this definition, the FDA will not accept your NDI notification.

What is a New Dietary Ingredient (NDI)?

An NDI is defined in section 413(d) of the FD&C Act as a dietary ingredient not marketed in the U.S. before October 15, 1994. If your product contains such an ingredient, it must go through the NDI notification process before being sold across state lines.

Note: Ingredients marketed before this date are not considered NDIs and do not require notification.

What Your Notification Must Include

To streamline FDA review your NDIN submission must provide:

• Full identity and composition of the ingredient
• Manufacturing process and quality specifications
• Scientific evidence supporting safety under the recommended conditions of use

Providing clear, complete documentation is key to minimizing delays and ensuring a smooth review process.

Need Help Navigating the Process?

For step-by-step instructions—including submission format, required documentation, and timelines—refer to the official FDA guidance on NDI notifications.

Or, if you prefer expert support in preparing a compliant and compelling submission, get in touch with our regulatory team today. We’re here to help you launch with confidence and stay ahead of compliance.