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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.

PRODUCT REGISTRATION

GRAS / NDI

Generally Recognized as Safe (GRAS): Ensuring Ingredient Safety with Confidence

If you're introducing a new food ingredient or substance into the U.S. market, obtaining GRAS (Generally Recognized as Safe) status can be a strategic advantage—saving time, cost, and regulatory burden.
The U.S. Food and Drug Administration (FDA) designates certain substances as GRAS when they are proven safe for use in food, either through extensive scientific evidence or a long history of common use.

What is GRAS?

Under the Federal Food, Drug, and Cosmetic Act, food additives typically require FDA pre-market approval. However, if an ingredient is “generally recognized as safe” by qualified experts, it can bypass this process through the GRAS pathway.
This means your ingredient can enter the market faster and with fewer regulatory hurdles—provided safety is well-documented.

Pathways to GRAS Status

GRAS status can be determined in two ways:

1. Scientific Procedures
   Based on robust, peer-reviewed scientific data, reviewed by experts in toxicology, food safety, and nutrition.
2. Common Use in Food (Pre-1958)
   If the substance has been safely consumed in food before 1958, and this use is well-documented, it may qualify under the common use criteria.

Voluntary Notification to the FDA

While not mandatory, manufacturers can voluntarily notify the FDA of their GRAS determination. The FDA may:

• Issue a "no questions" letter (a positive outcome),
• Request additional information,
• Or cease review at the notifier’s request.

Even with GRAS status, the responsibility for ensuring ongoing safety and compliance rests with the manufacturer.

Transparency & Trust

All GRAS notices submitted to the FDA are included in a public database, giving your stakeholders, investors, and customers added assurance about your product’s safety.

Why GRAS Status Matters for Your Business

• Faster Market Entry – Avoid lengthy food additive petitions.
• Cost-Efficient – Streamline regulatory pathways.
• Build Consumer Trust – Demonstrate commitment to food safety.
• Innovate with Confidence – Use novel ingredients backed by science.

Need Help Navigating GRAS?

We specialize in helping food and ingredient companies achieve GRAS status efficiently and effectively—from scientific evaluations to FDA notification support. Whether you’re looking to validate a new compound or leverage historical use, we can guide you every step of the way.