Nutrasource Blog

GRAS or NDIN: Which is the Right Regulatory Strategy for My Ingredient?

Posted by Amy Mozingo, MS, Director of Operations - GRAS Associates on Thu, Jan 17, 2019

You've developed a new product and are keen to market it as a dietary supplement in the U.S. You're confident it fulfills the FDA's definition, but its "star" ingredient is newer to the market and, to your knowledge, hasn't been used in foods to date. This means that if you marketed it as is, the product would be considered adulterated.

What options do you have to go to market, and what is the most effective way to do so without raising regulatory red flags and risking your brand reputation?

GRAS-vs-NDIN-sq

What to Consider When Choosing GRAS or NDIN

There are two different regulatory routes that make sense in this case: NDIN (New Dietary Ingredient Notification) or GRAS (Generally Recognized as Safe).

Both NDIN and GRAS have skyrocketed in popularity in recent years because of how effectively they allow companies to launch innovative ingredients safely, compliantly, and with minimal risk once approved.

Whether you choose NDIN or GRAS depends on a number of factors, including:

  • Whether the ingredient qualifies as a dietary supplement per DSHEA (Dietary Supplement Health and Education Act of 1994)
  • If use can be established prior to October 15, 1994
  • Whether the substance is found in the food supply
  • The level of safety evidence that exists
  • How "proprietary" you want your formulation, and its supporting data, to be
  • Which populations you wish to target and whether the product has safety concerns for specific groups (e.g., pregnant and lactating women, children under 3 years of age, etc.)
  • The product's organoleptic properties (e.g., smells or tastes not desirable in foods)
  • Your desired timeline from submission to FDA to approval
  • Considerations for certain ingredients (e.g., probiotics, nature-identicals, etc.)

GRAS vs. NDIN

The Main Differences Between GRAS and NDIN

To help you determine which regulatory route is right for your ingredient, below is a brief side-by-side comparison of GRAS vs. NDIN:

NDIN

GRAS

  • Supporting safety data not required to be publicly available
  • Use is based on recommended intake and can exclude certain populations
  • Undesirable organoleptic qualities can be masked
  • Notification to FDA is mandatory
  • Timeline: FDA response received ~90 days after filing date

 

 

  • Supporting safety data must be publicly available; use of Expert Panel review is typical
  • Specific to the intended use:
    • Food categories must be selected
    • Consumption analysis must be conducted to determine maximum daily intake possible; safety data must support intended level of use
  • Notification to FDA is voluntary
  • Timeline: FDA response received ~180 days after filing date

Where to Go From Here

Overall, determining the correct path for your ingredient can be tricky, but ultimately it is a necessary step to maximizing the market success of your product.

Working with an experienced consultant with longstanding expertise in GRAS and NDIN filings, like Nutrasource and GRAS Associates, will expedite the process and ensure you have all the information you need to successfully gain FDA approval.

With our 97% success rate, we will help you navigate the regulations, submit your NDIN or GRAS filing, and liaise with the FDA on your behalf. Contact our expert regulatory team to get started today.

Amy Mozingo-bw-cAmy Mozingo, MS, is Director of Operations at GRAS Associates (a Nutrasource subsidiary). She has over 15 years of experience in industry and consulting, holds a certificate as a Preventive Control Qualified Individual (PCQI), and is trained and experienced in ingredient approvals (GRAS, NDIN, FAP, CAP), product labelling, formulation reviews, and current good manufacturing requirements for dietary supplements. Amy is also an Associate with RNI Consulting and serves as international regulatory liaison for Nutrasource and GRAS Associates. Connect with Amy on LinkedIn.

Topics: Regulatory, Foods & Beverages, Dietary Supplements/Natural Health Products