Structure Function Claims, GRAS Filings, New Dietary Ingredient (NDI) Filings
Litigation Support including Due Diligence, Expert Testimony and FDA Responses
To GRAS or Not To GRAS?
by Ingredient Identity
Good August to you ladies and gentlemen! It has been a wonderful summer thus far and we're looking forward to Mr. Olympia next month in Las Vegas, as we're supporting a number of companies in the Bodybuilding market with their scientific marketing and ongoing compliance needs. Please let us know if you will be attending as we would welcome an opportunity to meet there. We will also be initiating a free, yes FREE, monthly Webinar Consulting Series covering any topics/question submitted by our guests. It's a rapid-fire Q&A style discussion for 60 minutes. The arrangement is first come, first serve and will be limited to 20 people only! If you are interested, please email us to sign up.
Since we routinely provide services involving the preparation and filing of notifications for Self-affirmed GRAS and NDI's, we felt it was a great topic this month as we've seen a significant increase in requests and/or submissions for these, which as one can imagine, comes with their own unique challenges.
As a quick recap, here are some definitions:
Generally Recognized As Safe (GRAS) is the designation by the FDA of a substance for use in foods and dietary supplements, that is recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use or otherwise excluded from the definition of a food additive. The GRAS notification for a substance can be a lengthy process that is ingredient/process specific.
A New Dietary Ingredient (NDI) is any Dietary Ingredient marketed after October 15, 1994. These must be notified to FDA at least 75 days prior to first sale. The NDI (New Dietary Ingredient) notification must include two main areas: accurate identification of the substance and the basis upon which the notifier determines that the substance is safe for use in Dietary Supplements at the levels recommended or suggested in labeling.
A very large percentage of NDI's submitted are rejected (>75%) by the FDA due to insufficient data or technical packets for the substance inclusive of poor characterization itself, the manufacturing of food substance, limited or insufficient safety data and/or poorly crafted claims associated with the ingredient.. There are also companies offering GRAS notification services where the "expert panel" consist of only one individual, which is typical viewed with more scrutiny by the Agency. A recent article in Nutra Ingredients shines more light on the topic.
Some key questions for you to ponder:
- What path is appropriate for your needs and business model?
- What's your market and the sales potential for your product/ingredient?
- What are the risks whether using in-house resources or a third-party?
- How can you ensure such products are not considered adulterated?
- What is a reasonable timeframe for you to complete a GRAS notification?
- Do you understand the cGMP requirements and how this impacts pricing?
- For GRAS, is an expert panel necessary for your Self-affirmed notification?
- Are there any conflicts of interest with your GRAS notification?
Lastly for a Self-affirmed GRAS notification, we've seen costs range from $30K to well over $200K. By comparison, for NDI submissions, we've seen costs range from $20K to nearly $100K. At the end of the day, both are significant investments that can give your ingredient and company an edge.