Circumventing NDIN with GRAS Status
Section 4(b)(2) of FDA’s NDI Draft Guidance says a company is not required to submit an NDI notification for a generally recognized as safe (GRAS) dietary ingredient as long as that ingredient hasn’t been chemically altered. The supplement that contains the GRAS ingredient must also contain less of the ingredient than would reasonably be expected to be in the diet, and it must be used for the intended use outlined in the GRAS literature. GRAS status can come from self-affirmation, FDA petition (which was how GRAS was handled pre 1997) or FDA non objection.
There was a time (I think up until the day before the draft guidance was issued) where supplement manufacturers were glad they didn’t need to have GRAS status to include an ingredient in a supplement. GRAS, used for food ingredients, need to have a general recognition of safety based on the views of qualified experts. The ingredients need to have safety information that is publically available. Evidence of safety is the same as is required to support approval of a food additive petition, according to Claire L. Kruger, Ph.D., D.A.B.T., SPHERIX.
Now, many supplement manufactures and ingredient suppliers are thinking GRAS status may be the way to go with their ingredients. This way, they would not need to submit an NDI notification to include it in their products. In fact, at the United Natural Product Alliance’s (UNPA) two-day seminar on the Draft Guidance, July 26 and 27, 2011, a survey at the end of day two found 80 percent of attendees said GRAS was a viable option for NDI notification.
This seems huge to me; that industry actually considers GRAS status to be less onerous than NDI notification.
In a company actually decided to go this route, it would take a lot of pre-planning. Along with gathering all the information that shows qualified experts agree that its safe, a company must market the ingredient in a food. According to Ashish Talati, JD, MS, RAC, partner, Amin Talati LLC, at the UNPA conference, this food product could be on the market for only two days before the ingredient could be sold in a supplement. But nonetheless, that requirement is there.
Loren Israelson, executive director, UNPA closed the discussion by saying the supplement industry needs to invest in GRAS education, and it’s time to make some close partnerships with food industry experts.
I’m curious to know more legal implications of going the GRAS route to market an ingredient in supplements. I also want to know what this would mean for a company. If a company is willing to gather the GRAS information and create a whole new food product, wouldn’t it be easier (or at least just as difficult) to submit an NDI notification?
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