Self-affirmed GRAS omitted from new NDI draft guidance

17-Aug-2016 - Last updated on 18-Aug-2016 at 17:08 GMT

The devil is in the detail, and one detail easily missed in the new draft guidance for new dietary ingredient notifications is that self-affirmed GRAS is no longer mentioned as an ‘alternative’ to an NDI notification.

If the ingredient has been judged to be GRAS (generally recognized as safe) then it is not subject to the NDI filing requirement. And since the first draft guidance in 2011 many companies have used this route to outflank the agency, particularly for synthetic, nature-identical compounds.

However, while the 2011 guidance specifically mentioned self-GRAS, the new version conspicuously omits this:

2011 language [emphasis added]: “Am I required to submit a NDI notification for a dietary ingredient that has been listed or affirmed by FDA as generally recognized as safe (GRAS) for direct addition to food, self- affirmed as GRAS for direct addition to food, or approved as a direct food additive in the U.S.?

“No, as long as the direct food additive or GRAS substance has been used in the food supply and is to be used as a NDI without chemical alteration.

2016 language [emphasis added]: “Am I required to submit an NDI notification for a dietary ingredient that is an NDI, but has been (a) listed or affirmed by FDA as generally recognized as safe (GRAS) for direct addition to food or (b) approved as a direct food additive in the U.S.?

“No, as long as the following conditions are met. The direct food additive or GRAS substance (1) has been used in the food supply (i.e., in conventional foods) and (2) is to be used as a dietary ingredient without chemical alteration.”

Commenting on the discrepancy, Ashish Talati from Chicago-based law firm Amin, Talati & Upadhye (who brought this issue to our attention) told us that this is something that people could easily miss in the new draft guidance. “Self-affirmed GRAS or independent conclusion of GRAS status (as FDA calls it in the GRAS final rule) is not something that FDA can change,” he said. “It’s perfectly legal, but it shows that the Agency doesn’t look favorably at self-affirmed GRAS and doesn’t want to encourage that route as a way to by-pass the NDI notification process.”

The FDA was contacted for clarification on August 16, and we are still awaiting their comments on this issue.