AHPA, which keeps tabs on NDI submission trends via its NDI Database, said based on the partial information it has received on 40 submissions submitted to FDA between November 2012 and February 2014, that 10 of these notifications were acknowledged by FDA without objection. AHPA promotes the database as a way for companies to see trends in notifications and to avoid some obvious pitfalls that lead to rejections.
“Overall there has been about an 85% rejection rate. We did that calculation based on notifications filed though 2007,” Ashish Talati, a principal in the Chicago-based law firm Amin Talati told NutraIngredients-USA. “If AHPA is saying that the approval rate is now 25%, that’s good. But that still means that 75% are not going through. Overall has it gotten better? That I really couldn’t say because I don’t have the data.”
Companies that want to use a dietary ingredient not marketed in the U.S. before Oct. 15, 1994 are required to submit an NDI notification explaining why the ingredient is reasonably expected to be safe. This notification must be submitted at least 75 days before the dietary ingredient is introduced or delivered for introduction into interstate commerce.
FDA does not "approve" or "disapprove" NDI notifications. Instead, the agency generally provides one of several types of responses. According to FDA, examples of these responses include, but are not limited to: (1) letter of acknowledgement without objection; (2) letter listing deficiencies that make the notification incomplete; (3) objection letter raising safety concerns based on information in the notification or identifying gaps in the history of use or other evidence of safety; and (4) letter raising other regulatory issues with the NDI or dietary supplement (e.g., the NDI is not a dietary ingredient as defined by regulation or the product is excluded from the definition of "dietary supplement" under current regulations because it is not intended for ingestion.
Raising the bar