UNPA: New thinking necessary from FDA on NDIs

Section 413 of DSHEA is interpreted in the comments as defining NDIs and clearly stating the process of notification would apply to ingredients [emphasis UNPA], not individual products. It then follows that those parties that must file an NDI notification (NDIN) are marketers of ingredients, not dietary supplements containing an approved NDI (ANDI). In fact, UNPA stated the Draft Guidance essentially creates a new dietary supplement notification system, a "proposed policy [that] is tantamount to requiring new drug approval requirements for dietary supplements."

In the area of ODIs, UNPA's ODI lista compilation of the ODI lists of the American Herbal Products Association, the Council for Responsible Nutrition, the Natural Products Association, and the United Natural Products Alliancewas reviewed by UNPA's NDI Working Group and submitted with the comments. UNPA asked FDA to confirm its willingness to accept such authoritative lists to provide the agency and the industry with an invaluable resource.

The food additive safety standard was another hot button topic for UNPA, as the association cited both court cases and DSHEA illustrating FDA's use of the food additive standard was unlawful. "FDA's proposal to merge the NDI safety standard into the food additive safety standard is without statutory basis and represents a major departure from FDAs NDI evaluation over the past 16 years. UNPA requests that FDA withdraw all reference to food additive safety standards and evaluation procedures and re-propose a standard of safety within an appropriate level of evidence based on the reasonable expectation of safety standards laid down by DSHEA."

When companies do develop an NDI, the investment in the process is among the greatest IP investments it will make, according to UNPA, with the expectation of a return on the investment. In its comments, UNPA urged FDA to recognize the ingredient and not the finished supplement is the NDI, and to practice appropriate enforcement discretion to affirm ANDIs are unique and similar NDIs should not rely on an ANDI for their own filing.