Industry Stakeholders Question FDA’s Cost Estimate for NDI Notifications
The dietary supplement industry continues to wait for FDA to publish a revised guidance on New Dietary Ingredients (NDI) and NDI notifications (NDINs). But recently, the Agency estimated that preparing an NDIN should take only twenty hours and incur no capital costs. FDA explained that its estimate isolates the time and expense of researching the safety of an ingredient from the time required to prepare an NDIN for FDA submission. Thus, FDA does not factor in research costs. According to industry stakeholders, however, research on new ingredients is directly linked to NDIN costs, and should be considered in calculating the expense of filing an NDIN.
It is also difficult to reconcile FDA’s conservative twenty-hour estimate with its lack of guidance on the content that firms should include in NDINs. The American Herbal Products Association (AHPA) recently updated its NDI database, which offers access to 670 NDINs and their associated FDA responses. The database reveals that FDA was “unable to establish the identity” of the ingredients in about forty percent of the most recent NDINs it received. The fact that well over one-third of NDIN submissions are deficient underscores the need for updated FDA guidance. In addition, it calls into question the idea that a firm could prepare a satisfactory NDIN in a mere twenty hours.
On the other hand, AHPA’s database shows that FDA rejected approximately fifteen percent of the latest NDINs because firms failed to comply with basic regulatory requirements, such as supplying the Latin binomial for botanicals, attaching references, or providing English translations for foreign-language documents. These are preventable mistakes that cost firms the additional time and expense of re-filing their NDINs.
As always, if you need legal assistance filing an NDIN or complying with federal, state, and local dietary supplement regulations, call us any time at 516-294-0300.