Manufacturers or distributors of new dietary ingredients (NDIs) must submit a pre-market notification called a new dietary ingredient notification (NDIN) to FDA at least 75 days before marketing a dietary supplement that contains an NDI (i.e., one not marketed in the U.S. prior to October 15, 1994). On August 12, 2016, FDA issued a revised Draft Guidance on NDIs and NDINs. The guidance addresses the circumstances under which an NDIN is required, the contents of an NDIN, and the process and timeline associated with NDIN submission and review. Of note, FDA indicated in the draft guidance that it was willing to develop an authoritative list of dietary ingredients that were marketed before October 15, 1994, and consequently exempt from the NDIN requirements in DSHEA.
Today, FDA announced in a Federal Notice (82 FR 42098) that it will hold a meeting on October 3, 2017 to discuss its future development of an authoritative list of old dietary ingredients exempt from notification requirements in the law. The meeting is slated to address two distinct issues that have elicited various opinions among stakeholders:
The standard of evidence required to show an ingredient belongs on the pre-DSHEA list; and
The process by which ingredients should be added to the list, such as the process for nominating and reviewing pre-DSHEA ingredients and how to treat confidential information.
FDA states in the Notice that “by providing clarity as to which ingredients do not require notifications, it would alleviate the burden on industry of preparing and submitting unnecessary notifications.” FDA further states that “by eliminating unnecessary notifications, an authoritative list would enable [the Agency] to more efficiently use [its] limited resources to review notifications for truly ‘new’ ingredients. In addition, an authoritative list would allow [the Agency] to better focus [its] enforcement efforts in alignment with [its] strategic priorities of consumer safety, product integrity and accurate information.”
The registration deadline for the October meeting is September 25, 2017. FDA recommends early registration as seating is limited. To register for the public meeting, click here.
FDA will allow interested parties to comment on the public meeting by submitting electronic or written comments through December 4, 2017. Keller and Heckman LLP has significant expertise in advising the dietary supplement industry. Interested parties with any questions regarding the upcoming meeting or who would like assistance in preparing comments regarding the development of a list of Pre-DSHEA dietary ingredients are encouraged to email us at firstname.lastname@example.org.