(Silver Spring, MD) -- The American Herbal Products Association (AHPA) and other trade associations were informed this morning that the Food and Drug Administration (FDA) has agreed to extend the comment period on its solicitation of information related to FDA’s premarket notification program for new dietary ingredients (NDIs). A formal notice to reopen the comment period for 60 days will appear in the Federal Register within the next several days.
FDA published a notice on October 20 to solicit comments on numerous issues related to NDIs and set a 45-day comment period, ending on December 3. AHPA submitted a request in cooperation with four other trade associations to request the extension that has now been granted. Comments will now be due in early February.
The questions posed by agency on October 20 ranged from inquiries about the types of information about an NDI that should be included in a submission and the legal status of an ingredient as a dietary ingredient and as an NDI, to requests for opinions as to whether the agency should define certain relevant terms (e.g., “botanical,” “extract,” and “tincture”) or establish guidance to assist in submitting the required notifications for NDIs.
The area in which FDA posed the most questions is in its request for input related to establishing a reasonable expectation of safety for a dietary supplement containing a new dietary ingredient. The agency asked, for example, what types of information should be included to establish a reasonable expectation of safety based upon history of use, and also what quality and quantity of data and information are needed to establish a reasonable expectation of safety based upon evidence other than history of use.
FDA also held a public meeting on November 15 to provide an initial forum for input on NDI regulations. AHPA President Michael McGuffin made a presentation that focused on the impact of these regulations on herbal ingredients.
AHPA will be preparing comments to FDA over the next several weeks.
Karen Robin, Director of Communications
American Herbal Products Association
Telephone: 301-588-1171 x107