(Silver Spring, MD) -- The Food and Drug Administration announced that it will hold a public meeting on November 15, 2004 and that it is soliciting comments on FDA’s premarket notification program for new dietary ingredients (NDIs).
FDA’s meeting notice was posted today on the agency’s website, in advance to it being published in the Federal Register on Wednesday. The notice also provides several questions “intended to focus public comment on specific NDI issues.” In describing the reasons for this meeting FDA stated that it “has identified a number of omissions and other problems” in notifications that it has received to date. The agency also cited a recently published article by American Herbal Products Association President Michael McGuffin and AHPA’s General Counsel Tony Young to substantiate its observation that the dietary supplement industry has recognized “that the quality of NDI notifications could benefit from FDA clarification of the statutory requirements.”
“Tony Young and I are pleased that the agency has noted the degree to which AHPA has established an interest in efficient implementation of the regulation of new dietary ingredients,” stated McGuffin, “and we will both attend and provide oral presentations at this meeting. All AHPA members should be encouraged that the agency has called for a dialogue on the federal NDI program, but should also pay attention to the detailed language in FDA’s notice.”
“The NDI section of DSHEA is the new ingredient safety provision of this good law,” added Young. “The Congress included this ‘gatekeeper’ section to clearly place upon industry the responsibility for demonstrating that new ingredients are reasonably expected to be safe for their intended use, and the industry and its trade associations must now be fully engaged in this regulatory process.”
The questions posed by FDA in its notice focus on numerous issues, from 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.
The November 15 meeting is scheduled from 9:00 am to 5:00 pm at FDA’s offices in College Park, MD. Pre-registration may be made until November 10 by providing information (name, title, business affiliation, address, telephone, and fax number) to FDA’s contact for this event, Kelly Williams-Randolph ([email protected]). Onsite registration will also be allowed, if space is still available. Persons who wish to reserve time for oral presentations should also contact Dr. Williams-Randolph.
AHPA requests that all member companies that would like to participate in the preparation of AHPA’s comments or that intend to attend this FDA meeting contact Michael McGuffin ([email protected]) in advance.
Comments to the notice are due by December 3, 2004.
Copies of FDA’s pre-publication meeting notice are on the FDA website, or may be requested from Karen Robin, AHPA’s Director of Communication. The AHPA press release dated July 23, 2004, that summarizes the article about NDIs by McGuffin and Young, published this summer in the Food and Drug Law Journal, is on the AHPA website. A copy of the article, which FDA cites in its meeting notice is also available upon request to Karen Robin.
The American Herbal Products Association (AHPA) is the national trade association and voice of the herbal supplement industry, the only trade association devoted solely to herbal issues. AHPA is the recognized leader in representing the responsible center of the botanical trade, and is comprised of the finest growers, processors, manufacturers and marketers of herbal products. AHPA's mission is to promote the responsible commerce of herbal products. AHPA committees generate self-regulations to ensure the highest level of responsibility with respect to the way herbs are manufactured, labeled and sold.
Director of Communications
American Herbal Products Association
Telephone: 301-588-1171 x107