FDA Sets Meeting on New Dietary Ingredients

WASHINGTON--The Food and Drug Administration (FDA) released an advance notice of a public meeting to be held in November on the topic of new dietary ingredients (NDIs) for use in dietary supplements. The notice was released on the Federal Register Web site Oct. 18, and will appear in the Oct. 20 issue. In addition to announcing the meeting, FDA included an extensive list of questions on the topic that it is requesting comment on before Dec. 3.

Interestingly, Susan Walker, M.D., director of FDA's Division of Dietary Supplement Programs, addressed the topic of NDIs during her presentation at SupplySide West in late September. Also, FDA's notice cited a recently published article by Michael McGuffin, president of the American Herbal Products Association (AHPA), and AHPA's general counsel, Tony Young, which stated FDA clarification on the topic could improve the quality of NDI submissions.

The Dietary Supplement Health & Education Act (DSHEA) included the NDI premarket notification as part of its safety protocol. Under DSHEA, dietary supplements containing NDIs are considered adulterated unless the company has submitted information to FDA on the safety of the new ingredient. According to the agency, many NDI notifications are failing to comply with DSHEA notification requirements and do not include adequate information.

FDA is seeking input on an extensive breadth of questions concerning NDIs and the notification procedures, as well as the possibility of issuing a guidance document. The questions include whether a list should be compiled listing dietary supplement ingredients marketed prior to DSHEA's passage, what chemical changes to basic ingredients would cause the ingredient to be considered an NDI, the types of information that should be mandatory in NDI submissions, and what types of information should be required to establish an expectation of safety for the NDI. FDA also asked questions about the types of studies to be used for establishing safety assessments and types of labeling for terms of use, as well as requesting help defining a number of terms including "amino acid," "botanical," "extract," "metabolite," "mineral" and "vitamin."

"The NDI section of DSHEA is the new ingredient safety provision of this good law," Young said. "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." Young and McGuffin are expected to speak at the November meeting.

Attendees must pre-register by Nov. 10 to attend the meeting, which will take place Nov. 15 in College Park, Md.; interested parties can contact Kelly Williams-Randolph at 301-436-2506 or kelly.williams@cfsan.fda.gov. Comments must be filed by Dec. 3 and can be sent electronically (www.fda.gov/dockets/ecomments) or in written form (Division of Dockets Management, HFA-305, FDA, 5630 Fishers Lane, Room 1061, Rockville, MD 20852). The notice can be found online at www.accessdata.fda.gov/scripts/oc/ohrms/index.cfm.

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