FDA Reopens Comment Period on NDIsFDA Reopens Comment Period on NDIs

WASHINGTON--The Food and Drug Administration (FDA) reopened to Feb. 1, 2005, the comment period on new dietary ingredients (NDIs). In early December, the agency verbally notified industry associations of its intent to reopen the comment period, which closed Dec. 3; however, official notice is being published in the Dec. 27 Federal Register (www.gpoaccess.gov/fr/).

In early November, the American Herbal Products Association (AHPA), Council for Responsible Nutrition (CRN), Consumer Healthcare Products Association (CHPA), National Nutritional Foods Association (NNFA) and Utah Natural Products Association (UNPA) jointly petitioned FDA to extend the comment period to Feb. 1, 2005, citing the breadth of the topic and the extent of impact on industry. During the Nov. 15 meeting, FDA officials noted they were reviewing the petition, but had no decision. The transcript of the Nov. 15 meeting is now available online (www.fda.gov/ohrms/dockets/dockets/04n0454/04n-0454-tr00001.htm).

FDA's original Federal Register request for input on NDIs was published in mid October, and included inquiries about safety parameters for NDIs, whether to define relevant terms such as "extract" or "tincture", and whether the agency should develop official guidance on NDI submissions.