FDA REOPENS COMMENT PERIOD FOR PREMARKET NOTIFICATION FOR NDIs

The FDA has reopened the docket on the agency's premarket notification program for new dietary ingredients (NDIs) after receiving requests from trade associations representing dietary supplement makers.

The agency will accept comments through Feb. 1, from supplement makers and other interested parties relating to content and format requirements for NDI notifications made under Section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act.

In October 2004, the FDA announced in the Federal Register that it would convene a public meeting Nov. 15, 2004, to discuss its premarket notification program for NDIs and opened a docket to accept comments prior to the meeting. The comment period expired Dec. 3, 2004.

Trade groups representing dietary supplement makers contended the original comment period did not leave enough time for adequate consideration of the transcript of the Nov. 15, 2004, meeting, nor did it allow sufficient time to address specific questions put forth by the FDA or to assess the impact of the agency's new dietary supplement regulatory strategy on the industry, particularly on small businesses.

Comments on the FDA's premarket notification program for NDIs can be submitted electronically at http://www.fda.gov/dockets/ecomments (http://www.fda.gov/dockets/ecomments) for docket number 2004N-0454. To view the Federal Register notice announcing the new comment period, go to http://www.fda.gov/OHRMS/DOCKETS/98fr/04-28135.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/04-28135.pdf).