NEW FDA REGULATIONS PUBLISHED JANUARY 6th WILL BE ANALYZED AT FIM’S FEBRUARY 3rd /4th NUTRACEUTICAL CONFERENCE in New York, “The Current Nutraceutical Health Sector & The Next Phase of the Nutraceutical Revolution”.
The FDA has published 51 pages of new regulations, “REGULATIONS ON STATEMENTS MADE FOR DIETARY SUPPLEMENTS CONCERNING THE EFFECT OF THE PRODUCT ON THE STRUCTURE OR FUNCTION OF THE BODY” in the January 6th issue of The Federal Register. They can be read on the FDAs website by clicking the title.
These new regulations deal with FDA’s interpretation of the difference between a disease versus structure/function claim. This is an extremely important new development that will have a significant impact on the claims that can be made for dietary supplements (and also for other foods) by the health industry without triggering drug requirements. It will be discussed in open forum for the first time at the FIM conference. A panel of physician experts will discuss the FDA’s position regarding disease versus structure/function claims.
Several new problems are presented for industry by these regulations – for example – FDA now asserts that ALL structure/function claims for a dietary supplement must be submitted to FDA and must be accompanied on the label by the “DSHEA disclaimer”. FDA has discussed several types of claims that are important to the industry including claims ranging from cholesterol to pain to aphrodisiacs. Stephen H. McNamara, Esq. of Hyman, Phelps & McNamara, P.C., will lead this discussion.
For further information on the FIM conference, please call 908/272-4583 or visit our website at www.fimdefelice.org.