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In response to an increased growth in consumer desire and interest in nutraceutical products, the need for scientific foundations in the development and manufacture of dietary supplements or nutraceuticals has been recognized. It is estimated that Americans regularly spend billions of dollars annually on dietary supplements in an effort to reduce the risk of disease and generally to promote health.
Currently there is no requirement for manufacturers and distributors of nutraceuticals to register with the FDA. There are many studies reporting poor quality among different brands. Clinical research varies greatly in terms of quality making it difficult to scientifically measure efficacy of claims. Consumers ultimately have no basis for determining the quality of the product they are purchasing.
This focus group on Nutraceuticals will provide a forum for the advocacy of good scientific research into dietary supplements. This forum potentially will unite AAPS and other related organizations committed to providing the public and health care providers current and accurate information regarding claims, benefits and safety of nutraceutical products.
News and Notes
Useful Links
Dietary Supplements Overview
Guidance for Industry Botanical Drug Products
International Bibliographic Information on Dietary Supplements (IBIDS) Database
National Center for Complementary and Alternative Medicine (NCCAM)
“Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding
Operations for Dietary Supplements; Final Rule,” and “Petition To Request an
Exemption From 100 Percent Identity Testing of Dietary Ingredients; Interim Final Rule,”
recently published in the Federal Register at
this URL.
Meeting Minutes
Minutes from the Nutraceuticals Focus Group Business Meeting, October 28, 2003 (PDF)
JOIN THE NUTRACEUTICAL FOCUS GROUP
To join the Nutraceutical Focus Group, click here.
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