Notice Number: NOT-AT-10-006

Key Dates
Release Date: August 16, 2010
Revised Policy Effective Date: July 28, 2010

Issued by
National Center for Complementary and Integrative Health (NCCIH formerly NCCAM)

Other Relevant Notices

See NOT-AT-05-004, NCCAM Interim Applicant Guidance: Product Quality: Biologically Active Agents Used in Complementary and Alternative Medicine (CAM) and Placebo Materials, and NOT-AT-05-003, NCCAM Interim Policy: Biologically Active Agents Used in Complementary and Alternative Medicine (CAM) and Placebo Materials.

Purpose

This Notice is to inform the research community that NCCAM has updated its Policy and Guidance on Product Integrity of agents used in NCCAM funded research. Policy and guidance documents have been combined into a single document. Product categories have been reorganized and include Complex Botanical Products, Complex Animal Products, Probiotics, Refined Products, and Placebos. Additionally, within each categorgy, there are subsections listing information needed for in vitro studies, animal studies, and human studies. The specific information requested is largely the same as in the previous version of the Guidance. However, the level of detail requested varies depending on the complexity of the product and its intended use. Of note, the Policy requires independent analysis of all products to verify identity, purity, etc. claimed by the supplier. Furthermore, the information is evaluated now by NCCAM staff with input from external experts as needed rather than by a working group of the NCCAM Advisory Council. The revised policy can be viewed by going to http://nccam.nih.gov/research/policies/naturalproduct.htm.

Inquiries

For questions or further information, contact:
D. Craig Hopp, Ph.D.
Program Officer
National Center for Complementary and Alternative Medicine
National Institutes of Health
6707 Democracy Blvd., Suite 401
Bethesda, MD 20892
ph: 301-496-5825
fx: 301-480-1587
e-mail: [email protected]