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Posted June 13, 2012

FDA Warns of Multiple Violations with "Himalayan Institute" Supplements

The U.S. FDA recently posted a Warning Letter to Himalayn Institute of Buffalo regarding multiple violations of FDA regulations in the production and marketing of its liquid dietary supplement products.

Inspection of the company's manufacturing facility in Pennsylvania in January 2012 found that the facility has serious violations of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements. Products affected include: Elixir 29, Immuno-Stim, Sweet Dreams, Safe Travel, and Sages Treasure.

In addition, review of the company's website (www.himalyaninstitute.org) found products being promoted with health claims causing them to be considerd "new drugs" by the FDA. A new drug may not be legally marketed in the United States without prior approval from FDA and these products have not been approved. The products include: Inflam-Away, Himalayan Triphala Oil, and Namastea Black.

For more details, use the link below.