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Posted October 5, 2011

FDA Warns Herbal Nitro of Manufacturing Violations

The FDA has published a Warning Letter dated September 22, 2011 to Herbal Nitro Inc. regarding manufacturing violations at its facility in Yucaipa, CA.

During an inspection in May 2010, FDA investigators found significant violations of the Current Good Manufacturing Practice (CGMP) regulations causing the company's dietary supplement products to be considered adulterated. The violations include:

-- Failure to establish specifications for identity, purity, strength, and composition for each component used in the manufacture of the dietary supplement products, as well as for the products themselves -- specifically male libido enhancement capsules and alluraTRIM appetite suppressant capsules.

-- Failure to conduct at least one appropriate test or examination to verify the identity of a component that is a dietary ingredient, prior to its use. Instead, the firm relied on certificates of analysis (COAs) from suppliers. A COA from a supplier may not be used to verify the identity of any component that is a dietary ingredient.

-- Failure to make and keep records of product distribution.

In addition, the FDA noted that the firm includes expiration dates on the labels for its dietary supplement products but does not conduct or have any data supporting the expiration dates. Further, the firm stated that these dates are arbitrarily assigned based on product sales. Any expiration date on a product label should be supported by data that demonstrates the product’s shelf life.

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