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Posted February 5, 2014

Maker of Digestive Health Supplement Warned For Manufacturing Violations, Drug Claims

On January 22, 2014, the FDA issued a warning letter to Intensive Nutrition Incorporated, following a facility inspection which found the company's digestive support supplement, Tanalbit, to be adulterated because it was prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.

These violations include failure to establish finished product specifications for purity, strength, and limits on heavy metal contaminants and failure to establish and follow written procedures for the responsibilities of quality control operations.

In addition, statements made about Tanalbit on product packaging and on the company's website, www.intensivenutrition.com, were found to be drug claims. These statements include "These tannins... effectively remove pathogenic yeast and bacteria cells through cellular binding," and "the antioxidant potential of tannins ... many studies have been performed indicating their potential as anti-carcinogenic and anti-mutagenic compounds..."

Tanalbit contains zinc tannate, milk casein, lotus root and L-proline. It is promoted for its "anti-fungal", "anti-yeast" and "antioxidant activity" that fights inflammation and food insensitivities and "supports gastrointestinal health." It is sold on various websites.

See ConsumerLab.com's Reviews of Zinc Supplements, Pomegranate Juice and Supplements and Probiotic Supplements for tests of related products.

To read the FDA's warning letter, use the link below.