FDA WARNING_LETTER - Herbal Extracts Plus, LLC - January 03, 2012

On January 3, 2012, the FDA issued a Warning Letter to Herbal Extracts Plus, LLC, following a November 2011 review of their website, www.herbalextractsplus.com. The FDA determined that the products "Cholesterol Reduction Support," "Support for High Blood Pressure," and "Kidney and Bladder Support" were promoted with claims that cause them to be unapproved new drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)].

The claims, including those from product descriptions and customer testimonials, indicated the products were intended for the cure, mitigation, treatment, or prevention of disease, such as reducing cholesterol, regulating blood pressure, treating arteriosclerosis, heart attacks, strokes, and various infections like cystitis, urethritis, and kidney stones.

These products are considered "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their promoted uses and lack prior FDA approval as required by section 505(a) [21 U.S.C. § 355(a)]. Furthermore, the products are misbranded under section 502(f)(