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Posted January 11, 2012

Herbal Extract Company Warned by FDA of Making Drug Claims

On January 3, 2012, the U.S. FDA sent a Warning Letter to Herbal Extract Plus, LLC regarding legal violations for claiming its herbal products can cure or prevent diseases.

The FDA reviewed the company's website at www.herbalextractsplus.com in November 2011 and determined that its “Cholesterol Reduction Support,” “Support for High Blood Pressure,” and “Kidney and Bladder Support,” products are promoted for conditions that cause these products to be drugs under the Federal Food, Drug, and Cosmetic Act.

In addition to citing examples of these claims, the FDA noted that the “Cholesterol Reduction Support,” “Support for High Blood Pressure,” and “Kidney and Bladder Support” products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under the law. New drugs may not be legally marketed in the U.S. without prior approval from FDA.

Furthermore, the “Cholesterol Reduction Support,” “Support for High Blood Pressure,” and “Kidney and Bladder Support” products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, these products are misbranded, in that the labeling fails to bear adequate directions for use.

For more details, use the link below.