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Posted August 29, 2012

Herbal Supplement Company Warned For Medical Claims

On August 2, 2012, the FDA issued a warning to HSAC Enterprises, Inc. dba Kare-N-Herbs subsequent to a facility inspection and website review in May 2012 which found statements made about Kold Kare, Energy Kare and Tranquility Kare dietary supplements to constitute drug claims. Energy Kare and Tranquility Kare were also deemed misbranded by the FDA for inadequate directions for use.

HSAC Enterprises told the FDA it would remove medical claims from its website within 60 days of the initial inspection, but failed to do so as of August 1, 2012.

Kold Kare contains the traditional Indian herb Andrographis paniculata, and was promoted to prevent colds and flu, relieve sinus pain, and reduce fever, congestion and fatigue.

(See's Review of Echinacea Supplements for tests of related products commonly taken for cold and flu.)

Energy Kare contains Rhodiola rosea and was promoted to treat sexual and erectile dysfunction in men. Tranquility Kare contains Withania somnifera, an herb used to make the traditional Indian herbal remedy called Ashwagandha. It was promoted for the treatment of joint inflammation and insomnia.

(See's Reviews of Sexual Enhancement Supplements, Joint Supplements, Valerian Supplements (commonly taken for insomnia), and Ashwagandha Supplements for tests of related products).

For more details regarding the FDA's warning letter, use the link below.