HSAC Enterprises, Inc. dba Kare-N-Herbs – FDA Warning Letter, May 1, 2012

The FDA conducted an inspection of HSAC Enterprises, Inc. dba Kare-N-Herbs from March 26 to May 1, 2012, and reviewed their website in August 2012. The inspection and review revealed that products Kold Kare, Energy Kare, and Tranquility Kare are promoted with therapeutic claims, classifying them as unapproved new drugs under sections 201(g)(1)(B) and 201(p)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B), § 321(p)(1)].

Specific violations include claims for Kold Kare such as "Cold & Flu, Sinusitis," "Reduces headache pain, fever, irritation, congestion & general fatigue," and "Prevents Colds & Flu." Energy Kare is promoted for "Improves sexual performance" and "successfully treats sexual disorder in men." Tranquility Kare claims to "reduce insomnia" and "inflammation at joints." These claims, including personal testimonials, establish the products as drugs intended for disease treatment or prevention, requiring FDA approval.

Furthermore, Energy Kare and Tranquility Kare are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] because they are offered for conditions