FDA WARNING_LETTER - Kenshin Trading Corporation - November 30, 2009

On December 8, 2009, the FDA issued a Warning Letter to Kenshin Trading Corporation following a November 5, 2009, review of their website, http://www.kenshin.com. The review identified several violations related to the marketing and sale of medical devices and unapproved new drugs.

The UNICO ST8 Acupuncture needles were cited as an adulterated device under section 501(f)(1)(B) of the Act because Kenshin Trading Corporation lacked an approved premarket approval (PMA) or investigational device exemption (IDE). The device was also misbranded under section 502(o) for failure to submit a 510(k) premarket notification.

Additionally, several products, including Katsu Natto-Kinase Tablets, Katsu Kelp Root Tablets, Shijimi Capsules, VitalFocus Sanza Capsules, Natural Tree Sap Pouch, and Shiunko Burn Cream, were deemed unapproved new drugs under section 201(g) and 201(p) of the Act due to therapeutic claims on the website. These claims, such as "fight osteoporosis" for Katsu Natto Kinase Tablets and "helpful in lowering blood pressure" for Katsu Kelp Root Tablets, establish the products as drugs intended for disease treatment or affecting body function. The Shiunko Burn Cream was specifically noted as not conforming to the OTC Skin Protect