Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration
  Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506
Telephone: 949-608-2900
FAX: 949-608-4415

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

December 8, 2009

W/L 04-10

Kunio Suzuki
President
Kenshin Trading Corporation
22353 S. Western Ave. Suite 201
Torrance, California 90501-4156
Los Angeles, California 90025

WARNING LETTER

Dear Mr. Suzuki:

The U.S. Food and Drug Administration (FDA) has reviewed your website at http://www.kenshin.com on November, 5th, 2009. Our review shows that you market and offer the UNICO ST8 Acupuncture needles for sale. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act)[ 21 U.S.C. § 321(h)], this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or function of the body.

Your UNICO ST8 Acupuncture needles are adulterated under section 501(f)(1)(B) of the Act [21 U.S.C. § 351(f)(1)(B]), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act [21 U.S.C. § 360e(a)], or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act [21 U.S.C. § 360j(g)]. The device is also misbranded under section 502(o) the Act [21 U.S.C. § 352(o)], because you did not notify the agency of your intent to introduce this device into commercial distribution, as required by section 510(k) of the Act [21 U.S.C. § 360(k)]. For a device requiring premarket approval, the notification required by section 510(k) of the Act [21 U.S.C. § 360(k)], is deemed satisfied when a PMA is pending before the agency. Title 21, Code of Federal Regulations, section 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.

Additionally, we also reviewed the labeling on your website for the following products, including your online product catalog: Katsu Natto-Kinase Tablets, Katsu Kelp Root Tablets, Shijimi Capsules, VitalFocus Sanza Capsules, Natural Tree Sap Pouch, and Shiunko Burn Cream. Our review showed that these products are promoted for conditions that cause them to be drugs under section 201(g) of the Act [21 U.S.C. § 321(g)]. The therapeutic claims on your website establish that your products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the body of man. The marketing of the products with these claims violates the Act.

Examples of some of the claims observed on your website include:

Further, based on the drug claims noted above for the Shiunko Bum Cream, this product is subject to the Final Monograph for Over-the-Counter (OTC) Skin Protectant Drug Products (21 CFR part 347). However, this product is neither formulated nor labeled in accordance with the above referenced monograph. Therefore, as formulated and labeled, Shiunko Bum Cream is a "new drug" within the meaning of section 201(P) of the Act (21 U.S.C. § 321(p)), because it is not generally recognized as safe and effective for its labeled uses.

Your products are not generally recognized as safe and effective for the above referenced uses and therefore, they are "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)). New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)). FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. In addition, these products are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] in that the labeling for these drugs fail to bear adequate directions for use.

You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.

Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Your response should be sent to:

Acting Director, Compliance Branch
Food and Drug Administration
19701 Fairchild
Irvine, CA 92612-2506

If you have any questions about the content of this letter please contact: Dr. William Vitale, Compliance Officer at 949-608-2919.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter may be symptomatic of serious problems in your firm's operations. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.

Sincerely yours,

/S/

Alonza E. Cruse
District Director

This page was posted on January 31, 2010.

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