Source: https://www.casewatch.net/fdawarning/prod/2009/kenshin.shtml
Timestamp: 2019-04-24 02:09:18+00:00

Document:
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.
(Testimonial) "According to the research information available to me, kelp appears helpful in lowering blood pressure, relieving constipation, reducing swelling... "
(Testimonial) "I have suffered from thyroid trouble, I felt like I never returned to normal. I started using Katsu Kelp Root tablets, in about three months nails and hair had returned to normal."
(Testimonial) "A year ago my father was diagnosed with a liver disease. His health was in a pretty bad condition. A practitioner told me about the use of clams in Japan. She searched online and she told me about Kenshin's Shijimi (Corbicula Clam Extract)."
(testimonial): "I have been giving Sanza regularly to some of my patients with high cholesterol since last November. I am planning to do a study on a large population with high cholesterol. Sanza is one of the best supplements I have come across so far that may be helpful in lowering cholesterol"
"As trapped toxins build up in the body, especially in the feet, they impair the ability of the blood to circulate properly resulting in all kinds of physical discomforts and leave the body vulnerable to illness. Relief may be found with the use of the Natural Tree Sap Pouch."
(Testimonial) "For these reasons, I am especially interested in the Kenshin Trading Corporation product, 'Tree Sap.' The 'Tree Sap' may pull toxins out of the body, especially from the bottom of the feet."
(Testimonial) "After a night of adhering to the bottoms of the feet, the 'Tree Sap' packet changes in form, texture and smell. This change comes from the fluid, that may contain toxins, which are pulled out through the bottom of the feet."
"It is a safe way to protect skin from burns and to help soothe skin that has been burned."
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.
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.

References: § 321
 § 351
 § 360
 § 360
 § 352
 § 360
 § 360
 § 321
 § 321
 § 321
 § 355
 § 352