Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Center for Devices and Radiological Health 9200 Corporate Blvd Rockville, MD 20850|
DEC 3 2008
VIA FEDERAL EXPRESS
KIDS Co., Ltd. YUGENGAISHA KIDS
2nd Floor, 3-3, 1-chome, Nishidai
Itami City Hyogo 664-0858
Re: Pyro-Energen II and the Pyro Nerve Stimulator
Dear Johdic Takano:
The Food and Drug Administration (FDA) has learned that your firm is marketing the Pyro-Energen II and Pyro Nerve Stimulator Devices in the United States (U.S.) without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
The FDA has reviewed your website, www.pyroenergen.com. for the Pyro-Energen II and Pyro Nerve Stimulator products. The pyro-Energen II and the Pyro Nerve Stimulator are devices within the meaning of Section 201 (h) of the Act, 21 U.S.C. 321(h), because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.
The Pyro-Energen II and the Pyro Nerve Stimulator devices are adulterated under section 501(f)(1)(B) of the Act 21 U.S.C. 351 (f)(1)(B), because you do not have approved applications for premarket approval (PMA) in effect pursuant to section SI5(a) of the Act, 21 U.S.C. 360e(a), or approved applications for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The devices are also misbranded under section 502(o) of the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the devices into commercial distribution, as required by sections 510(k) of the Act, 21 U.S.C. 360(k).
The Pyro-Energen II device is also misbranded under section 502(a) of the Act, 21 U.S.C. 352(a), in that the labeling for this device, including your website and referenced information, e.g., the Pyro-Energen Reference Book, contain statements which represent or suggest that the Pyro-Energen device is effective to treat diseases that include "AIDS/HIV, Allergies, Arthritis, Asthma, Cancer, Diabetes, Fibromyalgia, Hepatitis, Herpes, Hypertension, Influenza, Insomnia, Kidney Diseases, Leprosy, Leukemia and Meningitis." These representations or suggestions are false or misleading or otherwise contrary to fact because this device has not been demonstrated to be effective for such purposes.
The Pyro-Energen II device is also misbranded under section 502(f)(1) of the Act, 21 U.S.C. 352(f)(1), in that the labeling for the device fails to bear adequate directions for use for the purposes for which it is intended, because adequate directions cannot be written for such purposes, i.e., the treatment of specific disorders that include cancer or viral disease.
The Pyro-Energen II and the Pyro Nerve Stimulator devices are also misbranded under section 502 of the Act, 21 U.S.C. 352(0), in that the devices are manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under 21 U.S.C 360; and were not included in a list required by 21 U.S.C. 360(j).
Given the serious nature of the violations of the Act, the Pyro-Energen II and the Pyro Nerve Stimulator devices distributed by your firm are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. 381(a), in that they appear to be adulterated and misbranded. As a result, FDA may take steps to refuse these products, known as "detention without physical examination," until these violations are corrected. In order to remove the devices from detention, you should provide a written response to this Warning Letter as described below and correct the violations described in this letter. We will notify you if your response is adequate.
The FDA requests that Kids Co., Ltd. immediately cease the dissemination of all promotional materials, including those on the Internet for the Pyro-Energen II and the Pyro Nerve Stimulator devices the same as or similar to those described above. You should take prompt action to correct the violations addressed in this letter.
Please submit a written response to this letter within IS working days from the date you receive this letter, describing your intent to comply with this request, listing all promotional materials for the Pyro-Energen II and the Pyro Nerve Stimulator devices the same as or similar to those described above, and explaining your plan for discontinuing the use of such materials. Please direct your response to Jennifer Medicus at the Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Division of Enforcement B, Radiology, Neurology, and Anesthesiology Devices Branch (HFZ-340), 2094 Gaither Road, Rockville, MD 20850, facsimile at (240) 276-0129. We remind you that only written communications are considered official.
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for the Pyro-Energen II and the Pyro Nerve Stimulator devices comply with each applicable requirement of the Act and FDA implementing regulations.
Timothy A. Ulatowski
Office of Compliance
Center for Devices and Radiological Health
1305 S. Lariat Dr.
Mustang, OK 73064
cc: Yuichi Shimmi Office Director Office of Compliance and Standards Pharmaceuticals and Medical Devices Agency Shin-Kasumigaseki Building 3-3-2 Kasumigaseki, Chiyoda-ku Tokyo 100-0013, Japan
This page was posted on July 19, 2010.