FDA WARNING_LETTER - Kids Company Ltd Yugengaisha Kids

The FDA issued a Warning Letter to Johdic Takano KIDS Co., Ltd. for illegally marketing the Pyro-Energen II and Pyro Nerve Stimulator devices in the U.S. without required marketing clearance or approval. The FDA reviewed the firm's website and determined the products are devices under Section 201(h) of the Act. The devices are adulterated under Section 501(f)(1)(B) due to the absence of approved premarket approval (PMA) or investigational device exemption (IDE) applications. They are also misbranded under Section 502(o) for failing to submit a 510(k) premarket notification. Furthermore, the Pyro-Energen II is misbranded under Section 502(a) due to false or misleading labeling claims, including treating serious diseases like AIDS/HIV, Cancer, and Diabetes, for which effectiveness has not been demonstrated. It is also misbranded under Section 502(f)(1) as its labeling lacks adequate directions for use, which cannot be written for its intended purposes. Finally, both devices are misbranded because the manufacturing establishment is not duly registered under 21 U.S.C 360, and the devices were not included in the required list under 21 U.S.C. 360(j). The FDA mandates immediate cessation of all promotional materials for these devices. The firm must submit a written response within 15 working days detailing its compliance plan, listing all promotional materials, and outlining steps to discontinue their use. Failure to correct these violations will result in the devices being subject to refusal of admission into the U.S. under Section 801(a) of the Act.