FDA WARNING_LETTER - Kids Company Ltd Yugengaisha Kids - April 15, 2015

On April 15, 2015, the FDA issued a Warning Letter to Kids Co., Ltd. Yugengaisha Kids, Japan, regarding the marketing of PYRO-Energen II and PYRO Nerve Stimulator in the United States. The FDA determined these products are devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).

The devices are deemed adulterated under section 501(f)(1)(B) of the Act because the firm lacks an approved premarket approval (PMA) application or an investigational device exemption (IDE). They are also misbranded under section 502(o) of the Act for failing to submit a 510(k) premarket notification.

Additionally, the firm's website, www.pyroenergen.com, makes unsubstantiated claims that PYRO-Energen II is effective in treating HIV/AIDS, cancer, herpes, and influenza. The FDA is not aware of any evidence supporting these claims.

The FDA requests the firm immediately cease activities resulting in the misbranding or adulteration of these devices, including commercial distribution. Due to these violations, the devices are subject to refusal of admission into the U.S. under section 801(a) of the Act, leading to "detention without physical examination."

The firm must provide a written response within fifteen business days detailing specific corrective