FDA WARNING_LETTER - Winter Goals - February 12, 2014

On March 5, 2015, the FDA issued a Warning Letter to Ms. Cheri DeShaw, owner of Winter Goals, following an inspection on January 24 and February 12, 2014, and a review of the firm's website, www.alternativecancer.us. The FDA determined that Winter Goals manufactures "Energetic Test Kits aka Alternative Cancer Treatment Test Kit aka The Muscle Test Kit (Kinesiology)," which are considered devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) due to their intended diagnostic, treatment, or structural/functional impact.

The Test Kits were found to be adulterated under section 501(f)(1)(B) of the Act because the firm lacked an approved premarket approval (PMA) application (section 515(a)) or an approved investigational device exemption (IDE) (section 520(g)).

Furthermore, the devices were misbranded under section 502(o) of the Act because Winter Goals failed to provide notice to the FDA of its intent to introduce the device into commercial distribution, as required by section 510(k) and 21 CFR 807.81(a)(3)(i). The firm also failed to register its establishment under section 510 of the Act and did not include the device in a