Holistic Healing Devices – FDA Warning Letter, Jan 7, 2010

The FDA issued a Warning Letter to Curt Kreil of Holistic Healing Devices for marketing unapproved and uncleared medical devices. The FDA reviewed the firm's website, www.holistichealingdevices.com, on January 7, 2010, and identified the Body/Molecular Enhancer, Thermo Therapy Unit for prostate and vaginal use, and Breast Health Beauty Spa Equipment as devices under the Federal Food, Drug and Cosmetic Act.

These devices are considered 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 failure to provide notification of intent to introduce the devices into commercial distribution, as required by section 510(k).

The Warning Letter cites specific medical claims made on the website, such as the Body/Molecular Enhancer's purported relief for Fibromyalgia, Lupus, and cancer, and the Thermo Therapy Unit's use for vaginal conditions and prostate issues, including promoting leukocyte production. The Breast Health Beauty Spa Equipment was claimed to "eliminate cellular tissue" and "remove measles."

Holistic Healing Devices is required to immediately cease disseminating promotional materials for these devices and submit a written response within 15 working days. The response must detail corrective actions, a plan to prevent recurrence, and a list of all similar promotional materials