FDA WARNING_LETTER - Healing Ways - January 30, 2013

On August 15, 2012, the FDA issued a Warning Letter to Healing Ways, owned by Lewis David Blodgett, following a July 2012 review of their website, http://www.healingways.com. The FDA determined that Healing Ways' Silver Colloids, ABC Detox Program, and Shell Powder products are promoted for conditions that classify them as drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), due to claims of intended use in the cure, mitigation, treatment, or prevention of disease.

Specific violations include claims such as "anti-microbial" for Silver Colloids, "can kill parasites, bacteria and viruses" for Shell Powder, and "successfully used in cancer therapy" for the ABC Detox Program. The website also featured testimonials making disease claims. These products are considered "new drugs" under section 201(p) of the Act because they are not generally recognized as safe and effective for their claimed uses and lack FDA approval under section 505(a).

Furthermore, these products are deemed misbranded under section 502(f)(1) of the Act because they are intended for conditions not amenable to self-diagnosis and treatment, thus lacking adequate directions for layperson use. The introduction of misbranded drugs into interstate commerce violates section 301(a).

Additionally, Healing Ways failed to register its facility