Hormonal Health, LLC – FDA Warning Letter

The FDA issued a Warning Letter to Hormonal Health, LLC, regarding the marketing of its Kelatox suppository and METALDETECTOR Instant Toxic Metals Test on their websites.

The Kelatox suppository is marketed as a dietary supplement but is classified as an unapproved new drug under sections 201(g)(1) and 201(p) of the Act. It is intended to affect body structure/function and treat diseases like lead poisoning, Alzheimer's, Parkinson's, and macular degeneration. Since it's a suppository, not ingested, it doesn't meet the dietary supplement definition. As a new drug, it requires FDA approval, which it lacks, violating sections 301(d) and 505(a). Furthermore, it's misbranded under section 502(f)(1) because adequate directions for self-treatment of these conditions cannot be provided to a layman, and it's not exempt from this requirement without an approved application.

The METALDETECTOR Instant Toxic Metals Test is classified as an adulterated device under section 501(f)(1)(B) because it lacks an approved premarket approval (PMA) or investigational device exemption (IDE). It is also misbranded under section 502(o) as the establishment was not registered, the device was not listed, and required notifications were not provided to the FDA.

Hormonal Health