FDA WARNING_LETTER - Med-Chem Labs

The FDA issued a Warning Letter to Med-Chem Labs regarding their product "Lauricidin," promoted on www.lauricidin.com. An August 2011 review of the website determined that "Lauricidin" is marketed for conditions that classify it as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)], due to claims of intended use in the cure, mitigation, treatment, or prevention of disease.

Specific claims cited include "adversely affects bacteria, yeast, fungi, protozoa, and envelope viruses," "fluidizing the structure in the envelope of the virus, causing the disintegration of the microbial membrane," and inactivation of various viruses (e.g., measles, herpes simplex, HIV, hepatitis C), bacteria (e.g., *Listeria monocytogenes*, *Staphylococcus aureus*, *Helicobacter pylori*), fungi, yeast, and protozoa (e.g., *Giardia lamblia*). Testimonials on the website also claimed efficacy against herpes outbreaks, Candida, and reduction of viral load in Hepatitis C.

The FDA states that "Lauricidin" is a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)] because it