IMULUX, LLC – FDA Warning Letter

The FDA issued a Warning Letter to IMULUX, LLC, regarding their product "IMULUX," marketed on www.imulux.com. The product is promoted with claims to prevent, treat, or cure diseases like herpes (including genital herpes, shingles, oral herpes) and genital warts, and to affect body structure/function. Examples include "Treat Once For Life Today," "Kills all Herpes Viruses," and "Frees you from further outbreaks for life." Metatags also reinforce these intended uses.

The FDA determined IMULUX is a drug/device combination product and a "new drug" under 21 U.S.C. § 321(g)(1) and (p) because it's intended for disease treatment/prevention and is not generally recognized as safe and effective. Its introduction into interstate commerce without an FDA-approved application violates 21 U.S.C. §§ 331(d) and 355(a).

Furthermore, the product is misbranded under 21 U.S.C. § 352(f)(1) because it addresses conditions not amenable to self-diagnosis, and adequate directions for lay use cannot be written. The claim "IMULUX is a patented system composed of two US FDA approved class I medical devices" is misleading, implying FDA approval for its intended use as a combination product. Marketing IMULUX also violates 2