FDA WARNING_LETTER - Johnson Creek Enterprises, LLC - September 25, 2009

The FDA issued a Warning Letter to Johnson Creek Enterprises, LLC, regarding their "Smoke Juice" and "Johnson Creek" cartridge replacement products, intended for use with electronic smoking devices. The FDA determined these products are unapproved new drugs and misbranded under the Federal Food, Drug, and Cosmetic Act.

The products are considered drugs due to labeling and promotional claims on their website and brochures, suggesting they act as smoking deterrents, reduce dependence on traditional tobacco, and deliver nicotine, which is a pharmacological agent. These claims indicate the products are intended to affect body structure/function and mitigate/treat/prevent disease. As "new drugs," they require FDA approval via an application, which Johnson Creek Enterprises lacks, violating section 505 of the Act. They are also misbranded under section 502 for not having an approved new drug application and lacking adequate directions for their intended drug uses, including smoking deterrence.

Furthermore, a September 2009 inspection of Johnson Creek Enterprises' manufacturing facility revealed significant Current Good Manufacturing Practice (cGMP) violations, rendering their drug products adulterated under section 501(a)(2)(B) of the Act. Specific cGMP violations include: 1. Lack of a quality control unit with authority to approve/reject materials and review production records (21 C.F.R. § 211.22(a)). 2. Failure to test each batch of drug product for conformance with