Northern Lights Vapor LLC – FDA Warning Letter

The FDA Center for Tobacco Products issued a Warning Letter to Rick Rouse and Cat Tierney of Northern Lights Vapor, LLC, after reviewing their website, http://www.northernlightsvapor.com. The FDA determined that their e-liquid products, specifically "Northern Lights Vapor Blue Dream e-liquid," are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation identified is the distribution of a free sample of the "Northern Lights Vapor Blue Dream e-liquid" from their website. This action misbrands the product under section 903(a)(7)(B) of the FD&C Act because it violates 21 C.F.R. § 1140.16(d)(1), which prohibits retailers from distributing free samples of tobacco products, with limited exceptions not applicable here.

The FDA requires immediate correction of this violation and any similar non-compliance. The company must ensure all tobacco products, labeling, and advertising on their website and other media comply with the FD&C Act and FDA regulations. Failure to comply may result in further FDA actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Adulterated and misbranded imported tobacco products are also subject to detention.

A written response detailing corrective actions, including dates of discontinued violative activities and a plan for maintaining compliance, is required