For the first time, the FDA recently issued warning letters to three different companies – Vaperz Ltd, Knoxville Vapor and Dr. K – for making FDA-related claims on their websites regarding their e-cigarette or e-liquid products. The three companies each received a warning letter for violations of Section 301(tt) of the Federal Food Drug & Cosmetic Act (FD&C Act), which prohibits companies from making certain statements or representations directed to consumers about tobacco products that, among other things, would mislead consumers into believing that the product is approved by the FDA, safe for use, and/or less harmful based on oversight or inspection by the FDA. General examples of the violations include claims of FDA lab certification (Knoxville Vapor) and FDA registration/approval (Vaperz Ltd. and Dr. K).
Because the products in question are tobacco products that are “made or derived from tobacco and are intended for human consumption,” the FDA has the authority to issue warning letters for violations of this nature. These violations are specific to the FDA-related claims being made, and are unrelated to the FDA’s proposal to regulate these products under its tobacco product authorities in Chapter IX of the FD&C Act. The companies have 15 working days to submit a written response to the FDA describing the corrective actions. Failure to ensure full compliance may result in the FDA initiating further action against the company without notice, including, but not limited to, civil money penalties, criminal prosecution, and/or injunction.
The FDA takes violations of this nature very seriously and will continue to monitor retailers, manufacturers and companies that make claims of this nature. If you believe a company that manufacturers tobacco products is making claims that violate the FD&C Act, please contact the FDA’s Center for Tobacco Product’s Office of Compliance and Enforcement at CTPCompliance@fda.hhs.gov. For additional information on tobacco warning letters, please visit the tobacco retailer warning letters page.