Is Vapor-riffic, Inc. Safe? FDA Warning Letter Review (2017)

Detailed Analysis

False Claims and Regulatory Violations

The Center for Tobacco Products ofthe U.S.Food and Drug Administration (FDA) recently reviewed the websitehttp://www.vapor-riffic.comand determined that the e-liquid products listed there are offered for sale or distribution to customers in the United States.Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 321(rr)), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), these products are tobacco products because they are made or derived from tobacco and intended for human consumption.Certain tobacco products, including e-liquids, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).

Potential Health Risks

Consumers should be aware of potential risks associated with products from Vapor-riffic, Inc..

Regulatory Context

FDA has determined thatyour Naked Fish Wahoo e-liquid ismisbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because yousoldthis productto a person younger than 18 years of age.

Sales to Minors Violation

FDA’s investigation of the websitehttp://www.vapor-riffic.comrevealedthat you sold an e-liquid product to a minor.Specifically,during our investigation ofhttp://www.vapor-riffic.com, a person younger than 18 years of age purchased Naked Fish Wahoo e-liquidfromthe website.No retailer may sell covered tobacco products, including e-liquid, cigar, pipe tobacco, waterpipe tobacco, and dissolvable tobacco products, as well as electronic nicotine delivery system (ENDS) products that contain any tobacco derivative, to a person younger than 18 years of age under 21 C.F.R. § 1140.14(b).Under 21 C.F.R. § 1140.3, a “covered tobacco product” is defined as any tobacco product deemed to be subject to chapter IX of the FD&C Act by 21 C.F.R. § 1100.2, excluding components or parts not made or derived from