FDA Acts to Smoke Out Online Tobacco Sales

On September 5, 2014, the FDA issued Warning Letters to four internet retailers that allegedly sold tobacco products to minors. The letters also allege other violations of the law, including misbranding, adulteration, and failure to include required health warnings. The letters direct each of the internet retailers to respond within 15 business days describing each corrective action it has taken and its plan to maintain compliance and stating the date that it discontinued each violation.

Sales to Minors

Federal regulations at 21 CFR sec. 1140.14 prohibit the sale of tobacco products to minors. Section 903(a)(7)(B) of the Food Drug and Cosmetic Act (FDC Act) provides that any tobacco product sold in violation of FDA regulations is misbranded. All four online retailers are alleged to have sold tobacco products to minors in violation of 21 CFR sec. 1140.14(a).

Modified Risk” Products

The sale of a “modified risk tobacco product” is not permitted without an FDA Order under FDC Act sec. 911(a). A modified risk tobacco product is labeled or referred to in marketing material as presenting a reduced health risk when compared to another commercial tobacco product. Typically, these products include cigarettes labeled as “light,” “lite,” or “mild” and smokeless tobacco. A modified risk tobacco product that is offered for sale in the United States without the required order is deemed adulterated. The owner of snuff.me.uk and mrsnuff.com was alleged to have violated these requirements with respect to smokeless tobacco. The owner of ilovecigarette.com and sikhoo0.com, and the owner of az-smokes.com and az-smokes.net were alleged to have violated the requirement with respect to cigarettes.

Omission of Required Health Warnings

The FDA alleged that the smokeless tobacco products sites lacked required health warning statements in violation of 15 U.S.C. sec. 4402. The alleged violators were mrsnuff.com, mrsnuff.co, snuff.me.uk, buysnuff.co.uk, and buychew.co.uk.

Unlawful Flavoring

Some site owners also were alleged to have marketed tobacco products with flavorings that are prohibited under FDC Act sec. 907(a)(1). The statute permits only tobacco and menthol flavorings. The letter to az-smokes.com and az-smokes.net alleged the unlawful sale of mint-flavored cigarettes, while ilovecigarette.com. and sikhoo0.com offered several cigarettes purporting to have added coffee or apple mint flavoring. The FDA stated that these products were adulterated under FDC Act sec. 902(5); alternatively, if the products do not contain the flavorings listed on the label, they are misbranded under FDC Act sec. 903(a)(1) or (a)(7).