Civil Money Penalties Issued Against Vendors for Selling Tobacco Products to Minors

HHS published eleven administrative decisions originating from the HHS Departmental Appeals Board (DAB) Civil Remedies Division involving the FDA’s Center for Tobacco Products (CTP) against various vendors of tobacco products for violations. The decisions imposed civil money penalties ranging from $250 to $500 against the vendors for violation of the Food, Drug, and Cosmetic Act (FDC Act) and its implementing regulations found at 21 C.F.R. Part 1140.

Underage Sales

Vendors were observed by FDA-commissioned inspectors to have sold cigarettes to individuals younger than 18 years of age during random inspections of the vendor’s establishments. The vendors had been informed that failure to respond to the served complaint could result in imposition of a civil money penalty; none of the vendors in question responded.

Improper Displays

Two vendors also impermissibly utilized a self-service display in a non-exempt facility and failed to ensure that all violative self-service displays, advertising, labeling, and other items were removed or brought into compliance with the FDC Act. The vendors did not respond to the administrative complaint notice served by the FDA.

Regulations

21 U.S.C. § 331(k) prohibits misbranding of a tobacco product. In turn, a tobacco product is misbranded if sold or distributed in violation of regulations issued under section 906(d) of the FDC Act. Under 21 C.F.R. § 1140.14(a), no retailer may sell cigarettes or smokeless tobacco to any person younger than 18 years of age. A civil money penalty was therefore permissible.

The decisions issued were: