Reference Number: 13SC004619
Dear Sir or Madam:
This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that District 25 Discount Tobacco was observed to be in violation of federal tobacco laws and regulations. Failure to correct these violations may lead to federal enforcement actions, including monetary penalties. Your response is requested in 15 working days.
On July 22, 2013, an inspector representing the FDA completed an inspection of the establishment, located at 3010 Augusta Street, Greenville, SC 29605. During this inspection the establishment was in violation because it offered individual cigarettes for sale.
This inspection revealed that the establishment sells, distributes, advertises, and/or promotes cigarettes, cigarette tobacco, and/or smokeless tobacco, which requires that the establishment and its owners comply with federal laws and regulations governing such practices. The violation observed during the July 22, 2013, inspection includes the following:
1. The establishment offered for sale individual cigarettes. Specifically, during the inspection, the inspector observed the clerk on duty sell one individual cigarette to a customer.
A retailer must NOT sell individual cigarettes. Doing so violates 21 C.F.R. § 1140.14(d).
The listed violation causes your cigarettes to be "misbranded" under 903 of the FD&C Act (21 U.S.C. §387c).
You should immediately correct the violation listed above. Failure to correct the violation may result in FDA taking regulatory action without further notice. These actions may include, but are not limited to, civil money penalty, no-tobacco-sale order, seizure, and/or injunction.
Ann Simoneau, J.D.