March 20 2014
Attn: Site Manager
325 South Main Street
Clintonville, WI 54929
Re: FDA Warning Letter Regarding Tobacco Retailer Inspection Violation
Reference Number: 14WI000132
Dear Sir or Madam:
This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that Schroeder Shell 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 December 23, 2013, an inspector representing the FDA completed an inspection of the establishment, located at 325 South Main Street, Clintonville, WI 54929. During this inspection the establishment was in violation because you or your employee sold cigarettes to a minor.
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 December 23, 2013, inspection includes the following:
1. A minor was able to buy Camel Menthol Silver cigarettes December 23, 2013, at approximately 3:10 PM in the establishment.
A retailer must NOT sell cigarettes, cigarette tobacco, and/or smokeless tobacco to a person younger than 18 years of age. Doing so violates 21 C.F.R.
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.