Inspections, Compliance, Enforcement, and Criminal Investigations

Marc's 1/25/18



Black HHS-Blue FDA Logo



U.S. Food & Drug Administration
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993 




JAN 25 2018

Attn: Site Manager
7359 Northcliff Avenue
Brooklyn, OH  44144

Re:  FDA Warning Letter Regarding Tobacco Retailer Inspection Violation 
       Reference Number: 18OH047258

Dear Sir or Madam:

This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that Marc’s 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 January 11, 2018, an inspector representing the FDA completed an inspection of the establishment, located at 7359 Northcliff Avenue, Brooklyn, OH  44144.  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, and/or advertises tobacco products, including cigarettes, which requires that the establishment and its owners comply with federal laws and regulations governing such practices.  The violation observed during the January 11, 2018, inspection includes the following:

1. A minor was able to buy Marlboro cigarettes on January 11, 2018, at approximately 7:28 PM in the establishment.

A retailer must NOT sell cigarettes, cigarette tobacco, roll-your-own tobacco, and/or smokeless tobacco to a person younger than 18 years of age.  Doing so violates 21 C.F.R. § 1140.14(a)(1) (2016).

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.

The violation indicated in this letter may not be a complete list of violations at the establishment.

We will periodically inspect your establishment and review your promotional activities (e.g., website(s)) related to FDA-regulated tobacco products to assess your compliance with all applicable laws and regulations, including access, marketing, labeling, and advertising restrictions. 

Please be aware that, effective August 8, 2016, FDA deemed additional products meeting the definition of a tobacco product, except accessories to these newly deemed products, to be subject to regulation under the Act.  These products include, but are not limited to, electronic nicotine delivery systems (including e-cigarettes), e-liquids, cigars, and pipe tobacco.  See Final Rule, Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products, 81 Fed. Reg. 28,974 (May 10, 2016), available at

For more information on these requirements, helpful resources for retailers, a database of inspections, and retailer education materials, visit our website at  The following Guidance documents provide additional information on compliance with retailer responsibilities: 

Guidance for Industry: Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents (

Small Entity Compliance Guide: FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements (

You have 15 working days from the date you receive this letter to respond.  In your response, explain your plan for correcting the listed violation and preventing future violations.  Include a telephone number and address.  Note your reference number of 18OH047258 in your response and mail it to:

Food and Drug Administration
Center for Tobacco Products
Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD  20993-0002

If you have any questions, contact the Center for Tobacco Products via email at or via phone at 1-877-CTP-1373, option 6.  Have your reference number ready when you call and include it with any email communications.

Ann Simoneau, J.D.
Office of Compliance and Enforcement
Center for Tobacco Products

Page Last Updated: 03/06/2018
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