Inspections, Compliance, Enforcement, and Criminal Investigations

Lolita’s Market & Deli 1/18/18

 

  

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

 

WARNING LETTER
January 18, 2018
VIA UPS
 
Lolita’s Market & Deli
Attn: Site Manager
800 Pearl Street
Boulder, CO 80302
 
Re: FDA Warning Letter Regarding Tobacco Retailer Inspection Violation 
       Reference Number: 18CO035447
 
Dear Sir or Madam:
 
This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that Lolita’s Market & Deli 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 29, 2017, an inspector representing the FDA completed an inspection of the establishment, located at 800 Pearl Street, Boulder, CO 80302. During this inspection the establishment was in violation because you or your employee sold e-liquid to a minor.
 
This inspection revealed that the establishment sells, distributes, and/or advertises tobacco products, including e-liquid, which requires that the establishment and its owners comply with federal laws and regulations governing such practices. The violation observed during the December 29, 2017, inspection includes the following:
 

1. A minor was able to buy VUSE Mint e-liquid on December 29, 2017, at approximately 1:37 PM in the establishment.

 
A retailer must NOT sell covered tobacco products, such as e-liquid, to a person younger than 18 years of age. Doing so violates 21 C.F.R. § 1140.14(b)(1) (2016).
 
The listed violation causes your e-liquid 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 https://federalregister.gov/a/2016-10685.
 
For more information on these requirements, helpful resources for retailers, a database of inspections, and retailer education materials, visit our website at http://www.fda.gov/TobaccoProducts. 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 (http://www.fda.gov/TobaccoProducts/ GuidanceComplianceRegulatoryInformation/ucm252758.htm)
 
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 (http://www.fda.gov/TobaccoProducts/ Labeling/RulesRegulationsGuidance/ucm499353.htm).
 
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 18CO035447 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 CTP-WL@fda.hhs.gov 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.
 
Sincerely,
/s/
Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products

Page Last Updated: 03/06/2018
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