Inspections, Compliance, Enforcement, and Criminal Investigations
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Center for Tobacco Products|
9200 Corporate Boulevard
Rockville, MD 20850-3229
SEP 20, 2012
Attn: Site Manager
550 North Main Street
Heber City, UT 84032
Re: FDA Warning Letter Regarding Tobacco Retailer Inspection Violation
Reference Number: 12UT001500
Dear Sir or Madam:
This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that Smith’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 June 8, 2012, an inspector representing the FDA completed an inspection of the establishment, located at 550 North Main Street, Heber City, UT 84032. During this inspection the establishment was in violation because it offered flavored cigarette tobacco 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 June 8, 2012, inspection includes the following:
1. Our compliance check inspection revealed that you offer for sale Wildfire Sunrise Strawberry cigarette tobacco, which are purported to contain an artificial or natural flavor that is a characterizing flavor of the product. Section 907(a)(1 )(A) of the FD&C Act (21 U.S.C. § 387g(a)(1 )(A)) provides:
[A] cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke.
As of September 22, 2009, cigarettes and cigarette tobacco marketed and sold in the United States in violation of this provision are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)). Thus, your flavored cigarette tobacco is adulterated.
If, however, this cigarette tobacco does not contain a characterizing flavor, it is misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) as its labeling is false and misleading because it makes the representation that the products contain strawberry as a characterizing flavor of the tobacco products.
A retailer must NOT offer for sale any cigarettes or cigarette tobacco that contains an artificial or natural flavor (other than tobacco or menthol) or an herb or spice that is a characterizing flavor of the product. Doing so is prohibited by section 301 of the FD&C Act (21 U.S.C. § 331).
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. The establishment must comply with all the applicable laws and regulations. For more information on these requirements, helpful resources for retailers, a database of inspections, and free Break the Chain of Tobacco Addiction materials, visit our website at http://www.fda.gov/TobaccoProducts.
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 12UT001500 in your response and mail it to:
FDA Center for Tobacco Products
9200 Corporate Boulevard
c/o Document Control Center
Rockville, Maryland 20850
If you have any questions, contact Aaron Weisbuch at (301) 796-9362 or via email at Aaron.Weisbuch@fda.hhs.gov. 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
cc: David B. Dillon, Chairman and CEO
The Kroger Co.
1014 Vine Street
Cincinnati, OH 45202