| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Center for Tobacco Products|
9200 Corporate Boulevard
Rockville, MD 20850-3229
FEB 11, 2014
619 E. Michigan Avenue
Jackson, MI 49201
Dear Mr. Lazaroff:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed your website, http://www/smokecitymichigan.com, and determined that your smokeless tobacco products listed there are offered for sale to customers in the United States. Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. § 321(rr)), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), these products are tobacco products because they are made or derived from tobacco and intended for human consumption. Certain tobacco products, including smokeless tobacco, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).
FDA has determined that your smokeless tobacco products are misbranded under section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because you fail to include in your smokeless tobacco product advertisements any health warning label statements. You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.
Health Warning Statement Violations
FDA has determined that your smokeless tobacco products aremisbranded under section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because you fail to include in your smokeless tobacco product advertisements any health warning label statements.
Section 3(b) of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (Smokeless Tobacco Act) (15 U.S.C. § 4402), as amended by section 204 of the Tobacco Control Act (P.L. 111-31, 123 Stat. 1846) requires that advertisements for smokeless tobacco products bear one of the following health warning label statements:
WARNING: This product can cause mouth cancer.
WARNING: This product can cause gum disease and tooth loss.
WARNING: This product is not a safe alternative to cigarettes.
WARNING: Smokeless tobacco is addictive.
A tobacco product is misbranded under section 903(a)(7)(A) of the FD&C Act, (21 U.S.C. § 387c(a)(7)(A)), if, in the case of any tobacco product distributed or offered for sale in any State, its advertising is false or misleading in any particular. Under section 201(n) of the FD&C Act (21 U.S.C. § 321(n)), in determining whether advertising is misleading, the agency considers, among other things, the failure to reveal material facts concerning the consequences that may result from the customary or usual use of the product.
Our review of your website, http://www/smokecitymichigan.com, revealed that you advertise and offer for sale in the United States the following smokeless tobacco products without any health warning statements: Jackson’s Apple Jack, Kentucky Twist, and Stoker’s chewing tobacco. Because your smokeless tobacco product advertisements do not include any health warnings, your smokeless tobacco products aremisbranded under section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)).
In addition, we note that you are required to follow all other applicable federal laws and regulations. For example, section 3(b)(3) of the Smokeless Tobacco Act (15 U.S.C. § 4402), requires the quarterly rotation of warning label statements on advertising for each brand of smokeless tobacco. Quarterly rotation must be done in accordance with a plan submitted by the tobacco product manufacturer, importer, distributor, or retailer and approved by FDA.
Conclusion and Requested Actions
The violations discussed in this letter do not necessarily constitute an exhaustive list. You should immediately correct the violations that are referenced above, as well as violations that are the same as or similar to those stated above, and take any necessary actions to bring your tobacco products into compliance with the FD&C Act.
It is your responsibility to ensure that your tobacco products and all related promotional materials on this website, on any other websites (including e-commerce, social networking, or search engine websites) and in any other media in which you advertise, or retail establishments comply with each applicable provision of the FD&C Act and FDA’s implementing regulations. Failure to ensure full compliance with the FD&C Act may result in FDA initiating further action without notice, including, but not limited to, civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Please note that adulterated and misbranded tobacco products offered for import into the United States are subject to detention and refusal of admission.
Please submit a written response to this letter within 15 working days from the date of receipt describing your corrective actions, including the dates on which you discontinued the violative promotion, advertising, sale, and/or distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act.
Please note your reference number, RW1400147, in your response and direct your response to the following address:
PAL-WL Response, Office of Compliance and Enforcement
FDA Center for Tobacco Products
9200 Corporate Boulevard
c/o Document Control Center
Rockville, Maryland 20850
If you have any questions about the content of this letter, please contact Ele Ibarra-Pratt at (301) 796-9235 or via email at CTPCompliance@fda.hhs.gov.
Ann Simoneau, J.D.
Office of Compliance and Enforcement
Center for Tobacco Products
VIA Electronic Mail and UPS
Phillip A. Lazaroff
3037 Fawn Lane
Jackson, MI 49201
Philip A. Lazaroff
4546 Page Avenue
Michigan Center, MI 49254