Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hilands-cigars-04022015
Timestamp: 2019-06-20 06:05:22
Document Index: 80172198

Matched Legal Cases: ['§ 321', '§ 387', '§ 387', '§ 1140', '§ 387', '§ 387', '§ 1140', '§ 387', 'art 1140', '§ 1140', '§ 387', '§ 4402', '§ 387', '§ 387']

Hiland's Cigars - 04/02/2015 | FDA
Hiland's Cigars - 04/02/2015
Hiland's Cigars 02/04/2015
6917 E. Thomas Road
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed your website, http://www.hilandscigars.com, and determined that your smokeless tobacco productslisted there are distributed or offered for sale to customers in the United States. Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (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 product, “Stoker’s Black Wild Cherry Chewing Tobacco,” is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because you sold this product to a person younger than 18 years of age, in violation of 21 C.F.R. § 1140.14(a). Additionally, FDA has determined that several smokeless tobacco products are misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) and/or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because your website regarding these smokeless tobacco products fails to include any health warning label statements.
FDA’s investigation of the website, http://www.hilandscigars.com, revealed that you sold smokeless tobacco to a minor. Specifically, during our investigation of http://www.hilandscigars.com, a person younger than 18 years of age purchased “Stoker’s Black Wild Cherry Chewing Tobacco,” from the website, http://www.hilandscigars.com. No retailer may sell cigarettes, cigarette tobacco, roll-your-own tobacco, or smokeless tobacco to a person younger than 18 years of age under 21 C.F.R. § 1140.14(a). Under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)), tobacco products are misbranded if sold or distributed in violation of regulations prescribed under section 906(d) of the FD&C Act, including those within 21 C.F.R. Part 1140. Because this product is sold or distributed to persons younger than 18 years of age in violation of section 21 C.F.R. § 1140.14(a), this product is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).
Additionally, our review of your website, http://www.hilandscigars.com, revealed that the website does not include any health warning label statements regarding the following smokeless tobacco products that you offer for sale in the United States: General Swedish Snus Mini Mint Dry Portion, General Swedish Snus Mint Portion, General Swedish Snus Original Portion, General Swedish Snus White Portion, Stoker’s Chewing Tobacco, Stoker’s Apple Chewing Tobacco, Stoker’s Black Wild Cherry Chewing Tobacco, Stoker’s Butternut Chewing Tobacco, Stoker’s Fred’s Choice Chewing Tobacco, Stoker’s Peach Chewing Tobacco, Stoker’s Tennessee Chew Moonshine Blend, and Stoker’s Tennessee Chew Original. 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:
Because your website does not include any health warning labels statements regarding the smokeless tobacco listed above, these smokeless tobacco products aremisbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) and/or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)).
It is your responsibility to ensure that your tobacco products and all related labeling and/or advertising on this website, on any other websites (including e-commerce, social networking, or search engine websites), in any other media in which you advertise, and in any retail establishment, 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 note your reference number, RW1500267, in your response and direct your response to the following address:
hilandsales@hilandscigars.com