Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/long-beach-cigars-and-tobacco-07082015
Timestamp: 2020-06-03 20:22:57
Document Index: 130212952

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

Long Beach Cigars and Tobacco - 07/08/2015 | FDA
Long Beach Cigars and Tobacco - 07/08/2015
Long Beach Cigars and Tobacco July 08, 2015
5900 E. Spring Street
Long Beach Cigars and Tobacco / Long Beach Smoke Shop
Attn: Gary Patel
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website, http://www.lbcigarandtobacco.com, and determined that the smokeless tobacco products listed 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 several of your 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 webpage regarding these smokeless tobacco products fails to include any health warning label statements related to smokeless tobacco.
Our review of the website, http://www.lbcigarandtobacco.com, revealed that it does not include any health warning statements related to the following smokeless tobacco products that you offer for sale or distribute in the United States: Copenhagen, Kodiak, and Skoal. 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 webpage does not include any health warnings related to smokeless tobacco, your smokeless tobacco products listed there 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)).
Please note your reference number, RW1500320, in your response and direct your response to the following address:
Long Beach Cigars and Tobacco - Close Out Letter 10/21/15