Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm523706.htm
Timestamp: 2019-03-23 20:26:56
Document Index: 292406299

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

Mission Pipe Cigar Shop 9/29/16
Mission Pipe Cigar Shop, Inc. / Ryan Brown and Julie Brown
missionpipe@gmail.com; ryan@theshoppad.com
Dear Mr. Brown and Ms. Brown:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://www.missionpipecigarshop.com and determined that the smokeless tobacco products listed there are offered for sale or distributed to consumers 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 thatyour General Wintergreen Portion (General Snus) smokeless tobacco product 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.
FDA’s investigation of the website http://www.missionpipecigarshop.com revealed that you sold a smokeless tobacco product to a minor. Specifically, during our investigation of http://www.missionpipecigarshop.com, a person younger than 18 years of age purchased General Wintergreen Portion (General Snus) from the website. No retailer may sell 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 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)).
Please note your reference number, RW1600505, in your response and direct your response to the following address:
ryanod@gmail.com