Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/noor-wholesale-farmville-01272016
Timestamp: 2019-07-19 13:41:13
Document Index: 781059504

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

Noor Wholesale of Farmville - 01/27/2016 | FDA
Noor Wholesale of Farmville - 01/27/2016
Noor Wholesale of Farmville Jan 27, 2016
Noor Wholesale of Farmville
959 Myers Street
Noor Wholesale of Farmville / Sunny Thawrani
d/b/a Sunny’s Wholesale
sunnyswholesales@gmail.com; thawranis@aol.com
Dear Mr. Thawrani:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://www.sunnyswholesale.com and determined that the smokeless tobacco products listed there are offered for sale or distribution 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 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 webpages regarding smokeless tobacco products fail to include any health warning label statements.
Our review of the website http://www.sunnyswholesale.com revealed that the following smokeless tobacco products that you offer for sale or distribute in the United States do not include any health warning statements: Beechnut, Beechnut Wintergreen, Cannon Ball, Gold River, Grizzly Fine Cut Wintergreen, Kayak Apple Long Cut, Kayak Peach Long Cut, Kayak Wintergreen Long Cut, Kayak Grape Long Cut, Kayak Fine Cut, Kodiak Premium Wintergreen Pouches, Kodiak Premium Mint, Kodiak Premium Wintergreen, Kodiak Premium Straight, Lancaster, Levi Garrett, Railroad Mills Plain Scotch Snuff, Red Man, and Timber Wolf. 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, requires that advertisements for smokeless tobacco products bear one of the following health warning label statements:
A tobacco product is misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) if its labeling is false or misleading in any particular. In addition, 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 labeling and/or 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.
Because your webpages regarding smokeless tobacco products do not include any health warnings, your 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)).
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. Section 3 of the Smokeless Tobacco Act also mandates that advertisements for smokeless tobacco products comply with certain requirements, including those regarding warning label statements and format.
Please note your reference number, RW1600452, in your response and direct your response to the following address:
abuse-law@weebly.com
abuse-human@weebly.com
hostmaster@228.34.199.in-addr.arpa