Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/play-sport-gear-corp-04222015
Timestamp: 2020-08-04 10:20:58
Document Index: 91329650

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

Play Off Sport Gear, Corp. - 04/22/2015 | FDA
Play Off Sport Gear, Corp. - 04/22/2015
Play Off Sport Gear, Corp. April 22, 2015
Play Off Sport Gear, Corp.
10801 NW 14 St.
playoffusa@hotmail.com
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed your website, http://www.playoffsport.com, and determined that your smokeless tobacco products listed there are offered for sale or distributed 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 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 labeling and/or advertisements any health warning label statements. You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.
Our review of your website, http://www.playoffsport.com, revealed that you offer for sale or distribute in the United States the following smokeless tobacco products without any health warning statements: Red Man Golden Blend, Red Man Fine Cut Natural, Red Man Long Cut Straight and Red Man Long Cut Wintergreen. 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 labeling and/or 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 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 labeling and/or 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.
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 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, RW1500283, in your response and direct your response to the following address:
Play Off Sport Gear, Corp. - Close Out Letter 9/10/15