FDA WARNING_LETTER - K Va T Food Stores - March 01, 2016
Discuss this record with AI
The FDA's Center for Tobacco Products reviewed Food City's website, http://www.foodcity.com, and found that smokeless tobacco products offered for sale lacked required health warning labels, leading to misbranding violations. Products identified include Bowie, Hawken, Days Work, Grizzly, Husky, Kayak, Lancaster, Levi Garrett, Longhorn, Red Seal, Skoal, and Timberwolf.
These products are considered tobacco products under section 201(rr) of the FD&C Act. The absence of health warnings on the website's advertising for these products violates section 3(b) of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. § 4402), as amended by section 204 of the Tobacco Control Act. Specifically, the website failed to include any of the four mandated warnings: "WARNING: This product can cause mouth cancer," "WARNING: This product can cause gum disease and tooth loss," "WARNING: This product is not a safe alternative to cigarettes," and "WARNING: Smokeless tobacco is addictive."
This omission renders the products misbranded under sections 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(1) and § 387c(a
ID · 3f89a549-8366-42da-b359-2ad997e9107b
Full citation text and observation details available on the Dashboard.