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WARNING LETTER
•www.smoke-mall.com•November 15, 2012

www.smoke-mall.com – FDA Warning Letter, Nov 15, 2012

Record Details

On October 25, 2012, the FDA's Center for Tobacco Products issued a Warning Letter to Domains By Proxy, LLC, regarding products offered for sale on www.smoke-mall.com. The FDA determined that several cigarette products were adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because they were promoted as modified risk tobacco products (e.g., "Lights" or "Ultra Lights") without an FDA order, violating section 911(a) (21 U.S.C. § 387k(a)).

Specifically, products like "Marlboro Gold" and "Camel Silver" were cited for using these descriptors. Additionally, products such as "Aroma Rich Apple" and "Kiss Super Slims Fresh Apple 100s" were found to be adulterated under section 902(5) (21 U.S.C. § 387b(5)) for containing characterizing flavors other than tobacco or menthol, which is prohibited for cigarettes under section 907(a)(1)(A) (21 U.S.C. § 387g(a)(1)(A)). If these flavored products do not contain a characterizing flavor, they are misbranded under section 903(a)(1)

Company
www.smoke-mall.com
Inspection date
November 15, 2012
Product type
Tobacco
Office
Department of Health and Human Services
People
  • Ann Simoneau (Director)
  • Ele Ibarra-Pratt (Acting Director)
View Company Profile

ID · 07df6ecb-02f8-4cbe-8090-c20e25aa0890

Violation Codes9
21 U.S.C. 321(rr)21 U.S.C. 387a(b)21 U.S.C. 387b(8)21 U.S.C. 387b(5)21 U.S.C. 387c(a)(1)21 U.S.C. 387k(b)(2)(A)(ii)21 U.S.C. 387k(a)21 U.S.C. 387k(g)21 U.S.C. 387g(a)(1)(A)

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