FDA WARNING_LETTER - Tobacco Source Three LLC

The FDA's Center for Tobacco Products (CTP) issued a Warning Letter to Mr. McBride regarding advertisements on valpak.com for Tobacco Source retail establishments. The FDA determined that the advertised cigarettes are adulterated under section 902(8) of the FD&C Act because they were promoted as "modified risk tobacco products" without an FDA order. Specifically, the advertisement included claims such as "LOW PRICE AND CHEMICAL FREE ... JUST LIKE THE GOOD OL’ DAYS," "We are a chemical free tobacco store," and "CHEMICAL FREE TOBACCO," which implicitly represent the products as not containing or being free of a substance, thus classifying them as modified risk tobacco products under section 911(b)(2)(A)(i). Introducing or delivering such products into interstate commerce without an FDA order under section 911(g) is a violation.

Additionally, the cigarettes are misbranded under section 903(a)(7)(B) of the FD&C Act due to a violation of 21 C.F.R. Part 1140. The advertisement offered a "FREE CIGARETTE CASE AND LIGHTER WITH THE PURCHASE OF 2 BOXES (200 COUNT) HOUSE BLEND EXCLUDED," which violates 21 C.F.R. § 1140.34(b) prohibiting offering gifts with the purchase of cigarettes.

The FDA noted the advertisement no longer