FDA recently issued draft guidance regarding how a manufacturer can establish that its tobacco product was commercially marketed in the United States as of February 15, 2007, thus exempting the product from the onerous premarket requirements of the Tobacco Control Act (“TCA”).  The guidance first explains that FDA interprets the phrase “as of February 15, 2007” as meaning that a tobacco product was commercially marketed – not in test markets – in the United States on February 15, 2007.Consequently, if a tobacco product was commercially marketed in the United States before February 15, 2007, but was not commercially marketed on this date, then it cannot be commercially marketed unless the manufacturer obtains a marketing order under the TCA .

FDA’s guidance also gives examples of documents that may help manufacturers demonstrate to FDA that a product was commercially marketed in the United States as of February 15, 2007, including dated copies of advertisements, dated catalog pages, dated promotional material, dated trade  publications, dated manufacturering documents, dated bills of lading, dated freight bills, and/or dated waybills.  This is not an exhaustive list of documents acceptable to FDA.  Rather, FDA suggets that manufacturers submit any information and as much information as possible that demonstrates that a tobacco product was commercially marketed in the United States on February 15, 2007.

To review FDA’s draft guidance in its entirety, click here.

For questions and/or comments, please contact Bryan Haynes, at 804.697.1420 or by email.