FDA Tobacco Regulation Dominates Summit

Publish Date: 
September 16, 2009

Convenience distributors and retailers, as of September 22, will be unable to sell any cigarette or cigarette paper that contains an artificial or natural flavor other than tobacco or menthol as a result of the Family Smoking Prevention and Tobacco Control Act (FSPTCA), which gives the Food and Drug Administration the power to regulate tobacco products.

Questions surrounding the new law and how FDA’s new powers may affect convenience distributors dominated the Summit yesterday, and an industry panel moderated by AWMA President & CEO Scott Ramminger attempted to provide some answers. While there are many uncertainties, the law specifies that flavored cigarettes will be considered adulterated products after September 22 and it will be illegal for them to be sold.

A Sept. 14 letter received by AWMA from FDA states that any such projects that are sold or held for sale in the U.S. after that deadline “may be subject to seizure” and that manufacturers, distributors, and retailers “may be subject to injunction actions, civil money penalties, and/or criminal prosecution for violating the requirements of the Act.” (photo caption: Addressing distributors at a critical time in tobacco history were (l to r) John Hoel, Altria Client Services, Dave Riser, R.J. Reynolds Tobacco Company, and Ron Funk of Funk Consulting.  AWMA President Scott  Ramminger moderated the session.)

FDA said it “intends to use the full range of enforcement tools within the Agency’s authority to ensure compliance with the new requirement.” The FDA’s letter said all tobacco products that meet the definition of “cigarette” under the law, even if they are labeled as cigars or some other product, are subject to the requirement. Questions regarding the provision may be addressed to Tobacco2@fda.hhs.gov.

Ramminger said AWMA is drafting a letter to FDA asking the agency to provide a list of which products are, in fact, covered and for clarification as to steps distributors should take. Distributors were encouraged to contact FDA as well, indicating that they wish to comply but need specificity as to which products are covered.

Joining Ramminger on the panel were John Hoel, Senior Director, Federal Government Affairs, Altria Client Services, Inc.; Dave Riser, Vice President, External Relations-Trade Marketing, R. J. Reynolds Tobacco Company; Ron Funk, President/Owner, Funk Consulting, Ontario, Canada; and Gene Lange, AWMA General Counsel.

Panelists agreed that the industry needs to work together to educate the new FDA staffers who will be regulating tobacco at FDA so they understand how the industry works and the implications that overly restrictive rules might have on the government’s objective of reducing tobacco use, particularly among young people.

Both Hoel and Riser urged distributors to contact FDA as well as their representatives in Congress to express their concerns regarding pending regulations. AWMA is finalizing its comments on the overall issue of FDA regulation and will submit them by the Sept. 29 deadline.

Riser, meanwhile, pointed out that R.J. Reynolds and several other companies have filed a suit challenging the constitutionality of provisions of the new law that restrict tobacco marketing activities as a violation of the first amendment right of free speech.

Distributors were urged to attend the 2010 Day on the Hill conference in Washington May 12-13, when they will have an opportunity to discuss their concerns directly with members of the House and Senate.

“We need you at the Day on the Hill,” Ramminger said. “If this (the new tobacco law and the pending new regulations) doesn’t do it, I don’t know what will.”