T H E I N D U S T R Y A U T H O R I T Y O N T O B A C C O R E T A I L I N G Official Publication of the International Premium Cigar & Pipe Retailers Association (IPCPR) APRIL 2012 www.smokeshopmag.com www.smokeshopmag.com INSIDE: INSIDE: > IPCPR: On a Mission > IPCPR: On a Mission to Save Premium Cigars to Save Premium Cigars > FDA Oversight of > FDA Oversight of Additional Tobacco Additional Tobacco Products Looms Large Products Looms Large MIDLAND MI Labor of Love Labor of Love PERMIT 182 Customer Service Rules Customer Service Rules PAID in Portland in Portland at Broadway Cigar Co. at Broadway Cigar Co. US POSTAGE PRSRTD STD
> REGULATION FOCUS pated issuing so-called “deeming” regu- lations, subjecting these additional tobacco products to its jurisdiction, by October 2011. FDA did not issue the reg- ulations in October, and on October 14, 2011, Senators Richard Blumenthal (D- CT), Frank Lautenberg (D-NJ) and Sherrod Brown (D-OH) wrote to FDA Commissioner Dr. Margaret Hamburg to request FDA’s action to regulate these tobacco products. The Senators urged FDA to “move swiftly” to issue the deeming regulations, and requested that FDA update its progress on the regula- tions and its timeline for releasing the regulations. The Senators also requested a meeting with Commissioner Hamburg to discuss the matter in more detail. Based on FDA’s prior commitment to issue the regulations in October, and the Senators’ urgent request, industry FDA: On the Verge of Regulating observers expected that FDA would Cigars, Pipe Tobacco, & E-Cigarettes? issue the regulations shortly. However, as of mid-March 2012, FDA still had not The wheels are turning and all signs point to the likelihood of the FDA issued the deeming regulations. In April 2012, FDA further reaffirmed asserting jurisdiction over additional tobacco products by regulation. its intent to issue deeming regulations, >BY TROUTMAN SANDERS TOBACCO TEAM when it sent letters to electronic cigarette manufacturers requesting information regarding the safety of electronic ciga- T he 2009 Family Smoking Pre- “device” or combination product under rettes. The letters note that FDA has vention and Tobacco Control Act the Food, Drug and Cosmetic Act authority under the Tobacco Control Act (“Tobacco Control Act”) signifi- (“FD&C Act”). FDA’s action came on to regulate electronic cigarettes, and that cantly changed the regulatory landscape the heels of the District of Columbia it intends to do so. The letters requested for tobacco products, giving the Food Circuit Court of Appeals’ decision in information from manufacturers regard- and Drug Administration immediate Sottera, Inc. v. Food & Drug ing consumer complaints and “adverse jurisdiction over certain tobacco prod- Administration, (D.C. Cir. 2010), in event issues,” reports of “consumer mis- ucts. Specifically, the Tobacco Control Act which the court concluded that FDA use,” descriptions of product labeling requires FDA to regulate cigarettes, roll- lacked authority to regulate electronic and systems in place to review consumer your-own tobacco and smokeless tobac- cigarettes under the FD&C Act, but that complaints and adverse events. co and permits FDA to regulate other FDA had authority to regulate electron- In the meantime, there is legislation tobacco products, such as cigars, pipe ic cigarettes as “tobacco products” pending in Congress that would exempt tobacco and electronic cigarettes. FDA under the Tobacco Control Act. FDA’s so-called “traditional large and premium must issue regulations to assert authority letter to stakeholders advised that FDA cigars” from FDA’s reach. The bill, which over the latter group. intended to propose a regulation that has been introduced in both the Senate All signs indicate that FDA regula- would extend the agency’s “tobacco and House of Representatives,” defines a tion of these tobacco products will come product” authority to other tobacco “traditional and premium cigar” as a roll later this year. In April 2011, FDA wrote products. Those tobacco products pre- of tobacco wrapped in leaf tobacco, con- a letter to industry stakeholders indicat- sumably would include electronic ciga- taining no filter, and weighing at least six ing that FDA intended to assert authori- rettes, pipe tobacco, cigars and dissolv- pounds per 1,000 count. The bill would ty over all “tobacco products,” which able tobacco (which FDA has deter- remove such cigars from FDA’s potential are defined under the Tobacco Control mined is not covered by its existing authority under the Tobacco Control Act. Act as any product “made or derived authority over smokeless tobacco). Thus, under the legislation, “traditional” from tobacco that is intended for human Later that year, in July 2011, FDA cigars would not be subject to FDA’s consumption” but that is not a “drug,” advised interested parties that it antici- authority, whereas smaller cigars that are 52 SMOKESHOP April 2012
> REGULATION FOCUS more similar to cigarettes would be TOBACCO CONTROL ACT’S PURPOSE undisputed health effects of cigarettes potentially subject to FDA’s authority. As FDA considers its regulations, it will and the prior marketing conduct by the The bill, which was introduced in 2011, be important to consider the Tobacco major cigarette companies. This ration- remains in committee and has not been Control Act’s purpose, as outlined in the ale is arguably inapplicable to other scheduled for a hearing. law’s preamble. The preamble addresses types of tobacco products, such as elec- the health effects of tobacco use, and dis- tronic cigarettes, where the evidence of DEEMING REGULATIONS— cusses court proceedings in which the adverse health effects is scant and there A SQUARE PEG IN A ROUND HOLE? major cigarette companies were found to has been no demonstrated pattern of When FDA issues the deeming regula- have continued “to target and market to marketing conduct. tions, the proposed regulations will be youth,” to have “dramatically increased NEW PRODUCT REQUIREMENTS Under Section 905 of the Tobacco Control > The FDA will need to consider whether the Act, if a company proposes to sell a new tobacco product (one that was not com- existing regulatory landscape for cigarettes, roll- mercially marketed as of February 15, your-own tobacco, and smokeless tobacco can or 2007, or a product that has been changed since February 15, 2007), the company should apply in the same ways to cigars, pipe must first show that the product is “sub- tobacco and electronic cigarettes. stantially equivalent” to a pre-February 15, 2007 tobacco product or that any modifications to a pre-February 15, 2007 followed by a period of notice and com- their advertising and promotional tobacco product are minor changes that ment, during which stakeholders will spending in ways that encourage youth do not present different public health have an opportunity to shape how FDA to start smoking subsequent to the sign- issues. The product cannot be sold to will regulate these additional tobacco ing of the Master Settlement Agree- consumers unless FDA has approved the products. As FDA considers its deeming ment,” and to have “designed their ciga- product, although there was a limited regulations, it will need to consider rettes to precisely control nicotine deliv- exemption for products introduced prior whether the existing regulatory land- ery levels and provide doses of nicotine to March 22, 2011. scape for cigarettes, roll-your-own sufficient to create and sustain addiction The ostensible purpose of the “sub- tobacco, and smokeless tobacco can or while also concealing much of their nico- stantial equivalence” requirements is to should apply in the same ways to cigars, tine-related research.” One could argue make sure that any new tobacco prod- pipe tobacco and electronic cigarettes. In that Congress’ rationale for enacting the ucts are not more harmful than existing doing so, FDA will need to address sev- Tobacco Control Act is inapplicable, or tobacco products. The substantial equiv- eral areas in which the current require- only partially applicable to other tobacco alence requirements prompted the intro- ments may be ill-suited for these prod- products. For example, Congress enact- duction of several new tobacco products ucts. These issues are discussed below. ed the Tobacco Control Act in light of the after the Tobacco Control Act’s passage 54 SMOKESHOP April 2012
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