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BEFORE the FEDERAL TRADE COMMISSION Washington, D.C. 20580 in Re Proposal to Rescind FTC Guidance Concerning the Current Cigaret

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BEFORE the FEDERAL TRADE COMMISSION Washington, D.C. 20580 in Re Proposal to Rescind FTC Guidance Concerning the Current Cigaret i ? lUUR BEFORE THE FEDERAL TRADE COMMISSION Washington, D.C. 20580 ) In re Proposal to Rescind FTC ) Guidance Concerning the Current ) No. P944509 Cigarette Test Method ) ) COMMENTS OF PHILIP MORRIS USA INC. Philip MOlTis USA Inc. ("PM USA") hereby submits the following comments in response to the Federal Trade Commission's Proposal to Rescind FTC Guidance Concerning the Current Cigarette Test Method, 73 Fed; Reg. 40,350 (July 14,2008) ("FTC Proposal"). For more than forty years, the Federal Trade Commission ("FTC") has taken the position that "factual statements of the tar and nicotine content of the mainstream smoke of cigarettes would not be in violation of legal provisions administered by the FTC," as long as such statements were adequately supported by "tests conducted in accordance with the Cambridge Filter Method." See FTC Proposal, 73 Fed. Reg. at 40,351. However, over the course ofthe past four decades - both before and after the FTC issued its guidance in 1966 - the FTC, the public health community, and members of the cigarette industry all have raised questions and concerns regarding the adequacy ofthe Cambridge Method. In 1966, various tobacco companies commented to the FTC that the Cambridge Method "does not measure the volume ofsmoke - or the PM [particulate matter] or nicotine in the volume of smoke - that any human being will draw -1­ from smoking any particular cigarette.,,1 In 1966 and throughout its more than forty-year period ofguidance, the FTC itselfacknowledged the limitations ofthe method, recognizing that the method "does not and cannot measure [the] many variations in human smoking habits." See Press Release, FTC to Begin Cigarette Testing (Aug. 1, 1967). More recently, as noted in its Proposal, the FTC in 1994 "asked the National Cancer Institute ("NCI") to convene a consensus conference to address cigarette testing issues," and in 1997 the FTC issued a notice for comment on proposed revisions to the testing methodology. See FTC Proposal, 73 Fed. Reg. at 40,351 nA. In 1998, the FTC requested that the Department ofHealth and Human Services ("HHS") "conduct a complete review ofthe FTC's cigarette testing methodology." HHS in turn asked NCI to review the evidence ofthe relationship between machine-measured cigarette yields and disease risk. In September 2002 (following the issuance of"Monograph 13" by NCI), PM USA submitted a Petition for Rulemaking noting issues that have been raised regarding the limitations of the Cambridge Method, and requesting, among other things, that the FTC "reconsider its use of the Camblidge Method and consider whether a new method for detennining tar and nicotine yields will more accurately estimate tar and nicotine delivery to the smoker." See In re Petition for Rulemaking Concerning Tar and Nicotine Testing and Disclosure 5 (Sept. 18, 2002) ("2002 Petition"). PM USA continues to support action by the FTC or other federal authorities to identify and implement a standardized testing methodology that addresses the concerns raised regarding the Cambridge Method. I Supplemental Observations Following November 30, 1966 Hearing Before the Federal Trade Commission 2-3 (emphasis omitted). Cigarette manufacturers continued to point out the liInits ofthe test method even after the Cambridge Method was adopted. For instance, in the context of the Barclay dispute, discussed below, Brown & Williamson advised the FTC that "[a]ny one smoker can and may reduce the dilution by the way he or she holds the cigarette with hand or lips." Letter from Martin London to Matthew L. Myers 17 (July 16, 1981) (Ex. 1). -2­ That the Cambridge Method has shortcomings - a fact undisputed for decades - does not lead inexorably to the conclusion that the public interest would be best served by immediate rescission ofthe FTC's longstanding guidance. If the current guidance were simply rescinded ­ thereby eliminating any standardized methodology for tar and nicotine yield measurements - the FTC would effectively create a regulatory vacuum.2 To the extent that tar and nicotine yields are disclosed in this unregulated environment, such disclosures could lead to substantially greater consumer confusion than any possible confusion that may exist under the current guidance. Accordingly, PM USA respectfully submits that the FTC should take a measured approach in its Proposal. Rather than abruptly rescinding its guidance after more than forty years and leaving nothing in its place, the FTC should retain its guidance pending consideration by appropriate federal authorities of alternative standardized testing methods to replace (or to supplement) the Cambridge Method. As indicated in its 2002 Petition, PM USA stands ready to work with the FTC in the development of an alternative to the Cambridge Method. The retention of a uniform testing method - even a method with the limitations inherent in the Cambridge Method - during the search for an alternative method is preferable to the total abandonment ofany uniform method.3 The fact that many other jurisdictions - including the European Union - continue to rely upon a virtually identical version of the Cambridge Method Z We recognize that legislation is currently pending that would give FDA authority to regulate tobacco products, including authority to require disclosures relating to the results of the testing of tar and nicotine through labels or advertising. PM USA has supported such legislation, and the House ofRepresentatives recently passed its version ofthis legislation. However, it is not clear whether or when such legislation may be enacted. 3 Ifthe FTC decides to rescind its guidance concerning the Cambridge Method without providing guidance concerning an alternative method, PM USA urges the Commission to set a future effective date for such a rescission with a reasonable lead-time ofnot less than one year, to provide manufacturers with time to make any change that they may determine is appropriate in packaging and other materials. -3­ (the ISO Method)4 supports the view that the FTC's current guidance should be retained pending adoption of an alternative testing method. Moreover, during the period prior to the adoption of an alternative testing method, the FTC could reduce any perceived risk of consumer confusion by taking one or more ofthe following steps: (1) explain the limitations ofthe Cambridge Method in a "Consumer Alert" (as the FTC did in 2000); and/or (2) require cigarette manufacturers to include specific disclaimers about the Cambridge Method when they disclose tar and nicotine yields (similar to PM USA's disclaimers, discussed infra). Furthennore, if it deems it important, the Commission can address its additional stated concern that "consumers are likely to interpret [the tenn 'FTC Method'] as FTC approval, ownership or endorsement of the Cambridge Filter Method," FTC Proposal, 73 Fed. Reg. at 40,352, by amending its guidance to preclude references to "FTC Method." This approach would deal effectively with this expressed concern without fostering the greater consumer confusion that could result from opening the door to non-unifonn test methods. Below we (J) provide background infonnation about current use of the Cambridge Method and alternative testing methodologies that have been adopted or are being considered by the public health community and by other government entities, and (2) discuss the importance of having a unifonn testing methodology, rather than opening the door to claims made in a regulatory vacuum. ------------ 4For purposes of this comment, PM USA uses "Cambridge Method" to include the ISO Method. -4­ I. The Creation of the Cambridge Method, Its Current Use, and Research Into Alternative Methods A. Creation of the Cambridge Method The Cambridge Method has been the official standardized methodology for measuring tar and nicotine yields in the United States since 1966, despite the fact that the FTC from the beginning has recognized that the method does not model individual smoking behavior. As the FTC Proposal notes, the Cambridge Method was, from the outset, "intended to produce unifonn, standardized data about the tar and nicotine yields ofmainstream cigarette smoke, not to replicate actual human smoking." FTC Proposal, 73 Fed. Reg. at 40,351 (emphasis in original). "Because no known test could accurately replicate human smoking, the FTC believed that the most important objective was to ensure that cigarette companies could present tar and nicotine infonnation to the public based on a standardized method that would allow comparisons among cigarettes." Id. In other words, the FTC historically recognized that the limitations on the adequacy ofthe Cambridge Method to replicate actual smoking behavior did not destroy the consumer benefits that could be derived from requiring tar and nicotine yields to be based on a unifonn standard. In the mid-l 950s, in response to what it perceived as a rising number ofhealth claims in cigarette advertising, the FTC issued Cigarette Advertising Guidelines. Among other things, the Guidelines prohibited claims "that any brand of cigarette or the smoke therefrom is low in nicotine or tars ... when it has not been established by competent scientific proof... that such difference or differences are significant." CCH Trade Regulation Reporter 39,012, at 41,602 (Sept. 22, 1955). The result was that different manufacturers employed different methodologies to support claims regarding tar and nicotine yields. In its February 16, 1958 Press Release, FTC Seeks Unifonn Testing ofCigarette Smoke (Ex. 2), Charles
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