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William T. Godshall, MPH
Executive Director
Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15217
412-351-5880
FAX 351-5881
http://smokefree.net/bg-announce/messages
Smokefree Pennsylvania is a nonprofit organization founded in 1990 whose goals include protecting people from the involuntary exposure to tobacco smoke pollution, reducing tobacco marketing to youth, increasing cigarette prices, preserving civil justice remedies for injured tobacco victims, and increasing tobacco prevention and cessation services.
Smokefree Pennsylvania strongly opposes the introduced version of S. 625, the “Family Smoking Prevention and Tobacco Control Act” that would authorize the U.S. Food and Drug Administration (FDA) limited regulatory jurisdiction over tobacco products.
In sum, Smokefree Pennsylvania opposes the current text of S. 625 because it would:
- mislead the public into believing FDA regulation reduces tobacco products risks,
- protect cigarettes from market competition by less harmful smokeless tobacco products,
- increase Philip Morris’ 51% cigarette market share, as well as Marlboro’s market share,
- increase inaccurate public beliefs that smokeless products are as hazardous as cigarettes,
- encourage FDA to set cigarette emission standards based upon inaccurate machine tests,
- increase inaccurate public beliefs that certain cigarettes are less hazardous than others,
- mandate counterproductive and/or ineffective warning labels on tobacco products,
- fail to adequately inform consumers of comparable risks of different tobacco products,
- prohibit harm reduction marketing of lower risk smokeless products to smokers,
- do very little, if anything, to reduce cigarette caused disease, disability and death,
- allow tobacco manufacturers and others to promote cigarettes as FDA approved,
- severely limit the FDA’s authority to issue effective tobacco product regulations, and
- reduce cigarette manufacturer liability by misleading potential jury pools.
Reducing health risks of future tobacco products
Effective regulations gradually phase out the most hazardous products, and encourage the development of and transition to lower risk products. Effective product regulations also adequately inform consumers of relative and comparable product risks. In sharp contrast, S. 625 protects the most hazardous tobacco product (cigarettes), the largest cigarette company (Philip Morris) and the largest cigarette brand (Marlboro) from market competition from far less hazardous noncombustible tobacco products by misleading consumers to incorrectly believe that smokeless tobacco products are just as hazardous as cigarettes, and by prohibiting truthful harm reduction marketing claims by smokeless tobacco products that are directed towards already addicted cigarette smokers.
Cigarettes kill fifty percent of addicted smokers, and up to 63,000 American nonsmokers annually (from secondhand smoke and fires). In contrast, smokeless tobacco kills about one perecent of addicted users, and ZERO nonusers. Swedish smokeless (snus) and other new low nitrosamine noncombustible tobacco products pose even fewer risks. Smokers who switch to smokeless products can sharply reduce their disease and death risks.
But S. 625 perpetuates the myth/fraud that noncombustible tobacco products are just as hazardous as cigarettes by requiring larger labels on smokeless packs and advertisements that state: "This product is not a safe alternative to cigarettes," and by failing to inform smokers (e.g. via labels on cigarette packs and advertisements) that smokeless tobacco products pose fewer morbidity and mortality risks than cigarettes. If U.S. Congress is sincere about truthfully informing consumers about the health risks of different tobacco products, this misleading warning MUST be removed from smokeless tobacco products.
S. 625 also could be improved if FDA was encouraged to approve clean nicotine products (e.g. skin patches, gum, lozenges, inhalers) for nicotine maintenance instead of just for temporary use as a smoking cessation aid. Shiffman et al found that 36.6% of nicotine gum users consumed the product for longer than six months, despite the product warning urging discontinued use after twelve weeks. Clean nicotine products are far less hazardous than relapsing to cigarettes, and should be approved for nicotine maintenance.
Although Section 911 of S. 625 includes provisions for FDA to approve the marketing of “modified risk tobacco products”, it is highly unlikely that any product would be approved since any manufacturer applying for FDA approval for a modified risk product would need to demonstrate that the product wouldn’t discourage smokers from quitting tobacco use and wouldn’t result in use by non tobacco users. Besides, the Campaign for Tobacco Free Kids, American Cancer Society and other proponents of S. 625 have repeatedly alleged that the marketing of smokeless tobacco products for harm reduction discourages smokers from quitting and encourages youth to begin using those products.
In contrast, Section 911(g)(2) of S. 625 would allow a cigarette manufacturer to apply for and receive FDA approval for "an explicit or implicit representation that such tobacco product or its smoke contains or is free of a substance or contains a reduced level of a substance, or presents a reduced exposure to a substance in tobacco smoke." This clause could very likely result in the FDA approving the marketing of a “reduced exposure” cigarette even if the cigarette is as hazardous as other cigarettes. Even worse, the marketing of an FDA approved “reduced exposure” cigarette is likely to confuse smokers into believing that the product is less hazardous than other cigarettes.
Cigarette machine testing methods are inaccurate, and only serve to misinform
Effective product regulations also protect consumers from health frauds. Although S. 625 eliminates cigarette brand descriptors “Light”, “Low-Tar” and “Mild,” (which arguably is the deadliest consumer fraud of the 20th century), consumers of these products would barely notice this change because these brands would remain on the market in their easily recognized package designs and colors (minus one word). Marlboro Lights, which has the largest market share of any cigarette, would simply become known as Marlboro Gold, while Marlboro Ultralights would simply become known as Marlboro Ultras or Marlboro Silver. Meanwhile, S. 625 does nothing to warn smokers that the brands previously named “Lights” and “Ultralights” are just as hazardous as other cigarettes.
But far more troublesome, S. 625 authorizes the FDA to establish cigarette emission standards for various smoke constituents based upon inaccurate smoking machine testing methods similar to the notorious FTC smoking machine tests that were partly responsible for creating the thirty five year old consumer fraud that duped smokers into believing that Low-Tar, Light and Ultralight cigarette brands were less hazardous than other cigarettes.
Although a recent study by the Harvard School of Public Health concluded that cigarette companies have increased the nicotine yields of cigarettes by about ten percent during the past decade leading some news reports to claim that cigarettes are now more addictive, that same study also concluded that (during the past decade) nicotine yields of Light brands were about twenty five percent less than those of Full Flavor brands, and that nicotine yields of Ultralight brands were about thirty percent less than those of Light brands. But in fact, all cigarettes are similarly and quite adequately addictive. The fundamental problem with the Harvard study is that it relied upon another inaccurate smoking machine testing method somewhat similar to the defective FTC testing method.
Hammond et al recently evaluated the accuracy of the International and Canadian cigarette machine testing methods, and concluded that neither of those machine testing methods are accurate, and that NO machine testing method should be relied upon for establishing government regulatory standards for cigarette smoke emissions.
Besides, cigarette smoke contains more than 50 carcinogens and 3,000 other constituents. So even if an accurate FDA machine testing method is devised (which doesn’t appear viable), an FDA product standard that reduces or removes one, two or a few chemicals or carcinogens from cigarette smoke would not reduce the overall health risks of cigarettes.
Any FDA product standard for cigarettes almost certainly would be perceived by smokers and the public as making cigarettes less hazardous, which could discourage smokers from quitting and could encourage youth and ex-smokers to begin smoking.
S. 625 also authorizes the FDA to reduce nicotine levels in cigarettes, and some supporters of S. 625 have advocated mandatory nicotine levels reductions in cigarettes. Yet, there is broad scientific consensus that smokers of cigarettes with purportedly lower nicotine yields simply puff more intensely, take more puffs and/or smoke more cigarettes in order to obtain a similar level of nicotine that they are accustomed to receiving, which is known as “nicotine compensation”. As such, smokers of purportedly lower nicotine yield cigarettes inhale greater quantities of smoke, which increases their disease risks.
Thus, it would be counterproductive for public health if the FDA mandated reductions in nicotine, because doing so could make cigarettes even more hazardous. If the FDA were to require any changes in nicotine content (assuming that an accurate machine testing method could be developed), it would be better for public health to require higher levels of nicotine in cigarettes, because smokers would inhale less cigarette smoke.
Constitutional concerns about S. 625
Another concern with S. 625 is that some of its tobacco advertising restrictions are virtually certain to be struck down by the Supreme Court for violating a manufacturer’s First Amendment right to advertise to its adult customers. That is precisely why in 2001 the Supreme Court (in Lorillard Tobacco Co. v. Reilly) struck down a Massachusetts regulation that prohibited outdoor tobacco advertisements within one thousand feet of a school or playground. And yet, a similar one thousand foot outdoor advertising restriction is contained in S. 625.
Denying FDA authority to effectively regulate tobacco products
Effective product regulations also allow regulatory agencies unfettered authority to issue regulations that reduce use of and access to the most hazardous products. But S. 625 prohibits the FDA from issuing many of the most effective regulations that could reduce cigarette usage, especially among youth, including prohibiting the FDA from:
- increasing the minimum age to purchase cigarettes beyond 18 years;
- eliminating cigarette sales from any type of retail outlet;
- requiring prescriptions to buy cigarettes (as FDA requires for other hazardous drugs);
- removing nicotine from cigarettes; and
- eventually removing cigarettes from the market.
While these restrictions limiting the FDA’s authority to regulate tobacco in S. 625 are not necessarily opposed by Smokefree Pennsylvania, our organization is never-the-less concerned that their inclusion in S. 625, along with the many truly counterproductive provisions that were previously cited, have severely compromised this legislation.
The following report compares the health risks of different tobacco products and recommends the only viable tobacco product and policy harm reduction strategy for smokers who are not ready or willing to quit tobacco use; providing truthful comparable product risk information, and encouraging switching to a smokeless tobacco product.