Ever since the “Family Smoking Prevention and Tobacco Control Act” was negotiated and agreed to by Altria and the Campaign for Tobacco Free Kids, and introduced by Senator Kennedy and Representative Waxman in 2004, Smokefree Pennsylvania has opposed the legislation (and has advocated amendments to improve public health), because it:

- does very little to reduce adult smoking, while duping the public to believe otherwise,
- does very little to prevent youth smoking, while duping the public to believe otherwise,
- prohibits the FDA from issuing truly effective tobacco regulations to reduce smoking,
- protects cigarettes from market competition by less harmful smokefree tobacco products,
- perpetuates the widely believed myth/fraud that smokefree tobacco products are as hazardous as cigarettes,
- perpetuates the widely believed myth/fraud that some cigarettes are less harmful than others,
- includes provisions (perhaps many) that violate the 1st Amendment, which almost certainly will be struck down by the courts, and
- reduces cigarette manufacturer risks in ongoing and future litigation.

New law does very little to reduce smoking

While supporters of new FDA tobacco law have claimed the new law will significantly reduce smoking and save millions of lives, the Congressional Budget Office has estimated that the new law will reduce youth smoking by only 11% during the next decade, and by just 2% among adults.   In comparison, youth smoking declined by 50% to 70% (depending upon age group) during the past decade, while per capita adult cigarette consumption decline by 30%.

Most reductions in youth and adult smoking during the past decade were due to state/local smokefree workplace laws, state/local cigarette tax increases, the 1998 Master Settlement Agreement between States and tobacco companies, and state/local tobacco marketing restrictions to protect youth.  There is no evidence that any of the provisions in the newly enacted FDA tobacco law (except for Senator Mike Enzi’s amendment to require color graphic picture warnings on 50% of cigarette packages, which was advocated by me and was opposed by supporters of the new law) will reduce smoking.

The recently enacted SCHIP legislation (that increased the federal cigarette tax $1/pack will do far more to reduce smoking among adults and youth than the new tobacco law.

Smokefree tobacco/nicotine products are far less hazardous alternatives to cigarettes

Fair and effective regulations adequately inform consumers of relative and comparable product risks, encourage the development of and transition to lower risk products, and gradually phase out the most hazardous products.  In sharp contrast, the new FDA tobacco law 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 smokefree tobacco products by misleading consumers to incorrectly believe that smokeless tobacco products are just as hazardous as cigarettes, and by prohibiting smokefree tobacco product manufacturers from truthfully informing cigarette smokers that smokefree products are far less hazardous alternatives to cigarettes.

Cigarettes kill 50 percent of addicted smokers (about 400,000 Americans annually), and up to 63,000 nonsmokers from secondhand smoke.  In contrast, smokefree tobacco products are attributable for no more than several hundred oral cancer deaths each year, and pose no harm to nonusers.  The tobacco smoke (or more accurately, the repeated inhalation of tobacco smoke), not the nicotine or tobacco, is the leading cause of disease, disability and death in America.

Smokefree tobacco products also pose significantly fewer risks for oral cancer than cigarettes.  Although cigarettes and smokefree tobacco products are similarly addictive, cigarettes are 100 times deadlier than smokefree tobacco products.  Swedish smokefree tobacco products (snus) and other new low nitrosamine smokefree tobacco products pose even fewer health risks, as do electronic cigarettes and nicotine gums, lozenges and skin patches.

Smokers who switch to smokefree tobacco/nicotine products reduce their disease, disability and death risks nearly as much as occurs by quitting all tobacco/nicotine use.  Millions of smokers in American and Sweden have already switched to smokefree tobacco/nicotine products, and the percentage of nicotine obtained from smokefree tobacco/nicotine products in the US has increased from 10% to 20% in the past decade, with smokeless tobacco products accounting for the vast majority of this change.  Unfortunately, 85% of smokers inaccurately believe that smokefree tobacco products are just as hazardous as cigarettes.  I coauthored a report delineating these issues “Tobacco harm reduction: an alternative cessation strategy for inveterate smokers” at http://www.harmreductionjournal.com/content/3/1/37

But the new FDA tobacco law protects cigarettes at the expense of public health and far less hazardous smokefree tobacco products by requiring even larger misleading warning labels on smokefree tobacco products that state “This product is not a safe alternative to cigarettes,” and “This product may cause mouth cancer.”  The new law also fails to inform smokers that smokefree tobacco products are less hazardous alternatives to cigarettes, and specifically prohibits any tobacco company from truthfully informing smokers that smokefree tobacco products are less hazardous alternatives.
Although Section 911 of the new tobacco law includes provisions for FDA to approve the marketing claims for “modified risk tobacco products”, it is highly unlikely that any application (under this provision) would be approved by the FDA (even for far less hazardous smokefree tobacco products) because the manufacturer also 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.

New law perpetuates the safer cigarette myth/fraud

Section 911 of the new FDA tobacco law also requires the FDA to promulgate regulations for tobacco companies to apply for making “reduced exposure” claims for cigarettes, which would perpetuate (under FDA oversight) the 60 year old myth/fraud that reducing exposure to a some of the many thousand constituents in tobacco smoke (including more than 40 carcinogens) can make cigarettes less hazardous.  During the 1950’s and 60’s filters were added to cigarettes to make smokers believe that they were less hazardous, and since the 1970’s cigarette companies have similarly marketed low-tar, light and ultralight cigarettes.  Surveys consistently find that about 85% of smokers inaccurately believe that light and ultra light cigarettes are less hazardous than other cigarettes, which explains why light and ultralight cigarette brands account for most of the US cigarette market share.

The new FDA tobacco law also authorizes and encourages the FDA to establish cigarette emission standards for various smoke constituents, which are based upon similarly inaccurate and unreliable smoking machine tests that were relied upon to fool the public into believing that low-tar, light and ultralight cigarette brands were less hazardous than other cigarettes.

While the new FDA law wisely bans the use of low-tar, light, ultralight and mild cigarette brand descriptors, the new law fails to inform smokers or the public that these brands (which will remain on the market) are just as hazardous as other cigarettes, and requires the FDA to perpetuate the myth/fraud that less hazardous cigarettes can and will be made under FDA regulatory oversight.
The new law also authorizes the FDA to reduce nicotine levels in cigarettes (and other tobacco products), and proponents of the new law have touted this as an effective way to reduce the addictiveness of cigarettes.  Yet, there is broad scientific consensus that smokers of cigarettes with lower nicotine yields 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, any FDA regulation to reduce nicotine amounts in cigarettes almost certainly will make cigarette more hazardous, not less.

New law contains unconstitutional provisions

Another problem with the new FDA tobacco law is that some (and perhaps many) of its advertising/marketing restrictions are virtually certain to be struck down by the Supreme Court for violating a manufacturer’s First Amendment right to communicate with its adult customers.  In 2001 the Supreme Court (in Lorillard Tobacco Co. v. Reilly) struck down a Massachusetts regulation because it prohibited outdoor tobacco advertisements within 1,000 feet of a school or playground.  And yet, that same 1,000 feet outdoor advertising restriction is contained in the new FDA tobacco law.

The new FDA tobacco law also bans other forms of tobacco advertising (e.g. large outdoor tobacco billboards, sports events, magazines with few youth readers) that could similarly be struck down by the Supreme Court for violating the 1st Amendment.  While the 1998 Master Settlement Agreement, agreed to by 46 State Attorneys General and the large tobacco companies, prohibits these types of tobacco advertisements, a Supreme Court ruling striking down these provisions as unconstitutional could even result in some (or all) tobacco companies withdrawing from that settlement (in order to resume those types of advertisements that are seen by many youth, and in order to avoid annual payments to states that totally about $8 billion).

Other provisions in the new FDA tobacco law that could be ruled in violation of the 1st amendment of tobacco companies include prohibiting them from truthfully claiming that their products are regulated by the FDA, and from truthfully claiming that smokefree tobacco products are less hazardous than cigarettes.

Since 2004, Altria (the world’s largest cigarette company, which spent many millions of dollars lobbying to enact the FDA law) has claimed that it too believes the court will strike down some provisions of the law for violating the 1st Amendment.

New law denies 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 the new tobacco law explicitly prohibits the FDA from issuing many of the most effective regulations to prevent and reduce cigarette smoking, including:
- eliminating cigarette sales in retail stores frequented by youth,
- increasing the minimum age for cigarette sales above 18 years,
- requiring prescriptions to buy cigarettes (as FDA requires for other harmful drugs), and
- eventually removing cigarettes from the market.

Although supporters of the new FDA tobacco law claim that it protects youth from tobacco and from marketing by tobacco companies, the law prohibits the FDA from banning the sale of cigarettes (and thus, their advertising as well) in hundreds of thousands of retail stores that are frequented by youth because it specifically prohibits the FDA from banning tobacco sales in any of the many different categories of retail outlets.  While cigarette consumption has declined by 50% since 1982 in the US (from 32 billion packs to 16 billion packs), the number of cigarette retailers has remained about the same.  The new law ensures that virtually all youths will continue to be exposed to tobacco advertising and marketing.

By prohibiting the FDA from increasing the minimum age of tobacco sales above 18 years, the new law allows tobacco companies to legally market their products to virtually all 12th grade high school students, which ensures easy access to tobacco products by most other high school students.  Just as raising the legal minimum age for alcohol sales to 21 years significantly reduced youth drinking and automobile injuries, increasing the minimum age for cigarette sales to 19, 20, or 21 could significantly reduce youth consumption.  Can anyone imaging Congress passing a law purported to protect youth from alcohol that allows alcohol to be sold to 12th grade high school students?
More manageable liability risks for cigarette companies

While the new FDA tobacco law doesn’t give tobacco companies any specific protections from lawsuits, the impact of the new law is likely to indirectly do so by reducing the likelihood that judges and juries will impose punitive damages on losing cigarette company defendants (as punitive damage awards are intended to punish losing defendants for their egregious behavior), or require any product changes (e.g. the verdict in the DOJ case against cigarette companies banned light, ultralight and mild cigarette claims).  The new law is also likely to result in fewer lawyers and lawfirms being willing to file expensive and risky lawsuits against cigarette companies in the future.

Summary

Although the new FDA tobacco law contains several sound public health policy provisions (e.g. requiring color graphic warnings covering 50% of cigarette packs, and banning of light, ultralight cigarette descriptors), there are many other provisions in the new law that protect cigarette markets at the expense of public health and less hazardous smokefree tobacco/nicotine products.

But perhaps the biggest problem with the new law is that Congress and the public have been duped into believing that the new law has resolved and will sharply reduce the nation’s leading cause of disease, disability and death.   This will make it far more difficult during the next several decades to successfully advocate public policies that truly reduce smoking, which is a big win for Altria and cigarettes.

Smokefree Pennsylvania is a nonprofit organization founded in 1990 which has worked to protect people from the involuntary exposure to tobacco smoke pollution, reduce tobacco marketing to youth, increase cigarette prices, preserve civil justice remedies for injured tobacco victims, increase tobacco prevention and cessation services, and inform smokers that smokefree tobacco/nicotine products are far less hazardous alternatives to cigarettes.

Bill Godshall

Executive Director, Smokefree Pennsylvania