Modified Risk – the Big Tobacco Issue for the Next Decade

The FDA is being called upon to make a pronouncement on whether certain tobacco products, such as smokeless can be officially designated reduced risk. This will require a veritable judgment of Solomon. On the one hand the tobacco companies argue that since the toxic substances which cause cancer are in smoke then QED non combustible products are safer. Bodies such as the IOM argue that the reduced risk credentials of aspirant lower risk products are unproven.

According to a recent report issued by the Institute of Medicine (IOM), modified risk tobacco products including smokeless tobacco products, and also e-cigarettes (although these do not contain tobacco) must be subject to rigorous scientific evaluation before being approved to be marketed as modified risk by the Food and Drug Administration, According to the IOM, there is a shortage of scientific evidence on the health effects of modified risk tobacco products. Modified risk is important to the tobacco industry because it offers the potential to replace the volume sales of cigarettes lost in markets like the US as smoking prevalence falls but the concept is of equal importance to the anti-smoking lobby. This is because, as the IOM report states, only about 6% of smokers are able to successfully quit tobacco use, and because quitting is so difficult, many smokers will probably want products that allow them to continue smoking with fewer health risks. The IOM also cites the danger that, because there is no research that proves that modified risk tobacco products are safer than traditional cigarettes, these new products may ultimately carry risks comparable with regular cigarettes.

The US tobacco control act and modified risk

The US Family Smoking Prevention and Tobacco Control Act of 2009 states that modified risk tobacco products must be subject to an approval process comparable to medical drugs and devices. The act states that the FDA must be presented with scientific proof that not only will the product reduce harm to individual users, but it must also benefit the health of the general population in order for it to be marketed. The act also directed the FDA to consult with the IOM on how studies should be designed and conducted. The American Lung Association agrees with the IOM, recently stating that, if a tobacco product is allowed to be marketed as ‘safer’ that the product must actually be safer, citing the example of ‘light’ and low tar products.

It is highly relevant that the report by the IOM coincided with another government sponsored study which showed cigarette use hitting historic lows among US teenagers. The National Institute on Drug Abuse recently reported that cigarette use by eighth, 10th and 12th grade students had dropped to its lowest level since polling of teenagers began in 1975. The proportion of students in the grades saying they had smoked in the previous 30 days fell to 11.7% in 2011 from 12.8% in 2010. The study by the University of Michigan showed smokeless use among youths came down in 2011 though not sufficiently to reverse a rise in rate since 2005.

This was partly because, according to reports, more teenagers have been switching to smokeless products such as moist snuff – American style ‘dip’ and Swedish style snus – available as brand extensions to major cigarette brands like Marlboro and Camel. If this is true then it might be argued that the US is moving towards the so called ‘Swedish Solution’. Sweden has (along with Finland) the lowest smoking prevalence in the EU because usership of the smokeless tobacco product snus is higher than usership of cigarettes (though the market for snus is currently worth less). (See also article EU Promises to Look Again at Snus Ban).

The world waits for the FDA to pronounce on reduced risk

The FDA then, is currently deliberating on whether to allow companies to advertise some tobacco products as safer than cigarettes and plans to publish regulations or (more likely) guidance on scientific testing requirements by April 2012 as part of its review. There is no doubting the importance of this judgment to both the tobacco industry and the anti-smoking lobby, not only in the US but globally. The FDA could be laying down a path for the future of the whole tobacco industry.

But to reach a judgment is as fraught with difficulty as when Solomon, according to the Old Testament had to decide without benefit of DNA testing, the maternity of a baby claimed by two mothers. One big problem for the FDA, according to the IOM report, is the dearth of ‘reliable’ evidence concerning the effects of modified risk tobacco products on both individual users and public health in general. The FDA has stated that it will take the IOM report into consideration.

U.S. tobacco companies have cited studies and provided the details to the FDA showing smokeless tobacco to be less harmful than cigarettes because cigarettes release carcinogens through combustion which non combustible products do not. The industry believes that offering smokers the smokeless tobacco alternative is a path forward, as demonstrated by Altria’s US$10bn purchase of UST and Reynold’s investment in smokeless tobacco via its American Snuff Company. Reynolds petitioned the FDA earlier in 2011 to change a label on smokeless products to ‘No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.’ The FDA has not acceded to this request. The current warning states, ‘This product is not a safe alternative to cigarettes’.

How dangerous is smokeless?

The IOM report recommends that tobacco companies use FDA approved, independent third parties to oversee health research on their products because it believes the industry’s own research cannot be regarded as impartial. But the question of how the modified risk issue should be treated is still extremely complex. On the one hand it may be argued that modified risk makes it easier for smokers to give up cigarettes, on the other hand, there is the ‘replacing one addiction with another argument’. According to the Campaign for Tobacco-Free Kids, smokeless products contribute to tobacco addiction and stop smokers quitting outright. There is also, in the case of oral snuff products, the question of whether the products present their own dangers – currently US Government labels warn that moist snuff products can cause mouth cancer and gum disease. Indeed it was because of a WHO quoted report suggesting this that the sale of oral snuff was banned in the EU (except for Sweden). The latter research has been disputed by Sweden and forms part of its argument for the lifting of the EU ban. And in India, the world’s biggest user by far of smokeless products, laws are currently being passed, against the use of oral tobacco products on the grounds of the dangers to health.

So what is the FDA going to say? Euromonitor International would put the odds against a pronouncement allowing the industry in the US to state that smokeless products carry a lower risk than cigarettes, not because of lack of scientific justification but because the tacit acceptance that any tobacco product is less dangerous than another is too close to recommending its use to be politically acceptable.