Here is my ten minute presentation at the FDA TPSAC meeting today on dissolvable tobacco products.
I’m Bill Godshall, founder and executive director of Smokefree Pennsylvania. Since 1990, we’ve advocated local, state and federal policies to reduce indoor tobacco smoke pollution, reduce tobacco marketing to youth, increase cigarette tax rates, hold cigarette companies accountable, and to otherwise reduce cigarette consumption.
For disclosure, neither Smokefree Pennsylvania nor I have ever received any funding from any tobacco, drug or electronic cigarette company.
Once again, I urge TPSAC to cite in its report the extensive and consistent evidence that smokefree tobacco products are about 99% less hazardous than cigarettes, that >99% of tobacco diseases and deaths are attributable to daily inhalation of tobacco smoke, and that several million smokers in US have already quit smoking cigarettes by switching to smokefree alternatives.
It was wrong for cigarette companies to mislead the public about the risks of cigarettes for decades. But it is far worse when public health agencies deceive the public about the comparable health risks of cigarettes and noncombustible tobacco products.
Ever since Congress mandated the three inaccurate and misleading warning labels on all smokeless tobacco products in 1986, federal health agencies been committing public health malpractice by deceiving the public to believe that smokeless tobacco products are as hazardous as cigarettes, and by discouraging smokers from switching to far less hazardous smokefree alternatives.
Until recently, however, federal health agencies correctly stated that “cigarette smoking is the leading cause of disease and death”. But during the past several years, federal health agencies have begun to claim that “tobacco use is the leading cause of disease and death” in another deceitful attempt to confuse smokers and the public to believe that all tobacco products are as hazardous as cigarettes. Federal health agencies also have begun to falsely claim that the “cigarette epidemic” is a “tobacco use epidemic” to further deceive the public.
Last year, the FDA falsely stated on its MRTP webpage entitled “Health Fraud” that “To date, no tobacco products have been scientifically proven to reduce risk of tobacco-related disease, improve safety or cause less harm than other tobacco products." That is a lie.
Since 2009, the FDA has misrepresented its own laboratory test findings on e-cigarettes to scare the public and falsely claimed the products were target marketed to youth. Those and other false and misleading health claims are still on the FDA’s website.
Smokers have a human right to be truthfully informed that smokefree tobacco products are far less hazardous alternatives to cigarettes. Consistently, health agencies, organizations and professionals have an ethical duty to truthfully inform smokers that smokefree tobacco products are far less hazardous alternatives to cigarettes.
The good news is that during the past decade in the US, cigarette consumption declined 32% (from 21.3B to 14.4 B packs), including a 20% decline in just the past three years. Meanwhile, moist snuff consumption increased 54% (from 800M to 1.28B cans) the past decade, with adult smokers accounting for the majority of new snuff users. During the past five years, snus consumption has increased by double digits annualy, with adult smokers accounting for most new snus users, and e-cigarette consumption has had triple digit annual increases, with adult smokers accounting for virtually all e-cigarette users.
In the past decade, smokefree products have increased from 10% to 20% of overall tobacco consumption in the US. Our public health goal is to increase it to 50%.
Since several million smokers in the US have already switched to smokefree tobacco alternatives, it is mathematically impossible for smokefree tobacco products to increase tobacco attributable mortality even if every American begins using dissolvables and/or other smokefree tobacco products.
The 2010 National Survey on Drug Use and Health found that nearly 70 million Americans reported using a tobacco product in the past month, including 58 million cigarette smokers, 13 million cigar smokers, 9 million smokeless tobacco users, and 2 million pipe smokers. And a recent CDC survey found that 2.7 million Americans had used an e-cigarette in the past month.
But only half of the nation’s 70 million tobacco users, the 33 daily cigarette smokers, will suffer the overwhelming majority of tobacco diseases and deaths. That is why the only effective way to reduce tobacco disease and death is to continue reducing daily cigarette smoking and cigarette consumption. In contrast, tobacco mortality reductions will be negligible even with huge reductions in the number of smokefree tobacco product users, cigar smokers, or even non daily cigarette smokers, which now account for 30% of all cigarette smokers.
Dual usage of cigarettes and smokefree tobacco products is a necessary prerequisite for smokers to switch to less hazardous smokefree alternatives, and dual usage can occur for weeks, months or years. While complete cessation from cigarettes provides the most health benefits, smokers who don’t quit smoking, but instead substitute smokefree alternatives for many/most cigarettes, also reduce their risks.
Smokeless tobacco opponents have long claimed that smokeless tobacco is a gateway to cigarettes. But survey data has consistently found otherwise. In September, SAMHSA released the most comprehensive assessment to date, and found that two thirds of US residents (who had reported using both cigarettes and smokeless tobacco in their lifetime) had used cigarettes prior to using smokeless tobacco, and that fewer than one third had used smokeless tobacco prior to cigarettes.
Since surveys have consistently found that more than 75% of Americans inaccurately believe that smokeless tobacco is as hazardous as cigarettes, the most cost effective way to reduce the number of smokeless tobacco users who switch to cigarettes is for health agencies, organizations and professionals to begin truthfully informing the public that smokeless tobacco products are far less hazardous alternatives to cigarettes.
For more good news, according to the MTF survey, during the past fifteen years, cigarette smoking has declined by 75% among 8th graders, 67% among 1oth graders, and by 50% among 12th graders.
The MTF survey also found declines in smokeless tobacco use among youth during that time, while the 2010 National Survey on Drug Use and Health found that past month use of cigarettes, cigars, smokeless tobacco and pipe tobacco among youth 12-17 years ALL declined from 2007 to 2010.
Illegal tobacco sales to minors have also declined sharply, as recent FDA inspections found just 4% of retailers selling to youth, compared to 50% of retailers selling to youth when we urged Congress to enact the Synar law twenty years ago and when we convinced then FDA Commissioner David Kessler to include retailer inspections in his proposed tobacco regulations in 1995, and known as the 1996 rule in the FSPTCA.
In regards to the Committee’s Draft Summary Report on Dissolvables, I recommend eliminating Figure 1 because no evidence was presented indicating that dissolvables cause disease or death, cause nicotine addiction, reduce the likelihood of smoking cessation, or are a gateway to far more hazardous cigarette smoking.
In sharp contrast to Figure 1, the evidence indicates that all smokefree tobacco products are 99% less hazardous than cigarettes, that most new dissolvable tobacco users are adult smokers, and that smokers are far more interested in trying dissolvables than are non tobacco users. Mark Wolfson’s survey of college students found that smokers were 13 times more interested in trying a dissolvable than were non tobacco users, and only 1% of non tobacco users indicated an interest in trying any type of smokeless tobacco product.
In the Peer-Reviewed Literature section of the draft summary, the proposed statement claiming “one study showed that Ariva was perceived as being a non-tobacco product” should be either eliminated or corrected to state “one study found that Ariva tasted better than the Commit lozenge”. The proposed statement that “Consumers have not responded positively to current products” should be deleted because it is inconsistent with actual consumer purchasing behavior.
All references in the draft summary report to the “Indiana Experience and Y-Street presentations” should be eliminated because deceptive propaganda campaigns to demonize products cannot be considered objective evidence. Y-Street’s push-poll only found that some youth can be manipulated to agree that some “tobacco products look like candy” and that “they might want to try using the product” after being shown photographs of never-before-seen tobacco products that are strategically placed beside selectively chosen and recognizable candy products.
Y-Street also found that some adults can be deceived to believe that a push-poll is scientific research. Although it would have received an F in any basic research methods class, its authors were invited by the FDA to present their findings as scientific evidence to this committee, and several TPSAC members couldn’t even recognize the built-in bias of the so-called survey even after I repeatedly informed the committee. Besides, its unethical for anyone, especially health agencies, to deceive youth into believing that tobacco products are candy, as doing so only encourages youth to try using tobacco products.
I also urge the committee’s report to recommend eliminating three warning labels that are mandated for dissolvable smokeless tobacco products, as there is no evidence that dissolvable tobacco products cause mouth cancer, tooth loss or gum disease, and because the “not a safe alternative to cigarettes” deceives people to believe they are just as hazardous as cigarettes.
Thank you
Some of it was quite reasonable, but some of it was pure hogwash!
