CASAA files Amicus Brief in Nicopure/R2B FDA Deeming Rule Challenge

Washington D.C.

Last year, Nicopure Labs and The Right to be Smoke-Free Coalition (“R2B”) sued the FDA, arguing against portions of the Tobacco Control Act and the FDA’s Deeming Rule as they are being applied to vapor products. The court ruled in favor of the FDA at that time, so the plaintiffs filed an appeal in the D.C. Court of Appeals.

On appeal, Nicopure and R2B argue that “the Modified Risk Tobacco Product (MRTP) provision of the TCA, as well as the ban on free samples of vapor products, (1) violate the First Amendment of the U.S. Constitution, and (2) FDA was obligated to consider a less burdensome Premarket Tobacco Product Application (PMTA) process for vapor products while still protecting the public health.” A summary of these issues can be read here, and you can download the full brief here.

In support of that appeal, CASAA has filed an amicus brief with the court. An amicus brief is a legal document – filed by someone who is not a party to the action – that advises the court of relevant, additional information or arguments that they want the court to take into consideration. In this case, CASAA is not making any legal arguments, but instead providing additional information from the consumer perspective, such as how consumers use vapor products, the importance of sampling, and why it is critically important that consumers be able to receive basic, truthful information from vapor companies about, among other things, the low-risk nature of vapor products (something that the Tobacco Control Act prohibits). The full CASAA amicus brief can be read here.

Several other organizations and individuals listed below have also filed amicus briefs in the case. You can click the links below to read the individual brief or read a summary of the briefs on the Keller & Heckman website here.

  • The Washington Legal Foundation
  • NJOY
  • The State of Iowa
  • Clive Bates, Director of The Counterfactual and former Director of the UK’s primary anti-smoking non-profit Action on Smoking in Health, with public health advocates Philip Alcabes, Scott Ballin, Konstantinos Farsalinos, Bill Godshall, Jacques Le Houezec, Bernd Mayer, Jeff Nesbit, Joel Nitzkin, Riccardo Polosa, Sally L. Satel, Michael B. Siegel, Jeff Stier, and David Sweanor

This article was originally published at CASAA
Author: KNoll-Marsh

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Real World Evidence Doesn’t Support Pneumonia Concerns

— London, UK

Contrary to the headlines, a recent study published in the European Respiratory Journal offers no proof that vaping causes, or significantly increases, the risk of getting pneumonia. In fact, vaping may even decrease the risk in many users, who otherwise would be smoking.

While the research suggests that vaping might increase the risk of pneumonia-related bacteria “sticking” to human and mouse cells, this is speculation and not real evidence. Even senior author Jonathan Grigg, MD, of Queen Mary University of London, admitted that the bacteria that causes pneumonia can be present in airways without causing illness. Curiously, researchers didn’t report whether or not the mice exposed to both vapor and the bacteria actually became sick with pneumonia more often than the mice that weren’t exposed to vapor. In fact, a recently published paper by the same researchers who had originally thought that the “stickiness” increased risk shows that it plays a negligible role in increasing the risk of pneumonia.

“Researchers need to come up with a model that predicts future risk for pneumonia, given all of the different factors that contribute to it,” said Dr. Brian Carter, CASAA’s Director of Scientific Communications. “Then, and only then, can the effect of vaping be accurately estimated in terms of risk.”

“Even if they have the data to do this enormous undertaking, it’s likely that any possible increased risk of pneumonia related to vapor products would be so small as to be inconsequential,” Dr. Carter said. “At the least, that’s the most reasonable conclusion given the small amount of data they’ve provided. These are highly dubious and unreplicated findings that haven’t been proven in real-world situations. It is grossly unethical to report these ‘speculations’ that the general public will likely take as fact.”

Additionally, the researchers did not comment on past studies of propylene glycol, a primary ingredient in vapor products. Studies as far back as the 1940’s through the present day have shown that propylene glycol in aerosol form is a potent antibacterial agent, with “pronounced effects on both pneumococci and hemolytic streptococci.” It was also found that “control tests showed that failure of the glycol-treated microorganisms to grow on the agar plates was due to actual death of the bacteria.” This antibacterial effect of propylene glycol on bacteria is an important question that researchers didn’t ask. Clearly, dead bacteria isn’t going to lead to an infection, regardless of how much of it “sticks.”

Researchers also cited several study limitations, including lack of data on whether the vapor “stickiness” actually would cause humans to get pneumonia. While there are several bacteria types that cause respiratory illness, the study reported on a single type of bacteria associated with pneumonia, Streptococcus pneumoniae, commonly referred to as pneumococcal bacteria. Moreover, they completely failed to account for the effect of immunization that is widely available for this particular cause of pneumonia, which has been shown to reduce the risk of getting this form of the disease dramatically in both smokers and non-smokers.

It is important to note that real-world statistics don’t support the concern that vaping might increase the incidence of pneumonia. “While many would ask that we compare the risk to smoking, it is important to compare this alleged risk to other more important risks that affect the population as a whole. When compared to these other risk factors, it becomes clear that any potential risk from vaping is negligible,” said Bruce Nye, RN, CASAA Board Vice-president. “E-cigarette use has been around for more than 10 years, yet the incidence of pneumonia from all causes has decreased, due in large part to the increased use of pneumonia vaccine and improved hygiene.”

As pointed out in the 2016 study, “Respiratory infections and pneumonia: potential benefits of switching from smoking to vaping” (David Campagna, et al.) “Despite millions of regular vapor users, there has been no evidence of new emerging pneumonia outbreaks in recent years, or reports of infectious pneumonia in the medical literature.” A quick review of FDA Medwatch reports (here and here) of adverse events possibly related to vapor products reveals only three mentions of pneumonia. Considering the fact that pneumonia is a common illness affecting approximately 3 million people a year in the United States, those three unconfirmed reports are more likely due to other well known factors.

“The researchers failed to note that there are no cases of pneumonia in someone using vapor products that did not have other, well known, causal factors present that on their own would be cause for the disease. Indeed, it appears that these researches have deliberately used data and speculation in order to discredit one of the most important low-risk alternatives to smoking.” said Nye.

Both Dr. Carter and Nye agree: “The effect of this type of unfounded pseudo-scientific scare tactic by press release discourages smokers from trying products with a vastly lower risk, leaving them to continue to smoke and placing them at higher risk for diseases, including pneumonia. This is ethically questionable, directly harmful to smokers, and goes against the goal of good public health practice.”

This article was originally published at CASAA
Author: KNoll-Marsh

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Public Health England Reaffirms Support of Vaping

–London, U.K.

Public Health England (PHE) has released its latest annual report on e-cigarettes, again stating that vaping poses only a fraction of the health risk of tobacco smoking and should be encouraged among smokers.

A key finding of the PHE report was that “there is much public misunderstanding about nicotine. Less than 10% of adults understand that most of the harms to health from smoking are not caused by nicotine.”

“Our new review reinforces the finding that vaping is a fraction of the risk of smoking, at least 95 percent less harmful, and of negligible risk to bystanders,” said John Newton, a professor and director for health improvement at PHE.

“It would be tragic if thousands of smokers who could quit with the help of an e-cigarette are being put off due to false fears about their safety.”

The concern is well founded as the report states that 40% of smokers haven’t even tried vapor products.

“We face a similar crisis here in the United States,” said Alex Clark, CASAA’s Executive Director, “where 55 percent of consumers incorrectly believe that vaping is as harmful or worse than smoking. It certainly doesn’t help that our government’s health agencies have been manufacturing fear about the harm of ‘addiction’ and misplacing the blame on nicotine for decades. There are also a shocking number of medical doctors who still believe that nicotine causes cancer. The FDA and CDC need to be more aggressive in correcting this misperception about nicotine and it’s time for PHE’s leadership to rub off on them.”

PHE also concluded that concerns over youth use leading to smoking were not supported by the evidence.

“Concern has been expressed that e-cigarette use will lead young people into smoking,” said Professor Linda Bauld, author and Professor of Health Policy, University of Stirling and Chair in Behavioural Research for Cancer Prevention, Cancer Research UK. “But in the UK, research clearly shows that regular use of e-cigarettes among young people who have never smoked remains negligible, less than 1%, and youth smoking continues to decline at an encouraging rate. We need to keep closely monitoring these trends, but so far the data suggest that e-cigarettes are not acting as a route into regular  smoking amongst young people.”

The PHE report comes a few weeks after a U.S. National Academies of Sciences, Engineering and Medicine report on vapor products. Their conclusion on vaping safety also finds that, based on the available evidence, “e-cigarettes are likely to be far less harmful than combustible tobacco cigarettes.”

“The key element missing from the US tobacco policy is harm reduction,” explained Bruce Nye, RN, Vice President of CASAA.

“While the UK reduces the harm to smokers by recommending alternatives to combustible tobacco, the US policy remains essentially ‘Quit or Die’. Recent FDA applications to market low-risk alternatives have been denied, leaving only the most harmful products on the market. While the UK promotes information about the varied risks of tobacco products, the US promotes the false idea that all tobacco products are the same.

“What the UK has realized is that the social and economic costs of promoting low-risk alternatives is far lower than continuing a zero-tolerance prohibition policy,” said Nye. “It is time for the US to shift its policy from the current “War On Tobacco” towards a policy that values the lives of all it’s citizens, smokers and non-smokers, and embrace reduced harm products such as e-cigarettes, smokeless, and heat-not-burn.”

Public Health England’s full report is available on their website, here.

This article was originally published at CASAA
Author: KNoll-Marsh

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Multiple Vape Shops File Against FDA

–Washington D.C.

Pacific Legal Foundation (PLF), a donor-supported organization that has successfully litigated for limited government, private property rights, and free enterprise, announced Tuesday that it would be representing several small vape shop owners in lawsuits filed against the U.S. Food and Drug Administration. The filed complaints object to the FDA “Deeming Rule” that requires the nearly impossible Premarket Approval (PMTA) hurdles for vapor products.

Skip Murray, a vape shop owner and advocate in Brainerd, Minnesota, filed a challenge in the U.S. District Court for Minnesota, along with three other vaping businesses in that state. They are joined by the nonprofit Tobacco Harm Reduction 4 Life. Additionally, four businesses from California, Michigan, and North Dakota filed a federal challenge in the U.S. District Court for the District of Columbia. Finally, a vape shop in Mesquite, Texas, filed a challenge in the U.S. District Court for the Northern District of Texas. All are represented “pro bono” by PLF.

The lawsuits primarily argue that the deeming rule and its requirements are both burdensome and unconstitutional, banning truthful speech and thereby violating the First Amendment’s free speech protections. The complaints also argue that Leslie Kux, FDA Associate Commissioner for Policy, does not have the authority to issue rules like the Deeming Rule, and such rules are reserved by the Constitution for “Officers of the United States.”

“Rules that affect the American people must be issued by officials who are answerable to the political process, not by bureaucrats who have no political accountability,” said attorney Thomas Berry in PLF’s press release. “The Constitution requires that regulations with the force of law must be approved by agency executives nominated by the President and confirmed by the Senate.”

“In contrast, the vaping edict was imposed by a career civil service employee,” he said. “It also flouts the First Amendment by stopping businesses from advertising truthful information unless they run a regulatory gauntlet.”

In 2009, under the Family Smoking Prevention and Tobacco Control Act, Congress granted the FDA “new and flexible enforcement authority to ensure that there is effective oversight of the tobacco industry’s efforts to develop, introduce, and promote less harmful tobacco products,” defined in the Act as “Modified Risk Tobacco Products (MRTP).”

Unfortunately the requirements for MRTP status are even more difficult to achieve than PMTA.

“The bar for gaining a modified risk order is excessively high,” said Alex Clark, CEO of CASAA. “Arguably, the process is inherently cynical and prejudiced against any company in the tobacco or nicotine space.”

Not only must companies demonstrate that the product significantly reduces harm and the risk of so-called ‘tobacco-related disease’ to individual users, it must also show a benefit to the health of the population as a whole, taking into account the impact on both users and nonusers. The requirements are so unclear and ambiguous that it is unlikely that such a standard could ever be proven.

“And before a company even gets to that point,” Clark explained, “the cost of producing an application is beyond the means of the small to medium manufacturers who were driving innovation. Ironically, the market approval process favors protecting the market for the most harmful products, cigarettes.

“Both premarket approval and the MRTP standards create unnecessary barriers to consumer access of lower risk tobacco and nicotine products,” Clark said, “and they are effectively a de facto ban on truthful speech that is vital to saving lives.”

More information about the lawsuits may be found at

This article was originally published at CASAA
Author: KNoll-Marsh

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More misleading headlines about vaping

— New York City, New York

A poorly designed mouse study from the New York University School of Medicine in New York City is causing news outlets around the world to falsely report that the use of vapor products increases the risk of cancer and heart disease.

“In medical science, mouse studies are of very limited use in determining effects on humans,” said Bruce Nye, RN, Vice-President of CASAA. “We have cured cancer and other diseases many times in mice yet the results do not have the same effect on people. Mice are not men.”

The researchers say they found that mice exposed to e-cigarette vapor experienced DNA damage in the lungs, bladder, and heart and that such damage has been previously linked to an increase in the risk of cancer and heart disease. They also found similar damage in lab-grown human lung and bladder cells that had been exposed to liquified e-cigarette vapor, leading them to conclude that it is “possible that e-cigarette smoke may contribute to lung and bladder cancer, as well as heart disease, in humans.”

However, what the researchers considered “light use” exposure in mice might actually be far more than average exposure for humans. Ten mice were exposed to vapor containing 10 mg/mL of nicotine for 3 hours a day, 5 days a week, for 12 weeks. They exposed cell cultures directly to a liquid bath of vapor products, substantially differing from what happens in the real world. Because the study didn’t test real-world use or exposure, it cannot show that there would be any adverse effect on human health from vaping.

“The design of experiment matters,” explained Nye. “This design does not model real-world exposures. Instead the doses were concentrated hundreds of times and the exposures were continuous over 3 hours to ‘simulate’ the effect of vaping for longer periods. The problem with this is it violates the basics of toxicological research – the dose makes the poison and exposure makes the risk.

“Attempting to substitute short exposures at higher doses for small exposures at lower doses produces a false result which can not be duplicated in the real-world. This is the same as giving the entire adult daily dose of narcotics to an infant in a single dose – the infant will die. This is a basic mistake often made by those who are either not familiar with toxicology, or who have a specific goal of experiment in mind to support their pre-drawn conclusion.”

Curiously, the researchers hinge their conclusions about cancer risk from vaping on “nitrosamines that are derived from the nitrosation of nicotine.” Yet they showed no mechanism for the nitrosation of nicotine in such exposures. In fact, it has never been proven that nicotine exposure is a carcinogen in humans. More so, the FDA has strongly proclaimed nicotine as safe for long-term use and eliminated the required time limit recommendations on labeling for over-the-counter nicotine products. The most recent research still hasn’t shown a link between nicotine products and cancer, either.

Furthermore, the study didn’t compare damage from e-cigarette vapor to the damage caused by smoking. It is a gross oversight in any study of vapor products not to compare it to smoking, as the vast majority of vaping consumers would otherwise be exposed to smoke, rather than air. Every previous study that has compared vaping to smoking demonstrates that e-cigarette vapor is dramatically less harmful than smoke.

“Showing DNA damage that may increase the risk of cancer is not even close to the same as showing an actual increased risk,” Nye concluded. “DNA damage occurs regularly, it is a normal part of the biological process in every living thing.”

This article was originally published at CASAA
Author: KNoll-Marsh

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FDA ends nicotine addiction experiment on squirrel monkeys

Earlier this month, the FDA announced it was permanently ending nicotine addiction experiments on monkeys that were part of the agency’s potential effort to force cigarette manufacturers to lower the nicotine content of their products. In a November 2017 letter to Commissioner Gottlieb, CASAA commended this decision and urged the FDA not to resume these misguided studies or rely on their flawed results to inform public policy that affects more than 38 million Americans.

Presently, the biggest mistake made in tobacco and nicotine research is taking research results that may only inform theory or provide foundational knowledge and using them to support policy. This practice is not only grossly unscientific, it is a recipe for the construction of harmful policies.

The results of human studies (See Donny [2016] et al., and Benowitz [2015] et al.) on low nicotine cigarettes have already shown equivocal results in support of the FDA’s proposal to drastically reduce nicotine levels. In spite of these weak human study results, the FDA states it plans to rely in part on unreliable nicotine studies using monkeys to inform a policy that will significantly reduce the amount of nicotine in cigarettes.

A non-human animal that does not choose to smoke and is forced to live in a controlled, sterile and highly stressful captive environment is incredibly unlikely to adequately inform questions about the complex behavior of human smokers who have considerably more complex brain functioning and live in a much more complex world.

The use of animals in studies putatively designed to inform tobacco policy is misguided, unreliable, and unethical. CASAA strongly objects to them on this basis. The scientific justification for conducting these studies in the first place is extraordinarily weak and results have no place informing decision making on policy matters that stand to have an impact on a considerable number of people.

CASAA urges the FDA to discard these animal studies from considerations related to policy making on both scientific and ethical grounds. Moreover, if it is to accept animal studies for consideration, CASAA urges the FDA to accept only those with the highest scientific standards and justification, and then only used for informing basic concepts and theories related to the policy in question, not for informing the potential implementation of any particular policy.

–From Consumer Advocates for Smoke-Free Alternatives Association, Students for Sensible Drug Policy and Not Blowing Smoke in a letter to FDA Commissioner Scott Gottlieb

This article was originally published at CASAA
Author: KNoll-Marsh

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CASAA to FDA’s TPSAC: PMI’s modified risk claims should go further!

Full text of statement below.

Please note that a portion of our statement was omitted during the presentation due to time constraints. In the interest of transparency, we have included the omitted COI statement here.

January 25, 2018

Testimony Delivered to FDA Tobacco Product Scientific Advisory Committee (TPSAC)

RE: PMI IQOS Modified Risk Tobacco Application

— —

Members of the committee,

Good morning and thank you for the opportunity to speak with you today. My name is Alex Clark and I am the executive director of The Consumer Advocates for Smoke- free Alternatives Association. We are a 501(c)(4) nonprofit consumer organization with a membership of more than 200,000 consumers from all walks of life.

[[Original text not included in presentation due to time constraint]

By way of information, CASAA accepts donations from many sources and has no financial or policy agreements with industry stakeholders. In 2017, CASAA received a one-time, completely unrestricted contribution from Philip Morris International. CASAA’s policy for allocating resources is that all contributions are used for efforts that will maximize consumer access to and awareness of low-risk, smoke-free nicotine and tobacco products.]

I am here today to express CASAA’s support for PMI’s MRTP application as we agree that IQOS marketing should accurately inform consumers of the relative low risk of using this heat-not-burn tobacco product.

CASAA believes that consumers deserve honest and accurate risk communication about the products they use so they can make informed choices.

However, our support for PMI’s applications is not without concern. Specifically, we draw attention to the statement that  “scientific studies have shown that switching completely from cigarettes to the IQOS system can reduce the risks of tobacco related diseases.”

In our written comment we provide a footnote to this statement expressing our objection to the use of the term “tobacco related disease.”

To echo the recent statements made by Director Zeller and Commissioner Gottlieb regarding nicotine, CASAA believes that we must update the language we use to discuss the harms of smoking.

Broadly referring to the health consequences of smoking as “tobacco related harm” misinforms the public by wrongfully implying that all tobacco products carry the same risks as smoking. It is imperative that we have a constructive conversation about the relative risks of nicotine delivery products and consistency in our communications about the risks of consuming different tobacco products.

To underscore this point, the other statements that PMI is seeking approval for are consistent among one another in their focus on the fact that IQOS reduces the production of and exposure to harmful and potentially harmful constituents. PMI is not seeking approval to market IQOS as an alternative to low-risk products like smokeless tobacco, vapor products, or other smoke-free nicotine products. Therefore, marketing claims should not reference an outdated and politically motivated understanding of tobacco related harm. IQOS is a lower-risk alternative to smoking and marketing statements should narrowly focus on this fact.

CASAA strongly recommends that PMI amend the their proposed marketing language to read “smoking related diseasesand  that FDA allow this small but vital change.

We also question the wisdom of PMI’s self-imposed prerequisite that a consumer must be a smoker in order to purchase IQOS. It is unclear from the application materials whether or not IQOS might provide a protective or deterrent effect for at-risk never-smokers or former smokers who might relapse. CASAA believes that enforcing a “smoker test” may ignore a small but not insignificant group of consumers who are (for whatever reason) contemplating starting smoking and should have access to low-risk products instead of feeling that smoking is their only option.

Again, thank you for the opportunity to speak with you today and we urge the committee to issue a favorable recommendation to FDA regarding approval of PMI’s MRTP applications for the IQOS System.

  • Meeting materials for this TPSAC meeting are available here.

This article was originally published at CASAA
Author: Alex Clark

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CASAA to Address TPSAC Regarding Modified Risk Product

(Silver Spring, MD)

On January 24-25, 2018, the Tobacco Products Scientific Advisory Committee (TPSAC) will discuss modified risk tobacco product applications (MRTPAs), submitted by Philip Morris Products S.A. for the IQOS Heatsticks systems. TPSAC reviews and evaluates safety, dependence, and health issues relating to tobacco products and provides appropriate advice, information and recommendations to the Commissioner of Food and Drugs. IQOS is a “heat not burn” technology that will​ ​benefit​ ​the​ ​health​ ​of​ ​the population​ ​as​ ​a​ ​whole.​ As with vapor products and smoke-free tobacco, IQOS does not expose consumers to the greatest source of health risk associated with tobacco: the smoke.

CASAA submitted a comment to TPSAC in support of MRTPA on January 3rd, which can be read in full below or click here. CASAA CEO Alex Clark has been accepted to address the Committee during the public comment period on January 25th. To watch the proceedings live, click the links below. (A free download of Adobe Connect is required to view the live stream.)

Wednesday, January 24th, 8:00 AM – 5:00 PM

Thursday, January 25th, 8:00 AM – 3:00 PM (Public comment begins at 8:00 AM)

TPSAC MRTP Application Philip Morris

This article was originally published at CASAA
Author: KNoll-Marsh

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Modernize the Predicate Date for Vapor Products!

By January 19th, Congress will need to come up with a plan to continue funding the government. This could be just another continuing resolution or we could be looking at real budget talks happening in the coming weeks. In either case, today, we have an opportunity to urge support for predicate date change language in the appropriations side of the 2018 budget.

Sending this message to Congress is even more important now in the wake of rogue efforts by some in the industry who don’t understand the need to modernize the 2007 predicate date. Their fundamental misunderstanding of the Cole-Bishop language in the appropriations bill (Sec. 753) is creating confusion among our supporters and eroding relationships that have taken years to build.

At the same time, those of you who live in districts represented by a co-sponsor of the stand-alone version of the predicate date change (HR 1136) will be sending a thank you message. As much as some in Congress need encouragement to support us, those who are already on our side need to hear that we support them.

Help us show Congress that we are unified in our support for changing the predicate date to August 8th, 2016 and that we are in favor of reasonable regulation that preserves consumer choice.

This article was originally published at CASAA
Author: KNoll-Marsh

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CASAA Submits Comment to OMB Regarding CDC Campaign

Focus put on misleading “Tips From Smokers” campaign

In October 2017 the Centers for Disease Control and Prevention (CDC) submitted an information collection request titled “National Notifiable Diseases Surveillance System” to the Office of Management and Budget (OMB) for review and approval. The OMB subsequently requested comment from the public to determine whether or not the collection and evaluation of information generated from the CDC’s National Tobacco Prevention and Control Public Education Campaign (“The Campaign”) should continue to receive funding.

CASAA took this opportunity to make a strong statement condemning the misleading “Tips From Smokers” campaign, which included ads such as the ad pictured at the right. That particular ad included an accompanying story that stated “Months after using e-cigarettes, she ended up in the hospital with a collapsed lung…. Such wording was clearly an attempt to link her medical condition to the use of vapor products, rather than the fact that she continued to smoke up until her hospitalization.

In our comment to OMB, CASAA  noted:

  • The Campaign features misleading and inaccurate claims.
  • The Campaign is ineffective as designed and reported to date.
  • The Campaign does not adequately address the public health needs in that it promotes abstinence only, ignoring the lower opportunity costs along a continuum of risk reduction. 

CASAA recommended that The Campaign, “Tips from a Former Smoker,” be suspended and reworked to more adequately and truthfully educate the public. This will empower the smoking public to make a more informed choice about their tobacco use and health decisions.

CASAA strongly urged OMB to deny CDC’s request:

“It is time for the CDC to face the fact that The Campaign is inadequate to the task of promoting harm reduction in the smoking population. It is time that CDC change its focus from a nearly religious adherence to abstinence and align its mission with the core principle of public health – reduce the harm to the whole population, including smokers, through the promotion of harm reduction policies. It could do this best by recalling and retooling The Campaign towards promoting less harmful alternatives to combustible tobacco rather than presenting smokers with “Quit or Die” propaganda.”

The comment may be read here in its entirety:

Comment on CDC FR 2017-21122Comment on CDC FR 2017-21122.docx

This article was originally published at CASAA
Author: KNoll-Marsh

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