Tobacco (and Vapor) 21 looses steam in Washington State

(Update – 03.09.18)

For the second year in a row, the Washington State Legislature has failed to advance a bill that would raise the minimum purchase age for tobacco and vapor products to 21. Thanks to participation from consumers and advocates on the ground, smokers in Washington will continue to have access to low-risk alternatives to smoking, at least for the next year.

A special thank you is in order for Washington’s Pink Lung Brigade who have worked cooperatively with CASAA to keep our members informed and engaged. THANK YOU!!

Although we are concluding this call to action as successful, we are mindful that the discussion about Tobacco 21 in Washington continues. As noted during a committee hearing last year by Representative Paul Harris (R-H017 and HB 1054’s main sponsor), enacting tobacco (and vapor) 21 would create a revenue issue for the state. As a remedy, Rep. Harris is also sponsoring legislation (HB 2165) that would make up the difference by enacting a 60% tax on vapor products.

When speaking in support of his tax bill, Rep. Harris is one of the few lawmakers who has publicly admitted that what is he proposing is “really all about the money.” While we can certainly appreciate his candid assessment, the fact remains that Washington is rejecting Tobacco 21 for fiscal reasons rather than recognizing the consequences of restricting access to and misleading consumers about safer alternatives to smoking–also a fiscal concern.

Representative Harris, although misguided, is very passionate about protecting young people. Advocates in Washington can expect to see the Tobacco 21 and accompanying tax bill resurface in future legislative sessions. CASAA urges our members to remain vigilant and continue the dialogue with lawmakers about the benefits of harm reduction.

Thank you for your participation!



Did you find this update helpful? Please consider making a donation to CASAA. We rely on contributions to provide timely information and engagements to help protect everyone’s access to life-saving, low-risk nicotine and tobacco products.
CASAA is 501(c)(4) tax-exempt organization. While CASAA is a non-profit organization and pays no income taxes on the donations it receives, contributions or gifts to CASAA are not deductible by the donor as charitable contributions for federal income tax purposes.

This article was originally published at CASAA
Author: Alex Clark

Posted in All posts, e cigarettes, News, Smokeless Tobacco, Tobacco 21, Vaping, Vaping News, Washington | Comments Off on Tobacco (and Vapor) 21 looses steam in Washington State

CASAA Newsletter – March 2018

Welcome back to CASAA’s Newsletter. We know it’s been several months since we last sent this out, but we are once again able to devote resources to delivering this to your inbox monthly. We hope you’ll find our March update useful and informative.

On a personal note, February marked my five-year anniversary of switching to vapor products and becoming smoke-free. As some may remember, 2013 marked the start of vaping’s meteoric rise in popularity. In fact, between 2013 and 2015, CASAA membership skyrocketed as consumers became aware of the regulatory threat from the FDA and state laws that jeopardize our access to these life-saving products.

On Thursday, March 1, I had the opportunity to provide written testimony on behalf of CASAA to the Rhode Island Senate Health and Human Services committee regarding a bill (SB 2228) that would include vaping in the state’s existing indoor clean air law. It dawned on me that my vaperversary (as we are fond of calling it) is an annual opportunity to share my story and my passion for protecting access to smoke-free alternatives with lawmakers. It’s the perfect opportunity for you, too.

Hopefully, by now, you are aware of CASAA’s Testimonials Project–if you haven’t already added your story, please take a moment this weekend to add your voice. The Testimonials Project is a valuable tool that CASAA uses for advocacy purposes and can even be an incredible resource for research. But sharing your story isn’t limited to a collection on the internet or even as a mention among friends. In addition to sharing your smoke-free journey with us, I want to take this opportunity to encourage all of our members to share your smoke-free anniversary with lawmakers, every year.

You can find an up-to-date list of your state and federal officials and their contact information at www.THRvoter.org. 2018 is an election year, so please take advantage of the voter registration tools on the site as well.

If you don’t have a smoke-free anniversary coming up soon–and even if you do–please add your story to an email to congress urging them to support modernizing the predicate date for vapor products. You can take action at www.August8th.org.

Thank you for your support and participation!

Alex Clark

CEO, CASAA

________________________________________

NEWS

ACS to Clinicians: Vaping is an acceptable last resort…

…but we still want it regulated like cigarettes. — In February, The American Cancer Society (ACS) published a partial change in their position on the role that vapor products can play in helping people quit smoking. By way of summary, ACS has updated their advice to clinicians regarding vapor products by recommending that “clinicians support all attempts to quit the …

Read More »

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 …

Read More »

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” …

Read More »

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 …

Read More »

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 …

Read More »

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 …

Read More »

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 …

Read More »

CASAA Addressed 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. …

Read More »

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 …

Read More »

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 …

Read More »

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 …

Read More »

CALLS TO ACTION

US – Modernize the Predicate Date for Vapor Products!

Budget negotiations are happening right now and we only have a short time to make an impression. This is the time to reach out to Congress and urge them to support us.

By March 22nd, Congress will need …

Read More »

WA – Stop Tobacco (and Vaping) 21!

SB 6048, which would raise the minimum legal age to purchase ALL tobacco and vapor products, is scheduled for a public hearing on Thursday, February 22, 2018 (agenda) 3:30 PM Senate Committee on Ways & Means (committee page) Please make plans to attend this hearing. Even if you do not plan to speak your presence is important as it demonstrates …

Read More »

UT – Stop an outrageous tax on vaping!

(Estimated end of legislative session on March 8th)

(Update – 02.22.18) On Wednesday, February 21st, the House Revenue and Taxation Committee gave a favorable recommendation to HB 88 and voted it on to the next legislative step. The favorable vote came after the bill was amended to change the proposed tax rate for vapor products from 86% to 29% of wholesale.   But this is still an unjustifiable …

Read More »

Mankato, MN rejects Tobacco (and Vapor) 21. Help us say Thank You!

(Update 02.14.18) On Monday, February 12th, the Mankato City Council narrowly rejected an ordinance that would raise the age to purchase all tobacco and vapor products from 18 to 21-years-old by a 4 to 3 vote. North Mankato’s plans to implement Tobacco (and Vapor) 21 may also be affected by this decision. The ordinance was set to go into effect …

Read More »

MD – Stop Tobacco and Vapor 21!

SB 456 would raise the age to purchase ALL tobacco and vapor products to 21-years-old. This bill is scheduled for a public hearing on Thursday, February 15, 2018 Senate Finance Committee 1:00 PM 3 East Miller Senate Building 11 Bladen Street Annapolis, MD 21401 Please make plans to attend this hearing. Even if you do not plan to speak your …

Read More »

IL – Three bills would deny adult access to life-saving vapor products!

(Update – 02.08.16) Three bills that would raise the age to purchase vapor products and other low-risk tobacco products to 21-years-old are moving on to second and third readings in the house and senate. We need your help to stop these bills from going any further. Please take action now by sending a message to your lawmakers urging them to …

Read More »

NY – Rockland County – Stop Tobacco & Vapor 21!

(Update – 02.07.18) After hearing comments from the public at Tuesday night’s hearing, the Rockland Co. Legislature has scheduled a vote for the Tobacco 21 law on Tuesday, March 20, 2018 Please continue to reach out to county lawmakers and urge them to oppose this misguided regulation. Take Action – Send a Message Legislators’ phone numbers and email addresses are …

Read More »

IN – Lafayette – Stop an indoor vaping ban!

(Concluded – Ordinance Passed)

(Update – 03.06.18)

On Monday, the Lafayette City Council voted to adopt the ordinance which bans vaping in the same places where smoking is prohibited. Although this concludes CASAA’s engagement on this ordinance, Lafayette residents are encouraged to continue voicing their opposition…

Read More »

WA – Stop vaping taxes!

HB 2165, which would add a 60% tax on the sale of vapor products, is moving quickly to the floor of the Washington House of Representatives. While most consumers will feel this increase in the form of a wholesale tax (paid by the distributor when they purchase products from manufacturers), consumers who shop online will, effectively, pay a 60% sales …

Read More »

This article was originally published at CASAA
Author: Alex Clark

Posted in All posts, CASAA Newsletter, e cigarettes, News, Smokeless Tobacco, Vaping, Vaping News | Comments Off on CASAA Newsletter – March 2018

ACS to Clinicians: Vaping is an acceptable last resort…

…but we still want it regulated like cigarettes.

In February, The American Cancer Society (ACS) published a partial change in their position on the role that vapor products can play in helping people quit smoking. By way of summary, ACS has updated their advice to clinicians regarding vapor products by recommending that “clinicians support all attempts to quit the use of combustible tobacco,” even if it involves vaping. Patients having limited or no success with other quit methods, or are resistant to using FDA approved cessation products, “should be encouraged to switch to the least harmful form of tobacco product possible.”

CASAA acknowledges that ACS’s updated position on vaping is a very small step in the right direction and appreciates that, as supporting evidence continues to emerge, they are willing to adjust their messaging to medical professionals. But when considering the entirety of ACS’s statement, it is clear that the organization is not offering an endorsement of harm reduction. Instead, the ACS continues to advocate for policies that regulate smoke-free products just like cigarettes. “The difference between the ACS message then and now is that vaping was simply bad, bad, bad; now vapor products would be good, if they weren’t bad, bad, bad. Clearly we still have a long way to go before the ACS catches up with the available science.” said Bruce Nye,RN – CASAA Board Vice-President.

As CASAA explains on its tobacco harm reduction web page:

“It is widely acknowledged that discontinuation of all tobacco products confers the greatest lowering of risk. However, approved smoking cessation methods have a 90% failure rate, when used as directed. In addition, there is a considerable population of smokers who are unable or unwilling to achieve abstinence. Harm reduction is likely of substantial benefit to these smokers and public health. Providing reduced-harm alternatives to smokers is likely to result in lower total population risk than pursuing abstinence-only policies.”

Put simply, harm reduction is all about empowering consumers to choose safer alternatives to products which are known to be hazardous rather than pushing or shaming people into abstinence.

While the ACS goes a very short distance toward acknowledging that vapor products are a less harmful substitution for smoking, they continue their campaign of exclusively negative information about vaping. By presenting information about smoke-free alternatives as an equivalent risk to smoking, they reinforce their position that complete tobacco and nicotine cessation is the only acceptable goal. Moreover, this update fails to acknowledge that smokeless tobacco products such as Swedish snus and moist snuff (which actually contain tobacco) are also very low-risk alternatives to smoking. If there is any acceptance of tobacco harm reduction in ACS’s updated position, it seems to be limited to products that ACS would like to ultimately see regulated as a medicine and marketed strictly as a means to ending nicotine use altogether.

The ACS also fails to recognize dual use of smoke-free products and cigarettes as a transitory phase. As a practical matter, discouraging “dual use” presents smokers with a one-or-the-other decision. This is a source of grave concern because human nature often dictates that we stick with the devil we know. Instead, smokers need encouragement to explore smoke-free alternatives until they find what works best for them.

From an advocacy perspective, manufacturing fear about the alleged harm of dual use works to support calls for stricter regulation on where smoke-free products can be used. While, in reality, people who use smoke-free products are obviously compliant with most smoke-free air laws, the ACS and other anti-tobacco activists have convinced many lawmakers that these products exist mainly to “circumvent” place bans. This kind of messaging from ACS reinforces the belief that smokers and vapers are social deviants who need to be separated from the general population into designated areas. This narrative is part of an enduring shame offensive that the ACS has supported for decades.

Moving forward, we expect that as evidence continues to mount about the low risk of vaping and other smoke-free tobacco products, more organizations like ACS will publish their own updated positions. CASAA urges our members to read these updates with a critical eye for details. Are anti-smoking and anti-nicotine organizations really on your side, or are they moving the goalposts to support a prohibitionist agenda? Vapers might be living smoke-free, but the ACS is recommending to your doctor that “these individuals should be regularly advised to completely quit using all tobacco products.” And if the regular badgering from clinicians doesn’t convince you to quit, ACS will continue to devote resources to forcing people to change their minds.

—–

The American Cancer Society’s position statement regarding vaping and vapor products is available here.

CASAA’s Tobacco Harm Reduction webpage – Click here.

This article was originally published at CASAA
Author: Alex Clark

Posted in All posts, American Cancer Society, e cigarettes, FDA deeming, News, Smokeless Tobacco, Smoking Cessation, Vaping, Vaping News | Comments Off on ACS to Clinicians: Vaping is an acceptable last resort…

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

Posted in All posts, deeming, e cigarettes, FDA, News, news-all, Nicopure, R2B, Smokeless Tobacco, Vaping, Vaping News | Comments Off on CASAA files Amicus Brief in Nicopure/R2B FDA Deeming Rule Challenge

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

Posted in All posts, e cigarettes, health, Miscellaneous Health Impact Studies (E-Cigarette), News, news-all, pneumonia, Smokeless Tobacco, Vaping, Vaping News | Comments Off on Real World Evidence Doesn’t Support Pneumonia Concerns

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

Posted in All posts, e cigarettes, News, news-all, Smokeless Tobacco, Vaping, Vaping News | Comments Off on Public Health England Reaffirms Support of Vaping

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 https://pacificlegal.org/case/vape-litigation.

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

Posted in All posts, e cigarettes, FDA, News, news-all, Smokeless Tobacco, Vaping, Vaping News | Comments Off on Multiple Vape Shops File Against FDA

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

Posted in All posts, e cigarettes, iqos, modified risk, News, Smokeless Tobacco, TPSACX, Vaping, Vaping News | Comments Off on CASAA to FDA’s TPSAC: PMI’s modified risk claims should go further!