Senator Johnson Calls on FDA to Halt Implementation of E-Cigarette Deeming Regulations Pending the New Administration

In a letter written last week to the FDA, Senator Ron Johnson (R-WI) called on the FDA to halt implementation of the e-cigarette deeming regulations pending the change in administration coming this January.

Senator Johnson wrote: “The incoming administration and the 115th Congress will likely re-examine and unwind burdensome regulations imposed by the Obama Administration. The U.S. Food and Drug Administration’s (FDA) deeming regulations of e-cigarettes is a primary example of a rule that could eliminate an entire nascent industry. Accordingly, given the substantial likelihood that this burdensome rule will be undone, I urge the FDA to cease implementation of its deeming regulation to spare the growing e-cigarette industry unnecessary and avoidable compliance costs that it currently faces.”

The Rest of the Story

I do not generally agree with Republican calls for a loosening of public health regulations, but in this case, I wholeheartedly agree with Senator Johnson. The FDA e-cigarette deeming regulations are unduly burdensome and will result in the decimation of the e-cigarette industry, putting thousands of small vape shops and companies out of business and protecting cigarettes from competition from a much safer product. Moreover, the deeming regulations violate the free speech rights of e-cigarette companies, prohibit the companies from taking steps to improve the safety of their product, and force companies to lie to consumers about the primary benefits of their products. This is a public health mess, and it does need to be unraveled.

The good news is that it appears that the new administration, or at least the new Congress, are planning to conduct a serious re-examination of the regulation of electronic cigarettes. Therefore, it is possible that we may be able to come out of this with more than just the Bishop-Cole “emergency” measure that would salvage the industry. Instead, it is possible that we can achieve a more sensible regulatory framework for e-cigarettes, one that treats these products completely differently from tobacco cigarettes, allows smoking cessation and modified risk claims to be made, eliminates the burdensome pre-market applications, and instead, sets safety standards for these products to ensure uniform safety and quality control, thus maximizing the benefits of vaping products while minimizing the risks.

This presents an important opportunity for vapers to make their voices heard. While CDC director Dr. Thomas Frieden views vapers only as “anecdotes,” their collective experiences truly represent data that can help inform policy. Vapers need to share their experiences with members of Congress, especially members of the Senate Homeland Security and Government Affairs Committee, so that they will be able to separate out the fact of their experiences from the fiction that so many anti-smoking groups and health agencies have been spreading.

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New Study Shows the Blatant Bias in Modern-Day Tobacco Control Research and Demonstrates Why You Need to Look at the Actual Data

A new study published online ahead of print in the journal Tobacco Control purports to demonstrate that a smoke-free bar and restaurant law implemented in San Paulo, Brazil in August 2009 resulted in a 11.9% decline in the heart attack death rate for the first 17 months after the law was in effect (through December 2010).

The paper used a time-series analysis to compare the monthly rate of heart attack deaths prior to the smoking ban to the rate after the ban was implemented. The baseline period was January 2005 through July 2009. The implementation period was August 2009 through December 2010. Thus, the researchers had data for approximately 5 1/2 years before the ban and for 17 months after the ban.

The paper concluded: “In this study, a monthly decrease of almost 12% was observed in mortality rate for myocardial infarction in the first 17 months after the enactment of the comprehensive smoking ban law in São Paulo city.”

The methods used in the study are quite complex and are summarized as follows: “We performed a time-series study of monthly rates of mortality and hospital admissions for acute myocardial infarction from January 2005 to December 2010. The data were derived from DATASUS, the primary public health information system available in Brazil and from Mortality Information System (SIM). Adjustments and analyses were performed using the Autoregressive Integrated Moving Average with exogenous variables (ARIMAX) method modelled by environmental variables and atmospheric pollutants to evaluate the effect of smoking ban law in mortality and hospital admission rate. We also used Interrupted Time Series Analysis (ITSA) to make a comparison between the period pre and post smoking ban law.”

In simple terms, the investigators compared the trend in heart attack deaths in San Paulo before the smoking ban to the trend in heart attack deaths in San Paulo after the smoking ban. They concluded that there was an 11.7% drop in the heart attack death rate in the 17 months following the implementation of the smoking ban.

The investigators attributed the observed decline in heart attack deaths to a reduction in secondhand smoke exposure, citing evidence that just 30 minutes of exposure to secondhand smoke can cause a heart attack.

The Rest of the Story

To demonstrate the blatant bias in the reporting of the study results, simply take a look yourself at the actual data from the study. Below, I have plotted the data from Table 2 (Monthly number of deaths for myocardial infarction, city of São Paulo, Brazil, January 2005 to December 2010), but I have added the monthly numbers to yield annual figures, which smooths the data making it much easier to inspect visually.

The smoking ban went into effect in August 2009. You can easily see from the figure that in 2010, there was a striking increase in the number of heart attack deaths, which reached an all-time high for the study period.

Somehow, it appears that all this fancy modeling yielded a completely spurious result. This is why I teach my students to always start out by looking at the actual data. When you put the data into a fancy statistical model, strange things can happen. You always need to make sure that the results of a statistical model are consistent with what you are observing visually when you look at the data. If there is a major inconsistency, as in this case, then you must suspect that something is wrong: namely, that the statistical technique is for some reason not modeling the data correctly. It is also possible that the data are wrong. But clearly, something is wrong here.

Here, an examination of the actual data reveals that there is absolutely no basis to conclude that the smoking ban resulted in an 11.7% decline in heart attack deaths.

But why did nobody see this? It’s difficult to believe that the authors didn’t see it, the reviewers didn’t see it, and the journal editorial team didn’t see it. This should in fact be the first thing that everybody looks at. Even if you just look at the data in Table 2 without plotting it out, it is immediately apparent that there was a striking increase in heart attack deaths in 2010, wiping out the possibility that the smoking ban led to a large and sustained decline in heart attack deaths through 2010.

It appears that either nobody looked at the actual data or that they looked but ignored it. Either way, this demonstrates a severe bias on the part of the investigators, reviewers, and editorial team. Had the study found no effect of a smoking ban, you can rest assured that everyone would have scoured over the paper for hours, trying to find some explanation for why the results came out “wrong.” But here, since the results were “right” (that is, favorable), it appears that there was no desire to sincerely “review” the paper.

Finally, it is critical to mention that even if the paper had found a decline in heart attack deaths in 2010, this would not justify the conclusion that the smoking ban caused a decrease in heart attacks. The critical and fatal methodological flaw of this paper is that there is no comparison group. It is very possible that heart attack death rates were declining during the study period anyway, even in the absence of smoking bans. We actually know this to be the case from abundant international data. To conclude that the smoking ban had an effect on heart attacks, one would need to first control for secular trends in heart attack mortality that were occurring anyway, independent of the smoking ban. The paper could easily have done this by including some comparison group — such as a nearby city, the county, the state, or the country. But there needs to be some control for secular trends.

Thus, even if this paper had convincingly demonstrated that there was a decline in heart attacks in San Paulo after the smoking ban, it would not have been valid to conclude that this was a causal effect. Without a comparison group, this study is as good as worthless.

When the tobacco industry used to put out studies like this to show that smoking bans cause massive losses of revenue for restaurants, we attacked them for conducting time series analyses without using an appropriate control group. Now it appears that we are doing the same thing ourselves. This certainly has the appearance of a severe bias: results that are “favorable” are correct and the methodology is automatically valid and those which are “unfavorable” are incorrect and the methodology must be attacked.

Perhaps one of my great frustrations of 2016 is the way in which science has largely disappeared from the public policy agenda. Decisions are being made almost completely on political grounds. IT is a bad enough state of affairs that we in public health don’t need to contribute to it. Even though we are working for worthwhile causes, we cannot let loose our insistence on rigorous science. Once we do that, then we’re really sinking to the level of our opponents.

Finally, I should make it clear that any failure of this study to detect an immediate decline in heart attack deaths does not affect my support for smoke-free bar and restaurant laws. It’s just that in promoting such laws, I believe we need to rely upon solid scientific data, not hocus pocus that comes out of some complex statistical model that no one really understands and which ends up completely misrepresenting the actual data — data that one can see with one’s own eyes.

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CASAA Newsletter No.3 (July 2016)

Newsletter


July 2016

Top


**Urgent!**

The Child Nicotine Poisoning Prevention Act (CNPPA) of 2015 will take effect on July 26th, 2016. CASAA is recommending that members ask retailers if they know whether they will be carrying products that will be compliant with this new law. Details on this issue are below in our “legislative update” section.

FDA

FDAOn May 10th, 2016, The Food and Drug Administration officially published their “deeming regulations” in the Federal Register. The official publication started the 90-day countdown to the effective date (August 8th, 2016) and various compliance deadlines. Despite the fact that CASAA has been sounding the alarm about this day since 2010, the advance awareness of the deeming regulations has not made their finalization any easier to digest by the community. The past month has been an emotional rollercoaster for our membership and the community at large. If left unchallenged, the impact of the FDA deeming regulations will be devastating to both the vapor industry and public health. It would be an understatement to say that CASAA is deeply concerned about, and critical of, the FDA’s decision to move forward with these regulations.

In the past several weeks, efforts to push back against the regulations have started to take shape. But it should be made clear that the operative word here is “started.” CASAA acknowledges that developing useful regulation that will replace what the FDA is implementing requires a sustained effort over many years. The legal, political, and public awareness process is a long one, and our participation must be deliberate and thoughtful.

There are legislative strategies at work which we discuss later on in this newsletter.

Multiple lawsuits have been filed which seek to challenge specific provisions of the new FDA regulations. CASAA has pledged our support to one lawsuit in particular (here) that was filed on behalf of The Right to be Smoke-Free Coalition (RSF) and ten other complainants. Within the past week, this lawsuit has been combined with another suit (here) filed on behalf of Nicopure Labs, LLC.

Public relations campaigns such as the No More Casualties campaign are also being developed to better inform the public about the significant beneficial contribution that vapor products are making to public health.

It is critical for advocates to understand that different angles of attack are vital. It seems to be in our nature as humans to want to “back a winning horse,” so to speak. However, we are not talking about a race here. Amending existing laws and regulations and developing new ones that are beneficial to consumers, industry, and public health is a long and thoughtful process.

Misinformation

Community Rumors

Traditionally, this section is reserved for deliberate misinformation campaigns which are intended to confuse the public and policymakers about the risks associated with vaping. However, the vaping community has recently become painfully aware of misinformation originating from within its own ranks. Specifically, many members of the community have been misled to believe that the effort to gain co-sponsors for HR 2058 is a lost cause and, as such, should not be promoted.

On the contrary, HR 2058 continues to gain cosponsors and is part of a long-term effort to change the 2007 predicate date applied to new tobacco products by the Food, Drug, and Cosmetics Act. In fact, with the addition of Representative Collin Peterson (D-MN), HR 2058 is now considered a bipartisan bill. Moreover, although not specifically addressed by this legislation, urging support for this bill is important in our messaging efforts to change hearts and minds in Congress about the critical need to develop appropriate regulation for vapor products.

While it is unlikely that HR 2058 will advance successfully through the legislative process this year, it is wildly inaccurate and irresponsible to suggest that support for this bill is a “lost cause.” The simple truth is that support for this legislation will carry over to 2017 when the language (possibly with some additional language) is reintroduced and renumbered. CASAA also believes that it is unwise to put all of our resources behind one legislative strategy, especially when they are not mutually exclusive. Accordingly, CASAA will continue to offer support for not only HR 2058, but also for the Cole-Bishop Amendment to the Agricultural Appropriations Bill.

FDA Deeming Rumors

Speculation abounds regarding compliance deadlines and what this will mean for vapor retailers and manufacturers. Consumers are increasingly becoming aware that August 8th, 2016 is the effective date of the deeming regulation. Although three very important things happen on this date, they are unlikely to impact consumer access to vapor products in a substantial way.

First, August 8th 2016 is the start of the 24-month grace period for manufacturers to file their premarket tobacco applications (PMTA). For any new vapor product to be introduced to the market after August 8th, manufacturers will be required to file a PMTA with no grace period to allow for marketing before the application is granted. What this means is that as a practical matter, there will be no new products on the market after August 8th. August 8th, 2018 is the deadline for PMTAs for any product not on the market prior to February 15th, 2007.

Second, sales to minors will be prohibited in all 50 states. Although it is not clearly spelled out in the deeming regulations, online retailers will be required to use some sort of age verification process in order to prevent sales to minors through the mail. This will possibly include using a “signature on delivery” service provided for a fee by major carriers (FedEx, UPS). If you are accustomed to ordering your products online, you can expect to pay more now. Although signature on delivery is not a requirement — yet — online retailers may decide that requiring this service is the best way for them to be compliant. Unfortunately, this means that anyone under 21 will be unable to receive online purchases as these sign on delivery services were developed to accommodate alcohol shipments.

Third, although not something that has an immediate impact on consumer access, it is important to point out that the federal government now considers vapor products to be “tobacco.” Many in the community are speculating about how this definitional change affects state law. The rule of thumb to keep in mind is that states will need to update their definitions of tobacco in the various parts of their code on their own. Changing the federal definition of “tobacco” does not automatically change the definition for states.

Projects

10000CASAA’s Testimonials Project, has collected over 10,000 stories and continues to grow. We are working toward collecting testimonials with more detail so that we can provide state specific numbers to state and regional advocacy organizations that will assist them in their advocacy efforts.

Although not a CASAA project, The Vape a Vet (VAV) Project has been providing vapor products for free to veterans and active duty service members for three years now. Sadly, the FDA deeming regulation is having a negative impact on VAV and making it more difficult to provide this lifesaving resource to our nation’s bravest. When considering where to send your donations, please keep VAV in mind. You can learn more about the project and how to donate here.

Register to Vote before your state’s deadline! . . . and then, make sure you vote! Exercising your right to vote is vital to any advocacy effort. Engagement from voters carries weight with lawmakers as they consider input on legislation that comes before them. Lawmakers are not be able to see how you vote, but they will certainly check to see if you are voting.

Legislative Update

Although a lot of focus has shifted to the FDA deeming regulations, it is critical that consumers and vapor businesses are aware of other federal and state laws that will be taking effect soon.

National

Probably the most important law for consumers and retailers alike to be aware of is the Child Nicotine Poisoning Prevention Act of 2015 (CNPPA) which takes effect on July 26th, 2016. Consumers and retailers need to understand that there are specific testing protocols which are described in Title 16 CFR, §1700.20. Although child-resistant packaging exists in other parts of the world, it may not meet US Federal guidelines. In order to sell bottled e-liquid after July 26th, 2016, it must be sold in child-resistant packaging that is compliant with the US Code of Federal Regulations (CFR).

The Consumer Products Safety Commission (CPSC) has sent letters to several retailers notifying them of the new law and what they need to do in order to be compliant. You can read the letter here and share it with retailers in your area that may not be aware of the new law.

Pennsylvania

NO_PA_VAPOR_TAX.jpgReminiscent of 2016’s state budget drama, the 2017 budget has failed to be completed by the June 30th deadline. Although the legislature has sent a completed appropriations package to Governor Wolf, the revenue portion of the budget remains incomplete. An estimated 400,000 vapers in the Keystone State should be aware that there are two tax proposals for vapor products that are on the table. For more details, please see our active call to action for Pennsylvania here.


California

On May 4th, 2016, Governor Jerry Brown signed into law a package of bills that will affect how vapor products are sold and where they can be used. SBX2-5 and SBX2-7 will take effect on or before January 1st, 2017. Among other things, this legislation will raise the minimum legal purchase age for all tobacco products, which will include vapor products, from 18 to 21. The use of vapor products will also be prohibited in the same places where smoking is currently banned.

The new California laws raises an important point for all vapor consumers to understand in regards to the FDA deeming regulations. Even though the federal definition of “tobacco product” now applies to vapor products and devices reasonably expected to be used in the delivery of nicotine, in most cases, this will not automatically affect various state laws. We can expect a great deal of proposed legislation as many states seek to amend their laws in order to subject vapor products to existing tobacco regulation. The federal definition does not preempt state laws with regard to enacting stricter regulations on “the sale, distribution, possession, information reporting to the State, exposure to, access to, the advertising and promotion of, or use of, tobacco products by individuals of any age, or relating to fire safety standards for tobacco products.”

Utah

Effective July 1st, 2016, ALL ONLINE SALES TO CONSUMERS IN UTAH ARE PROHIBITED.

Vermont

On May 16th, 2016, Governor Peter Shumlin signed into law H.171 (Act 108) which prohibits the use of vapor products in the same places where smoking is banned. However, thanks to the consistent and repeated efforts of advocates in Vermont, the bill was ultimately amended to include an exemption for vapor shops and vapor lounges.

West Virginia

On June 12th, 2016, the West Virginia legislature passed SB 1012 which enacts a 7.5¢ per milliliter tax on e-liquid regardless of nicotine content (§11-17-4b). West Virginia is only the fourth state to enact any extra tax on vapor products. The effective date of this law is July 1st, 2016 and the first payments to the Tax Commission are due on August 15th, 2016. Taxes are only being collected on product that is sold starting with July 1st. For businesses outside of West Virginia, it is unclear whether they will be required to register with the state as tobacco dealers for the privilege of selling into the state. The appropriate forms and procedures are still being developed by the Tax Commissioner. At this time, the best advice for businesses wishing to continue doing business in West Virginia — other than consulting with legal council — is to contact the tax commission.

Indiana

Manufacturing regulations took effect on July 1st, 2016, affecting not only brick-and-mortar sales, but also online sales. For some in Indiana this has meant closing their businesses, while others face uncertainty as to how long they can remain open. In either case, the effect on consumers has been a loss of access to a significant portion of the diverse vapor industry.

The legal challenge to the Indiana regulations continues and politicians have promised to revisit the law in 2017. There is also debate over whether or not the law is sufficiently preempted by the FDA Deeming regulations. Unfortunately, substantial damage has already been done, and many in Indiana will not recover from the unnecessary and overreaching manufacturing standards that have gone into effect.

Rhode Island

Although several anti-vaping bills were introduced this year, the legislature has concluded their session without passing any anti-vaping legislation.

New York

On June 17th, the legislature concluded their session without passing any anti-vaping legislation.

Current

National

US – Take action to change to the predicate date for vapor products newly deemed as tobacco by the FDA

Updated – 05.18.16 CASAA is urging our members to support both HR 2058 and the Cole-Bishop…

States

PA – Take action to oppose a 40 percent wholesale tax on vapor products.

A 40% wholesale tax on vapor products is most likely back on the table as Pennsylvania legislators…

Local

Although there are no active local alerts at the time of this writing, CASAA urges members to pay close attention to local efforts to restrict where vapor products can be used and sold. It is also possible that some municipalities and counties will seek to enact taxes on vapor products.

Members are advised to monitor activities of anti-smoking activist groups and be on the lookout for events like informational town hall meetings that are advertised as informing the public about e-cigarettes. These events are typically a precursor to anti-vaping legislation being introduced at the local level.


In
“A Billion Lives”

On May 11, “A Billion Lives” had its world premiere in Wellington, New Zealand. CASAA has had several opportunities to meet with and get to know Director Aaron Biebert and some of the crew working on this documentary. We are very excited the film has been released and now people will finally be able to see it. The film recently had its European premiere at the Palace of Culture in Warsaw, Poland on June 16. This was a special showing for the delegates of the Global Forum on Nicotine. Our Director of Scientific Communications, Brian Carter, attended the premiere and says “everyone, vapers and non-vapers alike, should see this film. The level of dogmatic bias, dishonesty, and self-serving motives by those in power in an attempt to destroy a safer alternative to smoking is truly staggering.”

The documentary will have its North American Premiere on August 6th, 2016 in Milwaukee, WI. Tickets went on sale July 6th. For details, please visit the A Billion Lives Facebook page. Be sure to give them a like on Facebook and a follow on Twitter.


Join
Upcoming Events CASAA will be attending:

July 16th: United Vape Groups of Illinois – Wood River, IL

August 5th – 6th: Vape Deadwood – Deadwood, SD
August 19th – 21st: The Vape Showcase – Dallas, TX

Seminars at which CASAA presented:

June 17, 2016 in Warsaw, Poland – Global Forum on Nicotine This multi-stakeholder event (which last year had participants from 44 countries) includes policy analysts, regulators, academics, researchers, public health professionals, consumer advocates, and makers and distributors of alternative nicotine products – all with an interest in nicotine and its uses. Brian Carter, Director of Scientific Communications for CASAA, presented on the importance of non-nicotine pleasures (e.g., flavor, throat hit) for tobacco and e-cigarette users.   


Cassa

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CASAA Newsletter No. 4 (November 2016)

November 2016

Autumn 2016

This installment of CASAA’s newsletter was originally intended to come out in October. But, we were on an RV traversing the country lending the consumer voice to raising awareness about tobacco harm reduction and the legislative challenges we’ll be facing in 2017. Of course, in the wake of the US general election, we are looking at a significantly different political landscape at the federal level. The changes in our government will likely have a profound impact on regulations that affect our access to vapor products and other low-risk tobacco products.

In advance of the 2017-2018 legislative sessions, CASAA will be co-hosting a webinar with The Cating Group this December. Topics will include a preview of anticipated state legislative threats, the importance of meeting FDA compliance deadlines such as the upcoming registration and product listing requirement, and potential opportunities at the federal level to not only modernize the predicate date but also to fundamentally change how low-risk alternatives to smoking are regulated. This webinar will be free and open to all. If you know anyone interested in attending, please make sure they are signed up to receive updates from CASAA. They can register here.

2016 Election

2016 marked the inaugural release of CASAA’s Voter Education Guide — THRvoter.org. Of more than 1,000 candidates running for US Congress, we received over 130 responses. Although the response to our survey wasn’t as high as we would have liked, it was more than we expected for a first-time effort.

Heading toward mid-term elections in 2018, we will be working to expand our voter guide to include state elections, similar to what our Kansas City chapter put together this year. If you are interested in helping CASAA with this state-level deployment, please contact us at takeaction@casaa.org. Please include “State CQ” in the subject line.

Several states were faced with ballot initiatives this year that dealt with taxes on vapor products and/or smokeless tobacco. In California, Proposition 56, which was sold to voters as a necessary hike in cigarette taxes, will enact an equivalent tax of 60-70% wholesale on vapor products sold in the state. Even though Prop 56 passed, it is still unclear what the tax rate will be or even how it will be applied. On the other hand, Colorado (Amendment 72) and North Dakota (Measure 4) both voted down ballot initiatives that dealt with taxation of vapor/tobacco products.

Prior to the election, the outlook for the vapor industry appeared grim. However one might feel about the results of the US elections, the consensus is that there is a more visible pathway forward to enact genuinely beneficial regulation that will not stifle innovation or limit diversity. Our task going forward will be to help build these regulations and make sure they are built to last.

Despite the obvious political gains at the federal level, we are still anticipating that many states will move to enact taxes on vapor products as well as impose stiffer regulations. We also continue to be concerned that more state and local public health departments will be spearheading misinformation campaigns that discourage smokers from making the switch and help drive bad legislative and regulatory policy.

FDA

With the new White House administration, it is likely that we will see notable changes of key personnel in regulatory agencies. There is no confirmation of this yet, but President-elect Trump signaled late in the campaign that his administration would be working to undo regulations that unfairly restrict small- to medium-sized businesses. Even though this is on the horizon in 2017-2018, the deeming regulations are still at present the law of the land, and vapor businesses should be working toward compliance.

Product registration is a major compliance deadline that is right around the corner in December (the 31st, to be precise). This article by Azim Chowdhury helps explain that process: “FDA’s Establishment Registration and Product Listing Deadline is Fast Approaching – Are You Prepared?”

If you are receiving updates from the Food and Drug Administration or generally paying attention to breaking news in the vaporsphere, you may have seen the headline “FDA Withdraws Direct Final Rule Describing Acceptance Threshold for Tobacco Product Applications.” Many have misinterpreted this to mean that premarket tobacco approval (PMTA) is no longer necessary. Some have even taken this to mean that the entire deeming rule has been withdrawn. Both of these interpretations are incorrect.

Simply put, the FDA has accepted feedback they received during the comment period for this particular rule. This feedback highlighted not only the unreasonably high standards the agency was setting for submitting a PMTA, but also the fact that submissions with critical errors would not have the opportunity to be corrected. By withdrawing this proposed rule, the FDA is acknowledging the need for the agency to rework this particular stage of the PMTA submission process. Again, the deeming rule that was published on May 10th, 2016 is still in effect, and industry stakeholders should be taking steps to comply if they wish to remain in business.

Misinformation

The Pasadena Public Health Department (PPHD) has received a $1.3 million grant from the CDC for a media campaign that is targeting the city’s minorities and misinforming them about the risks of vapor products. Like other campaigns we’ve seen in the past, the PPHD is trafficking in shame and ridicule in a misguided effort to pressure smokers to quit and to discourage smokers from making the switch to low-risk vaping.

If you would like to review the campaign for yourself, you can do so here. If you would like to share your thoughts with PPHD regarding this campaign, you can send your comments to

Pasadena Public Health Department

1845 N. Fair Oaks Ave

Pasadena, CA 91103

Or call: (626) 744-6014

Please be respectful and focus on your experience with vapor products. If you have family members who are willing to share their perspective on your experience, please encourage them to call or write as well.

Projects

The Right to Vape Bus Tour

The RTV Tour started on October 2nd in Las Vegas, NV. CASAA, along with the American Vaping Association (AVA) and the Smoke-Free Alternatives Association (SFATA), took to the road to spread awareness about vaping and what’s needed in congress to protect our access to vapor products. There are three videos that were produced during the tour with a fourth on the way. Please take a moment to watch and share.

Chapters

In July, CASAA announced the creation of our first chapter in Kansas City, MO. You can read more about the chapter program here. In September, we announced that Kristin Noll-Marsh, a founding member of CASAA, would be stepping down from the Board of Directors to accept the new position of Chapter Coordinator.

We are excited for both Kristin’s new role and the formation of the Kansas City Chapter. We will be working to develop the program in 2017 in order to establish more chapters around the country.

CASAA’s Testimonials Project, has collected more than 10,000 stories and continues to grow. We are working toward collecting testimonials with more detail so that we can provide state-specific numbers to state and regional advocacy organizations that will assist them in their advocacy efforts.

Register to Vote

Exercising your right to vote is vital to any advocacy effort. Engagement from voters carries weight with lawmakers as they consider input on legislation that comes before them. Lawmakers are not able to see how you vote, but they will certainly check to see if you are voting.

Legislative Update

National

Going into the 2016 election, the clear legislative strategy was to support including predicate date change language in the omnibus budget bill. Many expected the contents of an omnibus spending bill to be decided in early to mid-December. However, the incoming administration and Republican-controlled congress are making a decision to delay this until spring of 2017. As a result, the vehicle for the predicate date change language — the Cole-Bishop amendment — is no longer in play. However, there is still value in referencing the language when communicating with lawmakers on this issue.

Although modernizing the predicate date is not likely to happen this year, it is still a necessary step toward developing useful and fair regulation and support for this effort is ongoing. The larger effort will be focused on creating a separate category for low-risk products. With a more sympathetic government, developing this new regulatory regime is now more likely.

Pennsylvania

The Pennsylvania General Assembly will reconvene on January 3rd. Efforts by advocates in the state to change the tax on vapor products are continuing. Tentatively, a rally has been scheduled for the end of January in Harrisburg. We will share updates as plans for the rally become more solid.

Pennsylvania’s vapor tax took effect on October 1st, 2016. The law now requires retailers to pay a 40% wholesale tax on all vapor products. This tax is collected by licensed wholesalers, distributors, and manufacturers selling direct to retailers. Retailers were also required to take an inventory on October 1st and pay a 40% tax on everything they had in stock. This floor tax is due at the end of December 2016. In addition to the taxes imposed on retailers, consumers purchasing from unlicensed out of state retailers are required to report their purchases to the state and pay a 40% tax on the retail price of what they buy. The report and payment are due at the end of every month following a month during which vapor products were purchased.

California

Proposition 56, which will impose a tax on vapor products equivalent to the tax on cigarettes, passed by a wide margin. The Board of Equalization will be determining the details of the tax rate and how this new tax will be applied to vapor products.

National

US – Take action to change the predicate date for vapor products newly deemed as tobacco by the FDA

States

36 states allow for pre-filing legislation. Currently, there is no vapor related pre-filed legislation. But, pre-filing periods will begin in nine states in December. You can find a full list of state legislative session start and end dates for 2017 here.

Local

Columbus, OH – Take action to oppose misguided Tobacco (and Vapor) 21 ordinance

Allegheny Co, PA – Take action to oppose an indoor vaping ban

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Where Can I Vape? [UK Edition]

The following is a guest post by Carolyn.  As always, opinions are those of the author Where Can I Vape? There are an estimated 2.6 million e-cigarette users or vapers in the United Kingdom with the majority of these being ex-smokers like myself. I personally smoked 40 plus cigarettes a day for 33 years and […]

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CDC-Funded Pasadena Health Department Campaign Calls Vapers "Stupid Sheep"; Rest of the Story Calls for a Public Apology

Federal taxpayer money is being used in a campaign that calls vapers “stupid sheep,” according to an article in the Pasadena Independent. The article reports that a major print advertisement in the campaign contains a headline that reads: “Don’t follow the herd. Vaping effects are unknown, stupid sheep.”

An article in the San Gabriel Valley Tribune also reports that: “The advertisements compare e-cigarette users to ‘stupid sheep.'”

The campaign is being funded by the Centers for Disease Control and Prevention (CDC).

The Rest of the Story

There really is no place for a campaign like this in public health. We should never call people stupid. Even if people are making poor health choices, it does not mean they are stupid. And we have no business calling them stupid. This gives public health a bad name and harms our reputation. It also undermines the public’s appreciation of what public health is really about.

In this case, there are some very good reasons why many people choose to vape. I don’t consider any of these to be “stupid.” Which of the following does the Pasadena Health Department consider stupid?

  • The desire to save one’s life by quitting smoking using e-cigarettes.
  • The desire to reduce one’s risk of debilitating disease by switching from smoking to vaping.
  • The desire to protect people around you by switching to vaping.
  • The desire to improve symptoms of asthma by getting off cigarettes using vaping products.

The rest of the story is that it is actually the Pasadena Health Department which is “pulling the wool” over people’s eyes (if there is any sheep-like behavior going on) by equating vaping with smoking.

In public health, we view the public as our “clients,” in a sense. They are not our enemies. We do not attack them or insult them. So we don’t ever call them stupid.

I call on the Pasadena Health Department to discontinue these advertisements and to apologize to all vapers. In addition, the CDC should make it clear to all grantees that it will not fund any health campaigns that call members of the public “stupid.”

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New Study on E-Cigarettes and Bronchitis: An Example of Scientific Dishonesty and Deception

A new study published online ahead of print in the American Journal of Respiratory and Critical Care Medicine along with a press release issued by the American Thoracic Society (publisher of the journal) conclude that youth use of electronic cigarettes contributes to “the burden of chronic respiratory symptoms in youth.” Specifically, the research concludes that there appears to be a causal relationship between e-cigarette use and “chronic bronchitic symptoms (chronic cough, phlegm or bronchitis)” among youth.

According to the press release: “E-cigarette use among teenagers is growing dramatically, and public health experts are concerned that these devices may be a gateway to smoking. Now, new research indicates that even if these young e-cigarette users do not become tobacco smokers, e-cigarettes may harm their health.”

One of the study authors was quoted in the press release as stating: “The Food and Drug Administration recently banned the sale of e-cigarettes to children under 18 years of age, and California just prohibited sale to young adults under 21. Our results suggest that these regulations and an environment that discourages the initiation of any tobacco product may reduce the burden of chronic respiratory symptoms in youth.”

While the paper considers the possibility that the relationship between e-cigarette use and chronic bronchitic symptoms may not be causal, it essentially concludes that there is most likely a causal relationship: “It is, therefore, more likely that the observed (2014) relationship of bronchitic symptoms with e-cigarette use was causal, because the e-cigarette effect estimates were unchanged after adjustment for 2010 symptoms and after restriction to adolescents with no bronchitic symptoms in 2010.”

The study involved a cross-sectional examination of the relationship between e-cigarette use and a past-year history of bronchitis symptoms and asthma symptoms (wheezing). The sample consisted of 2,086 southern California 11th and 12th graders, interviewed in 2014. Students were asked to report whether they had never used e-cigarettes, used e-cigarettes but not in the past month, or used e-cigarettes in the past month. Based on this question, they were categorized, respectively, as never users, past users, or current users of e-cigarettes. Current users were further classified into infrequent or frequent users based on whether they reported using e-cigarettes more than twice in the past month.

In the analysis, the investigators examined the relationship between the presence in the past 12 months of bronchitis or asthma symptoms and e-cigarette use. These relationships were then examined after controlling for two critical, potential confounding variables: (1) individual cigarette use; and (2) secondhand smoke exposure in the home.

The paper’s abstract (a summary of the most important findings) reports a total of five findings:

1. There was a significant positive relationship between past e-cigarette use and bronchitis symptoms (not controlling for smoking or secondhand smoke exposure).

2. There was a significant positive relationship between current e-cigarette use and bronchitis symptoms (not controlling for smoking or secondhand smoke exposure).

3. The relationship between current e-cigarette use and bronchitis symptoms was significant for both infrequent and frequent users and was stronger for frequent users than infrequent users (not controlling for smoking or secondhand smoke exposure).

4. After controlling for smoking and secondhand smoke exposure or restricting the analysis to never smokers, there was still a significant positive relationship between past e-cigarette use and bronchitis symptoms.

5. After controlling for smoking and secondhand smoke exposure, there was no significant relationship between e-cigarette use (past or current) and asthma symptoms.

The abstract also notes that the relationship between current e-cigarette use and bronchitis symptoms was “attenuated” after controlling for smoking and secondhand smoke exposure.

The Rest of the Story

What the abstract does not tell you is that there were several other important findings of the paper:

1. After controlling for individual smoking and secondhand smoke exposure, there was no significant relationship between current e-cigarette use and bronchitis symptoms.

2. Among never smokers, there was no significant relationship between current e-cigarette use and bronchitis symptoms.

3. After controlling for individual smoking and secondhand smoke exposure, there was no significant relationship between either infrequent or frequent current e-cigarette use and bronchitis symptoms, and there was no significant trend.

Why weren’t these critical results reported in the abstract? It certainly creates the appearance that the paper is trying to hide these important findings.

Moreover, it is deceptive to state that the relationship between current e-cigarette use and bronchitis symptoms was “attenuated” after controlling for individual smoking and secondhand smoke exposure. Actually, the relationship was no longer statistically significant. In fact, in none of the many analyses conducted was there a significant relationship between current e-cigarette use and any adverse respiratory symptoms – bronchitic or asthmatic – after controlling for individual smoking and secondhand smoke exposure.

In lieu of reporting these important “negative” findings, the paper instead uses the abstract to articulate the unadjusted study findings (results that do not control for smoking or secondhand smoke exposure), which are essentially meaningless because without controlling for these variables, one would actually expect to see an increase in respiratory symptoms in e-cigarette users (since we know e-cigarette use is highly correlated with smoking). So we can basically throw out the first 3 of the 5 reported results in the abstract.

What we are left with then, is that there was no association detected between e-cigarette use and asthma symptoms and that there was a positive association between past e-cigarette use and bronchitis symptoms, but not between current e-cigarette use and bronchitis symptoms. Taken as a whole, these findings do not support the conclusion that e-cigarette use has any adverse respiratory effects.

If there is no significant effect of current e-cigarette use on respiratory symptoms, then how can the study conclude that there is such an effect? The paper seems to gloss over the fact that the paper fails to find a dose-response relationship and in fact finds the opposite. Youth who use e-cigarettes frequently (at least once a month) are no more likely than never users to experience respiratory symptoms. The increase in respiratory symptoms was found only in youth who almost never use e-cigarettes!

While this study does not prove that e-cigarettes have no respiratory effects among youth, neither does it provide evidence that there is such an effect.

In fact, the headline of the paper – and its primary conclusion – should have been that there was no observed adverse effect of current e-cigarette use (including frequent e-cigarette use) on either bronchitic or asthmatic symptoms in youth vapers. Thus, there is no basis for the conclusion that electronic cigarette use contributes to “the burden of chronic respiratory symptoms in youth.”

What concerns me even more than the fact that the study conclusion appears to be severely biased is the fact that the paper and the press release are both very deceptive. The paper abstract is hiding important findings. The same thing is true of the press release. In fact, nowhere in the press release does it even mention that there was no significant relationship found between current vaping and respiratory symptoms of any kind.

The press release also emphasizes the unadjusted findings, which is going to greatly confuse reporters and lead to inaccurate reporting of the findings of the study.

The rest of the story is that essentially what we have here is an example of scientific dishonesty and apparently intentional deception of the journal readers and the public. For a movement that has devoted so much attention to attacking the tobacco industry for its deception and scientific dishonesty, I believe that we need to adhere to the highest standards of honesty and transparency in our scientific reporting. This is not happening in our reporting of the health effects of vaping, and it is certainly not happening in this study and the dissemination of its results.

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