Thursday, July 28, 2016

FDA Claims It Is Protecting Public Health by Keeping Slightly Altered Cigarettes Off the Market

Earlier this month, the FDA's Center for Tobacco Products (CTP) denied a substantially equivalent order for Maverick Menthol Silver Box 100s cigarettes. This means that this cigarette brand can no longer be marketed and sold in the U.S. By definition, a "not substantially equivalent" order means that the FDA has deemed that the product raises different questions of public health than cigarette brands already on the market in 2007.

Last year, CTP denied substantially equivalent orders for four Reynolds American brands: Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13 cigarettes.

The director of FDA's CTP - Mitch Zeller - boasted that these orders will help protect the public's health by making sure that cigarette products meet "the public health bar set forth under law." These orders will "protect the public from the harms caused by tobacco use," he said:

"These decisions were based on a rigorous, science-based review designed to protect the public from the harms caused by tobacco use. The agency will continue to review product submissions and exercise its legal authority and consumer protection duty to remove products from the market when they fail to meet the public health bar set forth under law."

The Rest of the Story

You can't be serious. This has to be some kind of nasty joke. How could the FDA possibly claim that by keeping these slightly altered brands off the market the agency is helping to protect the public from the harms caused by tobacco use? Is the FDA under the impression that the current cigarettes on the market are substantially healthier than these five slightly altered cigarettes, such that the new products don't reach "the public health bar," but the existing cigarettes do? How can the agency even suggest that one brand of combustible cigarette raises substantially different questions of public health than another? What the agency is saying is that some cigarettes on the market are safer than others.

What makes these rulings and statements even more ridiculous is that while the FDA apparently believes that slight variations in a cigarette may make that cigarette substantially healthier or more dangerous, the agency does not believe that completely eliminating the tobacco and completely eliminating the combustion process (i.e., an e-cigarette) makes a "cigarette" any safer. In fact, the agency has stated that it has not made a determination that e-cigarettes are any safer than combustible tobacco cigarettes which are killing more than 400,000 Americans each year.

This is an embarrassment. Our nation's leading medical and health regulatory agency believes that slight variations in a cigarette can make such a product substantially healthier, but the complete removal of the tobacco and elimination of the combustion may not have any effect on the safety of the product.

The FDA's official, stated position on the relative safety of tobacco vs. tobacco-free cigarettes is as follows: "There may be a perception that electronic cigarettes...are safer alternatives to conventional tobacco products. ... However, FDA is not aware of any scientific data to support those perceptions."

But apparently the agency does believe that minor differences in combustible tobacco cigarettes make some substantially safer than others, so that they raise different questions of public health. 

If I didn't know this was true, I would absolutely think that I was reading an Onion article.

Wednesday, July 27, 2016

Study Demonstrates Low Health Risks Associated with "Secondhand Vapor" from E-Cigarettes

A study published in the journal Nicotine & Tobacco Research demonstrates that "secondhand vapor" from e-cigarettes poses very little risk to bystanders.

(See: Czogala J, et al. Secondhand exposure to vapors from electronic cigarettes. Nicotine & Tobacco Research 2014; 16(6):655-662.)

The study methods were as follows: "We measured selected airborne markers of secondhand exposure: nicotine, aerosol particles (PM(2.5)), carbon monoxide, and volatile organic compounds (VOCs) in an exposure chamber. We generated e-cigarette vapor from 3 various brands of e-cigarette using a smoking machine and controlled exposure conditions. We also compared secondhand exposure with e-cigarette vapor and tobacco smoke generated by 5 dual users."

The results were as follows: "The study showed that e-cigarettes are a source of secondhand exposure to nicotine but not to combustion toxicants. The air concentrations of nicotine emitted by various brands of e-cigarettes ranged from 0.82 to 6.23 µg/m(3). The verage concentration of nicotine resulting from smoking tobacco cigarettes was 10 times higher than from e-cigarettes (31.60±6.91 vs. 3.32±2.49 µg/m(3), respectively; p = .0081)."

The study demonstrated that both in an experimental chamber and with actual vaping taking place, there were low concentrations of nicotine, transient increases in fine particulate matter, no increase in carbon monoxide levels, and no exposure to volatile organic compounds. The authors conclude that although "secondhand vaping" is associated with low-level nicotine exposure, it does not result in exposure to toxic tobacco-specific combustion products.

The Rest of the Story

In spite of these findings, which demonstrate that secondhand vaping is not a significant health threat, Dr. Stan Glantz has nevertheless informed the public that the study provides evidence that "e-cigarettes pollute the air and expose bystanders."

According to Dr. Glantz, the study found that "e-cigarettes pollute the air with nicotine and fine particles." His argument that secondhand vapor is a health hazard is based on the finding that vaping results in exposure to nicotine and fine particles.

Here is why Stan's argument is faulty:

Nicotine exposure: First, let's quantify the exposure to nicotine for a bystander. Assuming the highest nicotine level detected (6.2 micrograms per cubic meter), a breathing rate of 600 liters/hour and exposure of a full work-day (8 hours), the nicotine exposure will be 4.8 times 6.2, or about 30 micrograms per day. This is the equivalent of 0.03 cigarettes per day. Even if you were exposed for 8 hours every day for a year, your total nicotine exposure would amount to the equivalent of only 11 cigarettes.

Obviously, this is an extremely low level of nicotine exposure, and it is not going to pose any significant health risk.

Fine particle exposure: The average particulate exposure from vaping (152 micrograms per cubic meter) was more than 5 times lower than particulate exposure from secondhand smoke (819 micrograms per cubic meter). But even more importantly, the exposure to particulate matter from vaping was only transient, as the vapor particles dissipated within minutes. In contrast, smoke lingers and so exposure to the particulate matter is constant. The overwhelming majority of time that a bystander is in the room with the vaper, the bystander is not being exposed to particulate matter. Thus, fine particle exposure from vaping is dramatically lower than with smoking, and is unlikely to pose significant health risks.

Why then, are anti-tobacco advocates presenting these results differently? I believe it's because the findings are not consistent with their pre-conceived conclusion that both vaping and secondhand vaping are substantial health hazards. The only way to preserve the pre-existing ideology is to twist the results to fit the ideology, rather than to change the ideology to fit the science.

Monday, July 25, 2016

FDA's Convoluted Response to a Simple Question Shows How Arbitrary, Capricious, and Inane the Deeming Regulations Are

Someone shared with me the actual reply they received from the FDA in response to a very simple question:

"Are e-cigs that do not contain nicotine (or any other tobacco extracts) also covered by the FDA deeming regulations?  If so, will they also require pre-market approval like products that do contain nicotine?"

This seems like a simple and straightforward question that could and should be able to be answered with a simple "yes" or "no." After all, if e-cigarettes do not contain nicotine then there is no basis for the FDA to assert jurisdiction over them as tobacco products. Therefore, these nicotine-free e-liquids would not be subject to the pre-market approval requirements.

A simple answer of "no" would have and should have sufficed.

The Rest of the Story

Instead, here is the FDA's actual response:

Thank you for contacting the U.S. Food and Drug Administration (FDA) regarding its recently finalized rule, “Deeming Tobacco Products to be Subject to the Federal Food, Drug and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act” (Deeming rule).  The information contained in this message is what is provided to vape shops to assist them with any questions about compliance.  We hope that you find this helpful.

FDA anticipates that newly regulated businesses may have many questions and compiled this e-mail as a resource to help you better understand the Deeming rule and the potential impact to your business.  We encourage you to review this information and keep checking our website for new information such as compliance training webinars and updates based on questions FDA receives.

It may be useful for you to know that the Deeming rule published in the Federal Register on May 10, 2016, and takes effect on August 8, 2016.  While FDA continues to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco products, the Deeming rule extends FDA’s authority to “newly deemed” tobacco products such as electronic cigarettes, cigars, hookah, and pipe tobacco, as well as their components and parts, but not the accessories of newly deemed products. The Deeming rule also includes additional restrictions for “covered tobacco products.”  A “covered tobacco product” is any newly deemed tobacco product, but excludes any component or part that is not made or derived from tobacco.

The law defines a manufacturer as anyone who manufactures, fabricates, assembles, labels, or processes a tobacco product.  Establishments, such as vape shops, that mix and/or prepare combinations of liquid nicotine, flavors, and/or other liquids, or an establishment that creates or modifies an aerosolizing apparatus for sale to consumers would be considered a tobacco product manufacturer. 

The rule will subject all manufacturers, importers and/or retailers of newly-regulated tobacco products to any applicable provisions, bringing them in line with other tobacco products the FDA has regulated since 2009.  

These requirements include:
  • Register domestic manufacturing establishment(s) and submit product listings to FDA by December 31, 2016;
  • Reporting ingredients, and harmful and potentially harmful constituents;
  • Requiring premarket review and authorization of new tobacco products by the FDA;
  • Placing health warnings on product packages and advertisements; and
  • Not selling modified risk tobacco products (including those described as “light,” “low,” or “mild”) unless authorized by the FDA.
Manufacturers of newly-regulated products must show that the products meet the applicable public health standard set forth in the law and receive authorization from the FDA, unless the product was on the market as of Feb. 15, 2007. The review process gives the agency the ability to evaluate important factors such as ingredients, product design and health risks, as well as their appeal to youth and non-users.

For products that were not on the market as of the effective date, a premarket authorization is required prior to marketing those products.  For products on the market as of the effective date, under staggered timelines, the FDA does not intend to enforce the premarket review requirements for up to three years while manufacturers submit – and the FDA reviews – a new tobacco product application. The FDA will issue an order granting marketing authorization where appropriate; otherwise the product will be subject to enforcement.

FDA does not assess fees associated with the requirements identified above. The costs associated with compliance with these requirements may vary based on the type and complexity of the product, and, as a result, FDA is not able to provide an individualized estimate of costs that you may incur. However, FDA has included in the preamble to the Deeming rule its estimates of the quantified costs associated with the Rule over 20 years, as well as estimated hourly burdens on impacted entities (such as tobacco product manufacturers) for the requirements described above. Please see the links provided below for more information.

As it relates to e-liquids that contain zero nicotine, generally, if your zero-nicotine product is not made or derived from tobacco, it may still be a tobacco product subject to FDA regulation if it is intended or reasonably expected to be used with or for the human consumption of a tobacco product; or intended or reasonably expected to alter the performance, composition, constituents, or characteristics of a tobacco product (with certain exceptions relating to controlling moisture or temperature for storage and initiating external heat source), your product is subject to FDA regulation.  These products will be evaluated on a case-by-case basis.  This applies to closed and open system devices that contain zero-nicotine.

As a tobacco product, your product will automatically be subject to all of the requirements in Chapter IX of the Federal Food, Drug, and Cosmetics Act and its implementing regulations relating to tobacco products when the deeming rule becomes effective on August 8, 2016.  However, for many provisions FDA is providing a compliance period with additional time during which FDA does not intend to enforce compliance with the requirements, as stated in the final rulemaking document.

In addition, if you’re solely a supplier and your zero-nicotine product is sold only to another company for further manufacture into a finished tobacco product, at this time, FDA does not intend to enforce certain automatic provisions of the law with respect to your product.  Therefore, for example, FDA does not intend to enforce the requirement that you register your manufacturing establishment and list your products, submit premarket applications, or submit ingredient listings or health documents.

There are additional requirements in the rule, such as minimum age, identification, and vending machine restrictions and health warning requirements that apply only to “covered tobacco products,” which does not include a component or part that is not made or derived from tobacco.  Accordingly, if your product is not made or derived from tobacco, it is not subject to such requirements.  Even if your product is not a covered tobacco product, however, FDA regulations prohibit you from distributing free samples of your newly-regulated product, including its components and parts, to anyone.
Regarding your fourth question, if the product does not contain nicotine and you have submitted a statement to FDA certifying so, according to the regulatory requirement, then you would not have to include the mandatory warning regarding the contents of nicotine in the product.
For More Information
To assist the newly-regulated tobacco industry in complying with the requirements, the FDA is also publishing several other regulatory documents that provide additional clarity, instructions and/or the FDA’s current thinking on issues specific to the newly-regulated products.

Final Rule and Accompanying Documents
Resources for Additional Information
FDA continues to update its Deeming webpage to provide information designed to help industry understand the Deeming rule.  We anticipate that many of your questions will be addressed by the resources available on this website.  We plan to soon add a chart that may help you determine which provisions apply to you and the timeframes for complying.  In addition, FDA plans to post Tobacco Compliance Webinars, including one specifically addressing requirements for vape shops, to our website and updates will be provided as additional webinars are available. 

We also encourage you to subscribe to FDA’s “This Week in CTP.”  By subscribing, you’ll receive updates about regulatory activities, retailer notices, upcoming events, and public education campaigns.

Should you have further questions after reviewing this information, you may contact CTP using the following communication methods:

Email:
Phone:
1-877-287-1373
Mail:
Food and Drug Administration
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD  20993

____________________
Center for Tobacco Products
Food and Drug Administration
CTP Call Center: 1-877-CTP-1373

What Does This All Mean?

Despite having 11 years of post-secondary school education and a great deal of experience reading and interpreting legislation and regulations, I have no clue what the heck the FDA is talking about. I can't even imagine a scenario where a nicotine-free e-liquid would be incorporated into a "tobacco product," but if it were, it would only be a tobacco product if it was mixed with nicotine-containing e-liquid, in which case the manufacturer or retailer is not selling a nicotine-free e-liquid. Of course that would be considered a tobacco product.

The question here was much simpler. If I produce a finished e-liquid that is nicotine-free, is my product regulated and if so, do I have to submit a pre-market application? The answer appears to be no. But the FDA hides this answer in such a stream of incomprehensible jibberish that the poor small business owner (or even the large business owner) is more confused after having asked the question than they were before.

The time and resources necessary to even understand what is regulated and what is not regulated are prohibiting for most small business owners in the vaping market. And that's before even getting to the issue of what would be required in a pre-market application if the product is regulated.

This is quite obviously a nonsensical and non-workable regulatory approach and for that reason alone, it is not going to protect the public's health. Quite the opposite, it will harm the public's health by decimating the e-cigarette market, forcing thousands of owners of small entities out of business, and protecting real cigarettes from competition, thus increasing smoking-related disease and death.

In my opinion, this response from the FDA could be used by the plaintiffs in litigation against the agency in order to demonstrate the arbitrariness and capriciousness of the regulations, as well as their undue complexity and burden on small business owners.

So in response to the FDA's expressed hope to the inquiring business owner that "We hope that you find this helpful," I say: "Yes. Very helpful indeed."

Friday, July 22, 2016

Great Article on Vaping

This is one of the best articles on vaping that I've read. It makes a difference to have a young person's perspective because they are in the best position to have insight into the nature of smoking and vaping behavior among their peers.

Thursday, July 21, 2016

CDC Bemoans Failure to Decrease Overall Alcohol Product Use among Teens, Despite Large Decline in Current Drinking

According to data from the Centers for Disease Control and Prevention (CDC), the prevalence of current drinking among high school students has declined dramatically in the past decade and a half, dropping from 50.0% in 1999 to 34.9% in 2013. One would think that would be cause for celebration. However, the CDC is telling the public that despite this decline in drinking among youth, overall use of alcohol products has stayed the same.

The Office on Alcohol and Health issued a statement yesterday, arguing that the recent declines in youth drinking have been undermined and offset by an increase in the use of new and emerging types of alcohol product use. These products, which look just like traditional alcohol drinks and are consumed in a similar way, threaten the public's health according to CDC because they look like traditional alcohol drinks and are therefore re-normalizing drinking and serving as a gateway to traditional alcohol use.

However, an investigation by The Rest of the Story has revealed that the drinks which CDC is now classifying as "alcohol products" do not actually contain alcohol. In fact, our investigation revealed that these products were created with the specific intention of providing youth with beverages that look like alcohol products and are consumed the same way, but which are much safer because they don't actually contain alcohol.

By submitting a Freedom of Information Act (FOIA) request, we were able to determine that the CDC has rigged the numbers for the past five years by starting to classify alcohol-free beverages as "alcohol products." For example, the CDC now considers Shirley Temples to be alcohol products. Other beverages that the CDC now classifies as alcohol products include alcohol-free spritzers, alcohol-free Sangria, sparkling (non-alcoholic) limeade, and non-alcoholic watermelon/strawberry coolers.

Anti-alcohol groups throughout the U.S. have uniformly condemned Shirley Temples. In fact, one group released a report just yesterday entitled "Shirley Temples are Destroying America's Youth."

The Rest of the Story conducted an exclusive interview with the CDC about their new classification system. Here are excerpts from the interview:

Rest of the Story: Aren't you pleased with the recent declines in youth drinking? Wouldn't you say that is a public health accomplishment?

CDC: Unfortunately, the dramatic decline in youth drinking of traditional alcoholic beverages has been offset by an increase in youth use of novel alcohol products, such as Shirley Temples and non-alcohol spritzers. Drinking among high school students dropped to the lowest levels since the National Youth Risk Behavior Survey (YRBS) began in 1991, but the use of other alcohol products,  including Shirley Temples, among students poses new challenges.

Rest of the Story: But I don't understand. How can you classify Shirley Temples and other non-alcoholic beverages as "alcohol products" when they don't actually contain alcohol? Isn't that being dishonest, or at least, disingenuous?

CDC: Current drinking is at an all-time low, which is great news. However, it’s troubling to see that students are engaging in new risk behaviors, such as drinking Shirley Temples and alcohol-free sangria. We must continue to invest in programs that help reduce all forms of alcohol use, including Shirley Temples, among youth.

Rest of the Story: But what is the problem with youth drinking alcohol-free beverages? In fact, wouldn't we rather that youth drink alcohol-free beverages than drinks that actually contain alcohol?

CDC: There are concerns that Shirley Temples contribute to normalizing drinking as a social norm and may be a gateway to youth drinking.

Rest of the Story: But isn't the goal to prevent youth drinking of alcohol?

CDC: During 2011–2015, there was no change in current use of any alcohol product among middle and high school students, and in 2015, an estimated 4.7 million U.S. middle and high school students currently used any alcohol product. As in 2014, Shirley Temples were the most used alcohol product among U.S. middle and high school students in 2015. During 2011–2015, substantial increases in Shirley Temple use among middle and high school students were reported, resulting in an estimated total of 3.0 million middle school and high school Shirley Temple users in 2015. Although youth drinking declined during 2011–2015, there was no change in use of alcohol products during this time period. Because of increases in the use of Shirley Temples, no decline occurred in alcohol use overall during 2011–2015.

Rest of the Story: Isn't there evidence that drinking Shirley Temples is much safer than drinking alcohol-containing beverages?

CDC: Youth use of alcohol in any form is unsafe. For this reason, comprehensive and sustained strategies are needed to prevent and reduce the use of all alcohol products among youths in the United States.

Rest of the Story: Is there actual clinical evidence that drinking Shirley Temples is unsafe?

CDC: Despite what many people believe, Shirley Temples are not just pure water. Furthermore, youth consumption of Shirley Temples will re-normalize drinking behavior. Policies to denormalize alcohol use in society and historic reductions in alcohol consumption may be undermined by this new 'gateway' product.

Rest of the Story: But how can consumption of alcohol-free beverages normalize the drinking of alcohol? Wouldn't that in fact de-normalize alcohol consumption?

CDC: Youth should not use any alcohol product. Moreover, there are other problems with Shirley Temple use. For example, these products may cause former drinkers to relapse to alcohol use. They also may delay the achievement of sobriety among current drinkers. It would be devastating if alcoholics were to substitute Shirley Temples for their drinking instead of quitting alcohol use entirely.

Rest of the Story: Is there anything else you would like to emphasize to the public?

CDC: Yes. Shirley Temples are not just harmless water, as the alcohol industry has been advertising.

Rest of the Story: Thank you for your time.

Recently, the Food and Drug Administration (FDA) promulgated regulations which "deem" alcohol-free beverages like Shirley Temples to be "alcohol products." Restaurants which serve Shirley Temples will now be considered alcohol manufacturers. In addition, other component parts of these beverages will also be regulated as alcohol products, including the glasses they are served in. After consultation with multiple legal experts, The Rest of the Story has confirmed that the cherries that are served with Shirley Temples are also regulated under these alcohol product rules.

We asked the FDA whether this means that companies which sell cherries must submit pre-market alcohol applications (PMAAs) to the agency before they market their cherries. We were referred to the FDA draft guidance, which indicates that cherries will only be regulated if they are part of a "finished alcohol product." This means that companies which sell cherries to restaurants and bars will not have to submit PMAAs. However, if a restaurant incorporates those cherries into a finished alcohol product (e.g., a Shirley Temple), then the restaurant is considered an alcohol manufacturer and will have to comply with the regulations, including the requirement to submit a PMAA.

Despite the concerns of highball glass manufacturers throughout the country, we have confirmed that these companies will not have to submit PMAAs unless they are selling finished alcohol products, meaning a complete Shirley Temple. However, restaurants that prepare their own Shirley Temples will have to conduct safety testing on their highball glasses. In addition, companies that sell pre-made Shirley Temples will be regulated as alcohol manufacturers. Restaurants and bars that sell pre-made Shirley Temple cocktails will not have to comply with the regulations, but those which self-mix the Shirley Temples themselves will have to comply.

Making the PMAA even more burdensome is the FDA's requirement that any variation in the contents of a Shirley Temple require a separate application. This means that restaurants and bars will need separate FDA approval for every different ratio of 7-Up to grenadine that they use in their drinks. Moreover, a separate application will be required for every combination of 7-Up/grenadine ratio and type of glass. Different varieties of cherries will also require separate applications and a separate determination that the Shirley Temple with that particular cherry variety is beneficial for the public's health. That determination must take into account not only the impact of Shirley Temples on individuals who already drink alcohol, but on non-alcohol users who might start drinking Shirley Temples.

One restaurant has filed suit against FDA, arguing that the agency grossly underestimated the number of PMAA submissions that will be required under the regulations. While the FDA estimates there will be only 750 applications, the owner of this restaurant told us that he alone will have to submit 96 separate applications, as they use four different ratios of 7-Up to grenadine, three different types of glasses, four varieties of cherries, and two types of toothpicks.

According to many restaurant owners, the most troubling aspect of the FDA deeming regulations is that they will not be allowed to inform patrons that Shirley Temples are free of alcohol, are safer than real alcoholic beverages, or to even use the term "alcohol-free." For example, restaurants can no longer list Shirley Temples under a menu category of "non-alcoholic beverages." Instead, Shirley Temples will now be lumped in under a general category of "alcoholic beverages," so this menu item will be mixed in with each restaurant's selection of bourbon, fine scotch, rum cocktails, and schnapps.

Tuesday, July 19, 2016

Groundbreaking Research Finds that Products which are Cool and New Appeal to Youths

Anti-Vaping Advocate Says this Finding Adds to Evidence that E-Cigs are a Gateway to Youth Use of Tobacco Products

A groundbreaking study published yesterday in the Canadian Medical Association Journal presents the shocking finding that youth are drawn to products that are new and cool and that this is why they find electronic cigarettes appealing.

The study, which involved a survey asking Ontario youth why they find e-cigarettes appealing, reported the startling finding that a major reason for youth e-cigarette experimentation is that they like "engaging in seemingly exciting new behaviours." The paper's final conclusion was that: "Adolescents in this population appear to be motivated by the appeal of trying something new."

In an accompanying editorial, Dr. Matthew Stanbrook argues that this study adds to evidence that e-cigarettes are a "gateway" to youth tobacco product use, stating that the findings "add to mounting evidence associating use of e-cigarettes with tobacco use." He also cited a recent study involving US youth which "found that never-smokers in grades 11–12 who used e-cigarettes had sixfold higher odds of becoming cigarette smokers a year and a half later when they reached the legal age to purchase tobacco."

The Rest of the Story

The international reaction to these remarkable and shocking new findings has been intense. Marketers throughout the world have expressed their surprise at these findings and are already looking to change their tactics to take advantage of this new knowledge.

For example, Apple CEO Tim Cook told The Rest of the Story that: "This is truly a game changer. We had no idea that cool, exciting, new products would appeal to youth. We've been hammering away at young people for years with the same old Apple 1's, thinking that they are totally into old-fashioned, traditional products. Cook said that the findings of the study instantly gave him the idea of launching a series of what he called "i" products, such as multi-functional cell phones, with new versions coming out each year to attract young people to innovative, new, and exciting features.

Sony CEO Kazuo Hirai was also surprised by the study findings. "No wonder our Betamax video recorders haven't been selling well among the young people. It never occurred to us that to attract youth, you have to come up with something new and exciting. This is going to change the way we do business."

The Rest of the Story also interviewed Nintendo CEO Tatsumi Kimishima, who told us that the findings of this study sparked a novel idea: "Instead of just providing kids with the old, kind of boring video games where you catch Pokemon while sitting on your couch, we're going to integrate the Pokemon game with high-tech GPS and state-of-the-art mapping technology. This will create the novelty of young people having to get off their couches and venture into the real world to catch Pokemon in real-life settings. According to this new research, the novelty and excitement of this activity should really catch on quickly." While Kimishima has not officially decided on a name for the product, he told us that he was preliminarily calling it "Pokemon on the Go."

The Rest of the Story also interviewed several tobacco control experts, asking them what aspect of the new study shed light on the gateway hypothesis. One researcher kept us on hold for four hours, while frantically searching the paper in a seemingly hopeless attempt to find anything in the study which was relevant to the question of whether e-cigarettes are a gateway to youth use of tobacco products.

Another researcher told us that he couldn't find anything, but was having the article translated into three other languages to see if perhaps he was missing something.

A third researcher declined our request for comment, explaining that it would take him six hours to download the article on his Apple 1. When asked why he is still using such an antiquated computer, he told us that he "doesn't like new, cool things. That's why I still write my papers with an Olivetti Lettera 32 manual typewriter, watch my favorite programs on a GE 17-inch TV set, and listen to music on my Victrola 3-speed turntable."

Physician Recommends Against Quitting Smoking for Smokers Who Do Not Want to Use NRT or Cessation Drugs; Hides Conflict of Interest

An article in the Annals of Family Medicine argues that smokers who do not wish to use nicotine replacement therapy (NRT), varenicline, or other drugs should be counseled by their physicians not to quit smoking. Specifically, these patients should not be encouraged to try to quit using e-cigarettes. Moreover, the article scares physicians into thinking that if they do encourage smoking cessation via e-cigarettes, they are putting themselves into legal danger.

According to the lead author - Dr. Adam Goldstein of the University of North Carolina - e-cigarettes are dangerous and have not shown to be helpful in smoking cessation and should therefore not be recommended to patients. If they are recommended, he argues, physicians face legal risks:

"the ethical duty of medicine is to do no harm. Jumping from the 10th floor of a burning building rather than the 15th floor offers no real benefit. If a clinician recommends penicillin for a resistant infection in the face of more effective therapy, they would face an uncertain defense in front of their colleagues or courts. For clinicians that do recommend ENDS, do they document such in the medical record? Given the rise in medical lawsuits related to ENDS side effects or injuries, until such time that medical evidence supports ENDS safety and effectiveness, and robust regulatory frameworks exist, clinicians who recommend ENDS to patients in favor of more effective and safe products may face medico-legal risks."

The authors also argue that e-cigarettes should not be recommended to subgroups of smokers: "Some clinicians may be tempted to recommend ENDS for certain subgroups of smokers, but this approach is problematic."

They specifically advise physicians to recommend that asthmatic smokers keep on smoking rather than attempt to quit using e-cigarettes: "It is problematic to recommend ENDS for asthmatic tobacco users, as immediate reduction in lung function is observed when using ENDS."

The Rest of the Story

By advising physicians not to recommend e-cigarettes for smoking cessation, this article is actually advising them to recommend that smokers who don't want to quit using FDA-approved methods should continue smoking, rather than trying to quit by switching to vaping.

This is a dangerous and misguided recommendation that is completely non-evidence-based and which is destructive to the health of patients by discouraging them from quitting smoking unless the quit using a particular method favored by the physician.

I cannot emphasize strongly enough that if a patient is not interested in quitting using NRT or another drug, he or she should be advised to find some other method of quitting, including e-cigarettes. That patient should not be thrown under the bus, as is being recommended in this article. Better that the patient attempt to quit using e-cigarettes than not try to quit at all. Moreover, if the patient expresses particular interest in e-cigarettes and a disdain for or previous failure with FDA-approved therapies, he or she should be strongly advised to go for it. Millions of ex-smokers have successfully quit using vaping products and there is no justification for promoting continued smoking over a quit attempt with e-cigarettes.

Not only is the medical recommendation in the article misguided and damaging, but the evidence presented to support it is highly biased and incomplete. The paper cites research which identified potential risks of vaping but fails to cite any of the many articles which have documented the significant benefits associated with switching to e-cigarettes.

For example, the paper cites two articles which found sub-clinical increases in airways resistance among e-cigarette users, but failed to cite two other articles which documented significant improvement in lung function among asthmatic smokers. The recommendation against asthmatic smokers trying to quit using e-cigarettes ignores solid evidence that asthmatic smokers experience dramatic improvement in their respiratory symptoms and clinical lung function if they are able to switch to e-cigarettes.

The paper also fails to cite the most important study of all: the one and only clinical trial conducted on e-cigarettes, which happened to find that these products are just as effective as the nicotine patch for smoking cessation.

Unfortunately, the bias apparent in the paper has the appearance of being related to an unreported conflict of interest. Specifically, the lead author - Dr. Goldstein - failed to disclose that he has received funding from Big Pharma; in particular, funding from a company that makes Chantix, for which e-cigarettes are a major market competitor. It is imperative that a physician who publishes a medical recommendation like this disclose any relevant conflicts of interest, especially prior funding from a company that stands to benefit tremendously from the recommendation being made.

By his own acknowledgment, Dr. Goldstein has received research funding from Pfizer, the maker of Chantix. Pfizer certainly stands to gain financially from the recommendation that physicians discourage patients from using e-cigarettes to quit. So this conflict should have been disclosed. It appears that Dr. Goldstein received a $500,000 grant from Pfizer from 2010-2012. I think that a half million dollar grant from a corporation which stands to gain financially from the medical recommendation made in the article is something that readers deserve being made aware of.

Elsewhere, Dr. Goldstein acknowledges that he has served on advisory boards for Pfizer and for Boehringer Pharmaceuticals. In addition, the UNC Nicotine Dependence Program, of which Dr. Goldstein is listed as a member, has received funding from Pfizer.

Monday, July 18, 2016

Altria Urges Changes in FDA E-Cigarette Regulations that Would Decrease Its Share of Vaping Market and Help Save Many Smaller Manufacturers

In a move that casts serious doubt on anti-tobacco groups' maligning of the motives of the tobacco companies in marketing vaping products, Altria Client Services, on behalf of Nu Mark (the maker of Mark Ten e-cigarettes), has submitted comments to the FDA that blast its pre-market tobacco application (PMTA) requirements for e-cigarettes, arguing that these requirements are unduly burdensome, unnecessary, and beyond the scope of the agency's jurisdiction under the Tobacco Control Act.

In the comments, Altria Client Services expresses particular concern that the burdensome PMTA requirements will force many manufacturers out of business, undermining the Tobacco Control Act's public health goals.

Altria writes: "The Draft Guidance is not aligned to the FSPTCA's goal of promoting public health because the complexity of information recommended for the application process and the short compliance period for FDA to complete PMTA reviews may result in some existing ENDS products being forced off the market."

Altria also notes that FDA itself acknowledged that a large number of e-cigarette companies would go out of business, yet failed to account for this in its regulatory impact analysis.

To remedy the situation, Altria suggests an approach similar to what I have been advocating: the agency should "establish baseline performance standards for ENDS products that, when met, would serve as the basis for an abbreviated or alternative marketing authorization pathway to satisfy the statutory PMTA requirements."

Two of Altria's main goals, as stated in the comments, are to:

1) "support manufacturers' efforts to develop and bring to market innovative products that may advance the public health."

2) "allow industry participants to engage and compete in a dynamic market."

The Rest of the Story

For tobacco control advocates and groups which continue to argue that the tobacco companies have failed to change their behavior, they need to check their calendars and realize that we're now in 2016, not in the pre-Engle time period. Things have changed substantially, and nowhere is this seen more noticeably than with the tobacco industry's embrace of true harm reduction products, especially e-cigarettes and vaping products.

Many of my colleagues continue to argue that Altria and Reynolds American are insincere in wanting to promote vaping, that they are merely trying to promote smoking by encouraging vaping as a mechanism to avoid smoking cessation, and that their main purpose is to try to recruit new smoking customers by getting youth addicted to e-cigarettes and then encouraging them to proceed on to tobacco cigarette smoking. Many of the anti-tobacco groups continue to accuse Altria and Reynolds American of marketing their products to youth and using slick advertising and youth-oriented flavorings like gummy bear and cotton candy to appeal to kids.

The truth is that these are not your father's cigarettes. What Altria and Reynolds American are doing with vaping products is nothing like what they used to do with the marketing of tobacco cigarettes.

In fact, Altria and Reynolds American are not offering youth-friendly flavors like bubble gum, cotton candy, and gummy bear. Their marketing is not targeted at youth, either in its advertising placement or content. Their sales practices for Vuse and Mark Ten are not directed at facilitating the youth purchase of these products.

VUSE
Candy and fruit flavors: None prior to 2015. Only tobacco and menthol. Last year, introduced four new flavors: Mint, Chai, Berry, and Crema.
Internet sales:  None. Only available in retail stores.
Disposable products: None. Only available in more expensive, rechargeable sets.

MARK TEN
Candy and fruit flavors: None before last year. Only tobacco and menthol. Last year, introduced two new flavors: Fusion and Mint.
Internet sales:  None. Only available in retail stores.
Disposable products: None. Only available in more expensive, rechargeable sets.

If these companies were truly going after kids, why would they be actively avoiding youth-friendly flavorings? Why would they refrain from selling disposable products, which are much less expensive and are most likely the type that youth purchase?

To be sure, there are a small number of "bad actors" in the e-cigarette industry. But Altria and Reynolds American are not among them.

Please note that I am not arguing here that companies which are selling e-cigarettes via the internet, marketing disposable products, or selling multiple flavors are targeting kids or that they have any desire for youth to use their products. Quite the opposite: these aspects of the market are essential to reach adult smokers and curtailing any of them would decimate the market, leading tens of thousands of ex-smokers to return to smoking and discouraging smokers from switching to vaping products in the future. I am simply pointing out that Altria and Reynolds American are clearly not targeting youth and using these points to demonstrate how inaccurate the anti-tobacco groups are in characterizing the behavior of these companies.

If there were any remaining doubt about the sincerity of the two major domestic cigarette companies in marketing vaping products, it should disappear after reviewing Altria's comments to the FDA. (First of all, recognize that these comments are not a publicity ploy because the company is not publicizing them -- I was unable to even find them online.) In these comments, Altria supports policy changes that are not in its best financial interests in the sense that the current burdensome regulations are in Altria's favor and without changes to make them less burdensome, these regulations would essentially hand the entire vaping market to Altria and Reynolds American. Virtually no other companies have the financial resources to develop the required PMTAs. So Altria could easily just sit by quietly and then enjoy an oligopoly in the vaping market.

But this is not what Altria is doing. The company is actually trying to save at least some vitality in the e-cigarette and vaping market by urging the FDA to weaken the burdensome requirements so that many more manufacturers have an opportunity to stay on the market. And these two tobacco companies are also strongly behind the Bishop-Cole amendment which would grandfather existing vaping products, thus preventing the decimation of the e-cigarette market and the creation of a Big Tobacco oligopoly.

Anti-tobacco advocates are going to have to come to terms with the apparently threatening reality that our long-term mantra is no longer valid. Their entry into the vaping market is not merely a ploy to get youth hooked on nicotine so that they can get new smoking customers. They are legitimately interested in creating a new and robust market for harm reduction products.

Now I am not arguing that financial incentives do not play a role. Of course they do. The companies see an eventual decline in the use of combustible tobacco products in the United States, and they want to be able to derive some economic benefit even as smokers move away from these combustibles. By entering the vaping product market, the companies have an alternative source of revenues to help sustain them. And they can use price increases with their traditional cigarettes to help lessen the financial blow, by protecting revenue even as sales decline. And while their market share will not be nearly as high in a robust, thriving vaping market, the overall market will likely be much greater if there are a large variety of alternative choices for smokers who want to quit but do not feel able to do so without the aid of a vaping device.

But instead of denying that this could possibly be happening, we need to open our eyes and see that this is one example where there is a confluence of public health goals and economic incentives for the vaping industry. Profits from the sale of vaping products increase as the sale of traditional cigarettes fall.

At some point, we need to figure out what our goal is. Is the goal to save lives and improve the public's health by decreasing the tremendous burden of smoking-related morbidity and mortality. Or is the goal simply to continue an unrelenting attack on the cigarette companies, which creates nice publicity for our organizations' membership and helps to attract larger donations?

Thursday, July 14, 2016

Wednesday, July 13, 2016

FDA Botched Cost-Benefit Analysis of Its E-Cigarette Deeming Regulations

After reviewing the declaration of Nicopure Labs'  CEO Jeff Stamler in its lawsuit against the FDA, I have concluded that the FDA completely botched its cost-benefit analysis of the e-cigarette deeming regulations, drastically underestimating the costs of the regulations and without even attempting to quantify the benefits.

As such, this represents a violation of the Administrative Procedures Act, providing strong grounds for the D.C. District Court to overturn the regulations.

In its declaration, Nicopure reveals that it has 2,400 stock keeping units (SKUs), including e-liquids, vaporizers, and component parts. This means that in order to keep its products on the market, Nicopure will have two years to complete 2,400 pre-market tobacco applications (PMTAs), each of which is estimated by the FDA itself to cost approximately $300,000 and to require 1,500 hours to complete.

Nicopure estimates the actual cost of each PMTA to be between $3 million and $5 million. But even if we use FDA's more conservative estimate, it would cost Nicopure $720,000,000 ($720 million) to keep its products on the market. The company estimates that at very best, it could complete PMTAs for 12 of its products. Thus, the regulations - if not overturned - will decimate the overwhelming majority of Nicopure's offerings to vapers.

The Rest of the Story

The FDA estimated that it would receive only 750 PMTAs. So one of two things must have occurred:

1. The FDA grossly underestimated the number of regulated products on the market.

While the FDA apparently thought there were only 750 products, we now know that one company alone manufactures 2,400 different products. With hundreds of companies out there, it seems clear that the agency didn't even come close to providing an accurate estimate of the number of PMTAs that would be required under its regulations.

2. The FDA assumed that most companies would go out of business and therefore not submit any PMTAs.

A second possibility is that the FDA did have an accurate idea of the number of companies and products on the market, but assumed that the overwhelming majority of these companies would not bother to submit PMTAs because of the prohibitive expense and would therefore go out of business.

In both cases, the FDA would have botched its cost-benefit analysis.

In case #1, the agency grossly underestimated the costs of the regulations because it failed to even come close to an accurate estimate of the number of affected companies and products.

In case #2, the agency grossly underestimated the costs of the regulations because it failed to account for the economic costs associated with hundreds of small companies going out of business.

Either way, it seems clear that the FDA failed to conduct a proper cost-benefit analysis and therefore violated the Administrative Procedure Act, providing strong grounds for the D.C. District Court to overturn the deeming regulations.

Note that this is only one of many grounds upon which the deeming regulations have been challenged. I outlined some of the other grounds elsewhere.

Making the violation even worse is the fact that by its own admission, the FDA failed to quantify the expected benefits of the regulations. The agency could not document that e-cigarettes are currently causing substantial health harm that would be negated by its promulgation of these regulations.

After speaking with many vape shop owners and e-cigarette and e-liquid manufacturers in the weeks since the deeming regulations were released, it seems clear to me that the overwhelming majority of e-cigarette businesses are unable to afford the expense of completing any PMTAs. It is simply too expensive and these small businesses do not have the kind of capital on hand that would be required. As a result, many of these companies are resolved to do business for another two years and then drop out of the market. Others are deciding to drop the majority of their products and just focus on perhaps one or two flavorings.

There is no question that the combined effect of the regulations will be to decimate the vaping product market, both by forcing hundreds of small and medium companies out of business and by removing the overwhelming majority of vaping products and flavorings from the market.

The impact will be not only the severe economic losses to small and medium businesses, but also the damage done to the public's health by helping cigarettes restrain what otherwise would have been serious competition from safer alternative products. The deeming regulations are therefore a godsend to the tobacco cigarette market. It is brutally ironic that an agency entrusted with protecting the public's health has taken an action that will promote cigarette sales and protect cigarette profits.

Tuesday, July 12, 2016

Eating Corn Flakes is Half as Dangerous as Smoking, According to Reasoning of Anti-Vaping Researchers

Based on evidence that chemicals often found in e-cigarette aerosol produce endothelial dysfunction and decreased arterial compliance, Dr. Aruni Bhatnagar of the University of Louisville has concluded that e-cigarettes are no safer than real cigarettes, and Dr. Stan Glantz has argued that vaping is up to half as dangerous as smoking. Both of these anti-vaping researchers reasoned that since the dose-response relationship between smoking and cardiovascular disease is non-linear and risk saturates at rather low levels of exposure, and since e-cigarettes contain chemicals that can cause acute cardiovascular injury, vaping is therefore not much safer than (Glantz) or no safer than (Bhatnagar) smoking.

Bhatnagar concludes that: "The dose-response relationship between smoking and cardiovascular mortality is non-linear, suggesting that reduction in HPHC concentrations in e-cigarette aerosols may not result in proportional harm reduction and decreased HPHC exposure may be offset by increased use by individuals who believe that e-cigarettes are safer than conventional cigarettes. Thus, taken together, current evidence does not entirely support the notion that e-cigarettes are reduced harm products... ."

Glantz concludes that: "Given the evidence that effects on the cardiovascular system and lungs account for more than half the smoking-induced deaths and that at least some of the short-term effects of e-cigarette use on these systems are comparable to cigarettes, agencies concerned about public health should consider them at least 1/3 as bad as cigarettes and maybe as high as half as bad (or higher)."

The Rest of the Story

A study published in the Journal of the American College of Cardiology found that the hyperglycemic state associated with eating Corn Flakes results in measurable decrements in endothelial dysfunction, as assessed by endothelium-dependent flow-mediated dilation, among obese and overweight non-diabetic adults (see: Lavi T, et al. The acute effect of various glycemic index dietary carbohydrates on endothelial function in nondiabetic overweight and obese subjects. Journal of the American College of Cardiology 2009; 53:2283-2287).

The study found that: "Baseline FMD [flow-mediated dilation], not significantly different in the 3 carbohydrate-based meals, was reduced 2 h post-prandially in all groups, showing statistical significance in only high-glycemic index meals: glucose (15 ± 9% vs. 10 ± 8%, p < 0.01), cornflakes (13 ± 7% vs. 9 ± 7%, p < 0.01)."

Cigarette smoking has been shown to have similar effects on the endothelium.

So based on the above reasoning:

Given the evidence that effects on the cardiovascular system and lungs account for more than half the smoking-induced deaths and that at least some of the short-term effects of Corn Flakes ingestion on these systems are comparable to cigarettes, agencies concerned about public health should consider them at least 1/3 as bad as cigarettes and maybe as high as half as bad (or higher).

Using this reasoning, the cigarette companies would be justified in taking out advertisements that say: "Smoking is only twice as bad as eating Corn Flakes."

Bhatnagar and Glantz are making wild extrapolations that are simply not justified based on the nature of the existing data. And Bhatnagar's paper admits as such:

"CVD [cardiovascular disease] is a result of pathological changes in several processes (blood pressure regulation, cholesterol metabolism, insulin signaling, and endothelial function), and, therefore, the cardiovascular effects of inhaled toxins cannot be adequately simulated by simple in vitro assays but must be studied in animal models and humans... . Unfortunately, such data are not available for e-cigarettes... ."

So if the data needed to understand the effects of e-cigarettes on cardiovascular risk are not available, how are these researchers able to quantify the cardiovascular risk associated with vaping and to conclude that vaping is half as harmful or equally harmful to smoking?

The answer appears to be that they have drawn a pre-determined conclusion and are simply manipulating the existing data to support these conclusions.

If a cigarette company were to take out an ad saying: "Cigarette smoking is only half as bad as vaping," it would be attacked for making fraudulent statements and undermining the public's appreciation of the severe hazards of smoking. But the truth is that Altria could take out an ad today which truthfully informed smokers that: "Tobacco researchers have concluded that smoking is no more hazardous than, or only twice as hazardous as vaping. So if you're thinking of quitting smoking using e-cigarettes to improve your health, don't bother."

Sadly, this is precisely the message that these anti-vaping researchers are sending to smokers throughout the world. Don't quit because your Marlboros, Camels, and Newports are little worse than using tobacco-free e-cigarettes. And if you already have quit by switching to vaping, you might as well go back to smoking. These are dangerous statements that clearly undermine the public's appreciation of the hazards of smoking and which do actual public health damage by deterring many smokers from quitting and encouraging many ex-smokers to return to smoking.

I'm surprised that Altria doesn't take out ads saying: "Marlboro: 100 times the pleasure of an e-cigarette, but with only half the risk." Or that Reynolds American doesn't take out an ad saying: "Camel cigarettes: The same level of safety that you expect with a tobacco-free e-cigarette, but 100 times the pleasure."

Meanwhile, while anti-vaping researchers like Glantz and Bhatnagar are busy making wild extrapolations, some researchers are actually conducting clinical studies that measure the demonstrated effects of smoking compared to vaping in humans. And these studies are showing that vaping dramatically reduces health risks. Multiple studies, for example, have documented that asthmatic smokers who switch to vaping experience an improvement in their respiratory symptoms as well as in their lung function, as measured by spirometry.

And just today, a new study published in the journal Toxicology Mechanisms and Methods reports that smokers who quit by switching to electronic cigarettes experience a reduction in exposure to harmful and potentially harmful constituents which is equivalent to that experienced by smokers who quit completely (without the use of e-cigarettes).

Specifically, exposure to chemicals such as tobacco-specific nitrosamines and volatile organic compounds including acrolein, benzene, and acrylonitrile was reduced by the same amount among smokers who quit using e-cigarettes and those who quit without e-cigarettes. Furthermore, blood levels of carboxyhemoglobin were reduced by the identical amount in smokers who quit using vs. not using e-cigarettes.

The study was funded by Fontem Ventures, which is a subsidiary of Imperial Brands (a tobacco company which is also marketing e-cigarettes). While this needs to be considered in evaluating the validity of the findings, I do not see any scientific issues in the methodology or reporting of the results that lead me to question the validity of the basic finding that biomarkers of exposure to the above chemicals decreased by the same amount in smokers who switched to vaping as in smokers who quit completely without the aid of e-cigarettes.

That Glantz and Bhatnagar do not even mention these studies demonstrates an apparent bias. Strangely, there are extrapolating from data that does not directly measure e-cigarette risks among humans and ignoring data that directly measures the effects of e-cigarettes in the clinical setting.

To be clear, I am not arguing that vaping is risk-free or that exposure to chemicals such as formaldehyde and acrolein is not a problem. In fact, I have advocated directly addressing these risks by forcing the FDA to set standards for these chemicals, either directly or by regulating maximum coil temperatures or voltage/resistance combinations. This is an approach that, ironically, anti-tobacco groups have not supported. Instead, they want to virtually wipe out the vaping industry, which would likely cause tens of thousands of ex-smokers to return to cigarette smoking.

It should also be noted that both Glantz and Bhatnagar are claiming that vaping causes chronic obstructive lung disease. This claim is based solely on evidence of acute irritation of the airways associated with vaping. But it ignores research showing that vaping has no effect on clinical lung function, as measured by spirometry (which is in sharp contrast with cigarette smoking). It also ignores research showing that smokers who switch to vaping experience dramatic improvement in their lung function. To be clear to readers, there simply is not any existing evidence that vaping causes chronic obstructive lung disease. But this is precisely the assumption that goes into Dr. Glantz's estimate that vaping is half as harmful as smoking.

The information that we tell the public regarding the relative safety of smoking vs. vaping is critical and it truly has life or death implications. The public is relying on this information to make important decisions such as whether to try to quit smoking with e-cigarettes or to stay on tobacco cigarettes, or whether to continue vaping or to return to smoking. The statements of anti-vaping researchers like Glantz and Bhatnagar are instructing smokers not to try to quit smoking with e-cigarettes and are undoubtedly causing many former smokers to return to smoking.

The tragedy, and the rest of the story, is that these recommendations are based on extremely weak science, involve wild and unsupportable extrapolations, ignore actual clinical studies of the effects of vaping vs. smoking, and show evidence of severe bias.

Monday, July 11, 2016

Findings from New Pediatrics Study are Not Relevant to Overall U.S.

A new study published today in the journal Pediatrics concludes that overall nicotine product use among youth is increasing and that many youth who would not otherwise have used a nicotine product are doing so because of e-cigarettes.

(See: Barrington-Trimis JL, et al. E-cigarettes, cigarettes, and the prevalence of adolescent tobacco use. Pediatrics 2016; 138(2):e2015983.)

The study reports the prevalence of current cigarette smoking and e-cigarette use among a cohort of youth reaching 11th and 12th grade, after having been followed for a period of two to 12 years. The youth sample was drawn from schools in 12 southern California communities. Based on the finding that the combined use of cigarettes and/or e-cigarettes increased from 2004 to 2014, the authors conclude that overall nicotine use among youth is increasing due to e-cigarettes, meaning that many youth who would not have smoked cigarettes are becoming vapers.

Specifically, cigarette smoking among high school seniors at these schools dropped from 9.0% in 2004 to 7.8% in 2014, e-cigarette use increased from 0% in 2004 to 9.8% in 2014, and the combined use of cigarettes and e-cigarettes rose from 9.0% in 2004 to 13.7% in 2014.

The Rest of the Story

The most important thing for readers to understand is that this study pertains to 12 specific schools in southern California, so the results cannot be generalized to the overall United States. In fact, comparable data from the national Monitoring the Future survey refute the findings in this paper. On a national level, there was a HUGE decline in current smoking among high school seniors from 2004-2014, which was accompanied by a large increase in e-cigarette use, such that the overall use of nicotine products among these youth did not change much. Nationally, overall nicotine use has remained about the same, but the profile of that use has changed, with a shift from combustible tobacco products (tobacco cigarettes) to electronic (non-tobacco cigarettes).

Further, the data from California is not comparable to the overall U.S. because the youth smoking trends in California are vastly different than in the rest of the nation. For example, while the reported smoking prevalence for high school seniors in this article for 2004 is just 9%, the Monitoring the Future study for 2004 reports current smoking prevalence for high school seniors nationally of 25%. This is a drastic difference. While youth smoking prevalence in the overall U.S. declined markedly in the past decade, this paper found very little decrease (from 9% to 8%). Clearly, what happened in California is atypical so it is important not to draw generalized conclusions from this study for the national situation.

It is also important to point out that the survey in this study did NOT ask youth whether or not they were actually using e-cigarettes with nicotine. The Monitoring the Future study reported that about 60% of youth vapers use e-cigarettes without nicotine (they only contain flavorings). Therefore, it is still possible that overall nicotine use among these California youth did not go up (since the majority of the youth e-cigarette users may not have been using nicotine-containing e-cigarettes).

It is also important to recognize that this study is defining “current” e-cigarette use as any use within the past 30 days. This should not be equated with “regular” e-cigarette use, or with a youth being a “vaper.” It is very possible that many of these youth are using e-cigarettes in an experimental fashion, at parties, on an occasional basis, but that they are not becoming addicted to nicotine or using the product frequently enough to experience any adverse health effects.

Finally, even if it is true that among this specific population, the overall use of nicotine has increased, that is not necessarily a bad thing for the overall public health. We do not know whether e-cigarette use among youth has any significant adverse health impact, so it is possible that the benefits from the observed decline in cigarette smoking far outweigh minor risks associated with the use of non-tobacco vaping products.

Taken as a whole, this study does not change my overall assessment that nationally, the benefits from the huge observed decline in cigarette smoking among youth far outweigh the minor risks associated with youth vaping. Moreover, it does not change the important fact that nationally, the drastic increase in youth use of e-cigarettes has been associated with a dramatic decline in cigarette smoking, which argues against the hypothesis that e-cigarettes are a gateway to smoking and strongly suggests that these products may actually be deterring youth from smoking by serving as a more popular alternative to smoking.

Tuesday, June 28, 2016

Detroit Wayne County Mental Health Authority Issues Fraudulent Public Statements on Risks of Cigarette Smoking

In an action reminiscent of the tobacco industry of the 1970's, the Detroit Wayne County Mental Health Authority (DWMHA) has issued one of the most fraudulent claims about the risks of cigarette smoking as I have ever seen.

The DWMHA created a billboard in which it told the public that smoking is no more dangerous than vaping. "E-qually dangerous," the billboard asserts.



The Rest of the Story

There is abundant scientific evidence that vaping, which has caused no documented chronic disease or death in any identified individual, is safer than smoking, which kills more than 400,000 people each year, causes chronic lung disease, cardiovascular disease, and cancer, and contains more than 10,000 chemicals, of which more than 60 are proven human carcinogens.

There is no debate in the tobacco control community about this point. Even Dr. Stan Glantz - a fierce opponent of vaping - acknowledges that smoking is more hazardous than vaping.

Ironically, while the Detroit Wayne County Mental Health Authority is lying to the public, the tobacco companies are telling the truth. Each of the major tobacco companies has acknowledged that smoking its cigarettes is far more dangerous than vaping.

By informing the public that smoking is no more hazardous than using a product which contains no tobacco and merely creates an aerosol by heating propylene glycol, glycerin, nicotine, and flavorings, the DWMHA is dangerously undermining the public's appreciation of the severe consequences of cigarette smoking.

The misinformation that the Detroit Wayne County Mental Health Authority is disseminating is damaging to the public's health. First, it may discourage people from quitting smoking - people who otherwise would have greatly improved their health by quitting smoking completely with the help of e-cigarettes. Second, it may convince ex-smokers who have quit using electronic cigarettes that they are just as well off returning to smoking than remaining ex-smokers by virtue of those electronic cigarettes.

A study just published in the journal Addiction reported that at least 6.1 million people in the EU have quit smoking using e-cigarettes and another 9.2 million have substantially reduced the amount they smoke. This amazing public health accomplishment would obviously not have occurred had public health authorities in Europe conducted a fraudulent campaign to convince EU citizens that vaping is equally hazardous as smoking.

That this fraudulent statement is being made by a mental health services agency is particularly egregious because persons with mental health and substance abuse disorders have disproportionately high rates of smoking and are especially resistant to traditional methods of smoking cessation. These are people who could benefit the most from the availability of e-cigarettes for smoking cessation. But the DWMHA is actively discouraging them from trying to quit smoking. In fact, the message being sent is that you are better off (or equally well off) continuing to smoke than quitting smoking using e-cigarettes.

It's been close to two decades since we've seen a tobacco industry campaign to severely undermine the public's appreciation of the health hazards of smoking. That campaign is now back. It's just a shame that it is now being orchestrated by health agencies, while the cigarette companies are the ones providing accurate information to the public about the real hazards of smoking. Who ever thought it would come to this?

Monday, June 27, 2016

Four More Lawsuits Filed Against FDA to Block its E-Cigarette Deeming Regulations

Last month, I reported that Nicopure Labs, a maker of e-liquids and vaping devices, filed a lawsuit against the FDA challenging its deeming regulations, claiming that they are in violation of the Administrative Procedures Act (APA) and the First Amendment. Today, I report that four more lawsuits have been filed against the agency; all seek an injunction against enforcement of various aspects of the regulations or seek to overturn the regulations in their entirety.

1. Lost Art Liquids, LLC has filed a challenge to the deeming regulations under the APA, the Regulatory Flexibility Act, the First Amendment, and the Fifth Amendment. 

As the company explains: 

"Lost Art Liquids' Complaint alleges that FDA's regulation of vapor products is illegal in that it exceeds the very limited and specific scope of authority Congress granted FDA to regulate "tobacco products" under the Tobacco Control Act in 2009. "Vapor products are technology products, not tobacco products," said Ryan Thomas, Lost Art Liquids' Co-Founder and COO. "The legislative history and factual findings that serve as the predicate to the Tobacco Control Act make clear that Congress never intended to give FDA authority to regulate vapor products when it enacted the Tobacco Control Act in 2009. It was created to regulate products like cigarettes and smokeless tobacco, not vapor," he continued. "FDA has introduced one of the most burdensome, misguided and harmful regulations in its history without adequately sound science, or adhering to required, lawful procedures. These regulations will harm Lost Art Liquids' business and customers by eliminating vapor products from the market, forcing consumers to resort to more harmful products like cigarettes and cigars," added Thomas."

2. Larry Faircloth, a delegate in the West Virginia House of Representatives, has filed a lawsuit against the FDA, challenging the deeming regulations under the APA, the First Amendment, and the Tenth Amendment. 

First, the complaint alleges that FDA's application of the Tobacco Act to all vaping devices and their components goes far beyond the Act's definition of "tobacco products" and is therefore a violation of the APA. For example, "programmable software," "batteries," and "glasses and vials" are deemed to be tobacco products even though they clearly do not meet the Act's definition of a tobacco product (i.e., a product made of tobacco or containing a tobacco-derived component [nicotine]).

Second, the complaint alleges that the FDA's ban on new product introductions after August 8, 2016 is arbitrary and capricious and without a rational basis. The effect of this aspect of the regulation is to prevent the introduction of any new products and the improvement of any existing products, thus harming the public's health both by forcing many vapers to return to smoking and by precluding necessary safety improvements.

Third, the complaint alleges that the FDA failed to conduct a proper cost-benefit analysis, as it failed to quantify the benefits of the regulation and grossly underestimated the costs. For example, the agency estimated that only 750 pre-market tobacco applications would be required, while the truth is that there are single companies that would have to file that many applications alone.

Fourth, the complaint alleges that the regulations violate the First Amendment because they prohibit companies from making truthful and non-misleading statements about their products (such as that e-cigarettes contain no tobacco and produce no smoke or that they contain lower levels of various constituents compared to tobacco cigarettes).

3. A coalition of vaping-related associations, including the Right to Be Smoke-Free Coalition, the American E-Liquid Manufacturing Standards Association, and the American Vaping Association, has challenged the deeming regulations under the APA, the Regulatory Flexibility Act, the First Amendment, the Fifth Amendment, and the Fourteenth Amendment.

Many of the complaints in this lawsuit are similar to those mentioned above, including the allegations that the FDA exceeded its authority, violated the intent of Congress, lacks a rational basis for the regulatory scheme (especially since it treats e-cigarettes more harshly than cigarettes), fails to conduct a proper cost-benefit analysis, and infringes upon the free speech rights of companies by prohibiting them from making truthful, non-misleading claims about their products without any legitimate government interest in doing so. The suit challenges the grandfather date, the entire pre-market authorization process, the ban on allowing customers to try e-liquid flavors in vape shops that are restricted to adults, the application of the "tobacco product" definition to component parts of vaping devices that do not meet that definition, and the entire modified risk provision section.

4. Altria has filed a lawsuit which challenges the deeming regulations' prohibition on the use of the brand name "Black and Mild," which has been the trade name for one of its premium cigar brands for more than four decades.

This suit claims that the ban on the use of the term "mild" in the brand name violates the First Amendment because it restricts free speech without any legitimate government interest and violates the Fifth Amendment because it represents a taking of private property without compensation. Unlike the term "mild" as used in many cigarette brands and ads - which were documented to have been intended to falsely convey a sense of safety - the "Black and Mild" brand name has been around for more than 40 years and conveys information about the taste and body of the product, rather than its safety.

The Rest of the Story

All five of the lawsuits that have been filed so far present strong and solid legal challenges against the deeming regulations. I have been arguing for months that applying the modified risk provisions of the Tobacco Act to e-cigarettes would violate the First Amendment because there is no legitimate government interest in preventing commercial speech that is both truthful and non-misleading. In addition, I pointed out in my comments to OMB/OIRA that the FDA failed to conduct a proper cost-benefit analysis.

Monday, June 20, 2016

Pediatrics "Gateway" Article Author Hiding Conflicts of Interest with Big Pharma; Drug Companies Have Gotten More than their Money's Worth

Last week, I discussed an article published in Pediatrics which is going to deal a devastating blow to the vaping industry because it wrongly concludes that e-cigarettes are a gateway to smoking among youth. Evidence like this is the death knell to vaping, as perhaps it should be if it were true.

The problem, however, is that as I explained, the Pediatrics study cannot conclude that e-cigarettes are a gateway to smoking because it measured only e-cigarette experimentation at baseline and was unable to document that a single nonsmoking vaper actually became addicted to vaping. Nor was the study able to document that a single nonsmoking vaper actually used a product that contained nicotine. Since the Monitoring the Future study suggested that a solid majority of youth e-cigarette users do not use nicotine products, this is a major study limitation.

In fact, the overwhelming evidence suggests that e-cigarettes are actually contributing towards the denormalization of smoking. The magnitude of the gateway "risk" identified in the Pediatrics paper is mathematically impossible given the recent data showing that while e-cigarette experimentation has skyrocketed among youth, smoking rates among those same youths has plummeted. Furthermore, there is now direct evidence - this time from qualitative interviews with youth - that e-cigarettes may actually be a roadblock to smoking.

Today, I reveal that what makes the Pediatrics paper even more problematic than simply its unsupported conclusions is the fact that these conclusions have the appearance of being influenced by financial conflicts of interest among one of the study authors -- conflicts that the author hid from the public.

The Rest of the Story

Clearly, there is a strong financial interest in e-cigarette research among pharmaceutical companies that manufacture smoking cessation drugs. E-cigarettes and vaping products represent enormous potential competition to the sales of cessation drugs if they prove to be effective and of reasonable risk, which would lead to more lenient regulation.

One of these companies with a financial interest in e-cigarette research is GlaxoSmithKline, maker of the following cessation drugs: nicotine gum, nicotine lozenges, nicotine patches, Wellbutrin, and Zyban. Therefore, any of the Pediatrics study authors who has received money or research funding from GlaxoSmithKline has a significant financial conflict of interest that must be disclosed in the article.

Another company with a financial interest in e-cigarette research is Pfizer, which manufactures Chantix (varenicline), a very popular and lucrative smoking cessation drug. Therefore, any of the Pediatrics study authors who has received money or research funding from Pfizer has a significant financial conflict of interest that must be disclosed in the article.

However, all of the authors have signed a disclosure indicating that none of them have any financial conflict of interest: the disclosure statement reads "The authors have indicated they have no financial relationships relevant to this article to disclose."

Therefore, I would take this as meaning that none of the authors have had any financial relationships, such as receiving grant funding or consultant fees, from GlaxoSmithKline, Pfizer, or any other pharmaceutical companies that market smoking cessation medications.

Hiding a Conflict of Interest - the Rest of the Story

Unfortunately, this is not the case.

One of the study authors - Dr. Jonathan Samet - was actually named in a 2011 conflict of interest lawsuit filed by Lorillard and R.J. Reynolds against the FDA, which argued that: "During the last decade, Dr. Samet has received grant support for research and writing from GSK on at least six occasions, including in 2010. In addition, he formerly led the Institute for Global Tobacco Control, which is funded by GSK and Pfizer. Moreover, until 2009, Dr. Samet received regular honoraria from Pfizer for his service on the Pfizer Global Tobacco Advisory Board."

Dr. Samet has in fact acknowledged having received grant funding from GlaxoSmithKline. In addition, the organization that he directed - the Institute for Global Tobacco Control - was funded by GlaxoSmithKline and Pfizer. Furthermore, Dr. Samet agreed "to serve on Pfizer's global tobacco control advisory board and will be compensated." Dr. Samet acknowledged serving on Pfizer's tobacco control advisory board from 2004-2009.

The journal Pediatrics adheres to ICJME policies, and under those policies, authors are required to disclose all "relationships or activities that readers could perceive to have influenced, or that give the appearance of potentially influencing, what you wrote in the submitted work." This requirement does not specify that the relationships or activities must be current or within the past 3 years. There is no time frame given, so the clear intent here is to make sure that authors disclose any prior history of funding from corporations that could give the appearance of a potential conflict.

To remind readers, a conflict of interest does not represent wrongdoing, and it is actually in the authors' best interest to err on the side of being most inclusive. After all, conflict of interest procedures are largely in place to protect the author and the institution, not just the journal and the readers. Conflict of interest disclosures are not some sort of punitive procedure, forcing authors to pay penance for past wrongdoing. There is no wrongdoing. The sole purpose is to make sure that any financial relationships (no matter when they occurred) that could be perceived as potentially representing a conflict are disclosed.

In large part, the reason why virtually all scientific journals have conflict of interest policies now is this past history of failed disclosures of scientists' ties to the tobacco companies.

It is for this reason that it becomes so imperative for us, as scientists in the tobacco control movement, to disclose our own conflicts of interest. It would seem highly hypocritical for us to demand that past relationships with tobacco companies need to be disclosed but that past relationships with pharmaceutical companies can remain hidden. No one is suggesting that the public health implications are the same; however, the principle is.

Ultimately, if we want the public to take seriously our efforts to protect the integrity of science from influence by corporations which have a vested interest in influencing the public's opinion about the safety of their products, then it becomes critical that we set the example by being transparent about our own conflicts of interest.