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."

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.

E-Cigarette Companies: FDA Wants Smokers to Continue Smoking, But We Do Not; On the FDA's Decimation of the Vaping Industry

Totally Wicked - a Florida-based e-cigarette and e-liquid company that established the first brick shop in the U.S. - has announced that because of the FDA regulations, they have been forced to go out of business in 2018, once the pre-market tobacco application (PMTA) grace period ends. They will join what will certainly be thousands of other e-cigarette businesses and vape shops which simply cannot afford the capital costs associated with completing PMTA's.

In announcing the closing of its doors in 2018, Totally Wicked explained - in the most succinct and prescient manner I have heard - the absurdity and the irony of the FDA's approach to e-cigarette regulation:

"The FDA may want Americans to continue smoking; we do not."

As Totally Wicked explains:

"As a business we operate in both the EU and the USA, have a loyal customer base, offer a wide and dynamic range of hardware and e-liquids and try always to deliver the best possible service in an open and ethical way. However, this is clearly not enough for the FDA as they actively shut down this vibrant industry. With the stroke of a pen, the FDA is demanding fantastically unrealistic pre-market tobacco authorizations for a product that contains no tobacco, at a cost that is prohibitive to all but the tobacco giants, and bears no relations to the products’ risk or indeed, its remarkable potential when compared to the raging tobacco epidemic. It is designed quite simply to destroy the industry. By the end of 2018, there will be no independent vaping industry left within the USA - unless Congress decides to look deeper into this, or indeed the legal system is willing and able to hold the FDA to account for its fallacious representation of the risk impact that it has used to justify this regulatory abomination." ...

"This government and its federal bodies charged to defend and protect its citizens have failed the American smokers. While the majority of the rest of the world is moving towards an enlightened position on the transformational potential of consumer vaping products, the USA will retrench itself with a ‘year zero’ firestorm that is already alight in the USA and will consume all independent vape businesses like ours in Summer 2018."

The Rest of the Story

This is a perfect rendition of exactly what the FDA is doing with its misguided regulatory approach to electronic cigarettes. By treating vaping products exactly the same as deadly cigarettes (in fact, by regulating them more stringently than cigarettes), the FDA is essentially making it clear that it wants smokers to continue smoking rather than switch to a much safer alternative that could potentially save millions of lives. After all, the impact of the regulations - especially the PMTA requirement and the modified risk provisions - will be the decimation of the vaping industry and the creation of a huge impediment to the transformation of the nicotine market from the most toxic to the safest available products.

If the FDA truly wanted smokers to quit, then it would certainly craft regulations that promote smoking cessation, rather than regulations that block or impede smoking cessation by denying smokers the availability of a wide range of much safer alternative products. And it would certainly not create a regulatory infrastructure that gives a huge competitive advantage to real cigarettes over the fake ones.

It is very true: the FDA (and the federal government as a whole) has failed the American smokers. Rather than increasing the available options to quit smoking, the FDA has greatly limited those options. And instead of encouraging smokers to quit, the FDA has permanently stymied smoking cessation efforts.

But there is one ray of hope. As Totally Wicked suggests, the above scenario will occur: "unless Congress decides to look deeper into this." Fortunately, there are a number of federal lawmakers who have decided to look deeper into this. We will work with these members of Congress to try to prevent the FDA from carrying through with its destructive policies by enacting an alternative approach by which vaping products are regulating under a mechanism distinct from that which is used for products which actually contain tobacco.

As Totally Wicked says, it is sheer lunacy to regulate as tobacco products these devices that contain no tobacco.

Is There a Silver Lining in a Dark Cloud?

From a public health perspective, there are many reasons to be concerned about the outcome of Tuesday’s election. However, there is one reason to potentially be encouraged. With a Trump presidency, and with Republican control of the Senate, we ironically have a tremendous opportunity to once and for all craft a sensible regulatory strategy for electronic cigarettes and vaping products.

The Rest of the Story

Although the issue was not directly addressed during the campaign, I would expect President-elect Trump to be supportive of vaping products and especially of the thousands of small businesses that are likely going to be forced out of business under the FDA’s current nicotine regulatory policy. In addition, we know that there are several Republican senators (whose party will now control the Senate) who are sympathetic to the public health damage being done by current policy. Moreover, several senators have specifically considered holding hearings on the issue and are amenable to the introduction of legislation to chart a different course than the FDA is currently taking.

I believe that this is actually a historic opportunity, due to a strange but true alignment of the stars. We must take advantage of this opportunity to undo the damage that the FDA’s vaping products policy has done and is slated to do moving forward.

However, it is important that we not settle for a quick-fix. We can do better than that. I don’t think we need to settle for a Cole-Bishop type amendment that merely changes the grandfather date for vaping products. Instead, I think there is an opportunity to put on the table a proposal for a new, comprehensive regulatory strategy for vaping products that treats these products completely differently from tobacco cigarettes and tobacco products. I believe that we need to create a separate and distinct regulatory framework specifically for vaping products, one that is not based on the Family Smoking Prevention and Tobacco Control Act.

Such a policy must take into consideration the relative risk profile of e-cigarettes compared to real cigarettes and must regulate these products accordingly. While Mitch Zeller has publicly stated the need to do this, the agency’s actual deeming regulations do just the opposite: they throw e-cigarettes into the exact same box as cigarettes and in fact give preference to tobacco-full, rather than tobacco-free cigarettes.

I don’t even think that the FDA is necessarily the appropriate agency to regulate vaping products. Perhaps it would be more appropriate to give regulatory jurisdiction to the Consumer Products Safety Council or a similar agency with experience regulating the safety of consumer products, rather than an agency whose sole experience is with regulating drugs and devices, where the regulatory standard is “safety” and “effectiveness.” Vaping products are not designed to be either safe or effective. They are designed as an alternative to deadly cigarettes. And they need to be regulated as such.

The basis of a regulatory policy for vaping products should be the promulgation of a set of safety standards that will maximize the benefits of these products, while minimizing their potential harm. Regulation of battery safety, heating temperature (and therefore, levels of adverse chemicals such as formaldehyde), flavoring ingredients, quality control, and marketing should be a priority. The pre-market approval process should be completely abandoned. The modified risk provisions should not be applied to vaping products. And finally, the statute should clearly state that smoking cessation claims will not be considered to be drug claims and that therefore, vaping products will not be regulated as drugs unless they specifically make claims about treatment of nicotine dependence or withdrawal. Claims related to smoking cessation should be explicitly allowed, subject of course to accuracy and validity of the claims.

The Senate has been understandably hesitant to tackle this issue during the election season. However, with a new administration the time will be ripe to take this issue on.

One might argue that it is unlikely that an administration would completely repeal an agency regulation that is already in force. However, President-elect Trump does not seem timid about threatening to completely repeal other health statutes and regulations so I don’t see any reason why he would be reluctant to do that with the FDA’s ill-advised e-cigarette regulations.

Last Chance to Register for Regulations for E-Cigarettes Conference

An exciting conference - Regulations for E-Cigarettes - will be held December 6-7 in Alexandria, VA. This is the inaugural Regulations for E-Cigarettes event, and it will focus on the complex regulations facing the electronic cigarette and vaping industries. It is of particular interest to those in the e-cigarette, testing, research, public health, and public policy fields. I will be speaking on the FDA's e-cigarette deeming regulations. I urge everyone to consider attending. The agenda and registration information are available here.

Investigators Botch Interpretation of New E-Cigarette Study Results; American Academy of Pediatrics Misrepresents the Findings

A new study published online this morning in the journal Pediatrics purports to show that flavored e-cigarettes serve as a gateway to youth smoking by increasing nonsmoking youths' intentions to smoke and decreasing smoking youths' intentions to quit.

The study reports results from the 2014 National Youth Tobacco Survey. In a cross-sectional analysis, the investigators examined the relationship between flavored e-cigarette use and (1) intentions to smoke among nonsmokers; (2) intentions to quit among smokers; and (3) perceptions of the danger of tobacco products among both smokers and nonsmokers.

The study concludes that the use of flavored e-cigarettes by youth is a gateway to future smoking: "Consistent with previous findings about e-cigarette use, our findings suggest that youth use of flavored e-cigarettes might serve as a gateway for future cigarette use."

A press release from the American Academy of Pediatrics (the publisher of Pediatrics) reports the conclusion of the study as follows: "Flavored E-Cigarette Use May Increase Teens' Taste for Smoking."

According to this press release: "New research shows the use of electronic cigarettes with flavors such as gummy bear and bubble gum among U.S. middle- and high-school students may serve as a gateway for future smoking." The press release also states that: "The study ... suggests use of these products increases young people's intentions to begin smoking... ."

The Rest of the Story

This study makes one of the cardinal mistakes of causal inference: assuming that correlation in a cross-sectional study equals causation. The fact that there is an association between the use of flavored e-cigarettes and higher susceptibility to smoking does not demonstrate that the use of e-cigarettes increases susceptibility to smoking. Because the data are cross-sectional, it could alternatively be the case that higher susceptibility to smoking causes youth to experiment with e-cigarettes.

In other words, the direction of this relationship could go either way: from e-cigarettes to an intention to smoke or from an intention to smoke to use of e-cigarettes.

Despite the fact that the relationship could be in either direction and despite the fact that the paper acknowledges that "the data are cross-sectional; thus, we were unable to establish causal inferences," the paper nevertheless concludes that e-cigarettes may be a gateway to smoking. Moreover, the press release clearly presents the findings as suggesting that e-cigarettes cause smoking initiation among youth.

This is a great example of the widespread bias against e-cigarettes that has taken hold in the tobacco control movement. Instead of presenting the study as showing equivocal results, the investigators and the American Academy of Pediatrics have both "chosen sides." This is not science; it is biased interpretation and presentation of science.

Why should we even be spending money on conducting this research if investigators and organizations are going to draw pre-determined conclusions regardless of whether those conclusions are supported by the data? Why not just save the time and money and jump right to the conclusion that e-cigarettes are a gateway to smoking without the need for actual scientific evidence? After all, we're drawing that conclusion without the presence of scientific evidence anyway.

Why are CDC and the FDA Incapable of Telling the Truth? E-Cigarettes are NOT a Form of Tobacco Use

In an article published Friday in the journal Tobacco Control, the Centers for Disease Control and Prevention's (CDC) Office on Smoking and Health and the Food and Drug Administration (FDA) indicated that electronic cigarettes are simply another form of "tobacco use." The article noted that 68% of electronic cigarette users vape flavored e-liquids and concluded that: "It is important for tobacco prevention and control strategies to address all forms of tobacco use, including flavoured tobacco products."

The Rest of the Story

Vaping is not a form of tobacco use. Electronic cigarettes do not contain any tobacco. This is a tobacco-free product and to tell the public that vaping is a form of tobacco use is dishonest. What the CDC and FDA are doing here is "a form of" lying.

The interesting question is: Why are the CDC and the FDA apparently incapable of telling the public the truth? Why are they not able to be honest about the fact that electronic cigarettes do not contain tobacco?

Clearly, for some reason, the truth represents a great threat to these agencies. Perhaps they are worried that if the public understands that vaping does not involve the use of tobacco, many more young people will start vaping. But that hardly justifies lying to the public.

What is so potentially damaging about being honest and telling the public that while vaping is not a form of tobacco use and is therefore much safer than smoking, there may be some risks associated with long-term use?

And what is so damaging about being honest and recommending that in addition to being concerned about all forms of tobacco use, public health practitioners should also address the use of electronic cigarettes (among nonsmokers and particularly, youth)?

The dishonesty being displayed by health agencies like the CDC is having documented adverse consequences for the public's appreciation of the severe hazards of smoking. According to a paper published just last week in the American Journal of Preventive Medicine, the proportion of U.S. adults who incorrectly believe that smoking is no more hazardous than vaping tripled from 2012 to 2015.

The study concluded that: "The findings underscore the urgent need to convey accurate information to the public, especially adult smokers, about the available scientific evidence of the harm of e-cigarettes compared to combustible cigarettes." And my esteemed mentor - Dr. Michael Eriksen, dean of Georgia State's School of Public Health stated that: "Our public health messages should accurately convey to cigarette smokers that switching completely to e-cigarettes would reduce their risks even if e-cigarettes are addictive and not risk-free."

The CDC's dishonesty is problematic not only because it violates ethical principles of public health practice (i.e., honesty and transparency), but because it is actually doing public health damage: it is deterring smokers who might otherwise have quit using e-cigarettes, and it is encouraging many ex-smokers who quit using e-cigarettes to return to smoking. After all, if vaping is just another form of tobacco use, then why not enjoy the full-on experience of a good smoke?

RegulatorWatch Segment on the Vaping Controversy - Part Two

Here is the second part of a two-part series in which Brent Stafford interviews me about the vaping controversy. Brent did a fantastic job of covering all of the key issues in the debate, and I tried to explain the scientific reasoning behind my position on the major points of contention.

RegulatorWatch Segment on the Vaping Controversy

Here is the first part of a two-part series in which Brent Stafford interviews me about the vaping controversy. Brent did a fantastic job of covering all of the key issues in the debate, and I tried to explain the scientific reasoning behind my position on the major points of contention.

Why is the Massachusetts Health Council Helping Coca-Cola in its Marketing of Soda?

This coming Tuesday, the Massachusetts Health Council will be hosting its annual "Dining with the Stars" awards gala. One organization that should not be getting any public health awards is the Massachusetts Health Council itself. While the Council's mission is to promote "prevention and wellness," it is actually helping the soda industry to market the very products which are contributing significantly to the nation's obesity epidemic.

The Rest of the Story

If you look at the list of sponsors of the Massachusetts Health Council's awards gala, you'll find a long list of health organizations, including my own Boston University School of Public Health, the BU School of Medicine, the Harvard University T.H. Chan School of Public Health, the University of Massachusetts Medical School, and the Dana Farber Cancer Institute. But if you look a little more carefully, you'll see that one of the "health organizations" that is sponsoring the awards gala is the Coca-Cola Company.

It was just this past Monday that Dan Aaron and I published an article explaining how the soda companies are using corporate sponsorship as a tool to improve their public image, divert attention from the role of their products in the obesity epidemic, hide the fact that they are lobbying vigorously against public health measures designed to fight obesity, and ultimately - to improve their bottom line: namely, the sale of Coke, their signature brand. We identified 96 different health and medical organizations that accepted funding from Coca-Cola or PepsiCo during the period 2011-2015. We also documented that due to this funding, many of these organizations softened or eliminated their criticism of the soda companies, downplayed the role of soda consumption in weight gain, and ended their support of policies to reduce soda consumption.

It looks like we can add the Massachusetts Health Council to the list, penciling them in for 2016.

By accepting this money from Coca-Cola, the Massachusetts Health Council is allowing itself to be used as a pawn in a grand marketing strategy taken right from the Big Tobacco playbook. The tobacco companies used corporate sponsorship as a marketing tool to "promote tobacco sales, and therefore, the bottom line, for the sponsoring companies. Increased awareness of cigarette brands creates brand familiarity, a factor known to influence consumer buying behaviour. ... The second outcome of the marketing functions achieved through tobacco sponsorship is enhanced corporate image, which in turn affects tobacco policy by influencing social attitudes and values regarding tobacco. Through its corporate sponsorship, a tobacco company may be able to create good will among the public, even given the recognition that tobacco is a harmful product. In other words, it may help put a “human” face on the corporation and point out its contributions to the community, taking the focus away from damage caused by its products."

Corporate sponsorship is being used the same way by the soda companies. By accepting this money, the Massachusetts Health Council is actually playing a role in the marketing of soda by these companies. Clearly, participating in the marketing of soda is not consistent with the mission of the Massachusetts Health Council.

The Massachusetts Health Council should follow the lead of other health organizations such as the Academy of Nutrition and Dietetics and the American Academy of Pediatrics and renounce its sponsorship by the Coca-Cola Company.

Dieticians are Being Paid Off to Promote Soda Consumption and Oppose Soda Taxes, Defiling their Profession; Soda Companies Following Big Tobacco Playbook

(Note: See addendum below)

Earlier this week, Dan Aaron and I published an article revealing that the major soda companies - Coca-Cola and PepsiCo - are using corporate sponsorship of medical and health organizations as a strategy to improve their public image and head off potential negative publicity and public policies that might reduce soda consumption. Our article focused on the sponsorship of organizations. Today, I discuss the fact that the soda companies are also paying individuals in an attempt to improve their public image and divert attention away from the role that their products play in the obesity epidemic.

According to an article published last week at Ninjas for Health, the Coca-Cola Company is paying a group of dieticians to downplay the significance of soda consumption in weight gain and to oppose soda taxes as a method to reduce soda consumption.

"You may remember the surprise last year that Coca-Cola had paid health experts and university researchers to deflect blame about the health harms of soda. Upon further analysis of the payola list, we found that the majority of them were dietitians. Specifically they were all paid to write articles, TV appearances, and social media content touting mini-Coke cans as a “healthy snack”. ...

So when a group of dietitians suddenly began offering their opinions on the #sodatax hashtag on Twitter this week, I got a little suspicious. Soda taxes are a strategy dietitians should (and do) support in order to decrease soda consumption and promote healthy options. Yet these dietitians were all posting content against the soda tax, including the industry talking point that a soda tax is a grocery tax. That’s just a coincidence right?" ...

"So I compared these tweeters against Coke’s payola list, and guess who appears? Carol Berg Sloan, Robyn Flipse, Pat Baird, Sylvia Klinger, and Kim Galeaz are all part of Coke’s paid dietitian network. And Rosanne Rust discloses her consulting with the American Beverage Association in her Twitter profile. In several of their tweets, they mention @cartchoice (Your Cart Your Choice), a project fighting soda taxes funded by the American Beverage Association and sugar industry. That’s just a coincidence, right?" ...

 
"It looks like Coke is doing it again: Paying dietitians to perpetuate lies that promote soda and swing public opinion against policy solutions to the obesity epidemic it helped cause. These aren’t “health experts”, they are paid promoters of the sugar industry."

I conducted my own investigation and found that there is a large group of dieticians who are essentially being paid by Coca-Cola to express opinions downplaying the role of soda consumption in weight gain and opposing soda taxes. Here is what I found:


Robyn Flipse, MS, RD: Robyn Flipse has advocated against soda taxes. While her web site boasts about her affiliations with organizations like the American Dietetic Association and a number of medical schools, it does not reveal that she is a paid consultant for the Coca-Cola company. And although she lists a number of business clients, she does not disclose Coca-Cola as being one of them. Thus, she not only has a severe conflict of interest that has the perception of biasing her opinions, but she is not readily disclosing this conflict. Moreover, she is listed as a paid consultant to the American Beverage Association, a soda industry lobbying organization that opposes virtually every public health measure being considered to reduce obesity.

Carol Berg Sloan, RDN, FAND: Carol Berg Sloan has advocated against soda taxes. Her January 25 article opposing soda taxes does not disclose that she is a paid consultant of Coca-Cola. Thus, she not only has a severe conflict of interest that has the perception of biasing her opinions, but she is not readily disclosing this conflict. Moreover, she is listed as a paid consultant to the American Beverage Association, a soda industry lobbying organization that opposes virtually every public health measure being considered to reduce obesity.

Pat Baird, MA, RDN: Pat Baird has actually promoted soda consumption. In a recent article, she discloses that she is an "advisory partner" to the food and beverage industry, but does not explain that she, too, is a paid consultant of Coca-Cola. This fact is also hidden on her blog. Thus, she not only has a severe conflict of interest that has the perception of biasing her opinions, but she is not readily disclosing this conflict. Moreover, she is listed as a paid consultant to the American Beverage Association, a soda industry lobbying organization that opposes virtually every public health measure being considered to reduce obesity.

Amy Goodson, MS, RD, CSSD, LD: Amy Goodson has also promoted soda consumption.  Her bio conveniently hides the fact that she is a paid consultant of Coca-Cola. Thus, she not only has a severe conflict of interest that has the perception of biasing her opinions, but she is not readily disclosing this conflict. Moreover, she is listed as a paid consultant to the American Beverage Association, a soda industry lobbying organization that opposes virtually every public health measure being considered to reduce obesity.

Kim Galeaz, RDN CD: Kim Galeaz goes as far as actually promoting soda consumption as a method of hydration. That article discloses that she is an "advocacy consultant for the food, beverage and agriculture industry," but does not reveal that she is a paid consultant of Coca-Cola. Thus, she not only has a severe conflict of interest that has the perception of biasing her opinions, but she is not readily disclosing this conflict. Moreover, she is listed as a paid consultant to the American Beverage Association, a soda industry lobbying organization that opposes virtually every public health measure being considered to reduce obesity.

Amy Myrdal Miller, MS, RDN, FAND: Amy Myrdal Miller has also gone so far as to actually promote soda consumption. She is not listed as a paid consultant of Coca-Cola, but does consult with "a variety of food and beverage clients." Moreover, she is listed as a paid consultant to the American Beverage Association, a soda industry lobbying organization that opposes virtually every public health measure being considered to reduce obesity. 

Sylvia Meléndez Klinger, MS, RD: Sylvia Klinger has also written articles downplaying the importance of avoiding soda consumption. A recent article completely hides the fact that she is a paid consultant of Coca-Cola. Thus, she not only has a severe conflict of interest that has the perception of biasing her opinions, but she is not readily disclosing this conflict. Moreover, she is listed as a paid consultant to the American Beverage Association, a soda industry lobbying organization that opposes virtually every public health measure being considered to reduce obesity.

Rosanne Rust, MS, RDN, LDN: Rosanne Rust has also recommended soda consumption, while at the same time hiding the fact that she is a paid consultant of Coca-Cola. Thus, she not only has a severe conflict of interest that has the perception of biasing her opinions, but she is not readily disclosing this conflict. Moreover, she is listed as a paid consultant to the American Beverage Association, a soda industry lobbying organization that opposes virtually every public health measure being considered to reduce obesity.

Neva Cochran, MS, RDN, LD: Neva Cochran also downplays the problems with soda consumption (even diet soda is linked to obesity) by promoting diet soda consumption. At the same time, she hides the fact that she is listed as a paid consultant to the American Beverage Association, a soda industry lobbying organization that opposes virtually every public health measure being considered to reduce obesity. Thus, she not only has a severe conflict of interest that has the perception of biasing her opinions, but she is not readily disclosing this conflict.

The Rest of the Story

This is right out of the Big Tobacco playbook. For many years, the tobacco companies paid a group of researchers to write articles downplaying the health effects of smoking and opposing public policies that would reduce tobacco consumption. The goal of this effort was to make it appear that these were independent, objective scientists who had come to the unbiased conclusion that smoking was not particularly harmful. The truth was that these scientists were on the tobacco payroll, their opinions were heavily biased, and these severe conflicts of interest were often hidden from the public.

The soda companies are now doing the same thing. There is a network of dieticians who are essentially being paid off to express opinions in which they downplay the role of the soda industry in the obesity epidemic, question the link between soda consumption and weight gain, and oppose public health policies that would reduce obesity by lowering soda consumption.

All of these dieticians are also consulting for the American Beverage Association, which we showed in our paper is an industry-funded group that vigorously lobbies against virtually all national, state, and local public health policies supported by the health community to address the obesity problem.

The rest of the story is that these dieticians are essentially paid hacks of the soda industry. Just like the tobacco industry hacks who were discredited many years ago, it is time that these soda company hacks be exposed to the public. These are not objective, independent scientists who happen to be expressing opinions. This is a paid and coordinated campaign by the soda industry to undermine the public's appreciation of the health consequences of soda consumption, to divert attention away from the soda industry's role in the obesity epidemic, and to create opposition to policies intended to reduce soda consumption.

While I was surprised by many of our findings on soda company sponsorship, I am frankly shocked to see that a group of dieticians would allow themselves to be used by the soda industry as hacks like this. In my opinion, this defiles the profession of dietetics.

While the Academy of Nutrition and Dietetics has rightfully decided to discontinue taking money from soda companies, it is pathetic to see that a group of supposed public health practitioners are allowing themselves to be used as paid hacks of the soda industry and that in many cases they are hiding these financial relationships.

I am not really blaming the soda companies for pursuing these sponsorships and these consulting arrangements. It is actually a brilliant strategy. It worked for Big Tobacco and it is working wonders for the soda companies. But Coca-Cola and PepsiCo are not in the business of public health. Their job is to sell soda, and these sponsorships and consulting arrangements help them to do that. Their job is to sell soda and I can't really blame them for using the most effective marketing strategies available to do that.

However, dieticians are supposed to be in the business of public health. They are not in the business of marketing soft drinks. It is an unacceptable conflict for them to be taking money from soda companies while pretending to give the public objective and unbiased information about nutrition science. That's just not possible when you're being paid off by the soda industry.

It's time for everyone in the public health community - both organizations and individuals - to stop enabling the soda companies to use them as pawns in their grand marketing strategy by rejecting soda company funding.

ADDENDUM

According to an article published on October 6 by the New York Times, Coca-Cola has discontinued its practice of paying scientists, and the American Beverage Association has at least temporarily suspended its payment of scientific experts pending further review. 

FDA Poised to Issue Rule that Will Be Devastating for Public Health, and Possibly Unconstitutional

It appears that the Food and Drug Administration (FDA) is preparing to issue a rule that would prohibit e-cigarette companies from suggesting that their products may be useful for smoking cessation. The proposed rule, as reported by The Hill, would classify as a drug/device any e-cigarette or vaping product that makes any claims related to quitting smoking.

According to the article: "The White House is reviewing a final rule from the Food and Drug Administration (FDA) on tobacco products. The rule aims to clarify when the FDA can regulate a product like nicotine gum as a drug or device versus a tobacco product like electronic cigarettes. For the agency it all comes down to the product’s intended use. The FDA sent the rule, first proposed in September 2015, to the White House Office of Management and Budget (OMB) on Monday. The proposed rule states that tobacco products intended for human consumption are regulated as a drug, device or combination product if intended for diagnosing or treating a disease. ... “Given the availability of FDA approved drugs for smoking cessation, FDA believes that consumers are particularly susceptible to confusion where products made or derived from tobacco that otherwise appear to be products intended for recreational use make claims related to quitting smoking,” the rulemaking said."

The Rest of the Story

This rule would be disastrous for the protection of the public's health because it would mean that vaping companies could not inform consumers that the primary purpose of e-cigarettes is to help smokers get off of cigarettes (i.e., quit smoking). They could not share testimonials about smokers who have quit using e-cigarettes because doing so would likely be interpreted by the FDA as making a cessation claim, which would subject the product to the regulations related to drugs, which would require clinical trials before the product could be marketed.

This rule will essentially force e-cigarette companies to market their products as cool, digital devices - a message that resonates with youth and will increase the appeal of these products to youth. The alternative - that the FDA allow cessation claims - would enable companies to tell the truth to consumers and to market these products based on their actual intended use. In other words, this rule would essentially force e-cigarette companies to lie to consumers and to withhold from them critical information.

Here is why I do not believe that this rule will pass legal muster, if challenged:

The FDA is making a false assumption. They are assuming that smoking is a disease. The agency is apparently going to state, correctly I would add, that an e-cigarette that is primarily intended to prevent or treat a disease is a drug/device. However, the agency goes one step further and rules that products which make claims related to smoking cessation are therefore intended to treat a disease. This of course assumes that smoking is a disease.

I disagree. I don't believe that smoking is a disease. Rather, it is a health behavior. Sure, it is a health behavior that is related to a number of diseases, but smoking itself is not a disease, per se.

Simply stated, a smoking cessation claim - in isolation - is not necessarily a drug claim - because the intention is not to treat a disease, but to help consumers change a health behavior. Since changing a health behavior is not treating a disease, the FDA has no legal authority to regulate e-cigarettes which make smoking cessation claims as drugs or drug/device combinations.

OK, so you may ask: If a smoking cessation claim is itself not a therapeutic claim, then why is the FDA able to regulate nicotine replacement therapy and varenicline as drugs? The reason is that these products are designed and intended to treat a disease: nicotine dependence. The DSM recognizes nicotine dependence as a disease and nicotine withdrawal is a health symptom. Since these products are primarily intended to treat nicotine dependence and to prevent withdrawal symptoms, they are rightfully considered to be drugs.

Of course, if e-cigarettes are marketing with a claim that the product is intended to treat nicotine dependence or to prevent withdrawal symptoms, then it's a different story. But by itself, a claim that vaping can help people quit smoking, or even that it is intended to help people quit smoking, is not a therapeutic claim, and the FDA must allow such claims to be made.

Hopefully, this rule will be challenged in court.

Here is a more detailed treatment of this issue:

What is a therapeutic claim? Under the Food, Drug, and Cosmetic Act, it is defined as: "Promoting a product with claims that it treats or prevents disease or otherwise affects the structure or any function of the body will cause the product to be considered a drug under the FD&C Act, section 201(g)."

The key point is that in order to be making a therapeutic claim, one either has to claim that the product will treat or prevent a disease or claim that the product will affect the structure or a function of the body.

A. Is Smoking a Disease?

Is claiming that electronic cigarettes can aid in smoking cessation a claim that these products can treat or prevent a disease? That depends on whether smoking is a disease.

Smoking itself is not a disease, but a behavior. Just as eating unhealthy food is not a disease, but a behavior. Or as not exercising is not a disease, but a behavior. Or as drinking alcohol is not a disease, but a behavior.

In and of itself, a claim that electronic cigarettes can aid in smoking cessation is therefore not a therapeutic claim.

As long as electronic cigarettes are marketed as an alternative to cigarettes which may help the user cut down or eliminate cigarette use, then it is simply claiming that it may affect a health behavior, rather than that it will treat or prevent a disease.

Consider the following scenarios:

1. An apple orchard decides to promote consumption of its apples by putting out advertisements which claim that buying apples from this orchard will help consumers to improve their diet and reduce their consumption of junk food. Does the FDA have jurisdiction over such claims under FDCA?

Of course not. The apple orchard is not claiming that is products (apples) will prevent or treat any disease. It is merely arguing that eating its apples is a healthy behavior. What is being claimed is that these products will improve health behavior, not that these products will treat or prevent a disease?

If the orchard claimed that eating its apples would reduce the risk of heart disease, then that could be interpreted as a therapeutic claim because it is claiming that its product will prevent a disease. But a simple claim that eating these products will improve one's diet is a behavioral claim, not a therapeutic one.

If we applied the FDA's reasoning, then the apple orchard would have to stop making this claim. One can easily see, I believe, that the FDA's argument does not hold.

2. I decide to sell a calendar that includes inspirational pictures of people exercising. It also contains reminders on certain days of the week to remind people to exercise on those days. I send out a flyer, advertising my calendar, in which I claim that this calendar may help people to exercise more often. Is that a therapeutic claim?

Of course not. Lack of exercise is not a disease. It is a behavior. I am not claiming that my calendar will treat or prevent any disease. I am only claiming that my calendar could influence one's health behavior. But again, by the FDA's argument, this is a therapeutic claim and renders my calendars subject to the FDCA.

3. I conduct an educational program about alcohol, inviting people to come learn about the potential harms of alcohol use. At the program, I offer for sale a booklet that I claim can help people reduce their alcohol use. Do I need FDA approval to sell my booklet?

Of course not. It is only claiming to help people alter their behavior. It is not making a therapeutic claim. But again, by the FDA's reasoning, since it is claiming to affect a health behavior, it is indeed a therapeutic claim and would not be allowed.

I have demonstrated that in and of itself, claiming that electronic cigarettes may be useful in smoking cessation is not a therapeutic claim. Of course, the companies must refrain from claiming that the use of electronic cigarettes will reduce the risk of disease (that would be a therapeutic claim). But as long as they restrict their marketing to claims that these products may influence smoking behavior, then the claim is not a "therapeutic claim."

B. Is a Smoking Cessation Claim One that the Product Will Affect the Structure or Function of the Body?

It depends. Specifically, it depends on the mechanism by which the company is claiming smoking cessation will be achieved. If the mechanism involves any alteration of the structure or function of the body, then the claim could be interpreted as a therapeutic one. However, if the company is not claiming that the structure or function of the body will be affected, then it is not a therapeutic claim.

Suppose that an electronic cigarette company markets its products by boasting that they are intended to deliver nicotine with the goal of relieving symptoms of nicotine withdrawal and therefore making it possible for the smoker to quit smoking. If the primary intended purpose of the device is to deliver nicotine in order to prevent withdrawal symptoms by occupying nicotine receptors, then this type of marketing claim could be interpreted as a therapeutic claim.

This is, in fact, the reason why NRT products are regulated under FDCA. These products are specifically designed and intended to affect the structure and function of the body. They are designed to bind to nicotine receptors and prevent nicotine withdrawal, thus aiding the smoking cessation process. Similarly, Chantix is designed as a nicotine agonist. It works by altering the structure and function of the body.

However, suppose that an electronic cigarette company markets its products not by intending that the product's purpose is to prevent nicotine withdrawal symptoms during quit attempts, but instead, by simply intending that the product's purpose is to serve as an alternative to cigarette smoking. Suppose that the marketing of the product is focused on providing an alternative to cigarette smoking that does not involve tobacco or combustion. Then it is not making a therapeutic claim because it is not claiming that this product is intended to affect the structure or function of the body.

Summary of My Argument

There is no such disease or medical condition as smoking dependence. Smoking is not a medical disease or condition, it is simply a behavior. Smoking isn't any more of a disease as is bungee jumping or eating Vienna Fingers. What is a medical condition is nicotine dependence and nicotine withdrawal. These are conditions clearly defined in the DSM.

I have acknowledged, above, that if the primary intended use of electronic cigarettes is to treat a disease or medical condition, then they are subject to FDA jurisdiction under FDCA. This means that if a company claims that electronic cigarettes are designed specifically to help smokers quit by treating nicotine dependence, then the product can be regulated as a drug. However, what if the company markets the product merely as a smoking alternative? In that case, the product is not a drug and cannot be regulated under FDCA.

Now let's take a middle ground case: suppose a company states that electronic cigarettes are a smoking alternative that may help smokers to quit smoking. In that case, are the electronic cigarettes being marketed to treat any medical condition? If the intent of the manufacturer is for the consumer to simply switch over to electronic cigarettes, then I believe the answer is no. Smoking dependence is not a medical condition. So if the primary objective is to get the consumer off of cigarettes, then no therapeutic claim is being made.

In fact, unless an electronic cigarette company is making a specific claim that its products will treat nicotine dependence by eliminating the symptoms of nicotine withdrawal - and that is the primary aim or use of the product - then I believe that it is making no therapeutic claim and that its products cannot be regulated under FDCA.

In other words, simply stating that electronic cigarettes may help smokers quit smoking is not, in my opinion, a therapeutic claim.

As long as the primary intent of the electronic cigarette company is to maintain the customer on its products, then it is not treating nicotine dependence, and I do not believe it is making a therapeutic claim. If the purpose of the product were to help someone get over the hump of quitting smoking and then discontinue use of the product, that would be a different story. But that's not the way I see most electronic cigarettes being marketed.

The rest of the story is that the world is not as simple as the FDA would like us to believe. A smoking cessation claim, in and of itself, is not necessarily a therapeutic claim. The situation is a lot more nuanced than that.

In my opinion, electronic cigarette companies should be allowed to truthfully inform consumers that their products may be useful for smoking cessation, as long as these claims are made within the general framework of marketing electronic cigarettes as an alternative to tobacco cigarettes. Such claims are not therapeutic claims as defined by section 201g of the FDCA.

National Anti-Tobacco Groups File Feeble Lawsuit Against FDA While Continuing to Oppose Smoking Cessation via Vaping

Earlier this week, eight national anti-tobacco groups, headlined by the Campaign for Tobacco-Free Kids, filed a lawsuit against the FDA in an attempt to force the agency to re-issue a requirement for graphic warning labels on cigarette packs.

As the lawsuit explains, here are the key facts:

1. "The Tobacco Control Act became law on June 22, 2009. Section 201 required the FDA to  promulgate its final rule [regarding graphic warning labels] “not later than 24 months after the enactment” of the Act: June 22, 2011."

2. "On June 22, 2011, exactly two years after the Tobacco Control Act was enacted, the FDA promulgated a final rule designating nine graphic warning labels depicting the negative health consequences of cigarette smoking as required by Section 201 and set September 22, 2012 as the time by which such warning labels would be required."

3. "On September 2, 2011, a group of tobacco product manufacturers and sellers filed an action in the United States District Court for the District of Columbia alleging that the 2011 Rule was unconstitutional as applied because the specific required content, placement and type style of the mandated warning labels infringed their rights of free speech under the First Amendment."

4. "On February 29, 2012, the United States District Court for the District of Columbia found that the specific warning labels required by the 2011 Rule were unconstitutional and enjoined the  enforcement of the rule. On August 24, 2012, the Court of Appeals for the District of Columbia Circuit affirmed the judgment of the District Court and vacated the 2011 Rule. The Court of Appeals remanded the rule to the FDA and vacated the District Court’s permanent injunction."

5. "On March 15, 2013, Attorney General Eric Holder, in a letter to Congress, stated that, given the FDA’s plan to undertake research to support a new rule mandating graphic warning labels consistent with the Tobacco Control Act, the Solicitor General had determined not to seek Supreme Court review of the Court of Appeals’ ruling."

The lawsuit's complaint is that although "more than four years have now passed since the Court of Appeals vacated the 2011 Rule, the FDA has not even be gun rulemaking proceedings to promulgate a new graphic warnings rule as required by Section 201. No proposed rule even appears on the FDA’s Unified Regulatory Agenda for action during 2016."

The Rest of the Story

This is a very weak lawsuit. At this point, whether or not the FDA re-issues a rule regarding graphic warning labels is entirely up to the agency's discretion. The agency has already complied with the statute, which merely requires it to issue a graphic warning rule by June 22, 2011. The FDA did issue that rule, on June 22, 2011, as required. The rule was deemed unconstitutional by the D.C. District and Circuit courts and was vacated. Since the FDA issued the rule as required by the statute, it has fulfilled its obligation under the law and is not required to issue a subsequent rule. There is nothing in the statute indicating that if the initial rule is found to be unconstitutional, the agency must keep issuing additional rules until one finally passes Constitutional muster.

The key argument of the plaintiffs, which include the Campaign for Tobacco-Free Kids, American Cancer Society, American Heart Association, American Lung Association, and the American Academy of Pediatrics, is that the FDA has failed to comply with Section 201. I don't find that argument compelling because the agency has in fact complied with Section 201 by issuing a rule on graphic warning labels, as required, by June 22, 2011. The FDA is not in violation of Section 201.

While the plaintiffs have every right to use advocacy strategies to urge the FDA to re-issue a graphic warning label requirement that does not conflict with the First Amendment rights of the cigarette companies, their attempt to use the law to force the agency to re-issue a graphic warning label rule is unsupported by the facts of the case.

While not directly relevant to the legal issues in the case, the plaintiffs repeatedly claim that the scientific evidence shows that graphic warning labels are effective in getting smokers to quit. However, I do not believe that is the case. The evidence supporting the use of graphic warning labels to promote smoking cessation is weak. Moreover, there is substantial evidence that graphic warning labels are ineffective. A body of psychology and neurophysiology research suggests that graphic warning labels on cigarette packages will have very little effect in deterring smoking among existing smokers.

The Circuit Court recognized as much: "FDA has not provided a shred of evidence - much less the 'substantial evidence' required by the APA - showing that the graphic warnings will 'directly advance' its interest in reducing the number of Americans who smoke. FDA makes much of the 'international consensus' surrounding the effectiveness of large graphic warnings, but offers no evidence showing that such warnings have directly caused a material decrease in smoking rates in any of the countries that now require them. ... FDA's Regulatory Impact Analysis (RIA) essentially concedes the agency lacks any evidence showing that the graphic warnings are likely to reduce smoking rates. ... The Rule thus cannot pass muster under Central Hudson."

Thus, the lawsuit's claim that the failure of the FDA to issue a new graphic warning label rule is hindering the anti-tobacco groups' ability to carry out their mission is unsupported.

The rest of the story is that what is really hindering the ability of these groups to carry out their mission is their continued refusal to promote smoking cessation if that cessation involves anything that resembles smoking, even if no tobacco is involved. Of course, I am talking about their continued attack on electronic cigarettes and vaping, despite the evidence that vaping has helped millions of smokers to quit or substantially cut down on the amount they smoke.

The obsession of the anti-tobacco groups with graphic warning labels coupled with their vigorous protection of cigarette consumption by discouraging smokers to switch to vaping suggests that something else is going on beyond a simple desire to promote smoking cessation. It appears that the desire is to promote smoking cessation only in the way that these groups prefer. Whether the advocated strategy is actually the most effective or most helpful to smokers is not important. What is important, apparently, is not that smokers quit, but that they quit in the "right way."

Quitting using e-cigarettes is not the "right way" because it involves an activity that resembles the act of smoking (even though the product is tobacco-free). Quitting by being bombarded with graphic warnings is the "right way" because smokers are being punished and chided for what is viewed as an immoral or stupid decision to smoke (even though the approach has been shown not to be very effective).

These groups also continue to urge smokers to use other ineffective methods, such as nicotine replacement therapy, because they view these as a "right way" to quit. For the 90% of smokers who fail to quit using nicotine replacement therapy, and for whom e-cigarettes might be the only viable option, these groups still discourage vaping because it is just not the "right way" to quit.

IN MY VIEW: FDA is Partly to Blame for Explosion that Injured Teen on the Hogwarts Express

For several years, the FDA has been nagging us about how important it is that the agency claim jurisdiction over electronic cigarettes because of their safety hazards. Now that the FDA has that jurisdiction, it is the public health agency that is ultimately responsible for ensuring the safety of electronic cigarettes. And so far, it is doing a terrible job.

This past weekend, a teenager suffered burns after an e-cigarette exploded on the Hogwarts Express at the Universal Orlando theme park, sending a fireball in her direction. Since the FDA is responsible, upon its own insistence, for the safety of electronic cigarettes and this explosion occurred on its watch, the agency bears some responsibility for the girl's injuries.

After all, the agency has failed to set any standards, or even to issue a guidance or advisory, for electronic cigarette battery safety. Moreover, the FDA's Center for Tobacco Products has actually institutionalized the problem of exploding batteries because it promulgated regulations that prohibit e-cigarette companies from repairing the defects that are causing these explosions. Since August 8, companies have been prohibited from making any safety improvements on their products, including fixing the problem of exploding batteries. To correct such problems would amount to selling a new "tobacco product," something that is not allowed under the FDA's regulations.

Imagine being the president of the company that manufactured the product which injured this girl and having to explain to the girl's family that although a safety defect has been identified in your product, the FDA has prohibited you from fixing it. The idiocy of these regulations would be comical if they weren't causing so much human damage.

The Rest of the Story

The FDA regulations are so detrimental to the public's health that vape shops are interpreting the rules to mean that they cannot even fix defective e-cigarette devices of their customers: "In addition to talking about health benefits, the regulations now prohibit vape shops from working on customers' devices, which is something that shops charged money for as a service. "It's almost like going to a mechanic and the mechanic tells you what's wrong and how to fix it, but telling you that you have to do it yourself," said Jonathan Golin, a manager at Gorilla Vapes in East Brunswick."

So if a customer has a device that is overheating, leading to the release of formaldehyde, many vape shops apparently believe there is nothing they can do to fix these devices, which is going to harm the health of these customers unless they can fix the devices themselves, which is not something most people are able to do.

Suppose, for example, that a company or a vape shop discovered that it could prevent overheating, and therefore the formation of formaldehyde, by adding a second coil. Thanks to the FDA, the company or vape shop cannot do this because it would result in a "new" tobacco product, whose sale would be unlawful. While one might argue that if a customer already bought a device and then brought it back, the store could fix it; however, it would still essentially be selling a "new tobacco product."

As the official regulator of e-cigarette devices, including batteries, the FDA should be held responsible for its failed regulatory approach. Instead of regulating the safety of these products, the agency chose instead to take a prohibition approach -- wiping out 99% of the industry.

In the meantime, people riding the Hogwarts Express may want to practice their extinguishing spells, as the problem of exploding batteries is not going to be fixed any time soon, thanks to the FDA's Center for Tobacco Products shirking its responsibility for ensuring the safety of the products under its jurisdiction.

Medical School Researchers Criticize Campaigns Intended to Get Smokers to Quit

In a shocking and ironic development, a group of medical school researchers has attacked efforts to promote smoking cessation among adult smokers. Previously, I have only seen such an inappropriate attack coming from the tobacco companies. That in 2016, such an attack is coming from people in medicine, and not from Big Tobacco, is a surprising and troubling irony.

In this month's issue of Preventing Chronic Disease, researchers from the Washington University School of Medicine in St. Louis argue that: "Vaping poses a threat to smoking prevention progress, and it is important for those in tobacco control to understand and counter the tactics used by vaping companies to entice their consumers, especially on social media where young people can easily view the content."

They also argue that "the online use of price discounts or coupons that we observed on Twitter is a concerning practice from an industry that is rapidly growing and evolving."

Furthermore, the authors warned that: "We observed the promotion of flavored e-juices and images of colorful vape pens in our sample of tweets; these promotions and images could grab the attention of potential consumers and entice them to initiate use of these products."

In the introduction to the paper, the authors state that their primary objective in examining tweets about e-cigarettes and vaping is to investigate the marketing of e-cigarettes to young adults. They note that 32% of users are aged 18 to 29 years. Thus, this young adult group appears to be the primary focus of the article.

The Rest of the Story

It seems quite clear that the authors are opposed to the use of effective marketing techniques to promote electronic cigarettes. They attack e-cigarette companies for using price-based marketing, for trying to make their products taste good, and for trying to make their products look attractive. In other words, they are attacking electronic cigarette companies simply for promoting their products!

The authors conclude that we must "counter the tactics used by vaping companies to entice their consumers," implying that it is inappropriate for the vaping companies to be marketing their products.

The marketing campaigns of vaping companies, at least as they apply to adults, are aimed at achieving a single, primary objective: to get as many smokers as possible to quit smoking and switch completely to vaping. The clear financial incentive of vaping companies is to get smokers to switch completely because the fewer cigarettes smokers use, the more e-cigarettes they use. The avowed value proposition of NJOY is "to make smoking obsolete."

Vape shops are only going to stay in business if they can convince enough smokers to switch completely, or almost completely, to e-cigarettes. There is no market for adult nonsmokers to start vaping because the small number who do this are unlikely to vape with any frequency. The money is with smokers, especially those with long smoking histories or high tobacco consumption and dependence, who will vape early and often.

Thus, the rest of the story is that by opposing the efforts of vaping companies to promote their products, these researchers are opposing a major societal effort to entice smokers to quit smoking.

Would these authors also attack the pharmaceutical companies for using price discounts to promote nicotine patches or nicotine inhalers, to market nicotine replacement products with flavors, or to make their products look attractive? Their attack on e-cigarette companies for marketing to adult smokers, even if they are young adults, is the same as criticizing the promotion of smoking cessation drugs. Except it's probably worse because e-cigarettes are probably a little more effective than traditional nicotine replacement therapy.

The story would be different if this paper was focused exclusively on the marketing of vaping products to underage youth; that is, to minors. Everyone agrees that these companies should not be marketing to kids. But the study was not designed to examine the marketing of e-cigarettes to minors. The paper itself states that the primary audience of concerns is young "adults." This is the precise population for which electronic cigarettes are so important. If we can get young adult smokers to quit by switching to e-cigarettes, we can protect their health and save their lives before smoking has taken its toll.

The only thing that is not surprising to me about this story is that the article was published by the Centers for Disease Control and Prevention (CDC). From the get-go, the CDC has been vigorously opposed to smoking cessation via vaping products. Thus, it makes sense that they would publish an article which argues that we must counter all efforts to promote vaping products, even if the very purpose of that marketing is to try to make smoking obsolete.

Article Defending Nicotine Replacement Therapy Fails to Disclose Author's Conflict of Interest with Big Pharma

In another example that demonstrates the hidden influence of Big Pharma on tobacco treatment policy and the extent to which many defenders of nicotine replacement therapy (NRT) are going to hide their conflicts of interest, an article (letter to the editor/reply) defending NRT from criticism that was published online ahead of print in the Journal of Clinical Epidemiology fails to disclose the serious conflicts of interest of its lead author.

The article is a response to a paper published recently in the Journal which concludes that once one accounts for publication bias, there is no significant effect of NRT on smoking cessation.

The published article (a PDF of the accepted manuscript) does not disclose any conflicts of interest that the authors may have. There is no conflict of interest statement at all.

The Rest of the Story

The rest of the story is that the lead author has a long string of financial relationships with pharmaceutical companies, including some that manufacture drugs for smoking cessation, such as NRT.

In 2016, the lead author was the recipient of a Pfizer research award for the study of nicotine dependence. That announcement reports that he "has received consulting fees, honoraria and grants from several for-profit and non-profit organizations that develop smoking-cessation devices, medications, and services, including Pfizer."

The lead author's online CV acknowledges that he has performed consulting services for: "Abbot Laboratories,Acrux Ltd, ALZA Corporation, American Cynamid, Anesta, Aradigm, BASF/Knoll, Begbies Traynor; Boehringer-Ingelheim Pharmaceuticals, Celtic Pharmaceuticals, Ciba-Geigy, Cygnus, DynaGen Corporation, Elan/Sano, Eli Lilly Pharmaceuticals, Glaxo Wellcome, Dupont Merck Pharmaceuticals, Hoechst Marion Rouseau/Marion Merrell Dow/Merrell Dow Lakeside, Lederle Pharmaceuticals, McNeil Pharmaceutical/McNeil Consumer, Nabi, Inc, Neuromedical Technologies, Inc., Neuroscience Ventures, Pacific Pharmaceuticals, Parke Davis Pharmaceuticals, Pfizer Pharmaceuticals, Pharmacia & Upjohn/AB Leo Pharmaceuticals/Kabi Pharmacia/Pfizer, Proctor & Gamble, Sano Pharmaceuticals, Propagate Pharmaceuticals, Sanofi/Synthelabo Pharmaceuticals, SmithKlineBeecham/Glaxo SmithKline Consumer Healthcare, Xenova Limited."

The lead author reports (in the online CV) having received grants from Pfizer (Chantix), McNeil Pharmaceuticals (Nicotrol inhaler and nicotine nasal spray), Pharmacia & Upjohn/Smith Klein Beecham Healthcare (nicotine gum), ALZA (Nicoderm), Marion Merrell Dow (Nicorette), and DynaGen (NicErase). 

There doesn't appear to be any question that this author's financial conflicts of interest are hugely significant and highly relevant to the subject matter of the manuscript. Therefore, these conflicts of interest should have been disclosed in the published article so that readers can be aware of the conflicts and take that potential source of bias into consideration when evaluating the validity of the paper's conclusions.

It is not clear whether the failed disclosure in the published article is the fault of the authors or of the journal itself (i.e., it is possible that the authors disclosed these conflicts during the submission process but that the journal failed to add these disclosures to the published article). However, it doesn't matter because either way, readers are deprived of knowing about these important conflicts of interest. In addition, I believe it is the authors' obligation to ensure that the conflicts of interest are disclosed in the actual published paper. The authors are able to make such a correction when reviewing the manuscript proofs.

This is not the first example I have highlighted on this blog of the hiding of financial conflicts with Big Pharma in papers defending nicotine replacement therapy or other smoking cessation drugs. This is a general pattern I have observed. To me, it suggests that many defenders of NRT really do have something to hide. The evidence supporting NRT as a population-based strategy for smoking cessation is already flimsy, and it becomes even more flimsy once one considers the severe conflicts of interest of so many investigators who are evaluating these drugs. So it makes sense that there would be an effort to hide these conflicts from the public. But it is not an ethical practice, and it does a great disservice to the public and to the public's health.


(Thanks to John Polito for the tip.)

FDA Issues New Draft Guidance on Regulation Compliance for Certain Types of E-Cigarettes; CDC Comments

The FDA took steps yesterday to clear a big point of confusion that has arisen concerning a subset of electronic cigarettes on the market. Due to novel technology that allows nicotine to be extracted in concentrated form from potatoes, a number of e-cigarette companies have switched to using potatoes as a source of nicotine for their e-liquids. Several companies have asked the FDA's Center for Tobacco Products for guidance on whether they need to comply with the tobacco product regulations, since their products do not contain tobacco and the nicotine used is not derived from tobacco.

Here is the relevant excerpt from the FDA's guidance document which explains how these products will be treated by the agency:

On May 10, 2016, the agency published a final rule that deems all products meeting the statutory definition of “tobacco product,” except accessories of the newly deemed tobacco products, to be subject to FDA's tobacco product authorities under chapter IX of the FD&C Act. Section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)), as amended by the Tobacco Control Act, defines the term “tobacco product,” to mean “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product)” and does not mean “an article that is a drug under subsection (g)(1), a device under subsection (b), or a combination product described in section 353(g) of this title.”

Products that contain nicotine derived from tobacco meet the definition of a tobacco product under the FD&C Act and are required to bear a health warning on packages and in advertisements stating: “WARNING: This product contains nicotine. Nicotine is an addictive chemical.” For products that are made or derived from tobacco (but do not contain nicotine), manufacturers may submit a certification to FDA and, instead, bear the statement “This product is made from tobacco.”

The definition of “tobacco product” as set forth in section 201(rr) of the FD&C Act includes all components, parts, and accessories of tobacco products (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product). FDA interprets components and parts of a tobacco product to include any assembly of materials intended or reasonably expected: (1) To alter or affect the tobacco product's performance, composition, constituents or characteristics; or (2) to be used with or for the human consumption of a tobacco product. E-liquids that do not contain nicotine or other substances derived from tobacco may still be components or parts and, therefore, subject to FDA's tobacco control authorities, if they are an assembly of materials intended or reasonably expected to be used with or for the human consumption of a tobacco product and do not meet the definition of accessory.

E-liquids that contain nicotine derived from potatoes do not meet the statutory definition of "tobacco product" unless they are reasonably expected to be combined with a tobacco product. However, since e-liquids that contain nicotine derived from potatoes are "potato products," the agency declares that such products must comply with Marketing Order No. 946, as amended (7 CFR part 946), regulating the handling of potatoes, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”  

Under the order, regulated potatoes must be inspected and certified by FSIS. As authorized under the order, the Committee uses information included on FSIS inspection certificates as a basis for collecting assessments and compiling industry statistics. The order requires handlers to submit reports to provide information on the volume of red types of potatoes handled for the fresh market. The order includes handling regulations for all varieties or varietal types of potatoes grown in the production area. These regulations can include minimum grade, size, quality, maturity, and inspection requirements. They can also provide for the size, capacity, weight, dimensions, pack, marking, or labeling of containers used in the handling of such potatoes. 

Because the agency has deemed e-liquids using nicotine derived from potatoes to be "potato products," these e-liquids and any vaping devices intended for use with these e-liquids are subject to inspection and certification by FSIS. These e-cigarette manufacturers must also submit reports to provide information on the volume of red potatoes handled for the fresh market. They must also comply with the handling regulations for all varieties or varietal types of potatoes grown in the production area.

The Rest of the Story

I have to give the FDA credit for at least following its own logic. If e-liquids that use nicotine derived from tobacco are "tobacco products," then e-liquids using nicotine derived from potatoes are "potato products," and their manufacturers should be subject to all regulations for potatoes, including handling, inspection, packaging, labeling, and production requirements. However, I have to question why the agency ignored the recent emergence of companies that are using nicotine derived from eggplants to prepare e-liquids. Clearly, these products should be deemed "eggplant products" and should be required to comply with all USDA regulations governing the production, inspection, and labeling of eggplants.

Understandably, many small business owners who are in the e-liquid potato nicotine extraction business were upset. The president of NicoSpud E-Liquids was quoted as saying: "These regulations are going to decimate the potato nicotine extraction business. As a small company, we cannot afford the expense of complying with the detailed reporting, inspection, packaging, and labeling requirements. The FDA has basically handed the entire market over to Big Potato." Indeed, the two largest potato manufacturers have each put their own brand of potato-derived e-cigarettes on the market. The R.D. Offutt Company is now selling its "E-Tater" brand in major convenience stores across the country. J.R. Simplot is test-marketing its "SafeSpuds" in Colorado and Utah.

But the national anti-vaping groups defended the FDA's action. According to the Campaign for Tobacco-Free Kids: "Following the playbook of Big Tobacco, e-cigarette companies are using sweet flavors to entice kids to what could turn into a lifetime addiction to nicotine." The Campaign called out "Sweet Potate," a Tampa-based company, for using the word "sweet" in the very name of the product (Sweet Potate Cigs).

The CDC also supported the new guidance, saying: "The use of nicotine in any form is hazardous and can cause impaired brain development in adolescence. The great gains we have seen over the past decades in reducing youth smoking are sadly being undermined by their increased use of potato products."

The CDC, in classifying e-cigarettes using nicotine derived from potatoes as "potato products," has recently documented a large increase in youth potato use. While actual youth consumption of potatoes has fallen significantly, overall potato use among high school students has increased over the past two years.

I do not understand why the FDA and CDC need to lie about these e-cigarettes. They are not potato products simply because the nicotine in their e-liquids happens to be derived from potatoes. And classifying the use of these e-cigarettes as "potato use" is disingenuous at best. Why do we need to lie in order to make our point? Wouldn't it be enough to tell kids that these products are not made from potatoes and therefore do not carry the same safety profile as potatoes. Already, there is evidence of widespread public confusion. More than 50% of youth surveyed believe that e-cigarette use is no more hazardous than eating candied yams.

The rest of the story is that by treating e-cigarettes like NicoSpud, SafeSpud, and SweetPotate exactly like potato products and by classifying them as potato products, the FDA and CDC are essentially telling the public, including our children, that the hazards of vaping these products are virtually identical to those of consuming potatoes.

What will it take for these agencies to understand that just because the nicotine in the latest generation of e-cigarettes happens to be derived from potatoes, that does not mean they are potato products? It is misleading if not outright dishonest to talk about these e-cigarettes as "potato products," to classify them as potato products in surveys, and to claim that youth who are using these products are engaging in potato use.

ADDENDUM: It has come to my attention that many readers did not realize that this is a parody  – my attempt at satire. It is a sad state of affairs that the FDA’s logic has been so terrible that my readers don’t know if this is true or not. That was my exact point in doing this piece. I wanted to show the absurdity of the FDA’s approach – and I think this analogy points it out in a way that many anti-vaping organizations would not understand in any other way. If there is any doubt about whether the deeming regulations are "arbitrary and capricious," this is the proof.