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?
Monday, October 31, 2016
Monday, October 17, 2016
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.
Friday, October 14, 2016
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.
Thursday, October 13, 2016
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.
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.
Wednesday, October 12, 2016
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.
"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.
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.
Monday, October 10, 2016
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.
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."
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.
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.
Thursday, October 06, 2016
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.
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.
Tuesday, October 04, 2016
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.
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.
Monday, October 03, 2016
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.
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.
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