November 5, 2018

Stanton A. Glantz, PhD

FDA Commissioner Scott Gottlieb is falling into an old industry trap by expressing willingness to partner on “youth e-cigarette prevention”

In response to exploding youth use of e-cigarettes, led by Juul, the FDA has been talking tough but doing little.  The statement issued on October 31, 2018, by FDA Commissioner Scott Gottlieb on his meetings with industry suggests that he is falling into their old “youth smoking prevention” trap, by “welcoming voluntary steps by companies” and viewing their proposals to address youth e-cigarette use as “thoughtful.”  The path he is following promises to make FDA complicit in promoting the e-cigarette epidemic.

Before he and the FDA proceed down this path, they should carefully read what the 2012 Surgeon General Report Preventing Tobacco Use Among Youth and Young Adults has to say about what the industry is really up to.

 He and the FDA should start with this overall conclusion from Chapter 5:  “The tobacco companies’ activities and programs for the prevention of youth smoking have not demonstrated an impact on the initiation or prevalence of smoking among young people.”

Here are some more details of what the Surgeon General found (beginning on Page 552 of the report, page 657 of the PDF)

This section summarizes those tobacco industry programs with the stated purpose of  preventing smoking among youth; those programs began emerging in the 1980s. A review of industry documents made public under the terms of legal settlements shows that the focus of these programs and their timing has been in response to mounting public concern about the industry’s marketing practices and an attempt to forestall legislation or regulation that would restrict its activities (Landman et al. 2002; Mandel et al. 2006; Sebrié and Glantz 2007; Apollonio and Malone 2010). For example, a confidential presentation by the Tobacco Institute (which was dissolved in 1998 as a result of state litigation against the tobacco industry) that Landman and colleagues (2002) surmised was written around 1982–1983 indicates that the Tobacco Institute considered “the potential positive outcomes of adopting programs of this nature [youth smoking prevention] may be ... a more sophisticated understanding by government regulators of the needs/behaviors of our industry. For example, a program to discourage adolescents from smoking (an adult decision) might prevent or delay further regulation of the tobacco industry” (Tobacco Institute, n.d., Bates No. TIMN0018970/8979, p. 7).

Sussman (2002) has provided a useful chronology of  the industry’s youth smoking prevention programs, which reports that these efforts have tended to focus on parental and peer influences on youth smoking, general decision making and life skills, and issues concerning youth access to tobacco, especially the notion that underage smoking is illegal. It is notable, according to Sussman, that the prevention activities and educational programs developed and supported by the industry ignore the influence of tobacco advertising and promotion on the uptake of youth smoking, the importance of parents not smoking or quitting to provide nonsmoking role models for their children, and an explanation about addiction to tobacco and the problem of serious smoking-related illnesses. In brief, the industry’s youth smoking prevention activities fall broadly into five main categories: (1) family involvement self-help booklets, (2) school-based smoking prevention programs, (3) programs to prevent youth from accessing tobacco, (4) mass media campaigns advocating that youth not smoke, and (5) community-based programs for youth.

These activities rarely, if ever, include more effective messages that concentrate on the industry’s behavior (Figure 5.6; Mandel et al. 2006) and, consistent with industry advertising themes that present smoking as a way to join the adult world, stress that smoking is an “adult choice” or “adult decision.”

In addition, the section summary (page 563 of the report, page 668 of the PDF)

The tobacco industry’s youth smoking prevention activities and programs have not provided evidence that they are effective at reducing youth smoking. Indeed, unpublished internal industry documents available to the public because of litigation, and published academic studies, indicate that they are ineffective or serve to promote smoking among youth. Because older adolescents rebel against the programmatic message that tobacco is for adults only, these efforts can lead to a greater likelihood of uptake among youth (Donovan et al. 2006; Henriksen et al. 2006; Wakefield et al. 2006c).

Focusing programs on issues such as parenting, decision making by youth, life skills, and reducing youth access helps to focus the responsibility for smoking on the young people themselves and on their family environment and diverts attention from the tobacco industry’s marketing efforts and the addictiveness of tobacco products. The industry’s approach also positions tobacco as “forbidden fruit,” with tobacco use being portrayed as an “adult only” practice (DiFranza and McAfee 1992), a message consistent with industry marketing messages that present smoking as a way to be “adult.” The WHO Tobacco-Free Initiative recommends that both governmental and nongovernmental organizations avoid partnering with the industry’s youth prevention programs because the programs have been proven to be ineffective and are used to persuade policymakers to opt for weaker legislation (WHO 2004).

The tobacco industry receives five benefits from its youth smoking prevention initiatives:

  1. The industry uses these efforts to convey to the public, policymakers, judges, and the members of juries that it is doing something substantial about the issue of youth’s tobacco use. In this way, the programs serve to promote positive attitudes about the tobacco industry. Such positive attitudes could help to limit the industry’s legal liability and make it easier for its views to be heard on legislative issues.

  2. More favorable impressions of tobacco companies among youth and young adults can help to maintain the potential for youth to initiate tobacco use in their young adult years (Thrasher et al. 2006; Wakefield et al. 2006c; Ling et al. 2007, 2009).

  3. The industry has been able to use the relationships it has forged through its youth prevention programs to learn of proposed tobacco control legislation and to lobby against that legislation (Forster and Wolfson 1998; Landman et al. 2002; Apollonio and Malone 2010).

  4. The industry is able to use its efforts to prevent smoking by youth to argue that there is less need for public-health-funded tobacco control strategies (Mandel et al. 2006)

  5. Investment in these programs provides a venue for the industry to conduct research on determinants of smoking among youth for the stated purpose of developing its prevention programs. However, this information could inform the companies’ tobacco marketing efforts to youth (Mandel et al. 2006). Tobacco industry research on youth has included Philip Morris’ “Teenage Attitudes and Behaviors Study,” which tracked the smoking behavior and motivations of approximately 20,000 11–17-year-olds annually, with a total of 180,000 teens being surveyed between 1999 and 2007 (Philip Morris USA 2008b). Although tobacco companies assert that there is a “firewall” between the research done for the department concerned with preventing smoking by youth and their cigarette marketing efforts, Philip Morris has acknowledged that it rotates employees through both departments (Tobacco on Trial 2005).

Contrast these evidence-based conclusions with Gottlieb’s statement, reproduced in full with some key points highlighted:

Last month, I issued a call to action – to the FDA and to the e-cigarette industry – to stem the alarming increase in youth use of e-cigarettes. For the FDA, that has included an escalating series of steps that utilize the full range of our regulatory authorities, including increased enforcement of age- and identification-verification requirements, as well as re-examining aspects of our comprehensive plan on tobacco and nicotine regulation in order to strengthen our Youth Tobacco Prevention Plan. We’re committed to announcing a new action plan by mid-November that will set forth a series of new, forceful steps to firmly confront and reverse the youth addiction trends that are at epidemic levels.

For the e-cigarette industry, my message was simple: Step up. Even as the FDA builds a framework to mandate additional restrictions and actions to address these trends, we welcome voluntary steps by companies to address these concerns. I asked five manufacturers whose products, collectively, represent more than 97 percent of the current market for closed-system e-cigarettes to meet with me personally to discuss this vital public health challenge, as well as to submit written plans outlining the steps they intend to take to confront the rising trends in youth use. Each of these companies market products that recently had been sold illegally to minors, either through brick-and-mortar stores or online retailers. Everyone involved in this market has a shared responsibility to address this public health crisis.

Following that call to action, I have met in the past several weeks with the leadership of five companies – Altria Group Inc., JUUL Labs Inc., Reynolds American Inc., Fontem Ventures, and Japan Tobacco International USA Inc. These have been constructive meetings. The companies acknowledged the serious public health consequences associated with youth use of tobacco products. They presented thoughtful proposals, consisting not only of what steps they would take themselves to restrict youth access to and appeal of these products, but also steps that they think the FDA and other policy-makers can take to reverse the trends in youth use of e-cigarettes. Some stated explicitly that preventing youth use must be a priority, and that any potential benefits of e-cigarettes for adult smokers cannot justify significant increases in youth use and addiction.

The companies acknowledged the role that flavored e-cigarette products play in appealing to kids, as well as the role that flavored e-cigarettes can also play in helping adult smokers quit. On this point, their proposals at the meetings reflected a range of ideas: for instance, that the FDA restrict distribution of certain flavored products to channels with enhanced age verification processes. Or that the agency require certain products that are more appealing to kids to come off the market until these products receive premarket authorization from the agency.

The companies also acknowledged the power of social sourcing of tobacco products – in other words, of-age purchasers sharing or selling products to underage friends – in contributing to youth tobacco use. To address this issue, some companies said that they would support raising the minimum age to purchase tobacco to 21 years of age. Companies also described their current actions to promote retailer compliance with age- and identification-verification requirements, and they committed to providing more information in their written submissions to the agency.

These have been useful dialogues. We welcome the feedback and proposals to address the youth epidemic, which will help inform the FDA’s consideration of policy approaches.

At the FDA, we’re considering the data and proposals shared by the companies, in addition to the disturbing data in youth use trends that has come to light over the past months as we continue to re-examine the FDA’s regulatory approach. We are committed to taking the necessary steps to fully confront the epidemic of e-cigarette use that has gripped the nation’s youth and set in motion an accelerating epidemic. I’ve stated clearly, all options are on the table. In the coming weeks, we’ll continue to communicate about the steps that we are taking to forcefully address youth use of e-cigarettes. And we will continue to seek public input from a diverse set of stakeholders, including public health advocates and the manufacturers and retailers affected by these policies.

To inform our approach, we’re looking at a variety of factors, including how different types of electronic nicotine delivery systems (ENDS) products are used by kids; the popularity of various products, such as cartridge-based e-cigarettes; the popularity of non-tobacco flavors; and the strength of various distribution methods in ensuring robust age verification.

As we consider new and updated policies to our initial comprehensive plan for tobacco and nicotine regulation and address the rising rates of youth e-cigarette use, we’ll also stay true to the public health goals that animated the approach that we announced in July 2017. We still believe that new innovations that don’t use combustion, such as many e-cigarettes, may offer an important opportunity for adults to transition off combustible tobacco. We still believe that non-combustible forms of nicotine delivery may be less harmful alternatives for currently addicted adult smokers who still seek nicotine, without the risks associated with combustible cigarettes. And we want to keep this option for adults open.

But, as I’ve said before, the current trends in youth use are not tolerable. We have warned for more than a year that the availability of e-cigarettes cannot come at the expense of addicting a generation of youth on nicotine through these products. We gave ample warnings of the worrisome trends we were observing with respect to rising youth popularity of these products. Now we have hard data to support that public health tragedy that is now underway. And in order to firmly confront and reverse these trends – and fulfill the central premise of our public health mandate – we may need to take actions that might narrow the off-ramp from smoking for adults in order to close the on-ramp to nicotine addiction to kids. 

Achieving the right balance requires a strong regulatory process that protects our nation’s youth.

We welcome the constructive dialogue we had with manufacturers. These manufacturers have an opportunity to demonstrate – through their actions – that we can work collectively to address this crisis, and that they share our earnest intent to keep these products out of the hands of kids. We’ll continue to ensure that the companies making and selling these products are doing their part to reverse this epidemic and we’ll hold accountable those that don’t take this responsibility seriously.

Other things that are concerning about this statement include:

  • The statement that e-cigarettes help adults quit smoking is disputed by about 40 studies.  While there are a few people who do quit successfully with e-cigarettes, the data show that adult cigarette smokers who use e-cigs to quit are less likely to quit cigarettes than those who don’t.  By perpetuating this myth, FDA is harming public health. 
  • The statement that flavors help adults is also not supported by the evidence.  As we pointed out in our public comment on flavors, there only a very few studies of adults and they show mixed results.   There no evidence that adults need flavors to help use e-cigs instead of cigarettes.
  • The statement is continues to assume that tobacco products that are not set on fire (non-combusted products) are substantially safer than conventional cigarettes.  The more we learn about e-cigarettes and other heated tobacco products, the worse they look.  All these products work by generating dangerous ultrafine particles that damage lungs and the cardiovascular system, plus lots of other toxic chemicals.
  • Why do we need the industry to “support” the age of 21?  Hundreds of cities and states are doing this despite industry opposition.  And the FDA/feds cannot make this change anyway because the FDA law prohibits FDA from setting an age for sale above 18.

My guess on what the FDA will do next:  prohibit flavors in pod-style e-cigs like Juul (something Altria already did), but permit them in vape shops.  This is not that big a sacrifice on Altria’s part because Juul is dominating the pod market.  In addition, it is not just the pod design that matters, but also what’s in the pod, which includes not only flavors but the acid Juul uses in the e-liquid that increases nicotine delivery.  In addition while, FDA posted warning letter it sent to the Freeman online vape shop for underage sales. I doubt that these warnings are effective.  It’s easy enough to get into Freeman vape shop online; all you have to do is click the tab that says you’re 21.  

If Gottlieb is serious about doing something to prevent youth e-cigarette use, the FDA should implement the rule on flavors that President Obama killed:  Flavors should be prohibited unless a specific company can submit data to the FDA demonstrating  that the particular flavor would be “appropriate for the protection of public health,” the standard in the Family Smoking Prevention Act that the FDA is charged with implementing.

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