New Youth-Focused Rules for Tobacco Products

This month two major governmental actions—one by the federal FDA and one by the state of California—were announced that have the potential to change the landscape regarding the use of tobacco products. As most users of our web site know, after long deliberation the FDA just issued its deeming regulations regarding the sale and licensing of electronic cigarette devices and similar products. And California governor Jerry Brown signed legislation restricting the legal age of purchase of tobacco products to those over age 21, up from the previous limit of 18. California thus became the second state--after Hawaii--to raise the purchase age to 21, and other states are expected to follow suit. Governor Brown also signed four other tobacco control bills that will have major impacts on tobacco use in California; click here for more information.

What do these new rules mean for those involved in tobacco control? There is great controversy over the role of e-cigarettes, with the public health community split—often acrimoniously—on what the evidence shows and what the net effect of the devices would be on the health of the public in general and smokers in particular. The less controversial part of the FDA ruling calls for limiting purchase of e-cigarettes to those over age 18, with photo identification required for purchase for anyone under age 26. This is less controversial, because there is general consensus that exposure of the developing brain to nicotine, especially in adolescence, increases the risks of future undesirable behavior patterns. However, the FDA avoided taking other steps that might reduce the appeal of these devices to youth, such as forbidding the use of flavors, including menthol. Whether or not nicotine exposure through e-cigarette use can serve as a gateway to subsequent cigarette smoking remains controversial. At the same time as youth use of e-cigarettes has markedly increased, rates of youth cigarette smoking are at a modern low. Thus, although e-cigarettes may serve as a gateway to combustible tobacco for some youth, that is clearly not yet happening at the overall population level. Like with alcohol, motivated underage users of combustible tobacco and e-cigarettes will find a way to get the products they want. But the increased burden of seeking that product will probably dissuade some potential users. Indeed, that seems to have been the case for CVS customers who formerly purchased cigarettes there, as well as for residents in towns that have raised the purchase age for cigarettes. And, of course, signals sent by these restrictions reinforce the goal of de-normalizing the use of tobacco products.

The more controversial component of the FDA ruling is the restrictive standards imposed on the sale of e-cigarettes. The controversy has two basic roots. One is differing viewpoints about whether e-cigs are a useful way to switch from much more harmful combustible cigarettes or are merely another path to addict people to a harmful product. Here the data are inconclusive, and thus subject to misinformation. The United Kingdom has come down on the side of encouraging the switch from combustible tobacco to e-cigarettes for smokers unable to quit using conventional cessation tools such as counseling and approved medications. The other fear, which is grounded in history, relates to the likelihood that the tobacco industry will soon dominate the manufacture and sale of e-cigarettes. This is worrisome in two ways. First, because the industry is so wealthy, it will find it easier to surmount the new FDA hurdles required for product approval. By contrast, smaller companies that make only electronic cigarette devices and thus have no compunctions about weaning smokers away from combustible cigarettes, might be excluded from the market, thereby depriving society of a potential anti-smoking tool. Second, the tobacco companies have an inherent conflict of interest because they will resist incursions into the sales of their most lucrative product—cigarettes. Thus, if they dominate the market, they might position the new product as one to use when it is “inconvenient to smoke,” and to avoid potent nicotine concentrations that would succeed in weaning smokers off cigarettes.

For the present, the e-cigarette market will not change. But within two years manufacturers will have to submit applications for FDA approval, applications that are likely to require considerable resources. It is probable that by year 2019 the e-cigarette market will be concentrated among a smaller number of large companies, probably dominated by the tobacco industry. Whether or not some of the products that are not approved or do not apply for approval will go underground is unclear.

The Smoking Cessation Leadership Center has not been a major participant in the debate on e-cigarettes, in part because we are uncertain how helpful they might be in fulfilling our mission: increasing the number of smokers who try to quit as well as the likelihood that the quit attempt will succeed. That said, it is a rare social event when I don’t get asked questions about e-cigarettes. In brief, here is how I respond:

  • Combustible tobacco is what kills people.
  • The nicotine is what addicts some smokers, though other smokers—especially those who only smoke episodically--are not addicted to nicotine. They smoke for other reasons, including social cues.
  • Nicotine is quite safe, does not cause cancer, but may have relatively minor cardiovascular risks.
  • The choice between the long-term use of nicotine in any form (gum, patch, lozenge, inhaler, nasal spray, or e-cigarette) and continuing to smoke combustible cigarettes is easy. Do whatever you can to stop smoking cigarettes
  • Using the e-cigarette is not as safe as breathing ambient air. It is, however, much safer than smoking combustible tobacco. The British Royal College of Physicians estimates that the health risk of e-cigarettes is only about 5% that of combustible tobacco. Others have different estimates, and we don’t yet have data on long term use and consequences. But I would be shocked if the risk were more than 15%, and would bet at this time on the 5% estimate.
  • Although data on the dangers of second-hand vapor exposure are also scant, at this point it makes sense to include e-cigarettes as part of clean indoor air regulations. That would also help to mitigate the risk that e-cigarette use might serve to re-normalize tobacco use.
  • I agree with trying to keep youth away from nicotine in any form. For that reason, I would advocate banning flavors in e-cigarettes, including menthol. There are some people, however, who would only ban menthol in combustible cigarettes in order to make it more attractive to switch to e-cigarettes.
  • An ideal goal would be to maximize the use of e-cigarettes as a tool to quit smoking while at the same time creating policies to keep the product out of the hands of youth. It is not yet obvious how to accomplish simultaneously those two objectives, and that is one reason why there is so much controversy.
  • We should consider alternate approaches to the gamut of tobacco products, including tiered pricing so that the products that cause the most harm would carry the highest tax levies.
  • One benefit from the all the attention on e-cigarettes is that it brings into sharper focus the incredible damage that occurs from consuming combustible tobacco products.
  • Finally, this is a fast-moving field, new products are likely on the way as well as new federal, state, and local regulations. So, stay tuned, and don’t smoke combustible tobacco products.