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FDA’s Latest Tobacco Ruling: A Q&A about E-Cigarettes

Strasser, AndrewThe U.S. Food and Drug Administration (FDA) released new rules last week pertaining to what they have labeled “all tobacco products.”  These products include cigarettes, cigars, hookah tobacco, pipe tobacco and others, but perhaps the most controversial of all products now governed is the e-cigarette.

The ruling, which will help implement the bipartisan Family Smoking Prevention and Tobacco Control Act of 2009, aims to achieve the FDA’s goal of improving public health and protecting future generations from the dangers of tobacco use through a variety of steps, including restricting the sale of all tobacco products to minors nationwide. 

While there has been a decline in cigarette use among youth over the past decade, e-cigarette use has increased by nearly 900 percent from 2011 to 2016 in high school students, according to a recent survey supported by the FDA and Centers for Disease Control and Prevention.

Health advocates are praising the rulings as safeguards that will ensure age and access restrictions, safety reviews of products, and the oversight of marketing claims. 

The new rules, which begin in August with retailers being barred from selling tobacco products to anyone under 18, placing them in vending machines or distributing them as free samples, will require that e-cigarettes and their ingredients be reviewed by regulators to remain on the market. 

To gain additional insight into the FDA’s new regulations, the e-cigarette craze, and what has the vaping industry fuming (pun intended), I posed some questions to Andrew Strasser, PhD, an associate professor in the department of Psychiatry at Penn Medicine and the director of Penn’s Biobehavioral Smoking Lab.

Generally, what do you feel are the greatest public health implications for this new set of rules?

There are a few things to consider when weighing the impact of the new regulations. It is important that people understand that the new deeming does not ban e-cigarettes.  Rather, it places some, in my opinion, reasonable rules on who can purchase the product, the need to disclose the product contents and to regulate how the product is marketed, to avoid people being misled.  The new set of rules brings other tobacco products, e-cigarettes, cigars, hookah tobacco, under the same set of regulations as combustible cigarettes.

What are your thoughts on including e-cigarettes, a product not containing tobacco, in the new “tobacco products” regulations?

Because the nicotine used in e-cigarettes is derived from tobacco, e-cigarettes are considered tobacco products.  I do believe that FDA took the correct approach in applying the law this way.

To what do you attribute the significant rise in e-cigarette use among youth?

E-cigarettes have seen a remarkable increase in use since their introduction to the U.S. market.  You are correct that youth in particular have had notable increase in use.  There are likely a myriad of reasons for this.  The product is relatively new, and anything new tends to be appealing to youth.  There is a technology aspect to the product which is also appealing.   There is also the possibility to customize the product with flavors and nicotine levels and voltage which affects delivery. 

It is interesting that although flavors were banned in combustible cigarettes in 2009 through the same Tobacco Control Act, these flavors have not been banned thus far in e-cigarettes.  The marketing and online social media presence of e-cigarettes has been powerful and there is some evidence that these media campaigns are having high saturation in the youth market.  All of these reasons likely contribute to youth use of e-cigarettes.

Based on your knowledge/understanding of the issue, what will the new regulations require of the e-cigarette companies that has them so upset?

I suspect their upset comes from the change from a completely unregulated environment to one with some regulation.  When you look more closely at what will change: restriction of sales so that those under 18 cannot purchase e-cigarettes, that e-cigarettes cannot be sold in vending machines or given away as promotions, I can’t see why these should meet resistance.  These enforcements are reasonable safety measures that we encounter across other products.  

The second area of new enforcement is that the constituents of e-cigarettes must be disclosed.  It is not unreasonable to have laws in place to regulate contents of things Americans purchase and consume, and I would think most people would support such measures.  The last area of enforcement is to restrict how these products are marketing and advertised.  There is strong empirical evidence to support the association between advertising, product perception and likelihood to use a tobacco product.  While respecting freedom to market products, it is also essential that companies cannot falsely market, either explicitly or implicitly, their product in ways that misleads the population.  So, the types of enforcement seem reasonable and something that the population should expect to ensure safety: restrict sales to youth, disclose the contents of the product and don’t mislead consumers.

The perception is that e-cigarettes are less harmful to smokers than tobacco cigarettes.  Do we know this to be true?

It is complicated.  Here’s my perspective.   A combustible cigarette contains approximately 4,000 chemicals, at least 80 of those are carcinogenic, and many others are associated with other cardiovascular and respiratory diseases such as COPD, asthma and emphysema.   Cigarettes kill approximately half of those who use the product in the way the product is intended to be used.  The idea of being less harmful than a cigarette truly sets the bar low in regard to public health expectations.  The complicated part arises with how one chooses to make relative comparisons.  If we compare one e-cigarette, which contains nicotine, flavoring, propylene glycol and some other minor constituents, then that is likely less harmful compared to a combustible cigarette.  We do not know the long term effects of inhaling nicotine and flavors into the lungs, and while it is hard to imagine it would be greater than cigarettes, it may not be harmless.  For example, the flavors are approved for consumption as food flavorings but not for inhalation and depositing into the delicate lung tissue.  We do not know with certainty what the long term effects of inhaling nicotine, propylene glycol or flavor compounds into the lung might be.

Next, if we choose to consider the question at the individual level, then we need to think about situations where e-cigarettes might be dual used, meaning people use e-cigarettes at times they cannot smoke cigarettes and therefore consume more nicotine than they might have without e-cigarettes on the market.  There is growing evidence that dual use is one of the fastest growing phenotype of nicotine user and so there are questions about what is the long term effect of using both products.

Then there is the population level, which incidentally is the level on which the FDA makes decisions.  At the population level, we need to think about things like what number of persons began using e-cigarettes who otherwise would have forgone nicotine use altogether.  How many of those people then progress to cigarette smoking?  At the other end of the smoking trajectory, what number of people were able to use e-cigarettes exclusively and stop using combustible cigarettes, or eventually stop using all nicotine products?  And, what number of people who would have quit cigarettes if e-cigarettes were not available, end up using e-cigarettes because they believe they are harmless and an easier alternative to nicotine abstinence?  It is not an easy question and these are only some of the important questions we need to be asking.

There has been talk by many in the public health sector about progressing toward a “tobacco-free generation.” Do you believe, as a society we will ever see this happen? 

I am not expecting that we will see a 100 percent tobacco-free generation, and I am not certain that needs to be the goal.  There is evidence of smoking taking place in Europe since the 1500s and tobacco being grown and smoked in the United States almost as long. 

Tobacco use is closely tied to many social and cultural practices.  Currently about 1 in 5 adults Americans use tobacco every, or most, days.  It would be surprising to have this decrease to zero.  I think there will be a future where combustible tobacco will reach a prevalence level that it becomes a minor health problem, and the death count will not be the 500,000 we continue to observe annually.  I do think we will see a move toward safer ways to acquire nicotine that do not lead to cancer, cardiovascular and other diseases that we know are associated with combustible tobacco.  I also think that one of the downstream benefits of the regulation of tobacco products is that it will move people to demand more from the manufacturers of the products they use.  Smokers should be upset that they have been misled about tobacco product risk, such as we saw with Light cigarettes and their marketing; they should also be upset that some of the additives in cigarettes are there to increase the nicotine delivery to your brain, thus increasing the addictiveness of cigarettes.  With the passing of the Tobacco Control Act in 2009, there is an avenue for tobacco product regulation.  Nicotine content, other constituents, additives, product design, marketing and labeling can now be enforced if there is science to support there is benefit to the public health.

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