Monday, February 20, 2017

Why Trump Should Reverse Obama-Era E-Cigarette Regulations

I need a break from critiquing Trump's latest barrage of executive orders and policy recommendations. Instead, I would like to take a look at the previous Obama administration's bad policies and see what Trump could do. The policy that is of interest today is that of electronic cigarettes, more colloquially known as e-cigarettes. At the end of his second term, the Obama administration's Food and Drug Administration (FDA) created additional regulations on e-cigarettes by extending the regulations of the Family Smoking Prevention and Tobacco Control Act of 2009 to e-cigarettes. The FDA's mentality was "if it looks like a cigarette and acts like a cigarette, it must be a cigarette." That assumption defies common sense because e-cigarettes don't contain tobacco (even though some of the nicotine for e-cigarettes can be extracted from tobacco), they don't create the problems of second-hand smoke that regular tobacco products do, and the carcinogens tars and gases in regular tobacco products are absent from e-cigarettes. Those differences right there make me wonder what the FDA was thinking or even why we need as much regulatory oversight as regular tobacco products. However, we have to contend with the reality that the regulations exist. The question is whether they should still be in play.

Let's forget for a moment that the regulatory barrier of costing $1 million for each FDA application to approve a given product, which would de facto put the 90 to 99 percent of e-cigarette producers out of business. The primary concern about e-cigarettes is the health concern, mainly that they are comparably bad for one's health as regular tobacco products. I looked at the topic of e-cigarettes about three years ago. At the time, e-cigarettes were a new phenomenon, and research on the topic was still preliminary. Even with preliminary evidence, the academic literature at the time was showing that e-cigarettes are less harmful than regular cigarettes. What more recent academic literature can we add to the list?

  • Cancer Research UK released a study earlier this month about e-cigarettes. This study is significant because it is the first one to adequately measure the long-term effects of e-cigarettes. They were not about to say that e-cigarettes are completely harmless because let's be honest: any activity comes with at least some risk, no matter how small. However, using a comparison group of those who go through nicotine replacement therapy (NRT), e-cigarettes are about as safe as NRT, which means that e-cigarettes are much safer than regular tobacco products.  
  • A 2015 study from Public Health England, which is the United Kingdom's equivalent of the U.S.' Department of Health and Human Services (HHS), shows that e-cigarettes are 95 percent safer than regular cigarettes. 
  • The University of Victoria made public its study on vaping in January 2017. Not only is there no gateway effect in terms of bringing people over to regular tobacco products, but it is as effective as other NRT devices used to quit smoking. Also, the vapor from e-cigarettes is less harmful than cigarette or cigar smoke. 
  • The Royal College of Physicians stated in its 2016 findings that "the public can be reassured that e-cigarettes are much safer than smoking."
  • A 2017 study from the Irish government shows that e-cigarettes provide smokers a better chance to quit smoking. 
  • In April 2016, seven top international tobacco experts urged the FDA to keep an open mind on e-cigarettes. They illustrated their point by synthesizing current data to show the potential harm reduction in using e-cigarettes (Levy et al., 2016). 
  • Here are a list of studies showing how e-cigarettes can assist smokers in quitting smoking: Delnevo et al., 2016; Levy et al., 2016; O'Brien et al., 2015; Polosa et al., 2015Rahman et al., 2015; Adriaens et al., 2014Polosa et al., 2014.
  • Looking at CDC data on youth tobacco use for 2011-2015, we see that e-cigarette use increased. The plus side is that e-cigarettes were substituted for cigarettes and cigars (see below), both of which have higher risk to consumers. Furthermore, cigarette consumption for youths has been on the decline since 2008, which is around when e-cigarettes started to trend in the market.

Am I here to say that e-cigarettes are harmless? No. If you haven't started smoking e-cigarettes or conventional cigarettes, I wouldn't recommend it. At the very least, nicotine has addictive qualities. However, given that current academic literature shows benefits of e-cigarettes, it seems foolhardy for the FDA to take on an abstinence-only approach with such an important health issue. The government over-emphasizes potential risk to children while ignoring the harm-reduction benefits. Even if we want to see whether a small subset of teenagers or adults are harmed in the long-run (although current evidence shows that e-cigarettes are about as safe as NRT), we would have to wait for another 40 years to be absolutely certain. In the meantime, 36.5 million smokers in the United States do not have access to a low-risk alternative to smoking, which is the leading cause of preventable death in the United States. These 36.5 million individuals risk the potential of losing an average of 20 years of their life (Holford et al., 2014). It is not realistic to prevent every smoking-related death, but rather to prevent as much as possible. That is where tobacco harm reduction comes into play (see R Street policy brief here for policy alternatives). If it remains law, Obama's e-cigarette policy has the potential to hasten the deaths of thousands of Americans. Trump said that he wanted to cut the red tape for FDA pharmaceutical approval in order to save lives. Let's hope he applies that same thought process to current e-cigarette regulations.

Addendum 10-14-2017: Here is another study (Levy et al., 2017) modeling how vaping could save 6.6 million lives over the next ten years.

1 comment:

  1. E cigarettes shouldn't be compared with regular cigarettes because they are completely different from every aspect. The regulations regarding them should be different from regular cigarettes and regular smoking because researches have shown that vaping is not nearly as harmful as smoking. Thank you for sharing this none the less, really interesting to read.