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Increased e-cigarette regulation increases barriers to health

Carrie Wade —  11 December 2018

This post was co-authored with Chelsea Boyd

The Food and Drug Administration has spoken, and its words have, once again, ruffled many feathers. Coinciding with the deadline for companies to lay out their plans to prevent youth access to e-cigarettes, the agency has announced new regulatory strategies that are sure to not only make it more difficult for young people to access e-cigarettes, but for adults who benefit from vaping to access them as well.

More surprising than the FDA’s paradoxical strategy of preventing teen smoking by banning not combustible cigarettes, but their distant cousins, e-cigarettes, is that the biggest support for establishing barriers to accessing e-cigarettes seems to come from the tobacco industry itself.

Going above and beyond the FDA’s proposals, both Altria and JUUL are self-restricting flavor sales, creating more — not fewer — barriers to purchasing their products. And both companies now publicly support a 21-to-purchase mandate. Unfortunately, these barriers extend beyond restricting underage access and will no doubt affect adult smokers seeking access to reduced-risk products.

To say there are no benefits to self-regulation by e-cigarette companies would be misguided. Perhaps the biggest benefit is to increase the credibility of these companies in an industry where it has historically been lacking. Proposals to decrease underage use of their product show that these companies are committed to improving the lives of smokers. Going above and beyond the FDA’s regulations also allows them to demonstrate that they take underage use seriously.

Yet regulation, whether imposed by the government or as part of a business plan, comes at a price. This is particularly true in the field of public health. In other health areas, the FDA is beginning to recognize that it needs to balance regulatory prudence with the risks of delaying innovation. For example, by decreasing red tape in medical product development, the FDA aims to help people access novel treatments for conditions that are notoriously difficult to treat. Unfortunately, this mindset has not expanded to smoking.

Good policy, whether imposed by government or voluntarily adopted by private actors, should not help one group while harming another. Perhaps the question that should be asked, then, is not whether these new FDA regulations and self-imposed restrictions will decrease underage use of e-cigarettes, but whether they decrease underage use enough to offset the harm caused by creating barriers to access for adult smokers.

The FDA’s new point-of-sale policy restricts sales of flavored products (not including tobacco flavors or menthol/mint flavors) to either specialty, age-restricted, in-person locations or to online retailers with heightened age-verification systems. JUUL, Reynolds and Altria have also included parts of this strategy in their proposed self-regulations, sometimes going even further by limiting sales of flavored products to their company websites.

To many people, these measures may not seem like a significant barrier to purchasing e-cigarettes, but in fact, online retail is a luxury that many cannot access. Heightened online age-verification processes are likely to require most of the following: a credit or debit card, a Social Security number, a government-issued ID, a cellphone to complete two-factor authorization, and a physical address that matches the user’s billing address. According to a 2017 Federal Deposit Insurance Corp. survey, one in four U.S. households are unbanked or underbanked, which is an indicator of not having a debit or credit card. That factor alone excludes a quarter of the population, including many adults, from purchasing online. It’s also important to note that the demographic characteristics of people who lack the items required to make online purchases are also the characteristics most associated with smoking.

Additionally, it’s likely that these new point-of-sale restrictions won’t have much of an effect at all on the target demographic — those who are underage. According to a 2017 Centers for Disease Control and Prevention study, of the 9 percent of high school students who currently use electronic nicotine delivery systems (ENDS), only 13 percent reported purchasing the device for themselves from a store. This suggests that 87 percent of underage users won’t be deterred by prohibitive measures to move sales to specialty stores or online. Moreover, Reynolds estimates that only 20 percent of its VUSE sales happen online, indicating that more than three-quarters of users — consisting mainly of adults — purchase products in brick-and-mortar retail locations.

Existing enforcement techniques, if properly applied at the point of sale, could have a bigger impact on youth access. Interestingly, a recent analysis by Baker White of FDA inspection reports suggests that the agency’s existing approaches to prevent youth access may be lacking — meaning that there is much room for improvement. Overall, selling to minors is extremely low-risk for stores. The likelihood of a store receiving a fine for violation of the minimum age of sale is once for every 36.7 years of operation, the financial risk is about 2 cents per day, and the risk of receiving a no sales order (the most severe consequence) is 1 for every 2,825 years of operation. Furthermore, for every $279 the FDA receives in fines, it spends over $11,800. With odds like those, it’s no wonder some stores are willing to sell to minors: Their risk is minimal.

Eliminating access to flavored products is the other arm of the FDA’s restrictions. Many people have suggested that flavors are designed to appeal to youth, yet fewer talk about the proportion of adults who use flavored e-cigarettes. In reality, flavors are an important factor for adults who switch from combustible cigarettes to e-cigarettes. A 2018 survey of 20,676 US adults who frequently use e-cigarettes showed that “since 2013, fruit-flavored e-liquids have replaced tobacco-flavored e-liquids as the most popular flavors with which participants had initiated e-cigarette use.” By relegating flavored products to specialty retailers and online sales, the FDA has forced adult smokers, who may switch from combustible cigarettes to e-cigarettes, to go out of their way to initiate use.

It remains to be seen if new regulations, either self- or FDA-imposed, will decrease underage use. However, we already know who is most at risk for negative outcomes from these new regulations: people who are geographically disadvantaged (for instance, people who live far away from adult-only retailers), people who might not have credit to go through an online retailer, and people who rely on new flavors as an incentive to stay away from combustible cigarettes. It’s not surprising or ironic that these are also the people who are most at risk for using combustible cigarettes in the first place.

Given the likelihood that the new way of doing business will have minimal positive effects on youth use but negative effects on adult access, we must question what the benefits of these policies are. Fortunately, we know the answer already: The FDA gets political capital and regulatory clout; industry gets credibility; governments get more excise tax revenue from cigarette sales. And smokers get left behind.

In Credit Cards, Financial Regulation, Regulation, Truth on the Market , ,
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Applying harm reduction to smoking

Carrie Wade —  15 October 2018

Carrie Wade, Ph.D., MPH is the Director of Harm Reduction Policy and Senior Fellow at the R Street Institute.

Abstinence approaches work exceedingly well on an individual level but continue to fail when applied to populations. We can see this in several areas: teen pregnancy; continued drug use regardless of severe criminal penalties; and high smoking rates in vulnerable populations, despite targeted efforts to prevent youth and adult uptake.

The good news is that abstinence-oriented prevention strategies do seem to have a positive effect on smoking. Overall, teen use has steadily declined since 1996. This may be attributed to an increase in educational efforts to prevent uptake, stiff penalties for retailers who fail to verify legal age of purchase, the increased cost of cigarettes, and a myriad of other interventions.

Unfortunately many are left behind. Populations with lower levels of educational attainment, African Americans and, ironically, those with less disposable income have smoking rates two to three times that of the general population. In light of this, how can we help people for whom the abstinence-only message has failed? Harm reduction strategies can have a positive effect on the quality of life of smokers who cannot or do not wish to quit.

Why harm reduction?

Harm reduction approaches recognize that reduction in risky behavior is one possible means to address public health goals. They take a pragmatic approach to the consequences of risk behaviors – focusing on short-term attainable goals rather than long-term ideals—and provide options beyond abstinence to decrease harm relative to the riskier behavior.

In economic terms, traditional public health approaches to drug use target supply and demand, which is to say they attempt to decrease the supply of a drug while also reducing the demand for it. But this often leads to more risky behaviors and adverse outcomes. For example, when prescription opioids were restricted, those who were not deterred from such an inconvenience switched to heroin; when heroin became tricky to smuggle, traffickers switched to fentanyl. We might predict the same effects when it comes to cigarettes.

Given this, since we know that the riskiest of behaviors, such as tobacco, alcohol and other drug use will continue—and possibly flourish in many populations—we should instead focus on ways to decrease the supply of the most dangerous methods of use and increase the supply of and demand for safer, innovative tools. This is the crux of harm reduction.

Opioid Harm Reduction

Like most innovation, harm reduction strategies for opioid and/or injection drug users were born out of a need. In the 1980s, sterile syringes were certainly not an innovative technology. However, the idea that clean needle distribution could put a quick end to the transmission of the Hepatitis B virus in Amsterdam was, and the success of this intervention was noticed worldwide.

Although clean needle distribution was illegal at the time, activists who saw a need for this humanitarian intervention risked jail time and high fines to reduce the risk of infectious disease transmission among injection drug users in New Haven and Boston. Making such programs accessible was not an easy thing to do. Amid fears that dangerous drug use may increase and the idea that harm reduction programs would tacitly endorse illegal activity, there was resistance in governments and institutions adopting harm reduction strategies as a public health intervention.

However, following a noticeable decrease in the incidence of HIV in this population, syringe exchange access expanded across the United States and Europe. At first, clean syringe access programs (SAPs) operated with the consent of the communities they served but as the idea spread, these programs received financial and logistical support from several health departments. As of 2014, there are over 200 SAPs operating in 33 states and the District of Columbia.

Successes

Time has shown that these approaches are wildly successful in their primary objective and enormously cost effective. In 2008, Washington D.C. allocated $650,000 to increase harm reduction services including syringe access. As of 2011, it was estimated that this investment had averted 120 cases of HIV, saving $44 million.

Seven studies conducted by leading scientific and governmental agencies from 1991 through 2001 have also concluded that syringe access programs result in a decrease in HIV transmission without residual effects of increased injection drug use. In addition, SAPs are correlated with increased entry into treatment and detox programs and do not result in increases in crime in neighborhoods that support these programs.

Tobacco harm reduction

We know that some populations have a higher risk of smoking and of developing and dying from smoking-related diseases. With successful one-year quit rates hovering around 10 percent, harm reduction strategies can offer ways to transition smokers off of the most dangerous nicotine delivery device: the combustible cigarette.

In 2008, the World Health Organization developed the MPOWER policy package aimed to reduce the burden of cigarette smoking worldwide. In their vision statement, the authors explicitly state a goal where “no child or adult is exposed to tobacco smoke.”

Using an abstinence-only framework, MPOWER strategies are:

  1. To monitor tobacco use and obtain data on use in youth and adults;
  2. To protect society from second-hand smoke and decrease the availability of places that people are allowed to smoke by enacting and enforcing indoor smoking bans;
  3. To offer assistance in smoking cessation through strengthening health systems and legalization of nicotine replacement therapies (NRTs) and other pharmaceutical interventions where necessary;
  4. To warn the public of the dangers of smoking through public health campaigns, package warnings and counter advertising;
  5. To enact and enforce advertising bans; and
  6. To raise tobacco excise taxes.

These strategies have been shown to reduce the prevalence of tobacco use. People who quit smoking have a greater chance of remaining abstinent if they use NRTs. People exposed to pictorial health warnings are more likely to say they want to quit as a result. Countries with comprehensive advertising bans have a larger decrease in smoking rates compared to those without. Raising taxes has proven consistently to reduce consumption of tobacco products.

But, the effects of MPOWER programs are limited. Tobacco and smoking are often deeply ingrained in the culture and identity of communities. Studies repeatedly show that smoking is strongly tied to occupation and education, smokers’ self-identity and also the role that tobacco has in the economy and identity of the community.

As a practical matter, the abstinence approach is also limited by individual governmental laws. Article 13 of the Framework Convention on Tobacco Control recognizes that constitutional principles or laws may limit the capabilities of governments to implement these policy measures. In the United States, cigarettes are all but protected by the complexity of both the 1998 Master Settlement Agreement and the Family Smoking Protection and Tobacco Control Act of 2009. This guarantees availability to consumers – ironically increasing the need of more reduced-risk nicotine products, such as e-cigarettes, heat-not-burn devices or oral Snus, all of which offer an alternative to combustible use for people who either cannot or do not wish to quit smoking.

Several regulatory agencies, including the FDA in the United States and Public Health England in the United Kingdom, recognize that tobacco products exist on a continuum of risk, with combustible products (the most widely used) being the most dangerous and non-combustible products existing on the opposite end of the spectrum. In fact, Public Health England estimates that e-cigarettes are at least 95% safer than combustible products and many toxicological and epidemiological studies support this assertion.

Of course for tobacco harm reduction to work, people must have an incentive to move away from combustible cigarettes.There are two equally important strategies to convince people to do so. First, public health officials need to acknowledge that e-cigarettes are less risky. Continued mixed messages from government officials and tobacco use prevention organizations confuse people regarding the actual risks from e-cigarettes. Over half of adults in the United States believe that nicotine is the culprit of smoking-related illnesses – and who can blame them when our current tobacco control strategies are focused on lowering nicotine concentrations and ridding our world of e-cigarettes?

The second is price. People who cannot or do not wish to quit smoking will never switch to safer alternatives if they are more, or as, expensive as cigarettes. Keeping the total cost of reduced risk products low will encourage people who might not otherwise consider switching to do so. The best available estimates show that e-cigarette demand is much more vulnerable to price increases than combustible cigarettes – meaning that smokers are unlikely to respond to price increases meant to dissuade them from smoking, and are less likely to vape as a means to quit or as a safer alternative.

Of course strategies to prevent smoking or encourage cessation should be a priority for all populations that smoke, but harm-reduction approaches—in particular with respect to smoking—play a vital role in decreasing death and disease in people who engage in such risky behavior. For this reason, they should always be promoted alongside abstinence approaches.

In Health Care, International, Pharmaceuticals, Regulation, Taxes, Truth on the Market, United Kingdom , , , , , , ,
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