Lawmakers must recognize that e-cigarettes can help smokers quit
Under terms of 2009’s Family Smoking Prevention and Tobacco Control Act, the FDA adopted rules last August that will retroactively regulate all vaping products that came into existence after 2007. Manufacturers and vaping retailers have until the fall of 2018 to go through a costly pre-market tobacco application (PMTA) process for each and every combination of product, flavor and strength of nicotine, which many smaller sellers will not be able to afford.
Congress had a chance to move in the right direction with an amendment to the recent budget bill proposed by Reps. Tom Cole (R-Okla.) and Sanford Bishop (D-Ga). The Cole-Bishop amendment would have changed the original “predicate” date for e-cigarettes and other vaping products to become subject to the Tobacco Control Act’s pre-market review requirement. Alas, the amendment didn’t make it into the final version of the bill, which funds the federal government through Sept. 30.
There is still hope for the measure, which Cole and Sanford also have introduced as the standalone FDA Deeming Authority Clarification Act of 2017. In addition to changing the predicate date of newly “deemed” tobacco products, the bill would impose licensing and advertising guidelines for vapor products and direct the FDA to establish standards for the products. In addition, the FDA itself has put a pause on the upcoming deadline to regulate vapor products retroactively.
It seems that numbers have made the case for the FDA: 480,000 people die from smoking every year, cigarette smoke harms most of the human body’s 79 organs, cigarettes are linked to at least 13 types of cancer and cigarettes cost the United States more than $300 billion a year. Furthermore, the Centers for Disease Control and Prevention estimate that 68 percent of smokers want to quit completely, but only 55 percent attempt to quit for at least one day each year, with less than 10 percent actually succeeding.
What if there were a way to make quitting more palatable to the 45 percent who don’t try and easier for the 90 percent who don’t succeed? What if there were a way that didn’t require people to give up nicotine in order to lower their risk of death from tobacco-related diseases?
We all know that there is.
Introduced to the mainstream market in 2007, e-cigarettes are a promising way to encourage smokers to switch to non-tobacco forms of nicotine. The fundamental distinction between traditional cigarettes and e-cigarettes is the lack of combustible tobacco. Tobacco, when burned, accounts for more than 7,000 of the toxins and carcinogens that contribute to lung disease and the 13 different types of cancer that smokers are at a high risk for every time they light up. Public Health England, the executive agency of the United Kingdom’s Department of Health, estimates that e-cigarettes are 95 percent safer than combustible cigarettes.
In fact, both Public Health England and the Office of the Surgeon General report that e-cigarettes have a similar risk profile to other nicotine replacements, such as the patch and nicotine gum. However, it is pretty intuitive that, unlike the patch and gum, e-cigarettes are products that people might actually want to use. Using an e-cigarette means that people don’t have to break the ingrained habits that go along with smoking, such as inhaling, socializing and taking a break in their day. Another benefit is that they can be less expensive than combustible cigarettes.
The market share for small business vaping products is growing rapidly and provides necessary competition for larger e-cigarette distributors. But under the pending FDA “deeming” rule, the agency estimates that each PMTA will cost manufacturers more than $300,000 and take more than 500 hours to put together. This will put these small businesses out of business, increase prices and further deter smokers from choosing a less risky product.
This is why the Cole-Bishop legislation makes sense. As a harm-reduction tool, e-cigarettes should be available—even promoted—to current smokers as an alternative to traditional cigarettes. History has proven that abstinence approaches do not work: Teen pregnancy and sexually transmitted infection rates did not decline in states that emphasized an abstinence-only sex education curriculum and criminalization of heroin use did not stop overdose deaths. To the contrary, comprehensive sex education correlates with a decrease in teen pregnancy and STI rates, while the availability of needle-exchange sites correlates with a decrease in the prevalence of drug use in communities that embrace harm reduction.
The Cole-Bishop bill would help to put a stop to the abstinence-only approach that federal lawmakers and regulators have taken for far too long with regard to smoking cessation.
Image by AnastasiiaS