Summer Reading: Harm Reduction
August 16, 2019
By now, lawmakers have been lying beachside for about a week or two. There’s no shortage of nicotine cravings among the former smokers of Congress. But we all know that smoking isn’t good for you, and not just because going to the convenience store would mean less beach time! Hopefully, our ex-smoking lawmakers have come prepared with new reduced-risk products such as liquid refill pods for their vaping products. E-cigarettes and heat-not-burn devices (like the newly-approved IQOS) are, after all, more convenient than their conventional, combustible counterparts. And, even more importantly, they are 95 percent safer.
But the Food and Drug Administration (FDA) refuses to accept the scientific consensus on the safety of these products and wants to subject companies to an onerous premarket review process that would entail thousands of pages, take hundreds of hours, and cost millions of dollars. Originally, the FDA decided that existing vaping products on the market had to submit applications for FDA review by 2022. But, because of a recent court decision, producers will now have just ten months to submit applications to the agency.
Even though the court decision was outside of the FDA’s control, the agency is responsible for this premarket review hullabaloo because of the FDA’s 2016 “Deeming Rule” which classified vapes as “tobacco products” worthy of onerous regulation, despite the fact that vaping products don’t contain any tobacco whatsoever. And, because the sensation delivered to smokers comes without burning tobacco, far fewer carcinogens are released into the user’s lungs. This simple truth underlies widespread agreement amongst governments, health organizations, and researchers across the globe that these products are less harmful. An increasing number of governments and international agencies agree that smokers should be encouraged to make the switch to reduced-risk products.
In 2015, British government agency Public Health England concluded, “the current best estimate is that e-cigarettes are around 95% less harmful than smoking.” Currently, the organization runs advertising campaigns encouraging smokers to switch to vaping. The government of New Zealand agrees, stating, “Expert opinion is that vaping products are much less harmful than smoking tobacco but not completely harmless. A range of toxicants have been found in vapour including some cancer-causing agents but, in general, at levels much lower than found in cigarette smoke or at levels that are unlikely to cause harm. Smokers switching to vaping products are highly likely to reduce the risks to their health and those around them.”
These opinions reflect the findings of hundreds of studies attesting to the public health benefits of e-cigarettes. A 2017 American Journal of Preventive Medicine article examined an astounding 687 peer-reviewed studies published between 2010 and 2016 and found that…you guessed it…vaping products are far safer than cigarettes: “Human exposure to some potentially harmful chemicals is significantly lower for ENDS [Electronic Nicotine Delivery Systems] than for cigarettes. Laboratory studies find modest increases in nicotine biomarkers after vaping. Vaping has no or minimal impact on other physiologic measures (i.e., exhaled carbon monoxide, complete blood count, body weight), with improvements in outcomes seen for smokers switching to ENDS, such as reduced blood pressure, improved lung function, and improved disease symptoms (i.e., asthma and chronic obstructive pulmonary disease).”
And this vastly increased safety is important, since these products help millions of adults quit smoking. The aforementioned American Journal of Preventive Medicine analysis finds that, “ENDS are effective in helping some adult smokers to quit or to reduce their cigarette consumption. In the studies that assessed smoking cessation, rates of cessation in the ENDS study groups were similar to or higher than rates of cessation seen in previous clinical trials of nicotine-replacement therapy (NRT).” These findings are backed up by a 2019 study published in the New England Journal of Medicine, which concluded that former smokers were nearly twice as likely to kick the habit using e-cigarettes than with traditional nicotine-replacement therapy such as nicotine patches or gums. According to lead researcher Peter Hajek from Queen Mary University of London, “Health professionals have been reluctant to recommend their [e-cigarette] use because of the lack of clear evidence from randomized controlled trials. This is now likely to change.”
Despite this powerful evidence, things are unlikely to change at the FDA. In September 2018, the FDA raided (e-cigarette producer) JUUL’s offices and seized thousands of documents pertaining to “sales and marketing practices.” Of course, if the agency wanted to see how the company was marketing its product, they could just…turn on the TV and watch JUUL’s testimonials from former smokers trying to kick their deadly habits. Recently, the FDA abruptly pulled “44 flavored e-liquid and hookah tobacco products [from the market that] do not have the required marketing authorization, and thus cannot be legally sold in the United States.”
In a rare bit of good news, though, in April the FDA approved IQOS for sale in the U.S. The device heats tobacco rather than burning it, with the steam produced containing far fewer carcinogenic particles than through traditional combustion. The next step for IQOS is for it to be classified as a Modified Risk Tobacco Product which will officially deem the product safer than traditional cigarettes. Consumers can only hope that the FDA pursues similar action with vaping products, or better yet, remove e-cigarettes from the premarket review process altogether.
Lawmakers must keep a close watch on the FDA and ensure that the agency doesn’t stymie life-saving products that help millions quit smoking. Former smokers of Congress can reduce their risk of skin cancer at the beach by wearing sunscreen and should be able to reduce their risk of lung cancer by making the switch from smoking to vaping while they still have the chance. But once they get back to Capitol Hill, it’s time to hold the FDA accountable for foot-dragging and putting millions of lives in danger.