On July 28, new Food and Drug Administration commissioner Scott Gottlieb announced a bold shift in the way the FDA regulates tobacco, e-cigarettes, and nicotine. Dr. Gottlieb should be applauded for endorsing a scientific reality that has been well understood for decades but largely ignored by tobacco-control groups and U.S. policymakers: People smoke for the nicotine but die from the tar and carbon monoxide produced by combustion.
Gottlieb’s approach also recognizes that despite a relentless, 50-year anti-smoking campaign mounted by all levels of government, there are still about 40 million American smokers. The Centers for Disease Control estimates that more than 480,000 of those smokers will die prematurely every year if tobacco-control policy continues along its half-century path of ever more punitive taxes on tobacco products and restrictions on the ability of consumers to buy and use them.
“As a physician who cared for hospitalized cancer patients, and as a cancer survivor myself, I saw first-hand the impact of tobacco,” said Gottlieb. “And I know all too well that it’s cigarettes that are the primary cause of tobacco-related disease and death. What’s now clear is that FDA is at a unique moment in history, with profound new tools to address this devastating impact.”
President Trump’s new FDA commissioner acknowledged that nearly 500,000 American smokers are dying prematurely each year not because of the nicotine they consume but because of the cigarettes through which they consume it. “The overwhelming amount of the death and disease attributable to tobacco is caused by addiction to cigarettes. Addiction causes long-term sustained use. But it’s exposure to the harmful chemicals [from combustion] that causes disease.”
Gottlieb announced his welcome new approach in the midst of a battle over draconian Obama-administration FDA regulations that, even according to the FDA’s own estimates, would effectively ban by August 2018 at least 99 percent of nicotine-vapor products being sold in the U.S. The FDA’s e-cigarette rule, announced in 2016, has already halted innovation in the vapor-products industry, making it impossible to bring new products to market without navigating a tedious and prohibitively expensive pre-approval process.
Gottlieb extended the application deadline for vapor companies from 2018 to 2022. The extension allows existing products to remain on U.S. shelves for an additional four years. Gottlieb also indicated that the FDA would reconsider the guidelines as written and that he would direct the Center for Tobacco Products to issue final guidance to companies about the process, something the CTP had yet to do for its 2016 e-cigarette regulations.
Gottlieb’s actions are hugely significant for those who manufacture, sell, and use vapor products. They are potentially even more important for tens of millions of U.S. smokers who have yet to make the switch to a vaporizer. According to the CDC, there are about 10 million U.S. e-cigarette smokers, many of whom were long-term smokers of traditional cigarettes who used vapor products to kick their habits. Exactly like FDA-approved nicotine gums and patches, e-cigarettes deliver the nicotine smokers crave without the deadly harms of combustion.
Congress provided the FDA with jurisdiction over cigarettes and smokeless tobacco via the Family Smoking Prevention and Tobacco Control Act, signed into law by President Obama in 2009. Back then, e-cigarettes and other vapor products were so new to the U.S. market that Congress never contemplated the regulation of vapor products, making no mention of them in the bill. It wasn’t until late last year that the FDA stepped in to assert its jurisdiction, classifying e-cigarettes as tobacco products.
Under the Tobacco Control Act, all combustible cigarettes that were on the market prior to the 2007 predicate date may continue to be sold so long as they meet FDA regulations going forward. In announcing that vapor products would be reclassified as tobacco products, the FDA failed to afford the nascent industry the same chance to tweak its products so they comply. The FDA has taken the position that it doesn’t have the authority to change the predicate date for vapor products, so all vapor products on the market — and there are tens of thousands of them — would have to go through the aforementioned onerous, prohibitively expensive pre-approval process, which is seemingly designed to keep new products from ever coming to market.
Gottlieb previously indicated that he believes the existing act provides him with the tools he needs to reform tobacco-control policy so that it emphasizes harm reduction above all else. But even if he manages to streamline the process and the FDA approves thousands of innovative, safer nicotine-vapor products for sale, the category will never have a predicate product that would allow minor innovations that improve efficacy and safety through the FDA’s substantial-equivalence process. To truly foster the innovation he desires, Gottlieb will need Congress to at least change the predicate date as applied to vapor products and other innovative non-combustibles.
While nicotine (delivered via combustion) is indeed part of the problem, it’s hugely significant that Gottlieb identified nicotine (not delivered via combustion) as part of the solution in meaningfully reducing preventable death and disease caused by smoking. “Nicotine lives at the core of both the problem and, ultimately, the solution to the question of addiction, and the harm caused by combustible forms of tobacco,” explained Gottlieb.
Gottlieb demonstrates that he understands the political waters he’s navigating. Now, he must follow through with his actions.
While Gottlieb’s acknowledgment that non-combustible nicotine products potentially offer a life-saving alternative to cigarettes for millions of smokers is encouraging, not everything else in his announcement is cause for celebration. Perhaps throwing a bone to tobacco-control groups to avoid outright opposition to his new proposal, Gottlieb also indicated a desire to rely on the Center for Tobacco Products to develop product standards that would ultimately force tobacco companies to reduce nicotine levels in combustible cigarettes.
U.S. tobacco-control groups have enthusiastically endorsed Gottlieb’s call for low-nicotine cigarettes and panned his decision to reform a process that would effectively ban vapor products in less than a year. By contrast, public-health leaders pushing for harm-reduction policies in the U.S. and around the world have been critical of the call for low-nicotine cigarettes and have enthusiastically endorsed the call to make non-combustible nicotine products available to adult smokers.
The harm-reduction advocates are right. There is scant evidence that forcing tobacco companies to reduce nicotine in cigarettes will lead to public-health gains. Because of high taxes on cigarettes and significant tax discrepancies between jurisdictions, we already see a vast black market for combustible cigarettes in the U.S. According to research from the Mackinac Center for Public Policy and the Tax Foundation, in 2015 almost 60 percent of cigarettes sold in New York were smuggled in from elsewhere and purchased on the black market. The problem isn’t limited to big cities. According to the same study, in states such as Arizona, Washington, and New Mexico, almost half the cigarettes sold are smuggled in via the black market.
The Tobacco Control Act specifically directs the FDA to consider the potential that product regulations have to boost black-market tobacco sales before implementing them. Forcing tobacco companies to sell low-nicotine cigarettes would strongly encourage black markets for full-nicotine cigarettes. Even if it didn’t, there would still be a strong likelihood that current smokers would spike cigarettes by adding their own nicotine, or would simply consume more cigarettes to get their fix.
By avoiding any leaks of his announcement and scheduling it on the heels of the release of a major study indicating that e-cigarettes seem to have contributed to an increase in smoking cessation, Gottlieb demonstrated a political deftness that hasn’t always been prevalent in the Trump administration. Balancing the political benefit of announcing stronger regulation, favored by tobacco-control groups, alongside support for getting non-combustible nicotine products in the hands of smokers, Gottlieb significantly mitigated the outrage he might otherwise have faced from groups such as the Campaign for Tobacco-Free Kids and the American Cancer Society.
In his words, Gottlieb demonstrates that he understands the political waters he’s navigating. Now, he must follow through with his actions. In the waning days of the Obama administration, the FDA’s Center for Tobacco products, without warning, issued a draconian product standard for smokeless tobacco products that will have devastating consequences in reducing jobs, eliminating a multi-billion-dollar market for non-combustible, safe smokeless-tobacco products, and increasing smoking-related death and disease. Gottlieb should withdraw the rule.
The FDA also recently opened a docket in regard to a Modified Risk Tobacco Product application from Philip Morris for its IQOS product, which heats tobacco without burning it, dramatically reducing levels of the harmful carcinogens smokers would receive from combustible cigarettes. Smokers in Japan, the U.K., and Italy are demonstrating early success in using the products to move away from smoking to a safer alternative. How the FDA responds to the application will demonstrate whether Gottlieb’s desire for product innovation and safer, non-combustible nicotine delivery for smokers will be put into practice or whether his words ring hollow.
Last but not least, there is the fight over e-cigarette flavoring. At nearly every opportunity to speak about vapor and other non-combustible nicotine products, Gottlieb uses the language of tobacco-control groups in gratuitously suggesting (without any scientific basis) that flavors appeal to youth and should be regulated (or banned). To his credit, Gottlieb acknowledges that nicotine and flavors may play an important role in transitioning adults away from smoking. Rather than focus on flavors exclusively, he should move to create product standards for liquids that ensure consumers are receiving the ingredients claimed and the products are produced and marketed in a manner to ensure safety.
Ultimately, nicotine products are meant for adults. Sales to minors are prohibited in all 50 states, and over 150 cities (and most big cities) have raised the age of purchase to 21. Just as adults are and should remain free to choose from thousands of different types of wines and thousands of craft beers, they also should be free to choose among thousands of vapor products. Ensuring that adult smokers and former smokers have access to safer, non-combustible nicotine-delivery products will demonstrate that the FDA is serious about reducing the preventable deaths of almost half a million American smokers from lung cancer, chronic obstructive pulmonary disease, heart disease, and stroke every year.