A little over a year ago, Food and Drug Administration Commissioner Scott Gottlieb announced a fundamental shift in U.S. tobacco policy.
While recognizing it's the nicotine that hooks smokers, Gottlieb made clear what public health professionals have known for decades but have failed to communicate to the public. It's the smoke, not the nicotine that leads to the deaths of more than 480,000 American smokers a year.
Gottlieb's two-pronged approach, each dependent on the other, relies on reducing nicotine in cigarettes while ensuring a healthy marketplace for safer nicotine alternatives like e-cigarettes. The FDA hopes this will not just facilitate the already rapid declines in adult and youth smoking but shift smokers who cannot or don't want to quit to safer alternatives and prevent teens becoming addicted smokers in the first place.
True to his word, Gottlieb stayed implementation of regulations that would strangle the e-cigarette industry, eliminating all but the biggest players, including tobacco companies, until 2022. Earlier this year, the FDA issued an Advanced Notice of Proposed Rulemaking on slashing nicotine levels in cigarettes.
But aside from throwing vapers a temporary lifeline, no tangible progress has been made to ensure e-cigarettes can enter and remain on the market. In fact, whenever the FDA does discuss e-cigarettes, it heavily couches the conversation by noting the potential danger they pose to minors.
Any decisive role e-cigarettes may play in reducing the burden of smoking-related disease is treated as hypothetical, ignoring any possible link between rapidly declining smoking rates, the rise of vaping, and the millions of people who directly attribute their success in quitting to e-cigarettes.
The National Academies of Sciences, Engineering, and Medicine
, the American Cancer Society
, and the Royal College of Physicians
all agree smokers who switch exclusively to vaping substantially reduce their exposure to harmful chemicals. The U.K. government actively encourages smokers to switch to vaping. The smokeless tobacco snus is responsible for cutting Swedish smoking rates to the lowest in the developed world, while heat-not-burn tobacco products are enjoying enormous success in getting smokers to quit in Japan and South Korea.
But as the rest of the world embraces these products, supporting a virtuous circle of businesses creating jobs by making it easier and more enjoyable for smokers to quit, the FDA has failed to act on the most basic of measures.
No information campaigns are educating the public that nicotine is not lethal, or that switching to e-cigarettes is better than continuing smoking. The company Swedish Match is still waiting for approval of its Modified Risk Tobacco Application submitted in 2014, which would allow it to inform consumers that its snus products are safer than cigarettes.
Philip Morris International's heat-not-burn product IQOS hasn't even been approved for sale, despite submitting its application in March 2017. E-cigarettes remain under a cloud of regulatory uncertainty facing an approval process that presents an insurmountable barrier to most companies.
The FDA's failure to act is perhaps due in part to the intense pressure it faces from traditional anti-tobacco campaigners who demagogue any non-pharmaceutical nicotine product as a threat to kids or Big Tobacco 2.0. Despite garnering a sea of headlines, this moral panic fails to stand up to scrutiny. Teen vaping is stable at 11.7 percent after falling from a high of 16 percent, and youth smoking is the lowest on record
Teens are more likely to drink alcohol or smoke marijuana than they are to vape.
Gottlieb argues no kids should be vaping and the success of e-cigarettes should not come at the expense of addicting children to nicotine. While this is undoubtedly true, this is not a trade-off the FDA has to make. The founders of e-cigarette companies like Juul or Cue are not Big Tobacco executives knocking back cocktails at the Algonquin conspiring against the public health.
The makers of these products are innovators who have come up with a private sector solution to a public health problem. Tobacco companies themselves know which way the wind is blowing, and are investing billions in products that give their consumers the nicotine they desire without the smoke that may kill them. The real problem the FDA faces is ensuring that stopping kids from vaping does not come at the expense of preventing their parents from quitting smoking.
On August 2, the FDA made a small step
in the right direction by announcing it would be exploring product standards for e-cigarettes and opportunities to modernize the slow and expensive approval process for new nicotine products.
Reforming the regulatory process is essential, but the FDA must also understand why e-cigarettes and other nicotine alternatives are successful in the first place. E-cigarettes represent a bottom-up consumer based revolution. Through trial and error, smokers find which products and flavors work best for them and switch. Regulatory reforms that attempt to medicalize these products or impose a near impossible burden of proof as to their efficacy risk destroying what makes them successful and could still end up removing most products from the market.
Gottlieb's plan jarred the FDA out of its complacency and brought much-needed balance to the debate around nicotine and smoking. But if Gottlieb is to be successful, he cannot just act on what will give him the loudest applause from those whose minds are stuck in the tobacco wars of the 1990s. The FDA must recognize that while industry regulation is vital, control is deadly, and regulating too much can be just as lethal as regulating too little.