5 September 2019
Drs. John Maa and Jeffrey Wigand
In June of 2019, Mayor London Breed signed an ordinance effective January 2020 to suspend the sales and distribution in San Francisco of electronic cigarettes that have not undergone premarket review by the U.S. Food and Drug Administration (FDA).
This legislation by Supervisor Shamann Walton and unanimously approved by the San Francisco Board of Supervisors represents a logical and powerful public policy strategy to enforce the law. It also compels e-cigarette companies to follow federal requirements regarding FDA scientific and regulatory review of devices marketed with a therapeutic intent. Advertising e-cigarettes as a smoking cessation aid without an FDA marketing order is contrary to the Federal Food, Drug, and Cosmetic Act of 1938, which oversees the safety of food, drugs, medical devices and cosmetics.
In 2016, the Obama administration finalized a rule to expand FDA deeming authority to regulate e-cigarettes. E-cigarette manufacturers were allowed up to two years to submit applications, and a year to win FDA approval (which would have taken effect by today).
But in 2017, the FDA under the Trump administration issued “guidance” exempting e-cigarettes from premarket review until 2022. In 2018, the American Heart Association, American Cancer Society — among others — filed litigation to challenge this delay citing the risk posed to children.
In May 2019, a federal judge ruled that the FDA acted illegally in 2017 by allowing e-cigarettes to remain on the market without a safety review, and later ordered the FDA to impose a ten month deadline for e-cigarettes manufacturers to submit applications, and a one year deadline to obtain pre-market approval. The San Francisco suspension of e-cigarette sales should have a maximum of 17 months duration (shorter if applications are submitted earlier or FDA approval is granted sooner).
The sales of e-cigarettes are illegal in 25 nations worldwide, including Japan, Qatar, Hong Kong, and Thailand. The lack of scientific evidence regarding their efficacy as a smoking cessation aid, and risks of promoting drug abuse in addition to nicotine addiction are cited in support of these proactive public health actions. In August 2019, India’s health ministry proposed a ban on the production and import of e-cigarettes.
Juul’s response to the e-cigarette moratorium is a November 2019 ballot measure to allow them to continue selling e-cigarettes in San Francisco. It would change existing Tobacco 21 prohibitions on e-cigarette purchases, by now requiring the city to prove that the seller knew the buyer was under 21 for the restriction to be enforced.
The Coalition for Reasonable Vaping Regulations supporting the measure has thus far been funded solely by Juul with millions. Juul has financial reserves to lead this campaign, after Altria announced a $12.8 billion investment in 2018 to acquire a 35 percent interest in the company. The Altria relationship could accelerate youth vaping worldwide. Juul can now benefit from the expertise of the Altria lobbying team and legal division.
The San Francisco legislation serves as a pivotal pilot in long overdue FDA vaping regulation, to minimize the harm worldwide from youth vaping. In July 2019, a House Oversight Subcommittee hearing revealed that Juul spent hundreds of thousands of dollars to fund youth programming, and access students in classrooms.
The Juul leadership were pressed about the company’s role in youth addiction, a problem for which Juul’s CEO had already apologized. Continued congressional and state legislature hearings should explore Juul’s contribution to the vaping epidemic.
Additional scrutiny should come from the Federal Trade Commission, who have already launched in investigation into Juul’s marketing and use of influencers.
Altria is the parent company of Philip Morris, a signatory of the 1998 Tobacco Master Settlement Agreement (MSA). Specific MSA language addresses future successor products owned by Philip Morris that would also be subject to the terms of the MSA.
Philip Morris patented a prototype of a functioning e-cigarette by 1996, and perhaps Juul falls into the category of future products subject to MSA constraints on advertising that targets youth, political lobbying, and product placement in print media and television.
In July 2019, the Connecticut Attorney General launched an investigation into Juul’s marketing practices and health claims, following May 2019 action by the North Carolina Attorney General against Juul for targeting youth. Attorneys general across America should work together to ensure the Juul-Altria partnership complies with existing laws.
To assist FDA evaluation now required by 2021, the scientific evidence about the risks and benefits of e- cigarettes should be assembled. A starting point could be the World Health Organization 2019 report warning that e-cigarettes do not help reduce cancer, and should be regulated. Areas for further study include the vaping of marijuana, cocaine, heroin and other illicit substances (now linked to possible fatal respiratory disease and hospitalizations), and the global youth impact of e-cigarettes in nations without Tobacco 21 laws.
Ultimately, focusing on the concept of “vaping cessation” may enlighten the debate. Switching to lifelong vaping is not the desired final outcome for adult smokers, or youth who would have never smoked otherwise.
Final success would be a world where e-cigarettes no longer are produced. As e-cigarette sales increase, perhaps the production of combustible cigarettes should be held down accordingly?
Pressing e-cigarette design towards products without nicotine or flavors may reduce the addictiveness and appeal to youth. Perhaps FDA review will conclude that e-cigarettes should only be available in pharmacies, or through an physician prescription, to assist studies about their safety and efficacy?
During a first interview to become FDA Commissioner, David Kessler stated that his priority would be to “enforce the law.” The California cities of Livermore and Richmond followed the lead of San Francisco in advancing similar legislation to enforce FDA regulation and implement a moratorium in July 2019. This enforcement intent highlighted in Supervisor Walton’s legislation may be the most powerful justification for policymakers to regulate e-cigarettes in the face of epidemic levels of use by children.
John Maa M.D. is a general surgeon in San Francisco and a former president of the San Francisco-Marin Medical Society. Maa is the chair of the California Advocacy Committee for the American Heart Association. Jeffrey Wigand, Ph.D. is a medical biochemist and former vice president of research and development and environmental affairs at Brown & Williamson Tobacco Corporation based in Louisville, Ky., who worked on the development of reduced-harm cigarettes and in 1996 blew the whistle on tobacco tampering at the company.