Juul Labs Inc.'s hometown of San Francisco is proposing legislation that restricts e-cigarette sales and keeps the companies that make them off city-owned property.
The city, along with New York and Chicago, has also asked the FDA to speed up its review process for the products, the San Francisco City Attorney's Office announced March 19. As part of the proposed laws, San Francisco wants to ban any tobacco manufacturer from operating or expanding on city property. Juul leases space on the city's waterfront and could not expand further on city property to make or sell e-cigarettes that lack FDA premarket authorization if the new legislation becomes city law, according to the City Attorney's Office.
"Companies like Juul are contributing to increased numbers of people addicted to nicotine – people who would have never picked up a cigarette. Banning vaping products that target young people and push them towards addiction to nicotine and tobacco is the only way to ensure the safety of our youth," San Francisco Supervisor Shamann Walton said in a statement from City Attorney Dennis Herrera's office.
Under the proposed rules, e-cigarettes that have not received premarket authorization from the U.S. Food and Drug Administration could not be sold within city limits or shipped to any San Francisco address. The city already prohibits the sale of flavored tobacco including e-cigarettes, limits the number of tobacco shops in neighborhoods, and requires a minimum age of 21 to buy tobacco, Herrera said in a letter to the FDA.
The FDA allows companies to sell e-cigarettes that were on the market as of Aug. 8, 2016, but the makers must apply for premarket review by 2022. The agency on March 13 released draft guidance for e-cigarette makers that, if enacted, would move the application deadline up to Aug. 8, 2021, and restrict sales of most flavored e-cigarettes to online channels or age-restricted shops.
In a March 20 statement to S&P Global Market Intelligence, Juul said it remains committed to keeping e-cigarettes out of the hands of minors, but that the city's move would limit adult smokers' ability to switch from combustible cigarettes.
"This proposed legislation begs the question — why would the city be comfortable with combustible cigarettes being on shelves when we know they kill more than 480,000 Americans per year?" Juul said.
The best way to limit youth access is to require age verification for all tobacco products regardless of where they are sold, Japan Tobacco Inc. said in a March 20 statement.
"We do not believe that prohibiting the sale of [e-cigarettes] is an effective approach to counter youth access, and will instead harm retailers in San Francisco and drive adult consumers to purchase [e-cigarettes] outside the city limits," the company said.
Other e-cigarette makers — British American Tobacco PLC and Imperial Brands PLC — and Altria Group Inc., which owns a 35% stake in Juul, did not return messages seeking comment.
Cities call for FDA to speed up e-cigarette review
San Francisco, along with New York and Chicago, also sent a letter to the FDA on March 19 asking for the agency to immediately conduct a public health review of e-cigarettes and requesting records from the agency to determine whether a lawsuit is in order if regulators do not complete such a review.
"The FDA has the authority and ability to curb this crisis. To date, it has not," Herrera said in the letter that is also signed by Corporation Counsel for the City of Chicago Edward Siskel and Corporation Counsel for the City of New York Zachary Carter.
An FDA spokesperson on March 20 confirmed that no e-cigarettes had undergone premarket review and referred further questions to the agency's March 13 announcement of the new draft guidance and FDA Commissioner Scott Gottlieb's comment during a March 19 public event hosted by the Brookings Institution and broadcast on C-SPAN.
Gottlieb, who is resigning from the FDA in April, said during the event that the agency did not learn of rising e-cigarette use by minors until initial results from the 2018 National Youth Tobacco Survey were available, which occurred after the FDA in 2017 extended the premarket review application deadline for e-cigarette makers until 2022.
"If we had known what was going to ensue in 2018 when we made the decision in 2017 to put forward that comprehensive vision, would we have done the same thing? Absolutely not. But we didn't have access to that data. Once we did, we pivoted very quickly," Gottlieb said.