Note: The U.S. Food and Drug Administration issued a press release regarding its finalized guidance on premarket tobacco product applications for electronic nicotine-delivery systems or ENDS as this article was posted.
LAKEVILLE, Minn. — The Public Safety and Neighborhoods Committee of the San Francisco Board of Supervisors recently advanced local legislation that would effectively ban the sale of electronic cigarettes and nicotine-vapor devices in the city. The measure is expected to be before the full Board of Supervisors on June 18, and if passed, would make San Francisco the first city in the United States to effectively prohibit the sale of e-cigarettes.
The legislation, authored by City Attorney Dennis Herrera and Supervisor Shamann Walton, would ban nicotine-vapor products that have not successfully navigated the U.S. Food and Drug Administration’s (FDA's) premarket tobacco application (PMTA) process and received an authorization order from the FDA.
Several witnesses, including Jaime Rojas on behalf of NATO, emphasized that the FDA has pushed back the PMTA deadlines for e-cigarettes and has yet to issue a final guidance document providing information to manufacturer applicants about what specifically must be submitted and what standards are required to be met for approval of their e-cigarette products.
Only one vapor product, not a traditional electronic cigarette, has received PMTA authorization from the FDA to date. The FDA recently issued a PMTA approval for Philip Morris’ IQOS system that reduces consumer exposure to harmful constituents present in tobacco smoke by heating tobacco—not burning tobacco nor creating smoke. IQOS is the only product to have received FDA approval after a two-year-long process that included the submission of millions of pages of documents. The FDA is not considering any other current applications for vapor products.
Several million vapor products or e-cigarette product components have been registered with FDA. Manufacturers are currently in compliance by registering products with the FDA, but are awaiting guidance from the agency before investing millions of dollars in a process with no clear guidelines and no expectation of approval.
San Francisco established itself as a national leader in embracing harm-reduction approaches toward fighting the spread of HIV/AIDS and confronting substance-use disorders. While public health leaders and governments in the United Kingdom and New Zealand have embraced the public-health potential of vapor products and are actively encouraging adult smokers to switch to safer vapor products to save lives, San Francisco previously voted to ban flavored e-cigarettes and now is effectively considering banning them altogether.
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