March 22, 2019

Stanton A. Glantz, PhD

San Francisco makes a smart move to fill the void that FDA has left on ecigs

On March 20, 2019, San Francisco City Attorney Dennis Herrera and Supervisor Shamann Walton announced plans to introduce legislation prohibiting the sale of e-cigarettes in San Francisco until they are approved by the FDA.

I see this as a brilliant move to force the companies to follow federal law and demonstrate that the sale of these products would be “appropriate for the public health” as the law requires.

Not surprisingly, some, including, unfortunately, the San Francisco Chronicle editorial board, have labeled this action as “grandstanding” and raised the question of why not ban cigarettes.

This criticism ignores the reality of the federal law that gave the FDA jurisdiction over tobacco.

That 2009 law, the Family Smoking Prevention and Tobacco Control Act, granted the FDA authority over tobacco products contained a political compromise:  Any product on the market as of 2007 – including cigarettes – would be allowed to remain but new products would require that the FDA certify that marketing them was “appropriate for public health” before they could be sold. 

The idea was that we might be stuck with cigarettes but that the tobacco companies should not be allowed to continue unchecked when introducing new products.

When the FDA finally took jurisdiction over e-cigarettes in 2016, it gave Juul and the other companies that sold e-cigarettes until August 2018 to submit the needed “premarket approval” applications to demonstrate that allowing their sale would be “appropriate for public health.”  The law requires the FDA to act on such applications with 6 months.

Today, nearly 3 years later, neither Juul nor any other company has even submitted an application.

Why not?  My guess is that they probably wouldn’t meet the legal standard for selling a new tobacco product.  Youth use is exploding – pulling in a whole generation of kids who would likely have never picked up a cigarettes.  And, the more we learn about e-cigarettes, the more dangerous they look.  While they have a different risk profile from cigarettes, the evidence suggests that they are nearly as dangerous in terms of heart and lung disease and evidence is beginning to appear that they could be increasing cancer risk.

Since the FDA has extended the deadline for applying to 2022, Juul has even less reason to apply.  After all, they might be told “no.”

Even FDA Commissioner Scott Gottieb and Health and Human Services Secretary Alex Azar appreciate that they have a problem.  As they wrote in the Washington Post, "These products are on the market today only because the FDA exercised what is called enforcement discretion, thereby allowing them to be sold without official authorization. The agency thought the potential upside of e-cigarettes for adults merited their availability to the public before receiving the required marketing authorization. But the FDA had not accurately anticipated the upsurge in e-cigarette use by the young."

Unfortunately, as the title of their op-ed states, they are still waiting for the industry’s willingness to protect teens.   This view ignores the long history of the tobacco industry of pretending to want to reduce youth smoking while aggressively targeting them.  Juul is following its partner Philip Morris in advancing this PR position. 

In the meantime, the FDA has simply proposed moving the deadline to submit applications from 2022 to 2021.  That is too little too late; millions of kids will be addicted to Juul and other e-cigarettes while the FDA dithers.

Given this situation, City Attorney Dennis Herrera and Supervisor Shamann Walton did exactly the right thing in saying that the City will no longer be complicit with the FDA allowing these products, which have, unlike cigarettes, been wildly popular with kids, to be sold in San Francisco.

The fact that cigarettes got a pass in the FDA law is not a reason for continuing to give all other tobacco products a pass, especially products that expanding the tobacco epidemic among kids.

Significantly, city attorneys in Chicago and New York City joined with San Francisco in calling on the FDA to act.  Hopefully, they will also move similar legislation forward. 

National health, medical, and parent organizations should rally behind San Francisco and urge other cities to follow while the FDA continues to wait before taking meaningful steps to block the tobacco companies from promoting the epidemic of teen vaping.

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