FDA Approval Overdue for Electronic Cigarettes | National exam

A man uses a vaping product in Manhattan, September 17, 2019. (Carlo Allegri / Reuters)

The agency’s decision is supported by a damning evidence base. Why did it take so long?

The The Food and Drug Administration is facing backlash from anti-vaping members of Congress and other public health activists for officially approving an e-cigarette as “appropriate for the protection of public health.”

The FDA’s decision to approve the Vuse Solo e-cigarette last month is historic: it is the first time that the leading United States public health agency has officially recognized the potential of e-cigarettes to help smokers quit smoking. to smoke.

“The manufacturer’s data demonstrates that its tobacco flavored products could benefit addicted adult smokers who switch to these products – either completely or with a significant reduction in cigarette consumption,” said Mitch Zeller, director of the Center for Tobacco Products. of the FDA.

The FDA’s decision is both welcome and belated. Indeed, it has been clear for many years that electronic cigarettes are considerably safer than combustible cigarettes; the evidence base that supports it is overwhelming to boot. The United States, however, has always lagged behind other countries – such as the United Kingdom, France and New Zealand – in recognizing the science of tobacco harm reduction.

Yet rather than follow the advice of the FDA – and listen to the science about the potentially life-saving benefits of e-cigarette products – anti-vaping advocates have accused the agency of making a terrible choice.

For years the media have been pushing scary stories about electronic cigarettes; anti-vaping activists have done the same, casting doubt on the minds of voters and lawmakers as to whether these products are really safer than smoking. FDA approval of Vuse should put an end to the alarmism and disinformation that has plagued this subject.

Unfortunately, this will not be the case. Take the vaping opponents in Congress, who seem to completely reject the evidence.

“While I am glad that the FDA has refused the manufacturer’s requests to market certain flavors, I remain concerned given the popularity of this product with young people,” said representative Frank Pallone (D., NJ), co -sponsor of the Tobacco Control Act 2009 (TCA), which made the FDA responsible for approving vaping products.

Senate Majority Whip Dick Durbin (D., Ill.), Who is now concerning on “how the agency applies its risk management framework”.

The most brazen denunciation since the FDA decision has come from Representative Raja Krishnamoorthi (D., Ill.). “The FDA has turned its back on public health by approving a high nicotine e-cigarette,” the congressman said in a press release. “[The agency] ignored the data and missed another opportunity to tackle the youth vaping epidemic. “

Preventing smoking among minors is, of course, a laudable goal. But what the congressman and others forget to mention is that youth vaping had a downward trend before the pandemic and has declined by 60% in the past two years. In addition, the use by young people of the newly approved Vuse Solo products is so low that it cannot be reliably measured. A recent FDA survey showed that just over 1% of all high school students have used Vuse products in the past 30 days.

Anti-vaping activists increasingly seem to be waging yesterday’s war.

The public should ignore the hysterical claims of those who have made political capital by demonizing products that have effectively helped millions of people quit smoking. Instead of fighting a safer and unattractive alternative to smoking for young people, anti-vaping campaigners should ask a more fundamental question: why has one product been approved while others have been rejected?

In short, these products have been rejected because their companies do not have the legal and financial backing to go through a multi-year regulatory process and because the FDA has adopted a narrow approval standard. This arduous approval process is due to those who supported the ATT.

The FDA’s e-cigarette approval process is unlike any other public health approval process in the world. Every electronic cigarette product, of which there are millions, should be examined to determine how it will affect the health of smokers. and that of the entire population.

RJ Reynolds, who makes the Vuse Solo products, is a multi-billion dollar company and can afford to comply with the current FDA regulatory regime. But the agency has rejected millions of other electronic cigarette applications from small manufacturers. It would be wrong to assume that these products are inherently more dangerous than those from Reynolds.

Certainly, the FDA’s decision on Vuse Solo is to be applauded. It can no longer be argued that the public health agency does not recognize the basic science that vaping is safer than smoking. But the FDA process is in desperate need of reform. If vaping is to replace smoking, the status quo in which only the largest companies with the deepest pockets can bring their products to market must change.

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Guy Bentley is the director of consumer freedom research at the Reason Foundation.


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