A Long Overdue Course Correction At The FDA On Vaping

A Long Overdue Course Correction At The FDA On Vaping

The Food and Drug Administration (FDA) has been notoriously reluctant to allow consumers access to products that could save their lives. Under the Biden administration, the FDA denied over a million marketing applications for candy- or fruit-flavored vaping products, even though smokers rely on these products to kick their cigarette habits. The FDA under President Trump has not yet lived up to the administration’s deregulatory ambitions.

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But that’s quickly changing. The FDA recently approved marketing authorization for Los Angeles-based Glas electronic cigarettes in mango, blueberry, and two menthol varieties. Additionally, the FDA laudably announced it is deprioritizing enforcement against harm reduction products “if a product has a pending application that has been accepted and filed, or when a manufacturer has a pending and accepted Supplemental PMTA [Premarket Tobacco Application], and if FDA has determined the application includes data necessary to evaluate whether the product is appropriate for the protection of public health in the case of non-tobacco flavored … products.” (RELATED: Reynolds Launches $3,200,000,000 Investment In America-Made Smokeless Nicotine)

This news, which follows the encouraging renewal of modified risk granted orders to reduced-risk heat-not-burn devices, is a large leap forward for the millions of smokers desperately seeking out less harmful choices. Hopefully, departing Commissioner Makary’s successor continues this progress and gives smokers more options to quit cigarettes. The FDA must continue to approve new products and end its failed prohibitionary policies. 

For most of the roughly 30 million cigarette smokers in the U.S., quitting is no easy feat. Kicking the deadly habit is not easy or fun. Even relatively effective quit-smoking aids such as nicotine patches have a 6-month success rate of less than 20 percent. Author Earl Chinnici struggled mightily to end his 28-year addiction, lamenting, “I had not been at all fair to myself, or to anyone or anything near me, by keeping my cigarettes right there next to me or in my shirt pocket throughout the years.” In his book Maybe You Should Move Those Away From You, he offers an important insight into ending addiction: “it can help significantly to have some powerful weapons in your arsenal. Knowledge is a remarkably powerful weapon against cigarette addiction.” 

Reduced-risk products for weaning adults who smoke off cigarettes are safe and effective. According to a 2018 National Academies of Sciences report, “There is conclusive evidence that completely substituting e-cigarettes for combustible cigarettes reduces users’ exposure to numerous toxicants and carcinogens present in combustible tobacco cigarettes.” These products are better for smoker’s families too because there is “evidence that second‐​hand exposure to nicotine and particulates is lower from e-cigarettes compared with combustible tobacco cigarettes.” 

Studies have repeatedlyfound that e-cigarettes are far more effective than traditional therapies in getting smokers to quit, all while being about 95 percent safer than cigarettes. Flavors are a critical part of the switching process. Flavored vapes—which, in fact, entice adults—are especially effective in weaning smokers off cigarettes. It’s little wonder why flavor bans, which make the experience of quitting cigarettes far less enjoyable and attainable, increase cigarette smoking. (RELATED: Authorities Recover Stolen Cargo Of Tucker Carlson’s ALP In Massive Seizure)

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Until now, FDA bureaucrats opted to stick their heads in the sand rather than listen to the latest evidence. In guidance given to vaping manufacturers on greenlighting their products, the FDA made clear that providing airtight marketing plans to prevent youth from accessing e-cigarettes was the key to approval. The agency claimed these marketing plans were “critical” and stated unequivocally that it “will review the marketing plan[s]” in making approval decisions. Then, once one million product applications came in the door, the FDA did a surprise switcheroo and allegedly the marketing plans. It proceeded to deny virtually all the applications, claiming that the real key to approval was statistical evidence on switching from cigarettes to vapes, according to court documents. 

This behavior was lambasted in the courts as being “arbitrary and capricious”—which refers to baseless or erratic agency actions outside the scope of the Administrative Procedure Act. Unfortunately, the Supreme Court in the resulting FDA v. Triton Distribution case, though the justices did take note of the Taxpayers Protection Alliance’s arguments about the many legal and constitutional issues posed by anti-vaping laws. 

It appears that things are finally changing for the better, even without the Supreme Court moving the needle. For the sake of millions of smokers, let’s hope so. 

Ross Marchand is the executive director of the Taxpayers Protection Alliance. 

The views and opinions expressed in this commentary are those of the author and do not reflect the official position of the Daily Caller.

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