Last week, Attorney General Pam Bondi, Health and Human Services Secretary Robert F. Kennedy Jr., and FDA Commissioner Marty Makary were present at a raid outside Chicago that seized 600,000 units of illegal vapes.
The bust reflects a wider public health scandal: more than 80 percent of the vaping market comprises illicit products, a majority of which are smuggled in as disposable devices from China.
Although warehouse and convenience store raids make good television, they won’t put a dent in the illicit market. But even if they somehow did, many of the 25 million current adult vapers who use safer, if illicit, options will switch back to lethal cigarettes. The cigarette companies will be grateful for return customers, but no one else will be.
How did we get to the point where criminals are meeting Americans’ demand for safer nicotine products while the official regulator, the Food and Drug Administration (FDA), is effectively missing in action?
The culprit is the FDA’s sorely misjudged efforts to protect young people by erecting near-insurmountable barriers to authorizing lawful vapes.
The biggest problem by far is that manufacturers of new tobacco products must file expensive pre-market applications in pursuit of the essential FDA designation called “appropriate for the protection of public health.”
Under the FDA’s discretion to interpret and define the “appropriateness” standard, which was granted by Congress in the 2009 Tobacco Control Act, manufacturers must provide scientific evidence showing that the benefits of each individual product to the population as a whole outweigh the risks.
In short, although it is well established that vaping is undeniably less hazardous than smoking, and have helped millions quit smoking, FDA has decided that the risk of any – any --youth initiation of even vastly safer products outweighs the benefit of cessation through switching by at-risk adult smokers.
This approach has caused havoc in the market for smoke-free products and is costing the lives of smokers. In almost ten years, the FDA has authorized only 39 out-of-date vaping products with limited consumer appeal, compared with almost one thousand new cigarettes – yes, cigarettes.
What to do? Instead of using an “appropriateness” standard that tries to second-guess whether youth or adult smokers will use products before they even reach the market, the FDA should base its interventions on what actually happens. To achieve this, it must monitor both the illicit and legitimate markets, and target enforcement wherever harmful effects emerge.
The FDA also needs to streamline its wildly expensive and cumbersome application process for new products that deliver nicotine without smoke. Currently, the agency requires manufacturers to submit extensive scientific data for each individual new product. Instead, it should issue clear, pre-established product standards of safety, quality, packaging, and marketing.
The European Union and the United Kingdom regulate vape products this way, making thousands of vape products available with no adverse consequences to users. These reforms will reduce review time to the 180 days required by law, and cut application costs by a factor of at least ten, putting them closer to the estimates made by Congress.
Finally, the FDA must invest heavily in honest consumer education on the differential risks of combustible and smoke-free tobacco. American consumers have been badly misinformed about the general safety of nicotine and the considerable difference in health risks between smoked tobacco and use of smoke-free delivery systems. Too many health professionals are also confused.
HHS Secretary Robert Kennedy, a self-declared nicotine pouch user, knows these basic facts. “I think the nicotine pouches are probably the safest way to consume nicotine,” Mr. Kennedy said in an interview this summer. “Vapes are second. But the thing we really want to get away from are cigarettes.”
The illegal vaping market now largely fills the demand from millions seeking safer cigarette substitutes. The FDA should let American businesses do that job.
Sally Satel MD is a senior fellow at the American Enterprise Institute. Brad Rodu DDS is a professor of medicine at the University of Louisville
