FDA has a chance to finally “follow the science” on vapes

It wasn’t long ago that the phrase “follow the science” was all the rage.

During the pandemic, it was used to shut down dissent to COVID-19 rules, regulations and recommendations. If you wanted to shame someone — say for not wearing an N-95 mask while jogging outside in the summer heat or holding an opinion contrary to the lockdowns — simply scream “follow the science” loudly at them.

Following the science on individual matters and public policy generally should be commended, but we need to pay attention to the actual science. That’s a lesson that many officials, particularly those in the U.S. Food and Drug Administration, should learn. The hulking federal agency regulates a myriad of potentially and undeniably harmful products, like tobacco and its derivatives, and claims to have a keen interest in reducing combustible cigarettes’ dangers.

Despite those good intentions, the FDA has a long history of taking counterproductive steps that have helped entrench cigarette smoking by making safer alternatives harder to obtain. Given that each year there are nearly 500,000 tobacco-related deaths in the United States and 12,000 in Georgia, you’d think the FDA would take this situation more seriously. However, after a series of missteps, the health and consumer safety agency has a chance to reverse what appears to be an error in judgment and award more e-cigarettes market approval.

In 2022, the FDA banned Juul Labs’ e-cigarettes from American markets. This sent shockwaves through the vaping world. While the FDA has banned other e-cigarette manufacturers’ products, Juul was one of the largest e-cigarette producers at the time. If you compare this to another sector—the auto market—it would be akin to the feds abruptly banning Ford or Toyota with seemingly little rational justification.

So what was Juul’s unforgivable sin? That isn’t so clear, especially considering that the FDA operates a burden-of-proof system that considers products guilty and dangerous until its manufacturers prove otherwise. As it pertains to Juul, it had been operating for years before the feds decided that they needed to start regulating e-cigarettes and had become a political lightning rod. It engaged in controversial marketing strategies, and even though it has since abandoned those practices, they may be in part why it received the FDA’s ire.

Eventually, the FDA required that the company submit a premarket tobacco product application for its tobacco and menthol flavored e-cigarettes, and the FDA denied it. It did so based on its claim that Juul failed to provide enough information to prove that its products were safe and because they might contain “potentially harmful chemicals.”

Juul fired back that it disagreed and the FDA’s qualms with the company could have easily been settled over a “mere phone call.” Apparently, the FDA didn’t bother ringing Juul. The FDA’s decision was rich, considering that everyone knows how dangerous combustible cigarettes are, but the FDA permits their sale without question.

Meanwhile, e-cigarettes are about 95 percent less harmful than combustible cigarettes, according to Public Health England, which is the United Kingdom’s main health agency. The FDA even admitted, “Non-combusted products — such as e-cigarettes and other smokeless tobacco products — generally have lower health risks than cigarettes and other combustible tobacco products.” What’s more, e-cigarettes are one of the top tools used to quit smoking.

After banning Juul and others from the market, the court issued a stay on the FDA’s decision—permitting Juul to sell its products to consumers while its protracted legal fight meandered through the judicial process. Just days ago, the company received news that could be a boon to smokers.

“The U.S. Food and Drug Administration rescinded its marketing ban on Juul Labs on [June 6], opening the door to possible authorization of its products,” ABC News reported. “The reversal is based on a ‘review of information provided by the applicant’ as well as new case law stemming from court decisions involving marketing denial orders, or MDOs, for e-cigarette products, the FDA said.”

This decision essentially nullifies the FDA’s ban and starts the review process anew, which means Juul—and presumably others—could theoretically receive federal approval. That could provide millions of American smokers continued, effective cessation tools to finally kick the habit for years to come.

As the FDA resumes its review of tobacco harm reduction products, it has a chance to chart a more prudent course. I just hope the agency decides to follow the actual science and not scream at those who don’t conform to their preconceived opinions.