Disposable vapes, the new thorn in the FDA’s side, seem to be taking a toll on regulators with new bans emerging frequently as they scramble to fix this “problem.” 

But who is to blame for this $2 billion dollar market? 

With crushing regulations on small businesses that primarily sell open systems with free base e-liquids, the FDA decision-making process is denying adults their vaping product of choice. This results in a new demand for disposables that have flooded the US market. 

Evidence has emerged that FDA set artificially high standards after millions of PMTAs were submitted in 2020. Internal agency documents also revealed that CTP leadership overruled its scientific reviewers who were prepared to grant marketing authorization to some flavored vaping products. 

The Premarket Tobacco Application (PMTA) pathway, the agency’s regulatory approach is designed to ensure that a product appeals to adult smokers without enticing non-smokers, especially children. 

It seems like a reasonable standard, but the PMTA pathway is a nightmare for applicants. Submitting an application to the FDA’s Center for Tobacco Products (CTP) can take years and cost millions of dollars; earning the agency’s authorization is nearly impossible. To date, manufacturers have submitted PMTAs for nearly seven million vaping products, and the FDA has authorized just 23 tobacco-flavored e-cigarette liquids and devices.

So could all of this have been avoided with fair regulations and the consideration of how many adult vapers like flavors??

At the risk of repeating myself…. again… prohibition does not work. 

Can we learn from history? The intention behind alcohol Prohibition was to reduce crime, corruption, and social problems associated with alcohol consumption.

However, it had unintended consequences that led to various negative outcomes.

1. 1. Rise of Organized Crime: Prohibition created a lucrative black market for alcohol, which was exploited by organized crime syndicates. Criminal organizations like the Chicago Outfit, led by figures like Al Capone, became incredibly wealthy and powerful by smuggling, producing, and distributing illegal alcohol.
   2. Increase in Crime: Instead of reducing crime, Prohibition often exacerbated it. Organized crime groups fought over territory, leading to violence and gang warfare. Smuggling and distribution networks led to a surge in illegal activities, including bootlegging and bribery of law enforcement officials.

• Public Health Issues: With unregulated production and distribution of alcohol, there was a significant increase in the production of poorly made or even toxic alcohol products. People who consumed these substances faced health risks, including poisoning and death.

1. 1. Corruption: Prohibition led to widespread corruption within law enforcement agencies and government officials. Many law enforcement officers were bribed to turn a blind eye to illegal alcohol operations.
   2. Economic Impact: The legal alcohol industry was heavily impacted by Prohibition, resulting in the loss of jobs and revenue for legitimate businesses and the government.
   3. Social Issues: The ban on alcohol consumption led to the rise of “speakeasies,” illegal establishments where alcohol was served covertly. This encouraged a culture of secrecy and disregard for the law.

• Erosion of Respect for Law: Prohibition’s failure to effectively curb alcohol consumption eroded public respect for the law, as many people saw it as an unnecessary and unjust restriction.

So why does the FDA think that vaping prohibition will yield different results? 

The when a ban fails, ban it harder approach is clearly not stopping the vaping revolution. But what it is happening to these legitimate businesses has been painful and unjust. These small vape shops have one goal, to help people that smoke switch to a less harmful alternative. Most shop owners are heartbroken over the actions of the FDA, not only for themselves and the people they employ but for the consumers that have had nowhere to turn but to the illicit market.

With all we know about the deadly consequences from alcohol prohibition it’s time for the FDA to rethink their choices about what is truly appropriate for public health.