Many argue that the Food and Drug Administration’s regulation of novel tobacco products, particularly electronic cigarettes, is failing. Most of the FDA’s critics point to the so-called youth vaping epidemic even though youth vaping has dramatically declined.
The FDA is undoubtedly a problem, but a much more pernicious problem is increasing: counterfeit vapor products manufactured in Chinese factories with absolutely zero regulatory oversight and no accountability. And this market will only increase as the FDA and states move to push a nearly 2-decade-old market completely underground.
E-cigarettes were introduced to the United States in 2007, and almost immediately, the FDA attempted to seize regulatory control. In 2009, after several years in the courts, one court determined FDA had the right to regulate e-cigarettes as tobacco products. In 2016, FDA issued deeming regulations, applying strict standards and requirements upon the manufacturers of any tobacco product introduced to the U.S. market after February 2007. In 2020, the applications for most of those newly deemed products were due. And, like many other federal regulations, FDA effectively shut out 99 percent of a certain vapor product market such as open system e-liquids, while hundreds of thousands of products remain in a regulatory limbo of a review process. Meanwhile, as of September 2022, FDA has only approved 23 product applications from merely three manufacturers.
The FDA is not the only branch of government determining the regulatory fate of novel tobacco products. In 2019, responding to inflated alarmism purporting a so-called crisis of youth vaping, the Trump administration moved to ban the sale of flavored cartridge-based e-cigarettes, which, at the time, were the most common e-cigarette type used by youth. Additionally, governments in California, Massachusetts, New Jersey, New York and Rhode Island pushed and passed bans on the sale of all flavored e-cigarette products.
All states, besides California, are under flavored e-cigarette bans. In November, voters will decide if the Golden State will also ban the sale of flavored tobacco and vapor products.
As American history has shown with Prohibition and the opioid epidemic, bans do not work, and illicit actors will introduce clandestine products that circumvent federal and state prohibitions. Worse, such products are without regulatory oversight and severely harm consumers and, most of all, American youth.
In response to the flavored cartridge ban, disposable vapor products increased in use and market share. In fact, one market report estimated that in 2022 the global disposable e-cigarette market was worth $6.34 billion. And, in 2021, disposables accounted for nearly half (49.8 percent) of the U.S. e-cigarette market. The industry is expected to reach $18.3 billion by 2032.
Unfortunately, due to constraints in the very act that gave the FDA authority to regulate e-cigarettes, not one single disposable e-cigarette has been granted FDA authorization to market their products legally to American adults.
The lack of authorization has not stopped bootleg vape products from flooding store shelves and streets. In January 2021, the FDA applauded itself as it worked with other federal agencies and seized 42 shipments of counterfeit disposable vapor products from China. In March 2021, Customs and Border Protection officers in Chicago seized $1.5 million in counterfeit vapes.
Understandably, CBP is more concerned with the massive amounts of fake pills coming across the border. There are not as many reports of vape seizures as there were in 2021. Nonetheless, in other countries not grappling with a fentanyl epidemic, large shipments of counterfeit vapor products are being seized. This year, officials in Australia, China, Singapore and the United Kingdom have all reported massive seizures of counterfeit vapor products. The illicit products are so prevalent that a vapor product company has been actively working with government officials in China and has successfully shut down more than 20 factories manufacturing counterfeit vapes.
While contraband vapor products are not a uniquely American problem, the FDA’s process for authorizing novel tobacco products gives rise to illicit markets. Only 23 vapor products have been authorized for sale in the United States — all of which are available only in traditional tobacco flavors, none included in the $6 billion American disposable market in 2021.
Despite Michael Bloomberg-funded rhetoric that e-cigarettes are only meant to attract a new generation, vapor products are significantly less harmful than combustible cigarettes. In fact, in late September, a leading public health authority in the United Kingdom reiterated that “vaping poses only a small fraction of the risks of smoking.”
The FDA is missing an opportunity to save lives by helping adults who smoke switch to less harmful alternatives. And, while FDA dawdles away trying to figure out what other countries have already figured out, Chinese counterfeit vapes will be available with no FDA oversight.