Summer Reading: FDA and (Lack of) Access to Tobacco Harm Reduction

While the U.S. Food and Drug Administration (FDA) has been in the news recently for its role in regulating vapor products, it was not until 2009 that the agency was given authority to regulate tobacco products when Congress passed the 2009 Family Smoking Prevention and Tobacco Control Act (TCA).

In the years since the passage of TCA and the introduction of reduced tobacco harm products, youth and adult use of combustible cigarettes has significantly declined. In 2021, one percent of middle schoolers and only 1.9 percent of high school students reported current cigarette use. In 2020, only 12.5 percent of U.S. adults smoked cigarettes.

Despite these declines, public health has demonized novel tobacco harm reduction products such as e-cigarettes. Critics of these life-saving products have also created a so-called youth vaping epidemic. As such, policymakers including lawmakers and federal regulators, have pushed forward with prohibitionist policies which severely thwart adult access to less harmful alternatives to smoking.

Contrary to alarmist headlines, youth vaping is on the decline. In 2021, only 11.3 percent of highschoolers and 2.8 percent of middle schoolers were current e-cigarette users. Between 2019 and 2021, vaping among high school students declined by 58.9 percent and by 73.3 percent among middle schoolers.

But FDA continues to delay and deny marketing authorization for millions of e-cigarette products used by millions of adults.

E-cigarettes were first introduced to the U.S. market in 2007 – or two years prior to the FDA having authority over cigarettes. FDA was all too eager to regulate the newfangled tobacco technology. As soon as these products were introduced across the country, the agency tried to exert its authority over them, asserting they were medical devices. As such, manufacturers responded with a lawsuit contending the FDA did not have authority.

In 2010, a year after FDA was given authority to regulate tobacco products, the United States Court of Appeals for the District of Columbia Circuit Court ruled that products containing and/or being derived from tobacco with no therapeutic benefit can be regulated by the FDA as a tobacco product.

In 2016, the FDA finalized rules establishing a regulatory framework for e-cigarettes and other tobacco products that were introduced to the market after 2007 and not covered in the original 2009 TCA. Known as the deeming regulations, the new rules directed manufactures of newly deemed products – including e-cigarettes – to comply with a host of requirements including annual registrations, ingredient listings, and the eventual premarket tobacco product application (PMTA). Most importantly, all products had to be on market prior to August 8, 2016, in order to be offered for legal retail sale.

The PMTA process has been called a “bureaucratic nightmare” and has effectively shuttered thousands of small businesses across the country. In 2020, due to a lawsuit brought on by Michael Bloomberg-funded nanny-state organizations, all manufacturers of deemed tobacco products were required to submit a PMTA to the FDA. Prior to the submission date, it was estimated by the FDA that the cost of each application would be $330,000 per product.

Because of high costs, and a significant amount of confusion from the federal regulator to small business owners, many manufacturers could not afford the costs of a PMTA. In September, 2021, the FDA swiftly denied nearly 1 million applications for non-tobacco flavored e-liquid products.

As with many one-size-fits-all approaches from the federal government, the 2016 deeming rules did not take into consideration work arounds. For example, the rule did not cover nicotine derived from non-tobacco sources. In September 2021, after the federal government shut down businesses that had been on the market for at least six years, many manufacturers switched to synthetic nicotine.

In spring 2022, Congress, acting swiftly on vaping but little else, passed legislation enabling the FDA the authority to regulate nicotine – regardless of the source. Lawmakers went even further, requiring manufacturers to submit another PMTA in a 60-day period after the enactment of the legislation.

By summer, even the FDA admitted it had a major problem and reached out for an independent review. While it could be a welcoming sign, there is a deeper-seated issue at play in America: public health agencies that refuse to acknowledge to role that novel tobacco harm reduction products can play in helping adults who smoke quit.

Paradoxical to the alarmism, e-cigarettes are significantly less harmful than combustible cigarettes. Even the FDA has acknowledged this when issuing marketing orders for just three companies’ e-cigarette products in the past two years.

Moreover, they have helped adults quit smoking. The Centers for Disease Control and Prevention estimated that in 2019, 4.3 million e-cigarette users were former smokers. In 2021, the Cochrane Library living review of e-cigarettes found that “nicotine e-cigarettes help more people to stop smoking than nicotine replacement therapy.”

Unfortunately, as evidenced in the PMTA process, the FDA does not recognize the role of e-cigarettes in helping adults quit. In fact, as of June 2022, the FDA erroneously claims that “there is not yet enough evidence to support claims that e-cigarettes … are effective tools for quitting smoking.

If FDA truly wants to limit the number of people using combustible cigarettes, the agency must reverse course on its regulatory handling of novel tobacco products. The costs to bring new products to market must not be astronomical and it should not be more difficult for consumers to find a pack of cigarettes than a tobacco harm reduction product.