The world was simpler in 2009 when Congress enacted a law that gave the Food and Drug Administration (FDA) the power to regulate tobacco.
Back then, consumers’ choices were functionally limited to cigarettes and other combustible products, with little difference in risk between brands. The advent of nicotine vapor changed everything: E-cigarettes were not made by “big tobacco,” heated rather than burned their ingredients, and carried almost none of the risks of smoking. Regulations should have been amended to reflect this groundbreaking development. Now the failure of lawmakers and regulators to keep pace with innovation threatens to destroy an entire industry, eliminate a life-saving option for smokers, and put public health at greater risk.
As of September 9, 2020 all nicotine vapor manufacturers must submit an application to the FDA if they want to continue legally marketing their products. The requirement was spawned by the Family Smoking Prevention and Tobacco Control Act (TCA), enacted by Congress in 2009. Among other things, the TCA gave the FDA the power to require pre-market approval for any new tobacco products marketed after 2007. Though ostensibly intended to protect the public from new cigarettes, the TCA functionally acts as a way to protect the existing cigarette cartel by preventing new competitors from entering the market, leading some to dub it the “Marlboro Monopoly Act.” Indeed, a main reason Congress was able to pass the TCA was due to an alliance between anti-tobacco groups, like the Campaign for Tobacco-Free Kids, and traditional tobacco companies, like Philip Morris (maker of Marlboro.)
Of course, when Congress enacted the TCA, e-cigarettes did not exist. But the law also gave the FDA the power to decide what counts as a “tobacco product” that would fall under the law’s purview. Thus, despite e-cigarettes not containing any tobacco, the FDA in 2016 deemed them “tobacco products.” And, since no e-cigarettes existed on the market prior to 2007—grandfathering in date that would allow companies to bypass pre-market approval—every e-cigarette product is now required to file a Pre-market Tobacco Application (PMTA) with the FDA by September 9, 2020 or exit the market.
Michelle Minton – Competitive Enterprise Institute – September 9, 2020.