Congress and the Trump administration have taken significant steps to rein in the regulatory state and its negative impact on the economy. From executive orders and official policy changes at nearly every agency, much progress has been made in a short period of time. For thousands of small businesses selling products with an innovative solution to America’s greatest public health problem, however, an Obama-era law and its interpretation at the Food and Drug Administration still stands to kill tens of thousands of jobs and harm millions of consumers.
What began as a hobbyist enterprise, the homemade construction of electronic cigarettes and vapor products, has grown into a sophisticated multi-billion industry that is turning the tobacco industry upside down. Far more advanced than their first generation counterparts, vapor products delivery aerosolized nicotine to a user without the harmful effects of tar and smoke. The lack of combustion is precisely why a growing body of evidence and experts have concluded that vapor products are far less harmful than cigarettes.
Unfortunately these acknowledgements run counter to the current regulatory treatment of the products by the FDA. As a result, Congress must act to modernize a law originally intended to regulate traditional tobacco products like cigarettes so that the FDA can devise regulations that actually protect public health without crippling innovation.
In May of 2016, the FDA expanded the definition of “tobacco” products that were subject to premarket review by the agency. The process for bringing new products to market was essentially designed by Congress to prevent just that. This was by design, largely because new cigarette options were unlikely to benefit public health.
Any product that was on the market when the Tobacco Control Act was introduced on February 15 of 2007 was exempt from FDA review, however, ensuring they would remain available forever. That date was called the “predicate date” and it is the date the FDA is now using to determine the legality of vapor products currently on the market. This presents a problem to vapor products because it subjects manufacturers of products that did not exist in 2007 to a cost-prohibitive approval process designed to end in failure.
FDA Commissioner Scott Gottlieb gave the industry a temporary reprieve when he delayed the deadlines for submitting the approval applications until 2021 earlier this year, but unless the pending deadline and the approval process is modernized, products millions of smokers are successfully using to quit smoking will be removed from the market.
This is an issue everyone should be concerned about due to the impact of smoking on public health care costs absorbed by all state taxpayers. In Tennessee, the impact on Medicaid exceeds $824 million annually, according to the Campaign for Tobacco Free Kids. Everyone who pays taxes has a vested interest in driving down the Tennessee smoking rate, which is much higher than the national average, for this reason.
Fortunately the debate over whether this entire industry should be wiped out in 2021 has gained bipartisan attention in Congress. Language in the 2018 Agriculture Appropriations Bill sponsored by Congressmen Sanford Bishop (D-Ga.) and Tom Cole (R-Okla.) would modernize the predicate date and avoid universal prohibition for vapor products. Cole-Bishop would allow the FDA adequate time to roll out good manufacturing practices and product standards that actually protect consumers, instead of simply saying every single one of the hundreds of thousands of types of products on the market must obtain agency approval even if they are already on the market. The latter is simply unworkable, unaffordable, and will result in disaster.
“There would be no way Saffire Vapor could continue to employee 100+ individuals, continue paying rent on 23+ retail locations, and avoid bankruptcy,” unless the predicate date is changed, said Robert Arnold, the company’s Nashville-based CEO in an email.
For the same reason consumers deserve access to other smoking cessation products such as the nicotine patch, lozenge, or gum, it is important that vapor products remain an option for adult smokers trying to quit. That’s precisely why when Congress passes the 2018 budget, updating the predicate date for vapor products should make the cut for language that hits the President’s desk. Jobs and lives are on the line.
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Paul Blair is the Strategic Initiatives Director at Americans for Tax Reform. He can be reached at firstname.lastname@example.org or on Twitter @gopaulblair.