WASHINGTON, DC — Today, TechFreedom and the Taxpayers Protection Alliance led a coalition of civil society groups in urging the Food and Drug Administration to embrace technological, innovative solutions to public health problems. In particular, the letter calls for the FDA:
to create an environment that encourages smokers to switch from traditional cigarettes to less harmful alternatives like electronic and heat-not-burn products which research shows are significantly less likely to cause the deadly conditions associated with burned tobacco products.
“Our public health challenges require a forward-looking approach from the FDA,” said Evan Swarztrauber, Director of Public Affairs at TechFreedom. “Americans are already experiencing an analog-to-digital disruption in public health. Wearables like Fitbit are changing the way we exercise, and telemedicine is expanding access to doctors. Companies like Zipline are using drones to deliver medicine in Rwanda, but they can’t do the same in the U.S. due to stringent regulations. Tobacco is facing a similar disruption, and the FDA should welcome innovation that allows smokers to switch from harmful analog products to demonstrably safer digitized alternatives.”
Under the previous administration, the FDA issued a “deeming rule,” which requires any product that came to market after February 15, 2007 to undergo a premarket tobacco application (PMTA) process that, even by the FDA’s more conservative estimates, would cost around $6 million per product within the first two years of regulation. All but the largest businesses cannot afford to comply.
Early this month, the FDA announced that it would delay compliance deadlines for the deeming rule by three months to “allow new leadership…additional time to more fully consider issues raised by the final rule that are now the subject of multiple lawsuits in federal court.” In August of 2016, TechFreedom filed an amicus brief in support of Nicopure Labs’s challenge to the FDA rules.
We can be reached for comment at email@example.com. See our other work on e-cig regulations, including: