WASHINGTON, DC — Today, TechFreedom and a dozen other free-market organizations urged Congress to amend Food and Drug Administration rules that will cripple the e-vapor industry, destroy jobs, and deprive smokers of a far safer alternative.
In August 2016, the FDA established February 15, 2007 as the “predicate date” for e-vapor products. Any product that came to market after that date must now 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. The e-vapor industry is largely made up of small businesses and products that look nothing like their predecessors of ten years prior. Since all but the largest businesses can’t afford to comply, this predicate date would force most of the industry to shut down entirely.
The letter calls on Congress to pass an amendment that would change the predicate date to August 16, 2016, the effective date of the Deeming Regulations. This would save vapor products currently on the market which, according to the bulk of the research conducted so far, are 95% safer than traditional cigarettes. Further, there is no evidence that secondhand vapor causes significant harm.
The letter states:
The Amendment would change only the predicate date, not the FDA’s rules themselves. This would have no effect on the FDA’s ability to protect consumers and regulate vapor products, including safety standards, marketing, sale to minors, and batteries. Manufacturers would still be regulated under the Deeming Rule and would have to abide by FDA standards for their products to remain on the market. In requiring the FDA to consider the vapor market through a modern lens, the Amendment simply makes the approval process more fair, realistic, and affordable.
“Fixing the predicate date would avert catastrophe, but it’s only the first step,” said Evan Swarztrauber, Communications Director at TechFreedom. “While the language in the Cole-Bishop Amendment would preserve the current market, further legislation is required for a lasting framework that protects consumers without stifling innovation.”
“Technology isn’t just about apps and social media,” concluded Swarztrauber. “Innovation transcends regulatory silos, and we’ve already seen the potential for telemedicine and Big Data to disrupt healthcare — as e-vapor has done for tobacco harm reduction. Decades of education and anti-smoking efforts have helped humanity enormously, but smoking still remains a top global killer. Congress should intervene to ensure that technology remains a lifeline for the billion lives still threatened by smoking.”
We can be reached for comment at firstname.lastname@example.org. See our other work on e-cig regulations, including:
- Our amicus brief in support of a challenge to the FDA’s regulations
- A blog post on the problems with the FDA deeming rules
- Tech Policy Podcast #111: FDA Cracks Down on E-Cigs