• August 12, 2020

Support for deeming-rules challenge


‘In May, the FDA finalized its Deeming Rule regulations, which would force e-cig manufacturers to undergo an expensive and time-consuming premarket tobacco application process unless their products were on the market – or substantially equivalent to a product on the market – prior to the predicate date of February 15, 2007, long before modern e-cigs were introduced,’ the NCPPR said in a press note.

‘The high cost of the application process means most e-cig businesses will be forced to shut down, eliminating choices of dramatically safer alternatives to combustible cigarettes, which will leave smokers with fewer options to compete against the most harmful form of nicotine consumption, combustible tobacco.’ NCPPR said the brief concluded:

The FDA’s Deeming Rule fails to consider the scientific evidence readily available to the agency regarding the safety and the public health benefits of e-cigarettes. The Deeming Rule is improper under the APA not merely because it fails any manner of scientific analysis, and is therefore arbitrary and capricious, but also because it is in direct conflict with Congress’s intent to prevent smoking and aid cessation through the [Family Smoking Prevention and Tobacco Control] Act.

“E-cig technology has grown by leaps and bounds since the FDA’s arbitrary predicate date in 2007,” said Evan Swarztrauber, communications director at TechFreedom. “Setting a standard using technology from nearly a decade ago is absurd and highly stifling to innovation. The FDA should issue evidence-based regulations that address legitimate safety concerns without hindering products that improve consumer health by providing a less harmful alternative, rather than implementing a ‘Mother, may I innovate?’ approach that’s become all too common among regulatory agencies.”

Jeff Stier (pictured), senior fellow at the NCPPR, said that instead of developing science-based standards which would reduce harm, the FDA had directly admitted it didn’t understand or evaluate the potential benefits or harms of e-cigarettes. “Without that science, it relied on the ‘precautionary principle’ standard, in direct conflict with the evidence-based standard required by Congress,” he added.

And Daniel Suraci, an attorney working pro bono on behalf of the NCPPR, said regulations should be promulgated within the constraints of the rule of law, sound policy, and proportionality. “The FDA’s heavy-handed approach to e-cigarettes is an affront to smart governance as the regulations are in direct contradiction of the scientific evidence showing the public health benefits of vaping, and push the public back to cancer causing tobacco products,” he said.