The US Food and Drug Administration (FDA) published final regulations to extend the government agency’s legal authority over tobacco products to include additional products such as e-cigarettes, which do not contain tobacco.
The new rule will take effect in August, requiring any new e-cigarette product sold after 2007 to go through a lengthy and expensive regulatory review process known as “premarket tobacco application.”
‘Back Into the Dark Ages’
Christopher Snowdon, director of lifestyle economics at the Institute of Economic Affairs says the new rule will be bad for consumers.
“The effect of these rules will be that the vaping scene in the U.S. going to be thrown back into the dark ages,” Snowdon said. “A big black market will emerge for people who already use e-cigarettes while smokers who do not currently use e-cigarettes will be deterred from doing so.”
Snowdon says the new regulation is the result of lobbying from special-interest groups.
“I suspect the main influence has been from anti-nicotine fanatics, particularly from California, who have spent several years spreading lies and misinformation about e-cigarettes, in contrast to Britain, where health authorities have embraced e-cigarettes as a major tool in their battle against smoking, the U.S. has pandered to cranks and extremists.”
Jeff Stier, a senior fellow at the National Center for Public Policy Research, says the new rule does not promote public health.
“All products that are currently on the market, that have any significant market share, will be required to get premarket approval within two years,” Stier said. “My concern is that that’s an unrealistic amount of time. The very need to have new products that are less harmful be held to a higher standard, than the already entrenched, more dangerous products, the cigarette, doesn’t make sense from a public health perspective.”
Because e-cigarettes are used as a substitute to tobacco, Stier says the tobacco companies benefit from FDA’s new rule.
“People will go back to smoking, but, as the FDA will tell you, there is a procedure to get these products approved,” Stier said. “The only companies that will be able to afford this very expensive regulatory process are the tobacco companies.”
Stier says lawmakers in Congress need to rein in FDA’s regulatory rampage.
“The FDA has dug itself in, and now it’s up to Congress to act in the interest of public health and change the requirement, and change the grandfathered product date, so that products already on the market like e-cigarettes, will not be held to a standard that even cigarettes aren’t being held to.”
Elizabeth BeShears ([email protected]) writes from Trussville, Alabama.
Carla J. Berg, et al., “Cigarette Users’ Interest in Using or Switching to Electronic Nicotine Delivery Systems for Smokeless Tobacco for Harm Reduction, Cessation, or Novelty: A Cross-Sectional Survey of US Adults,” Nicotine & Tobacco Research, June 20, 2014: https://heartland.org/policy-documents/cigarette-users-interest-using-or-switching-electronic-nicotine-delivery-systems-sm/