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Opponents Sue to Speed Up e-cigarette Regulation

April 02, 2018

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By Ann Miller Baker

E-cigarette opponents are lighting a legal fire under a federal plan to hold off on industry regulation until 2022.

Several national medical organizations are suing the U.S. Food and Drug Administration (FDA) over a delay in regulating e-cigarettes, saying that it leaves kids and teens at risk of getting hooked on flavored vaping products.

But a Moffitt tobacco researcher says he’s concerned about over-regulating a useful tool in smokers’ attempts to permanently quit the addictive habit. He adds that the goal of any such regulations should be to maximize public health benefits.

A lawsuit filed in federal court on March 27 by the American Lung Association, the American Academy of Pediatrics and others challenges the FDA’s decision to allow e-cigarette products to remain on the market until regulatory review in 2022. Previously, the FDA had set a 2018 deadline for e-cigarette manufacturers to submit new tobacco product applications for agency review of their products.

Thomas Brandon, PhD
Thomas Brandon, PhD, director of the Tobacco Research and Intervention Program

The groups filing suit point to skyrocketing popularity among teens and young adults of certain flavored vaping products – some even shaped like USB flash drives. In a press release, they say the delay in regulatory review represents a threat to public health, especially among youth.

E-cigarette manufacturers and their supporters worry that the cost of new product reviews and possible FDA regulations could potentially cripple the vaping industry, shutting down smaller manufacturers and reducing access to smoke-free products for smokers trying to quit or get nicotine in less harmful forms.

Thomas Brandon, PhD, director of Moffitt’s Tobacco Research and Intervention Program, agrees that e-cigarettes should be regulated. "We need to know what’s in them as well as their safety and risk profiles," he said. "But we should be careful not to create regulations so burdensome that they harm current smokers’ access to a potentially helpful tool in overcoming their nicotine addiction. Available evidence suggests that these products have a potential for substantial public health benefit in the long run."

There is a "sweet spot in terms of regulation," Dr. Brandon says, while acknowledging it may be difficult to satisfy everyone involved in this discussion. "But these regulations should be written in a way that still allows people – particularly smokers – to have access to a product they should be encouraged to use instead of combustible cigarettes."

Dr. Brandon delivered opening address about e-cigarettes as an awards honoree at the March 2018 convention of the American Society of Preventive Oncology. His comments addressed what he views as a popular misconception among the general public that vaping products are as dangerous as combustible cigarettes, if not more so. He says that clearly does not appear to be the case, and it's important for the public to understand the distinction as regulatory discussions proceed.