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June 15, 2017

Miller, Health Policy Experts Urge FDA to Reconsider New Regulations Targeting E-Cigarettes & Lower Risk Nicotine Products

Group requests the agency to reconsider and improve tobacco and nicotine product regulatory framework, called “deeming” rule

DES MOINES – Attorney General Tom Miller and a group of a dozen internationally-recognized experts on public health policy and tobacco and nicotine science are requesting the U.S. Food and Drug Administration’s new commissioner to reconsider how the FDA’s “deeming” rule, finalized in 2016, which regulates all tobacco products, addresses lower risk nicotine products such as e-cigarettes.

“We support FDA jurisdiction for these products,” Miller and the group of experts write in a letter to Commissioner Scott Gottlieb, “but at this time we do not believe that the current regulatory framework for the low-risk nicotine products such as e-cigarettes and smokeless tobacco is appropriate or will deliver the substantial public health benefits we hope and expect FDA’s oversight will bring.”

On May 3 the FDA announced it would impose a three-month delay in enforcing certain provisions of the final rule to give the agency “additional time to more fully consider issues raised by the final rule that are now the subject of multiple lawsuits.” The delay affects certain deadlines that were set to take effect August 10, 2018. The deeming rule stems from the Family Smoking Prevention and Tobacco Control Act of 2009.

Miller and the group of experts ask Gottlieb to use the delay to “reconsider and improve the (deeming rule’s) regulatory framework,” adding the long-term regulatory framework “should be based on clear and transparent standards made through an open and consultative process.”

The group recommends that the FDA base its regulatory approach on certain principles, including:

  • Establishing regulations that are proportionate to the relative risk of products, which should not favor more harmful over less harmful products
  • Recognizing potential benefits as well as risks and be wary of unintended consequences
  • Formulating regulations that promote pro-health innovation in low-risk alternatives to smoking
  • Supporting risk communication that is truthful, plain-speaking and focused on helping consumers make informed choices
  • Protecting young people from using any tobacco or nicotine product, while being mindful of positive and negative public health impacts arising from changes in cessation uptake or use of other tobacco products that may arise as a consequence of regulatory intervention

The letter recommends FDA embrace an objective to bring public perception closer to reality. For example, the group suggests that the agency consider approving “standardized evidence-based and non-misleading statements that vendors of low-risk products could use in packaging and advertising” and exempt them from Tobacco Control Act misbranding provisions enforcement.

“It is clear beyond a reasonable doubt that vapor products present lower risks to nicotine users than smoking,” the letter states. “The costs and burdens of FDA’s approach threaten to heavily contract and constrain the emerging market in vaping and other low-risk technologies, and some action is required in the short-term to stabilize the market.”

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