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FDA Announces New Vision for Tobacco Regulation

August 4, 2017 at 2:35 pm

Last week, the Food and Drug Administrator Scott Gottlieb, MD, released the administration’s plan to regulate tobacco and nicotine products. The plan outlined by Commissioner Gottlieb centered around lower nicotine levels in cigarette to non-addictive levels, exploring the potential of e-cigarettes as cessation tools for those seeking to quit cigarette smoking, and offering e-cigarettes as reduced risk products.

While Dr. Gottlieb’s announcement outlined a case for urgent action, most of the announced plan focused on delay, including:

  • A four-year delay in the requirement for industry to submit new product information on e-cigarettes and flavored cigars
  • Essentially, four more years for industry to market kid-luring products like candy flavored cigars and e-cigarettes with minimal FDA oversight
  • Re-opening the discussion of exempting “premium cigars” from FDA any regulation.

In his announcement, Dr. Gottlieb called for a multi-year public discussion on several aspects of tobacco regulation, including the role of flavoring agents in tobacco products, premium cigar exemption and non-addictive levels of nicotine in cigarettes. What Dr. Gottlieb’s announcement failed to recognize is that many of the issues have already been extensively discussed by the FDA previously.

In issuing the rule expressing the FDA’s authority over all tobacco products – known as the Deeming Rule – the administration sought and received comments from industry, the health community and the public on several key issues including flavored nicotine products and exempting premium cigars. In issuing the final Deeming Rule, the FDA already provided extensive rationale for why it felt all cigar products should be regulated by the agency.  Further, in the final Deeming rule the FDA discussed in great detail the likely individual and public health effects of flavored nicotine products, noted how these products particularly appealed to youth and indicated the agency would take further action on flavored tobacco products.

In responding to the FDA announcement, Enid Neptune, MD, vice-chair of the ATS Tobacco Action Committee noted, “Dr. Gottlieb’s announcement of the FDA’s new vision for regulating tobacco products is long on delay and short on action. The health of the American public, and particularly today’s youth, will suffer as a result of the FDA’s failure to act.”

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