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FDA Seeks Data, Comments As It Reconsiders Premium Cigars

Mar 23, 2018 | By Andrew Nagy
FDA Seeks Data, Comments As It Reconsiders Premium Cigars

The U.S. Food and Drug Administration announced today that it will be taking a fresh look at how it regulates premium cigars, and the agency wants your help. The government agency issued an advance notice of proposed rulemaking (ANPRM) seeking comments and scientific data related to the patterns of use and the health impact of premium cigars, which will be used to inform the agency’s new regulatory policies. In other words, there is still hope that premium cigars could be exempted from FDA regulation.

“The goal is to ensure that FDA has a broad scientific and regulatory foundation to efficiently and effectively implement the Tobacco Control Act,” the FDA wrote in the issuance. “Moreover, the regulatory considerations with respect to premium cigars, their use, and related public health issues continue to be of significant interest to some stakeholders, as well as a topic of ongoing and emerging research.”

Last year, FDA Commissioner Dr. Scott Gottlieb announced a new comprehensive plan on its approach to tobacco and nicotine regulation. As part of his announcement, Gottlieb said that he would be asking for public comments and scientific data specifically on premium cigars. This is because when the FDA published the final version of its deeming rule in 2016, premium cigars were lumped into the agency’s strict rules alongside e-cigarettes, pipes and flavored tobacco products.

The agency is looking for comments and data on topics that include, but are not limited to, the following:

  • The definition of “premium” cigars;
  • Use patterns of “premium” cigars generally and among youth and young adults specifically;
  • Public health considerations associated with “premium” cigars, including the health effects;
  • Studies or information regarding consumer perceptions of the health risks of “premium” cigars; and
  • Studies or information on whether any applicable manufacturing, marketing, sale, distribution, advertising, labeling, and/or packaging requirements and restrictions should be applied differently to “premium” cigars compared to other tobacco products, including other cigars.

Today’s premium cigar ANPRM will officially be published in the Federal Register on Monday, and when that happens the 90-day comment period will officially begin. This means that comments can be submitted to the FDA until June 25.

The International Premium Cigar and Pipe Retailers association welcomed today’s FDA announcement.

“IPCPR is looking forward to engaging with the FDA on the pending premium cigar ANPRM. We believe it will provide another opportunity for IPCPR and others to equip the agency with even more evidence that the current regulatory approach to these products does not work for our industry and, just as importantly, it undermines the FDA’s own mission,” said Daniel Trope, senior director of federal government affairs for IPCPR.

Drew Newman, general counsel of J.C. Newman Cigar Co., which has been rolling premium cigars since 1895, also applauded the FDA’s announcement.

"We are are very pleased that the FDA is reconsidering the regulation of premium cigars. In the past few years, new research has confirmed what we always new: that handcrafted, premium cigars are fundamentally different from every other tobacco product,” said Newman. “This new research—many of which was conducted and funded by FDA itself—has founded that minors do not smoke premium cigars, premium cigar consumers smoke infrequently, and that there are no statistically significant adverse health effects from premium cigar smoking.”

[Update: The 90-day public comment period has officially opened. Click here to submit a comment.]

FDA

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