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Cigars Fall Under FDA Spotlight

Agency opens public-comment period for regulation of premium products

SILVER SPRING, Md. -- As it did with nicotine levels and tobacco flavors earlier this month, the U.S. Food and Drug Administration (FDA) opened a public-comment period on a third tobacco issue: premium cigars, the agency announced.

To inform the agency’s regulatory policies, the FDA on March 23 issued an advance notice of proposed rulemaking (ANPRM) to seek comments and scientific data related to the patterns of use and the resulting public health effects from what are often referred to as “premium” cigars. The agency is specifically requesting comments and information not previously submitted in response to the proposed deeming rule. 

“All tobacco products, including premium cigars, remain subject to manufacturing, distribution and marketing oversight by the FDA,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “However, given the ongoing interest from many parties on this issue—as well as the potential for new data on the topic since the deeming rule published—we’re providing stakeholders an opportunity to submit relevant new information that could inform FDA’s regulation of premium cigars.”

Through the ANPRM, the agency is requesting comments, data, research results or other information on topics including, but not limited to:

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

The FDA will consider all submissions to help inform the agency’s regulatory decision-making regarding “premium” cigars. The ANPRM will be available for comment from March 26 through June 25.

The ANPRM is one of three previously announced in July 2017 as part of FDA’s comprehensive plan on nicotine and tobacco regulation. Earlier in March, the FDA published the other two ANPRMs, “Tobacco Product Standard for Nicotine Level of Combusted Cigarettes” and “Regulation of Flavors in Tobacco Products.”

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