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News: FDA Again Considers Premium Cigar Exemption

26 Mar 2018


Handmade cigar industry groups supported President Trump’s appointment of Dr. Scott Gottlieb as the head of the U.S. Food & Drug Administration (FDA). Now they will see if that support was deserved.

On Friday, the agency announced its intent to seek comments about reconsidering existing regulations of premium cigars. The 90-day comment period opens today (Monday, March 26) and runs through June 25.

Here is the FDA’s summary of its action:

The Food and Drug Administration (FDA) is issuing this advance notice of proposed rulemaking (ANPRM) to obtain information related to the regulation of premium cigars under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), and regulations regarding the sale and distribution of tobacco products. Specifically, this ANPRM is seeking comments, data, research results, or other information that may inform regulatory actions FDA might take with respect to premium cigars.

In the notice, the FDA asks for “comments, data, research results, and other information related to the following topics: (1) definition of premium cigars, (2) use patterns of premium cigars, and (3) public health considerations associated with premium cigars.”

The request for comments also zeros in on an issue regarding the definition of youth (something we raised about the original 499-page deeming document): “Please provide any evidence or other information supporting your comments. Also, provide the definition of ‘premium cigar,’ ‘youth,’ and ‘young adult’ used for the studies, information, or views provided in your responses.”

The document specifically asks for additional research that might not have been considered when the FDA made the decision to not exempt premium cigars from their deeming rules in 2016. It specifically notes the PATH study published last September that reinforced the idea that different types of cigars have vastly different usage patterns.

Simply considering a premium cigar exemption, of course, doesn’t guarantee that the FDA will ultimately adopt one. The FDA notably considered and rejected such an exemption in its original regulation of cigars.

However, the willingness of the new FDA leadership to spend time and resources considering rolling back its regulations is a good sign for those who make, sell, and enjoy handmade cigars. Over the next 90 days, expect a big push from the handmade cigar industry for comments urging the agency to adopt a premium cigar exemption.

Patrick S

photo credits: Stogie Guys

4 Responses to “News: FDA Again Considers Premium Cigar Exemption”

  1. Patrick A Monday, March 26, 2018 at 7:24 am #

    I am not sure this is related, but early last week I was randomly called to take an anonymous survey related to tobacco usage. The company contracted to conduct the survey wasn’t able to tell me who hired them, what the survey was for, etc. But the questions included what types of tobacco I consume, how often I consume them, when I first started using tobacco, my age, income, marital status, etc.

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