FDA Seeks Additional Input on Premium Cigar Cigar Regulation
On March 23rd, 2018, our “friends” at the Food and Drug Administration (FDA) released a notice to the public seeking “additional input, scientific data on patterns of use, and resulting public health impacts of premium cigars.” It seems continually nagging of our legislature and their discussion with the FDA have caused the FDA to potentially reconsider their premium cigar regulation. In short, we might have a chance to eliminate the regulation of premium cigars! Please see below for guidance on how YOU can influence the regulations.
In the notice, the FDA stated, “We received numerous comments on the deeming proposed rule with respect to premium cigars, both in favor of and against regulating these products. However, the comments against regulation provided little data to support the opinions expressed and, where studies were submitted, provided little information about the studies cited. FDA is seeking comments, evidence, information, data, and analysis that were not submitted in response to the proposed deeming rule, or that may have become available since then, that could further inform FDA’s thinking about the regulation of premium cigars.”
The FDA also stated, “Today, the U.S. Food and Drug Administration issued an advance notice of proposed rulemaking (ANPRM) to seek comments and scientific data related to the patterns of use and resulting public health impacts from what are often referred to as ‘premium’ cigars to inform the agency’s regulatory policies. The agency is specifically requesting comments and information not previously submitted in response to the proposed deeming rule. In 2016, FDA finalized the deeming rule extending its authority under the Family Smoking Prevention and Tobacco Control Act to additional tobacco products, including e-cigarettes, cigars, pipe tobacco and hookah tobacco, among others. The rule includes provisions making these products subject to a range of requirements, such as mandatory age and photo-ID checks to prevent illegal sales to minors, required warning statements, submission of health documents, and the prohibition on marketing modified risk products without an FDA order in effect. When proposed, the deeming rule put forth two, alternative regulatory options, one of which would have excluded so-called ‘premium’ cigars from FDA regulation. After carefully considering the public comments on the rule, FDA concluded all cigars pose serious negative health risks, and the evidence did not provide a public health basis for FDA to exclude any type of cigars from regulation.
“All tobacco products, including ‘premium’ cigars, remain subject to manufacturing, distribution and marketing oversight by FDA. 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,” said Mitch Zeller, director of FDA’s Center for Tobacco Products.
Through the announcement, the FDA is requesting comments, data, research results, or other information not submitted in response to the proposed deeming rule on topics including, but not limited to:
- 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.
What can you do? Speak up about any of the topics listed above. Go HERE to comment but please be factual. This ain’t a discussion of politics on Twitter. This is your chance to influence the rule makers! You have until June 25th, 2018 to submit a comment. Do it!
