Dr. Scott Gottlieb, the newly-appointed commissioner of the U.S. Food & Drug Administration (FDA), testified yesterday in front of a Senate Appropriations Subcommittee regarding the agency’s budget and was asked about the regulation of premium cigars.
Specifically, Sen. Marco Rubio, R-Fla., asked Gottlieb whether the agency was considering reevaluating the deeming regulations, which went into effect last year.
Rubio: As you know, we’ve discussed for your confirmation, there are number of small business in Florida that have been making premium hand rolled cigars for generations. The industry is at stake because last year under the previous administration, they finalized the rule that would require premium cigars, not the stuff you get behind the counter, but the premium ones, to regulate the manufacturing, import(ation), packaging, labeling, advertising, promotion, sales and distribution at the premium cigar level. So it’s already illegal to sell tobacco products to anyone under the age of 18, which I think addresses the underage smoking issue. Plus, the premium cigar market really is not marketed towards that. It’s a different market altogether.Are there any plans to reevaluate the inclusion of premium, hand rolled cigars from this rule as was proposed from the preliminary rule?
Gottlieb: Thanks for the question. We’re currently looking at aspects of the rule, as you know there was a three-month delay in the implantation of certain compliance dates announced before I arrived at FDA and we’re coming up at the end of that delay. Whatever we do in this regard is going to need to be science-based of course. But, we’re cognizant of the challenges faced by small business. I also understand there are a number of legislative measures to exempt premium cigars. If Congress were to act, we’d be happy to work with legislators to mitigate any unintended consequences of these measures. I don’t want to comment too specifically given that there is pending litigation right now around this issue, other than to say that I understand the concerns. You and I have had the opportunity to talk about them on a few occasions now and I do understand the concerns of the small businesses that make premium cigars senators.
Rubio: And just for those who might be watching, we’re talking about the premium cigars, what the name implies, a premium cigars.
Gottlieb: That’s right.
Rubio: It’s an expensive product marketed towards a very specific audience. If it’s science-based, I think it will show, as we’ve seen repeatedly, that’s not a product that marketed at people underage or the like.
Gottlieb’s response referred to a few things. First, a lawsuit brought on by three cigar industry trade groups arguing FDA, amongst other things, did not fully consider the economic impact the rules would have—something that the agency is required to do—and the agency’s rules do not meet Congressional intent when it comes to regulating products that are targeted towards children and/or pose a public health risk.
The delay Gottlieb mentioned was brought about because of the lawsuit. In March, FDA asked for a one-month delay of the trial, which was granted. However, the trade groups argued that any further delay in the lawsuit should also be met with an equal delay an implementation of the deeming regulations.
In May, both sides agreed to a three-month delay in the trial and all future regulation deadlines.
For those following the regulations closely, Gottlieb’s response is not particularly surprising. Sources within the industry have told halfwheel one of the reasons behind the aforementioned delay is because the government has shown signs of reconsidering various parts of the rule. Furthermore, Gottlieb himself penned a 2012 op-ed where he argued regulating premium cigars was not part of the Congressional mandate of the Family Smoking Prevention and Tobacco Control, the law that gave FDA the authority to regulate all tobacco products.
Furthermore, Gottlieb’s boss, Dr. Tom Price, the new secretary of the department of Health and Human Services, was a former Congressman who supported multiple bills which would have exempted premium cigars from FDA regulation.
As for the trial, a new opening date has not been given, but it almost certain that it will not begin before December. The three-month delay pushes the trial to at least Nov. 30, which is Thanksgiving.