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FDA Commissioner Gottlieb grilled at Hearing

Sen. Rubio Grills FDA Commissioner Gottlieb During Hearings on Premium Cigar Deeming Regulations

June 23rd, 2017

Dr. Scott Gottlieb, the newly-appointed commissioner of the U.S. Food & Drug Administration, recently testified before the Senate Appropriations Subcommittee with regard to the FDA’s budget, and was asked a series of important questions by Senator Marco Rubio (R-FL) about whether the agency would consider reevaluating the deeming regulations that went into effect on August 8, 2016.

Senator Rubio prefaced one of his questions by reminding Dr. Gottlieb that many small businesses in Florida have been making premium handmade for generations and that it was the previous administration which finalized the rule that would require cigars manufacturers to regulate the manufacturing, importation, packaging, labeling, advertising, promotion, sales and distribution at the premium cigar level.

Moreover, the Senator stated that tobacco product sales to anyone under the age of 18 is already illegal which addresses concerns about the underage smoking issue, and stressed that the premium cigar industry is not and has never been aimed at that market.

“It’s a different market altogether,” added Rubio, who then asked, “Are there any plans to reevaluate the inclusion of premium, hand rolled cigars from this rule as was proposed from the preliminary rule?”

Dr. Gottlieb responded by saying that the agency was in the process of looking at aspects of the rule, also noting that there was a three-month delay with regard to the implementation of certain compliance dates before he was named as Commissioner.

“Whatever we do in this regard is going to need to be science-based, of course,” said Dr. Gottlieb. “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.”

Because pending litigation is already underway on the issue, Gottlieb kept his answer to a minimum, but added that he did “understand the concerns of the small businesses that make premium cigars.”

“And just for those who might be watching, we’re talking about the premium cigars, what the name implies, a premium cigar,” said Senator Rubio, to which Dr. Gottlieb replied, “That’s right.”

Rubio went on to reinforce the stance that cigars are “an expensive product marketed towards a very specific audience,” and that if the study is science-based, that alone would show that premium handrolled cigars are not products marketed at persons who are underage.

Other issues that may have influenced Dr. Gottlieb’s responses are the current lawsuits by three cigar industry trade groups who have charged the FDA with not fully considering the required economic impact of the rules on premium cigar manufacturers. Additionally, the agency’s rules do not meet the Congressional intent with regard to regulating products targeted towards children and/or those that pose a public health risk.

According to one online source that regularly reports on the cigar industry, the delay that Dr. Gottlieb referred to has to do with the lawsuits, but another reason for the delay is that the government may actually reconsider various parts of the rule. And it was Gottlieb, himself, who, in a 2012 op-ed stated that regulating premium cigars was not part of the Congressional mandate of the Family Smoking Prevention and Tobacco Control Act, which gave the FDA the authority to regulate all tobacco products, including premium handrolled cigars. Even the new Secretary of the Department of Health and Human Services, Dr. Tom Price, also a former Congressman and to whom Dr. Gottlieb reports, supported a number of bills that would have exempted premium handmade cigars from FDA regulation.

For now, the cigar industry will have to see how the lawsuits pan-out, and what Dr. Gottlieb decides is the best course of action for the agency based on the scientific studies.