Mitch Zeller Talks FDA & Deeming Updates at TMA Meeting
CHANTILLY, Va. — Understanding, navigating and embracing change is an appropriate theme for this week's Tobacco Merchants Association (TMA) 102nd Annual Meeting and Conference. The tobacco industry is dealing with change as the agency that regulates it, the Food and Drug Administration (FDA), welcomes a new head.
Simultaneously, TMA is launching into the evolving landscape with a new president and CEO, Chris Greer, at its helm.
"Change is the focus of our conference, relative to our members and the environment they work in," Greer said, pointing out several new developments in the first few months of 2017 such as elections in the United States and Europe, as well as the confirmation of Scott Gottlieb as FDA commissioner.
Gottlieb was confirmed by the U.S. Senate by a 57-42 vote on May 10.
Addressing the event as keynote speaker, Mitch Zeller, director of the FDA's Center for Tobacco Products (CTP), agreed the theme dealing with change was timely.
"What does the change in government mean for all us? The answer is TBD," Zeller said. "It's still very early days; the new commissioner is being sworn in today."
New leadership aside, the CTP is continuing its work regulating tobacco products, adding newly deemed products to its roster. Since the Aug. 8 effective date for the final deeming rule, the center has also issued several guidances to help the industry grapple with the changes — including guidances on Premarket Tobacco Applications, cigar warning labels, and vape shop activities.
In addition, earlier this week, the agency issued a guidance delaying some deadlines set in the deeming rule by 90 days, beginning with May 10, 2017 deadlines. The move, made in accordance with the FDA's agreement in a legal challenge brought by the cigar industry, does not apply to deadlines that went into effect before May 10.
As for the deeming rule, the CTP director acknowledged backlash. "To state the obvious, there was a lot of reaction to what the agency did."
The reaction, he added, includes freestanding legislation introduced in Congress to change the deeming rule grandfather date from Feb. 15, 2007 to Aug. 8, 2016; freestanding legislation to exempt premium cigars from the rule; and most recently, U.S. Rep. Duncan Hunter's (R-Calif.) proposed bill to remove electronic cigarettes and vapor products from the rule. Instead, under the Cigarette Smoking Reduction and Electronic Vapor Alternatives Act, the products would be regulated by the FDA using commonly accepted industry manufacturing standards, as CSNews Online previously reported.
In addition, eight separate legal challenges were filed in response to the final deeming rule; though they have since been dropped down to six cases — one case was voluntarily dismissed and two cases were combined, Zeller explained.
Despite the challenges and proposed changes, the FDA "hit the ground running" on enforcement of the deeming rule and its regulations. Since the Aug. 8 effective date, the newly deemed products have been included in regular compliance check inspections, according to the director. In the past nine months, the agency has issued more than 4,800 warning letters to brick-and-mortar and online retailers for selling newly regulated tobacco products to minors, he reported.
Inspections of vape shops and manufacturing facilities are also underway, Zeller said.
NEW COMMISSIONER
On the same day that Zeller addressed the TMA conference, the FDA was swearing in a new head. Gottlieb previously served as the FDA's deputy commissioner for Medical and Scientific Affairs and before that, as a senior advisor to the FDA Commissioner.
According to the agency, he also worked on implementation of the Medicare drug benefit as a senior advisor to the Administrator of the Centers for Medicare and Medicaid Services. In 2013, Gottlieb was appointed by the Senate to serve on the Federal Health Information Technology Policy Committee, which advises the Department of Health and Human Services on healthcare information technology.
With a new commissioner in place, and President Donald Trump's administration in its early days, Zeller said that "sooner rather than later, there will be substantive policy discussions with the administration."
The Tobacco Merchants Association's 102nd Annual Meeting and Conference is taking place May 10-12 at the Westfields Marriott in Chantilly, Va.