Tobacco attorney garners ink and a television appearance
Tobacco team leader and Richmond partner Bryan Haynes was quoted in a March 3 Washington Post article titled “ Zeller takes reins at FDA’s Center for Tobacco Products.”
The article examines the difficulties that await Mitchell Zeller - from assembling nationwide anti-smoking campaigns to ongoing legal battles over whether the FDA can force graphic warning labels to be placed on cigarette packages - as he ascends to lead the Food and Drug Administration’s Center for Tobacco Products as director this month. The Center, created three years ago by Congress to regulate tobacco for the first time in history, faces particular pressure from public health advocates and tobacco industry officials over the backlog of applications that tobacco companies have submitted for new products and changes to existing ones.
“As a general rule, there has been no substantive response at all [to the applications],” Haynes said in article. “That presents a serious operational concern… It’s absolutely stifling innovation.”
Somewhat in the same vein, Haynes was quoted in a March 6 Atlantic article about how the FDA is keeping new cigarettes off the market, essentially ignoring thousands of applications to create new cigarette brands, and interfering with market competition.
The Tobacco Control Act requires that the FDA rule on new product applications “as promptly as possible, and in no event later than 180 days after an application is received.” The FDA, however, states that the deadline does not apply to products applying via the substantial equivalence pathway and that those applications can be held in limbo.
“Why would you have a 180-day review for a presumably more complex process, and not for a presumably streamlined process,” Haynes questions.
Haynes also received press coverage for his comments on e-cigarettes in a television segment aired by Fox 5 DC a month prior to appearing in the Post and The Atlantic.
In the segment, Haynes stated that e-cigarette companies must be careful not to make health claims. “The FDA has said e-cigarette companies cannot market their product as more healthful than regular cigarettes,” he added.