Update: Ongoing CTP Regulatory Issues

Zeller talks menthol, graphic warning, substantial equivalence for e-cigs

Melissa Vonder Haar, Freelance Writer

Proposed Graphic Health Warning

WASHINGTON -- During last week’s Warner Series webinar with the Legacy Foundation, the director for the U.S. Food and Drug and Administration’s (FDA) Center for Tobacco Products (CTP) took the opportunity to outline the agency’s priorities, as well as the potential health benefits of electronic cigarettes. When it came time for questions, however, CTP head Mitch Zeller found himself addressing concerns over several ongoing regulatory issues including graphic warning labels, menthol and substantial equivalence.

“Spring of last year, the government announced the end of litigation on graphic warning,” Zeller said of a March 2013 decision not to appeal the U.S. Circuit Court ruling that found the FDA’s original graphic warning proposal violated the First Amendment rights of tobacco companies. “This essentially means it’s back to the drawing board for the FDA.”

That’s not to say the CTP has backed off regulations to require some kind of graphic warning labels on cigarette packages.

“We are funding and fielding new research to figure out how (not whether) to draft a new proposed rule that will have a sufficient scientific evidence base in the likely scenario we find ourselves back in court,” said Zeller. “That is where we stand today.”

Zeller was less clear about if or when the agency would propose any regulations on menthol in cigarettes. After issuing an “Advanced Notice of Proposed Rulemaking” alongside its preliminary report on menthol last summer, the CTP received approximately 167,000 public comments that it is legally required to review and address in any proposed regulations.

“The CTP is seriously considering all of the comments as we consider any regulations,” Zeller said, adding that the FDA did in fact address menthol specifically in its “Real Cost” campaign ads.

When asked whether the agency would also consider the recent European Union (EU) decision to ban menthol in cigarettes, Zeller said while he was paying attention to international actions, there was “not much comparison” between a legislative body, like the EU, and the Center for Tobacco Products.

“We are not a legislative body; we are a regulatory agency,” he said. “Governments here and abroad operate differently than regulators, who can only go as far as the science can take them.”

And though reviewing nearly 200,000 public comments on menthol seems like a daunting task, it is very likely Zeller and his CTP counterparts will be facing even more comments on the proposed deeming regulations for electronic cigarettes. One of the biggest issues the CTP is asking the public to weigh in on has to do with how, or if, electronic cigarettes can realistically file for substantial equivalence. It’s an issue so pressing that it was addressed by the CTP in the preamble to the proposed rule.

“Congress put a particular date into the law for purposes of how substantial equivalence was supposed to work,” Zeller said. “For a company to file a substantial equivalence application, they have to be able to point to a predicate: a product that was on the market as of February 15, 2007.”

Of course, that date put forth by Congress was part of the Tobacco Control Act of 2009: a time in which electronic cigarettes were barely a blip on the radar in the U.S. market.

“The trigger for all this is the date,” Zeller continued. “Questions have been raised about the ability of e-cigarette manufacturers in particular to even be able avail themselves of the substantial equivalence pathway if there weren’t predicate products on the marketplace as of February 15, 2007.”

As it stands in the current proposed deeming regulations, that February 15, 2007 date stands as the hard deadline for all substantial equivalence applications, electronic or not. But Zeller said he was open to suggestions on how to better handle this challenge and, as always, encouraged interested parties to participate in the regulatory process.

I’m just acknowledging what we’ve heard and that (the February 2007 date) may be a challenge,” he said. “It’s one of the things we were considering. If there’s a different or better way of doing it, please submit your comments to us and we will very, very carefully consider all suggestions.”