Fight on to keep e-smokes, cigars from FDA tests

WASHINGTON — The e-cigarette and cigar industries have enlisted high-profile lobbyists and influential congressional allies in an attempt to stop the U.S. Food and Drug Administration from retroactively examining their products for public health risks or banning them from the market.

The campaign targets a broad new rule that extends FDA jurisdiction to include cigars, e-cigarettes, and pipe and hookah tobacco.

The bipartisan anti-rule effort has featured a former senator who did not register as a lobbyist before going to work for the cigar companies and a former White House administration official, now a private consultant, who is trying to undo his earlier work reviewing the rule. In addition, one member of Congress introduced industry-written legislation without changing a word of it.

With more than 75 lobbyists, tobacco-aligned companies have argued that the FDA’s so-called Deeming Rule could hurt public health by forcing a large share of e-cigarette companies out of business.

“The FDA has blatantly ignored evidence that our products improve people’s lives,” said Christian Berkey, chief executive of Johnson Creek Enterprises, one of the first companies to sell the liquid ingredient used in e-cigarettes and vaping products.

FDA officials acknowledge that e-cigarettes, which use tobacco-derived nicotine, are potentially less harmful than cigarettes. But they insist they must examine whether the electronic cigarettes or the liquid nicotine juices might contain toxic chemicals such as diethylene glycol, an ingredient also used in antifreeze, or candylike flavors contributing to the surge in the numbers of teenagers using e-cigarettes. They also want to examine the safety of the devices themselves after reports of battery-related burns.

“In the absence of science-based regulation of all tobacco products, the marketplace has been the Wild, Wild West,” said Mitch Zeller, the director of the FDA’s Center for Tobacco Products, which is in charge of enforcing the new rule. “Companies were free to introduce any product they wanted, make any claim they wanted, and that is how we wound up with a 900 percent increase in high schoolers using e-cigarettes and as well as all these reports of exploding e-cigarette batteries and products that have caused burns and fires and disfigurement.”

The lobbying effort has been led by the Altria Group, the nation’s largest tobacco company, which has a growing e-cigarette unit. Documents obtained by The New York Times show that Altria last year distributed draft legislation on Capitol Hill that would eliminate the new requirement that most e-cigarettes already on sale in the United States be evaluated retroactively to determine whether they are “appropriate for the protection of public health.”

Altria delivered its proposal, the FDA Deeming Clarification Act of 2015, to U.S. Rep. Tom Cole, R-Okla., in April 2015, the documents show, even before the FDA rule became final.

Just two weeks later, Cole introduced the bill with the title and 245-word text pulled verbatim from the industry’s draft.

Separately, former Sen. Mary Landrieu, D-La., spent part of her first year after losing re-election pressing officials from the White House, State Department and FDA on behalf of the cigar industry — even though records show she had not registered as a lobbyist as required by federal law, which Landrieu said was an oversight.

“This is my fault,” she said. “I’m calling my lawyer now to get it corrected.”

Cole and Rep. Sanford Bishop Jr., D-Ga., who co-sponsored one of the tobacco-related measures originally drafted by Altria, said the rule would bankrupt small businesses and curb the availability of e-cigarette options, which some people use as a way to quit smoking.

“I don’t like regulating in the rearview mirror,” Cole said in an interview.