DC In A Battle Over E-Cigarette Regulation June 05 2015
By Lydia Wheeler - The Hill - 05/31/15 07:00 AM EDT
Washington is locked in a growing debate over what restrictions should be placed on the booming electronic cigarette industry.
The Food and Drug Administration is pushing ahead with a proposed rule that would ban the sale of e-cigarettes to people under the age of 18 and prohibit sales in vending machines.
But to the dismay of many health activists, the rule does not address online sales or television advertising for e-cigarettes, though the FDA has said future action is possible.
The proposed rule, which the agency released in April 2014, is a “deeming regulation” that gives the FDA the authority to regulate all tobacco products, including cigars, electronic cigarettes, pipe tobacco and certain dissolvable products like nicotine gels, among other things.
The lobbying around the proposed rule has been fierce, with much of the pressure centering on e-cigarettes.
After a 2014 survey showed e-cigarette use among high school and middle school students tripled from 2013 to 2014, Democrats in Congress started pushing FDA to issue a stronger rule that prevents companies from being able to market the products to children.
Sen. Barbara Boxer (D-Calif.) went so far as to ask five tobacco companies to voluntarily pledge to pull their ads.
Of the five tobacco companies — Altria Group, NJOY, Lorillard Inc., Logic Technologies and Reynolds American — four responded, but none said they would refrain from advertising on TV.
In it’s May 14 letter to Boxer, Altria Group Inc., the parent company of e-cigarette manufactures Nu Mark and Philip Morris, said the issue is one that the FDA should settle.
“But FDA should also consider adult tobacco consumers’ interest in information about and access to these products,” Altria Group said. “Indeed FDA has already acknowledged the emerging public health view that non-combustible products may — with the right regulatory framework — have a role to play in reducing harm from tobacco products.”
Reynolds American Inc. was the only company not to respond. Company officials referred The Hill to the comments it submitted to FDA and would not respond to questions about Boxer’s letter.
Though there are hundreds of companies manufacturing e-cigarettes, Boxer’s office said it chose the five that are controlling the largest percentage of the marketplace, hoping a favorable response from them would have a ripple effect on the industry.
In an April letter to Health and Human Services Secretary Sylvia Mathews Burwell, signed by Boxer and nine other Senate Democrats, lawmakers said e-cigarette companies are using celebrity endorsements, cartoons, teen magazines, music festivals and sporting events to advertise their products and specifically target children.
Citing a 2014 study in the journal Pediatrics, the senators said 24 million children were exposed to e-cigarette advertising between 2011 and 2013.
“In this context, it is unsurprising that youth use of e-cigarettes hay skyrocketed during the same timeframe,” the Democrats wrote. “It is well known that advertising influences consumer behavior, especially that of children, and we urge you to apply the same marketing regulations to e-cigarettes that already exist for traditional cigarettes.”
Congress in 2009 gave the FDA the authority to regulate more tobacco products, including electronic cigarettes, as part of the Family Smoking Prevention Act. It took the agency until April 2014 to propose the rule.
Health groups have criticized the agency for taking more than year to write the proposed rule and are expecting more delays with the final version.
Though the administration’s 2015 regulatory agenda set a June deadline for the e-cigarette rule, FDA Spokesman Michael Felberbaum said the agency “hopes to publish the final rule this summer.”
The American Lung Association said it is “very disappointed” that it has taken the agency this long to act.
Erika Sward, the association’s assistant vice president for national advocacy, said the rule hasn’t even gone back to the Office of Information and Regulatory Affairs for final review.
When asked the reason for the delay, Felberbaum said rulemaking is a complex process.
“This particular proposed rule resulted in more than 135,000 public comments for the agency to review and consider,” he said. “FDA is committed to moving forward expeditiously to finalize the rule.”
Sward said the American Lung Association is pushing FDA to extend the Tobacco Control Act rules, which cracked down on marketing to children, to include all tobacco products, including e-cigarettes.
“The most important thing for FDA to do is to extend the youth access provisions to all these newly deemed products and ideally that would happen in the deeming regulations,” Sward said. “While we are hopeful that these types of proven interventions would be included to protect kids from tobacco marketing, they were not in the initial proposal and are recognized that they are unlikely to be in the final rule.”
Felberbaum said FDA’s proposed “deeming” rule does give the agency the authority to later place restrictions on electronic cigarettes.
“These restrictions would require separate rulemaking and public comment,” he said.
Sen. Patty Murray (Wash.), the ranking Democrat on the Senate Health, Education, Labor & Pensions Committee, said e-cigarette companies are using the same youth-targeted tactics that tobacco companies used for years to lure new customers.
“To right this wrong, I urge the FDA to finalize and strengthen last year’s proposed deeming rules, and put in place restrictions that would prevent marketing targeted to minors, eliminate the sale of flavored e-cigarettes that appeal to children, and end online sales,” she said.
FDA said it does not comment on whether changes have been made to the proposed rule.
“At this time, FDA also cannot comment on details related to the final deeming rule,” Felberbaum said.
Under the proposed rule, age, identification and vending machine sale restrictions would take effect 30 days after the final rule is published. Manufacturers would have 24 months from when the rule is published to stop manufacturing tobacco products that do not have the new health warnings and 25 months to stop distributing them.
As for industry, Altria said it’s impossible to say how it will respond to the final rules without seeing them first, but it did not rule out the possibility of a court challenge.
“Obviously when final rules come out we’ll review and look at them like everyone else,” said Altria Spokesman David Sutton. “I couldn’t speculate on what might or might not happen.