Week ahead: Groups await FDA tobacco rule

Industry and advocacy groups are expecting the Food and Drug Administration to release its long-awaited final rule to regulate cigars and electronic cigarettes this month.

The FDA, though, is keeping their cards close to the vest. FDA spokesman Michael Felberbaum said he did not have any update to share on the timing of the rule’s release.

The anticipation may be wishful thinking, but health groups believe a final rule is imminent.

“I do believe they will come out this month,” said Matthew Myers, president of the Campaign for Tobacco-Free Kids.

“They are facing a serious deadline given the end of the presidential year. Having said that, the proposed rule came out in April 2014 and last spring they said they would be done by summer. Then last June they said they’d be done by the end of the summer. I guess they never said which year.”

Myers said the delays in releasing the final rule have damaged the agency’s credibility.

“The need for its release is urgent,” he said.

The delay has sparked speculation among industry leaders on what could be holding up the rule.

Ray Story, CEO of the Tobacco Vapor Electronic Cigarette Association (TVECA), believes the agency is hung up on one provision — a mandate that requires any nicotine delivery devices that hit stores after Feb. 15, 2007, to apply retroactively for approval.

Story argues that provision alone will wipe out the e-cigarette industry, which didn’t take off until after 2007.

“Even though FDA sees it as a serious issue, it cannot change it,” Story said. “It requires a change of the law.”

The agency has said it does not believe it has the authority to alter or amend the date, because it was set by statute in the Family Smoking Prevention and Tobacco Control Act that was signed into law by President Obama in 2009.

Story said Rep. Duncan Hunter (R-Calif.) is working on legislation to change the date.

In an email to The Hill, Duncan’s chief of staff Joe Kasper said the legislation is intended to ensure e-cigarettes are not regulated like traditional tobacco products.

“Vaping is not the same as smoking traditional tobacco and it shouldn’t be treated that way,” he said. “Vaping is really a proxy war for anti-tobacco forces and there’s nothing they want more than to continue associating vaping with regular tobacco.”

Kasper dismissed the FDA’s claims that the agency’s hands are tied by statute, calling the argument “bunk.”

“If they signaled support, this would be done by now and so many small businesses nationwide wouldn’t have the anxiety that they do.”

If the FDA releases the rule before Congress acts, Story predicted a legal challenge.

“If they push a rule forward, litigation will follow and stop FDA dead in their tracks and at that time they will have egg in their face,” he said.

Lawmakers from both chambers will be on Capitol Hill in the coming week, as the House returns from its spring recess.

On Tuesday, the House Rules Committee considers a bill that would ban the Federal Communications Commission from regulating Internet rates for consumers.

Also on Tuesday, a Senate Environment and Public Works subcommittee holds a hearing on how EPA regulatory actions affect small businesses.

On Wednesday, the full Senate Environment and Public Works Committee holds a hearing on how President Obama’s climate policies are affecting “access to energy and economic opportunity.”

The House Small Business Committee will hold a hearing Thursday, where Republicans will challenge regulations as a “hidden small business tax.”

The House Energy and Commerce Committee on Thursday will hold a hearing on legislation to slow down controversial ozone standards from the Environmental Protection Agency.


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