FDA e-cigarette rules subject to ‘significant’ delays

The Obama administration has failed to finalize federal regulations of electronic cigarettes nearly a year and a half after a proposed rule was issued, according to a story by Robert King for the Washington DC Examiner.

Health campaigners are said to be clamoring for a decision to rein in the growing industry, but the electronic cigarette industry is said to believe that the delay is due to legal issues surrounding whether the Food and Drug Administration has the authority to regulate these products.

The FDA issued a proposed rule in late April 2014 outlining several regulations that might be applied to the electronic cigarette or vaping industry. The regulations include a ban on sales to minors and a requirement that would subject new tobacco products to FDA review. Electronic cigarette suppliers would have to register with the agency and back up any health claims they made.

The FDA has no update on when the final rule will be released, but said that it would be subject to further review because of its significance.

Rulemaking was a complex process, agency spokesperson Michael Felberbaum was quoted as saying. And adding to the complexity were the more than 135,000 public comments that the agency had to review.

Normally, the agency would review the rule and then put out a final one, he said. However, the electronic cigarette rule was deemed ‘significant’ by the federal government. That meant the White House’s Office of Management and Budget had to review the rule before it was published.

But for some, the coming into force of FDA electronic cigarette regulations – as they currently stand – is not something that should be brought forward quickly. In an opinion piece on the dailycaller.com, Jan Verleur, the CEO of V2, said that if the rules went into effect as proposed, electronic cigarette manufacturers would have to submit applications for all products, even those on the market for the past eight years. The rules would require a multimillion dollar expenditure that would essentially put small, independent electronic cigarette manufacturers – not to mention countless sellers across the country – out of business.

‘Should the FDA e-cigarette rules take effect as written, there would only be one winner: Big Tobacco,’ Verleur said.

The Examiner story can be found here. Read Verleur’s piece here.