The Office of Management and Budget — the U.S. department that determines whether regulation is worth spending money on implementing — just put out a notice that suggests the FDA’s deeming regulations may be announced very, very soon. The FDA has not been shy about saying it thinks electronic cigarettes should be regulated as tobacco cigarettes (that’s what deeming means). But the timeline they set for themselves in implementing said regulations has been continually pushed back.
However, we’ve known for a bit that the FDA had a proposal on e-cig regulation being reviewed at the OMB. Now it seems the OMB has released a notice in preparation of announcing those regulations. You can check out the notice right here. Unfortunately for most anyone that isn’t well versed in government red-tape speak, the notice reads like nearly complete gibberish.
The short version is that this probably confirms that the FDA is pursuing electronic cigarette industry regulation as tobacco. Their primary (official) argument appears to be that nicotine is an addictive substance due the same attention that tobacco cigarettes receive from the government. This sounds like a reasonable justification except that it suggests that nicotine alone is as bad as the smoke used to deliver it in conventional cigarettes — most experts now agree that smoking and nicotine should not be used synonymously.
However, from what we hear, the Office of Management and Budget has meetings until pretty late in the month with organizations and individuals seeking to support more flexible legislation of electronic cigarettes. This means that an official decision may not actually come until the new year. But really, we won’t likely know when a decision is announced until it is already announced.
The primary concern for the OMB appears to be a legitimate one though. The review and considerations for the proposed regulations is whether electronic cigarettes pose more risk to public health than offered benefits. That’s a hard thing to prove, but we don’t know what circumstantial evidence that the FDA offers might be accepted as proof regulation is necessary.
Again, we’re not experts on legal red-tape, but this is our understanding of the notice. As always, we’ll keep as close an eye on the situation as we can.