The FDA hasn’t released any statements about what it may or may not decide regarding e- cigarettes later this year. That’s due in large part to the fact that the White House’s Office of Management and Budget has yet to make a final decision on the FDA’s proposed rule that would effectually bring e-cigarettes under its jurisdiction. If the OMB rules in the FDA’s favor, the FDA will then have to decide if e-cigarettes are a functional smoking cessation aid, or if it’s going to qualify e-cigarettes as equivalent to tobacco-burning cigarettes.
Through the end of 2013, the OMB received information from a number of e-cig company representatives, tobacco lobbyists, lawyers, and medical and public health professionals and advocates. If the OMB had inclinations one way or the other, it’s certainly keeping them to itself. And as of mid-January, 2014, the OMB has stopped receiving outsiders. The move is largely understood to indicate the OMB has heard all that it’s willing to hear on the issue.
As an industry, e-cigarettes are bringing in a nearly $2 billion bottom line. With expectations that the e-cig industry will overtake the tobacco industry – that is, the $80 billion per year tobacco industry – it’s unclear how the OMB may view the economic and social impact. It doesn’t help that plenty of the media continues to have a dim view of e-cigarettes, both with regards to safety and minors beginning to smoke and vape.
Politico notes another complication for the OMB. While some companies like Njoy Inc. operate independently of the tobacco industry and have attracted people like former U.S. Surgeon General Richard Carmona, such companies are not always the case. Big Tobacco is already dipping it’s fingers in the e-cigarette market, making the ability to separate cigarettes from e-cigarette all the more murky. It gives opponents a foothold, no matter how weak, to argue that e-cigs will only lead to increased smoking instead of acting as a cessation aid. Some, like Sen. Richard Blumenthal (D-Conn.), even use this reasoning to support their “think of the children” arguments.
As if all of this isn’t frustrating enough for retailers and vapers alike, perceived expectations for the FDA’s follow through vary widely. Statements from the FDA tobacco division make some think the FDA will be flexible about new regulations, a position bolstered by the recent European Parliament decision to reject proposals for similar regulations. Celebrity sponsorship and other forms of advertising are up in the air until the FDA announces its final decision. But even decisions that the e-cigarette industry is prepared to face, such as a minimum age requirements, could have complicated side effects; some say that because age cannot be verified online, vendors will be restricted from making e-cig sales via the internet, a heavy blow to an industry comprised of so many small businesses.
Even once the OMB and FDA make their decisions, the process for these regulations will be far from over. There will be an amount of time for commentary by the public, at which point the FDA will adjust the regulations (or reject the commentary) and release the finalized regulations. That process alone could take a year, and that’s without accounting for litigation against the finalized rules. A federal judge already ruled against the FDA once in 2010, when the FDA attempted to regulate e-cigarettes as medical devices.
The OMB has not yet projected a date for its decision.