FDA E-Cig Deeming Regulation Proposal Is Out There
In the absence of a government shutdown, it seems that the U.S. Food and Drug Administration is back to work pushing regulation forward on electronic cigarettes. According to an email electronic cigarette trade organization SFATA sent out to its members, drafts of the FDA’s deeming regulations have been sent over to the Office of Management and Budget at the White House for review.
If passed, the deeming regulation (as last claimed by the FDA) would classify electronic cigarettes as tobacco products. This would place regulatory control of the products in the hands of the FDA as part of its control of all tobacco products. Most likely this would also mean hefty taxes, testing and quality barriers, advertising and flavor bans, restrictions on who can sell them, packaging requirements, internet sales bans, and other elaborately designed obstructions. This would most likely ruin small (well, smaller than huge that is) electronic cigarette businesses and hand the industry almost entirely to the biggest three tobacco companies (Philip Morris, R.J. Reynolds, and Lorillard).
By law, the review must be completed within 90 days. Following final OMB approval, the proposal will be published to the Federal Register and the public will be given a time frame within which it must submit any comments to be considered. This time frame is likely to be 60 days. The FDA is required to review and analyze these comments before making its final decision.
This is not as much time as we might think. All said and done, regulation could easily be pushed through by the end of next year. It might even take another industry shaking set of lawsuits against the FDA to keep it from ruining the industry — like it did in 2008 and 2009 when the FDA banned electronic cigarettes without any real evidence that they deserved it.
We’ll keep you up to date as we learn more.