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October 28, 2015

Action Plan – OMB

As you may have heard, last week the FDA’s proposal to ‘deem’ vapor products to be ‘tobacco products’ under the Tobacco Control Act was sent to the Office of Management & Budget (OMB) at the White House for review.  At this point, it seems doubtful that the FDA has taken any serious steps that would allow even 10% of products on the market to remain. One single provision of this rule has the capacity to shut down thousands of businesses — a requirement that all e-liquids, devices, tanks, coils, etc. that have been put on the market since February 15, 2007 (the ‘grandfather’ date) go through a rigorous, potentially multi million dollar ‘premarket review’ process.  If you want a possible preview of what ‘premarket review’ could entail, take a moment to browse through this (unconfirmed) leaked draft of guidance that could soon be published by the FDA. In short, anyone who tells you that FDA regulation is just a matter of disclosing ingredients or mixing in clean rooms is just plain wrong. This is a classic death of ‘death by paperwork’ and it is shaping up to be far worse than even the draconian regs that will soon be enacted in the E.U.Without a massive push by this industry and consumers, every small business (those with under 500 employees) in this industry could be squashed.

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