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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