Thousands of e-cig and vaping products will now have to pass a Pre-Market Tobacco Application (PMTA) process if manufacturers want to keep them on the market, thanks to new FDA regulations just announced hours ago. All electronic cigarettes launched since February 15, 2007 are now under federal oversight. And the vaping industry is in jeopardy of essentially being wiped out as a result.
This latest FDA ruling takes effect in 90-days, affecting an estimated 99% of all e-cig and vaping products currently on the market. The PMTA process will be financially costly for retailers, and there is no guarantee of federal approval once the application is submitted. The FDA reviews each product and application based on its potential impact on “public health.” Those that do not submit the required application or those that submit but do not meet “FDA Standards” will have their products immediately removed from the market.
(Related Article: SECRET LAW MAY ACTIVATE FDA E-CIG REGULATIONS BY MAY 17, 2016)
The FDA ruling also prohibits the selling of vaping/tobacco products to minors, a requirement for retailers to ask for photo identification, health warnings on product labels, no vending machine sales unless located in adult-only establishments, certain advertising restrictions, and no free samples. This means that in 90-days, vape shops around the nation will no longer be able to let their customers test-test new e-liquid blends.
What about the Cole-Bishop Amendment?
In late April, the vaping community was experiencing a huge sigh of relief when the Cole-Bishop Amendment to the now official FDA deeming regulations made it past the House Appropriations Committee. In this FDA Amendment introduced by Rep. Tom Cole (R-Okla.) and Rep. Sanford Bishop (D-Ga.), the February 15, 2007 predicate date would be moved forward to the date in which the regulations are signed into action, which is now May 5, 2016.
The FDA regulations would still go in effect, but they could not retroactively penalize e-cig and vaping products already on the market. The Cole-Bishop Amendment would save the vaping industry, but it still has to be passed by a majority of House Representatives - that is, if the legislation ever makes it to the House floor. As the vaping industry reels from this latest news, many small business owners are not-so-secretly hanging their hopes on a Cole-Bishop amendment that may never see the light of day.
But this is all simply speculation at this point. Things are happening so quickly today that anything is possible. In fact, the Consumer Advocates for Smoke-free Alternatives Association (CASAA) is warning the vaping industry to not panic just yet. Organizations like the CASSA and the Smoke-free Alternatives Trade Association (SFATA) have enormous amounts of political influence on Capitol Hill. There is still plenty of time to come up with a countermeasure for this most recent FDA ruling.
(Related Article: CONGRESS SAVES VAPING BY PASSING FDA AMENDMENT)
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- Tags: Cole-Bishop Amendment, FDA amendment, FDA Deeming Regulations, FDA e-cig regulations