The FDA is getting ready to clamp down on vape stores and manufacturers to make sure that everyone is following the rules. Specifically, the FDA is looking for violations of its ruling that no new vaping products can be introduced after August 8, 2016. (If you wondered why there seem to be no new flavors, that’s a result of this FDA ruling.)
The “Deeming Rule” defines anything and everything related to vaping as a “tobacco product” (whether it contains any tobacco or not) and puts it under the jurisdiction of the FDA. This includes e-cigarettes, vaporizers, e-juice, replacement glass, and even batteries. Under the ruling, not only is it illegal to introduce new flavors, it is also a violation to change the size of the bottle, the nicotine level, or the ratio of propylene glycol to vegetable glycerin.
Technically it’s not illegal to introduce new products; it is illegal to do so without FDA pre-market approval – and that has not been forthcoming for a single product since August 8, 2016.
The FDA has budgeted $23 million to contract for inspection of vape shops and manufacturers over a five-year period, with the contract specified to go to a small, woman-owned business in order to promote diversity.
At the same time, the FDA is beginning to promote vaping as a way to help smokers reduce their tobacco use, especially once the reduced nicotine levels that the FDA is working on take effect.
The next big deadline for the vaping industry is August 8, 2018, when manufacturers – including your local vape shop if they make their own – need to have their Premarket Tobacco Applications for “newly deemed tobacco products” (read: non-tobacco products that the FDA classifies as tobacco products despite them having no tobacco whatsoever) that were on the market as of August 8, 2016.
One year later, on August 8, 2019, manufacturers must report on Harmful and Potentially Harmful Constituents (HPHC) for all “covered tobacco products”. And here’s another interesting tidbit: any product introduced after that date must be reported to the FDA at least 90 days before it goes on sale.
- New and Unapproved? FDA Inspectors Could Have Plenty to Look At, ecigintelligence.com, March 7, 2018
- FDA Is About to Crack Down on Non-Compliant Vapes, Vaping 360, March 20, 2018
keywords: #fdadeeming #deemingrule #deemingregulations #vapegazette
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