I really hate the FDA. Long post - a rant- skip it, I just need to get it out of my system.
From facebook:
Me:
When Congress gave the FDA authority to regulate tobacco I'm sure they did not envision that authority would extend to creating a Catch-22 PMTA system that would shut down thousands of small businesses and put hundreds of thousands of citizens out of jobs. Under the regulations anything even remotely connected to
vaping can be deemed a "tobacco product," even if it contains no tobacco, or, in fact, any organic material. It's like deeming a glass an alcohol product because there is wine in it.
America needs jobs. America needs to support small businesses in their efforts to innovate. An application system so expensive and so complex that only Big Tobacco companies have the funds to try to be approved ("try" as in there is no guarantee even they will be successful) is detrimental to our economy.
The FDA's reply to me:
If they contain nicotine derived from tobacco, e-cigarettes meet the definition of a “tobacco product” and are regulated accordingly. These new regulations do not ban e-cigarettes, but rather provide pathways for products to enter, or stay on, the market and incentivize manufacturers to conduct research & submit data to establish the public health benefit of e-cigarettes.
Me back:
Yeah, right. After 40 years of smoking I quit 4 years ago with ecigs. Nothing else I tried worked.
I have been reading the Final Regulatory Impact Analysis and it is flawed. Since there isn't enough current information available on the economic impact of the Deeming requirements put on ecigs, the analysis uses outdated statistics to extrapolate what they *think* the market might be. The market has grown beyond what was imagined in 2014.
Your own statement in the Deeming regs suggests a negative impact on small businesses:
"In a broad sense, because producers of ENDS products would need to incur sizable costs to be able to continue selling their products, we can expect the deeming rule to reduce the number of distinct ENDS products available on the market, relative to what would have been observed in the absence of the rule.
"However, chances are good that numbers of distinct ENDS products would fall anyway in years ahead, as competition causes consolidation of sales in the most popular product lines; as a result, the change caused by the rule has to be measured against an inherently dynamic counterfactual. For present purposes, an important point is that, although numbers of distinct ENDS products are expected to decline as the final rule takes effect, FDA expects that a range of delivery systems and
e-liquids will remain available to consumers.
"Consolidated" means to me that large companies that can afford to submit PMTAs will buy out smaller ones and the "range of delivery systems and
e-liquids" will be limited to products by those same large companies.
I wonder what, if anything, they will say back.
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