Well, the SFATA filed its
amicus brief on Tuesday. You can read it
HERE. Not a strong effort, IMO. It says:
“There is another significant segment within the vapor industry that produces e-Liquids. Those e-Liquids are heated within the vaporizer to produce a flavored vapor without
omitting the burned resins, chemicals, ash, and odor typically associated with combustible tobacco (e.g., cigarettes).”
"Emitting" is the word they were looking for.
Mistakes happen, but the primary flaw is that the brief consists mainly of assertions like these:
"SFATA’s own internal estimate for the number of e-Liquids on the market is significantly higher than FDA’s estimate."
"A study by Management Science Associates showed that vape shops sell a staggering number of products, on average selling 542 SKUs overall and 300 e-Liquid options. See Vape News Magazine, Vape Shop Owner Survey Results Revealed (Sept. 5, 2015)..."
"SFATA’s surveying shows that ninety-eight (98) percent of respondents operate a brick-and-mortar business, and almost seventy (70) percent of respondents are single-location owners."
"It has been estimated that micro businesses are the sole source of income for three-quarters of their proprietors. Association for Enterprise Opportunity, Opinion Poll: The Role of Micro Businesses In Our Economy, Oct. 9, 2012, at 3."
"A few example comments collected from SFATA’s member companies demonstrates the dire prospects for the industry under the Deeming Rule..." [grammar: a few comments demonstrate, not demonstrates]
And on, and on, and on.
These assertions, while undoubtedly true, are not supported by citations to the record. As I explained in an earlier post here, the time to submit evidence is before the regulation is adopted, not in the judicial review process. The judge will almost certainly ignore these assertions.
The main purpose of a legal brief is to cite law (cases and statutes) to support your position. Yet this brief contains no legal arguments or citations of any kind. Not one.
This is a missed opportunity to submit compelling legal arguments to this judge which have not yet been made. For example, millions of US citizens have invested goodly sums in vaping hardware. Hardware needs new parts from time to time. After 8/8/18 if you need replacement coils for your Nautilus, you might as well throw the thing away because new coils will probably be legally unobtainable. Or what if you need a new o-ring or drip tip? You'll be out of luck. This seems utterly arbitrary, unreasonable, and unjustifiable to protect public health, effectively rendering worthless things people have already paid good money for. Did the FDA take that into account--the economic, social and health consequences of it as they are required to do by law? Nope.
Hypothetically, let's say some federal agency decides that in two years it will be illegal to sell any automobiles which don't have prior agency approval, even if those same automobiles have already been bought by millions who are currently driving them around with no known defect. And let's say the regulation also states that it will be illegal to sell any parts for those automobiles unless it has approved the entire automobile, bumper to bumper. Any court would hold that to be unreasonable. Likewise, who is going to submit a PMTPA for an o-ring or a drip tip?
