I have a dumb question. How will the FDA determine the product did or did not exist prior to the predicate date?
Here's what the FDA says in the deeming doc:
https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-10685.pdf
Pg.20
Regarding concerns as to the inability to use the SE pathway for certain products, FDA
notes that an applicant may use as a predicate any tobacco product commercially marketed in the
United States as of February 15, 2007, or previously found substantially equivalent (note that we
interpret the phrase "as of" February 15, 2007, as meaning that the tobacco product was
commercially marketed (other than exclusively in test markets) in the United States on February
15, 2007. If your tobacco product had been commercially marketed in the United States before
February 15, 2007, but was not commercially marketed on that date, it is not a grandfathered
product and may not be commercially marketed unless you obtain a marketing authorization
under section 910 of the FD&C Act).3 This may possibly include a predicate that is in a different
category or subcategory than the new product that is the subject of the SE report. While FDA
currently does not have a policy that limits comparisons to the same category, we do see cross
category comparisons as more challenging for an applicant and we may express limitations on
such comparisons in the future, if they become warranted as we gain experience regulating
newly deemed products. FDA also is continuing to research e-cigarettes, other ENDS, and
heated cigarette products that likely were on the market "as of" (i.e., on) February 15, 2007.
Additionally, FDA has determined that some e-cigarettes and other ENDS were manufactured in
2006 and commercially marketed in the United States in early 2007. In particular, we have
identified an ENDS product that may have been on the market on February 15, 2007. This...
-----
³
FDA Guidance states that "f you cannot provide documentation specifically dated on February 15, 2007, FDA suggests you provide documentation of commercial marketing for a reasonable period of time before and after February 15, 2007." Guidance for Industry entitled "Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007**** (79 FR 58358, Sept. 29, 2014), The guidance also provides examples of sources of evidence, e.g., bills of lading.
Pg.21
...product may possibly be able to serve as a valid predicate for purposes of the SE pathway. The
burden of demonstrating that a valid predicate exists rests with the manufacturer submitting a SE
report. To facilitate the determination that a product is eligible to serve as a valid predicate, any
individual who has evidence that an e-cigarette or other ENDS was commercially marketed in
the United States on February 15, 2007, may submit a stand-alone grandfather submission to
FDA (See final guidance, "Establishing That a Tobacco Product Was Commercially Marketed in
the United States as of February 15, 2007" (79 FR 58358, September 29, 2014)). (Based on
FDA's experiences to date, and since stand-alone grandfather submissions are purely voluntary,
FDA does not anticipate that many manufacturers will make such submissions, but this option is
available.) Regardless of the predicate selected for comparison, manufacturers are responsible
for providing scientific data adequate to demonstrate that, in the case of an SE report, the
characteristics of the new product are the same as the predicate or, if the characteristics are
different, that these differences do not cause the new product to raise different questions of
public health. We encourage interested parties to review the applications FDA posts on
U S Food and Drug Administration Home Page for examples of products that do not raise different questions of public health when compared with the specified predicate product.
****Here's the guidance mentioned in note ³
http://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM416498.pdf
He'll make the most of it.
, and make us think they give a crap about our preferences.
(not a bad thing, just thought I'd share. 
)
