In case any of you have not heard...Nicopure recently filed for a summary judgement. You can read all of it here:
https://www.nicopure.com/wp-content/uploads/2016/07/20-1-004.pdf
Very well written and worth a read. If anyone is hesitating on stocking up (not likely on this thread), this might give you the incentive to go ahead. This is an excerpt from the petition for summary judgement:
The Deeming Rule estimates that a single
PMTA will, on average, take 1,500
hours to prepare, and cost $131,643 for e-
liquid products and over $465,000 for va-
porizer products. 81 Fed. Reg. at 29,078. (
See also
AR023,998–4,003.) Nicopure,
with over 2,400 products, would have to
invest 3.6 million hours (equal to 150,000
days or 411 years) to prepare PMTAs
for all of its existing products. (
See
Stamler
Decl. ¶¶ 13, 27.)
15
Even if Nicopure eliminated 80% of its products in response to
the Deeming Rule, submitting PMTAs for
the remaining 20% would take approxi-
mately 720,000 hours (equal to 30,000 da
ys or 82.2 years) to complete. (
Id.
¶ 27.) A
dedicated team of 10 employees would take
nearly a decade to complete that task if
all 10 team members worked 24 hours a day,
7 days a week, 365 days a year—yet
FDA has allotted only 2 years for comp
liance. 81 Fed. Reg. at 29,011. (
See also
AR149,701–2.)
https://www.nicopure.com/wp-content/uploads/2016/07/20-1-004.pdf
Very well written and worth a read. If anyone is hesitating on stocking up (not likely on this thread), this might give you the incentive to go ahead. This is an excerpt from the petition for summary judgement:
The Deeming Rule estimates that a single
PMTA will, on average, take 1,500
hours to prepare, and cost $131,643 for e-
liquid products and over $465,000 for va-
porizer products. 81 Fed. Reg. at 29,078. (
See also
AR023,998–4,003.) Nicopure,
with over 2,400 products, would have to
invest 3.6 million hours (equal to 150,000
days or 411 years) to prepare PMTAs
for all of its existing products. (
See
Stamler
Decl. ¶¶ 13, 27.)
15
Even if Nicopure eliminated 80% of its products in response to
the Deeming Rule, submitting PMTAs for
the remaining 20% would take approxi-
mately 720,000 hours (equal to 30,000 da
ys or 82.2 years) to complete. (
Id.
¶ 27.) A
dedicated team of 10 employees would take
nearly a decade to complete that task if
all 10 team members worked 24 hours a day,
7 days a week, 365 days a year—yet
FDA has allotted only 2 years for comp
liance. 81 Fed. Reg. at 29,011. (
See also
AR149,701–2.)