Another interesting post from IZOF Texas on other board:
izof_texas
One must presume that the product will only reappear as a drug. FDA
reiterated their stance that it is a drug in response to RCPI's apparent
attempt to rectify the supplement situation with a belated NDIN. No
dice, apparently.
They need to go the drug route, and [it appears] they cannot [FDA will
not allow] in the mean sell it as a supplement. Something can't be a
supplement and a drug [according to FDA, apparently].
The question would be will the drug be OTC or prescription (it can
[eventually] be both, but you have to start somewhere). I presume
prescription first, so that it can be prescribed for the first target
condition (likely osteoarthritis) AND for "off label" use, and get
doctors' attentions by the results they get, both for OA and for other
indications as reported by their OA patients.
I am (to remedy the situation of current takers) encouraging the co. to
immediately start another IND/clinical trial that would invite
participation by all previous takers via the supplement route,
ostensibly to keep track of both reported benefits and safety for the
long term.
I was worried about the cost of such a study, but it turns out that
there is no reason why the company could not only avoid bearing the
cost, but could actually profit from such a study. Though it is seldom
done, the company is not prohibited from charging for study participation.
It appears to be the only fair and legal thing they can do to continue
to provide support to those (like me) who depend heavily on anatabine
citrate for quality of life issues, and even for life itself. I presume
such a study could start in a few months if really pressed ... and they
certainly should.
izof_texas
I would add that part of me wishes they'd go back to selling it as a
supplement and fighting the chicken clucking FDA here in the U.S., and
developing it as a drug in Europe.
The FDA is screwed up on this matter and they even admit it, with
promised "clarifications" for YEARS.
The FDA's interpretation of the DSHEA cannot be reconciled with the
actual law, the DSHEA (as RCPI's reply to their letter demonstrates),
and ignores one provision of it, the one that RCPI (and other supplement
manufacturers in the same boat) depends on. CLUCK 'em!
