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Mitragyna Speciosa Group
Work to Date
•
1 In Person Meeting
•
2 teleconferences (October 2014 – November
2014)
•
1 SMPR Drafted
•
Public comment period (December 15 2014
,
–
January 30, 2015)
•
SMPRs made ready for SPDS review and
approval
•
2006 (street drug language in labeling)
•
2011 – Develop tox regulatory strategy for “low
hanging fruit” using NDI adulteration charge
No safety data or safety concern based on MOA
“ l
h”/
ll
d
Background (Agency History)
Lega Hig Centra y Active Ingre ients
Analysis of importation
•
2012 – Dietary Supplement (54) Import Bulletin
written for Kratom
•
Thousands of kilos of kratom detained/refused
(between 2012 and Present)
•
“Operation Log Jam” – not a massive nationwide crackdown
on kratom
S S di i
(S
2014) K
ld b h i
di
•
PD Pre ct on ept 5,
: ratom wou e t e ngre ent
of 2014 and 2015
•
September 25, 2014 – U.S. Marshals seized 25,000 lbs raw
Kratom (> $5M)
Today
•
Kratom is adulterated to CFSAN FDA because of the alkaloids
•
NDI filing would receive a “Not a Dietary Ingredient Letter”