AOAC SPDS Meeting Book March 19 2015

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 

Background (Agency History)

• 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 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”