AOAC SPDS Meeting Book March 19 2015

Background (Diastereoisomers of Mitragynine)

Speciociliatine

Speciogynine

(S)

(S)

(S)

(R)

(S)

(S)

Regulatory Guidance

 Kratom – should be slotted appropriately  comfrey  ephedra

 rauwolfia  red yeast rice  butterbur  Kratom could fit under 201(ff) as an herb or other botanical  (alkaloids with opioid activity are the issue)  Kratom (mitragynine or 7‐hydroxymitragynine) = adulterated based on 402(f)(1)(B)  Kratom (mitragynine and 7‐hydroxymitragynine removed) = allowable? (all other alkaloids left ‐ cause relaxation)  At what level would they be acceptable?  Zero tolerance?  Agency has to make that case