Class I is based on a single NHP Monograph. It has the highest level of ingredients certainty with an established efficacy and safety profile for the remedial ingredient. NNHPD performance target is approximately 60 days for an NPN number.
NHPs in this class are based on 2 or more NHP Monographs. This class possesses a safety and efficacy profile of medium certainty. NNHPD performance target is approximately 90 days for an NPN number.
At least 1 ingredient in the formula is either not monographed or outside the scope of an NHP Monograph (eg. dosage level, ingredient source or plant part, claims). NNHPD performance target is 210 days for an NPN number after an acknowledgement letter is received.