Abbreviated Labeling Standards for NHPs – NHPD Discussion Draft Summary Relating to Generalized Health Claims

February 4, 2009 By


The NHPD is exploring the option of developing generalized health claims for NHPs. A generalized claim is a lower level claim applicable when the use relates to self-limiting health conditions (i.e. minor conditions that run a specific course and resolve themselves without intervention). Generalized claims will not replace requirements for quality assurance of a product. Level 4 and 5 evidence may be acceptable to support these claims (i.e. non-clinical) although the exact level of evidence required will be related to the level of risk and benefit as determined by the NHPD. Thus, the NHPD is exploring the use of animal and in vitro evidence, currently permitted as supporting evidence only, as stand alone data to support the safety and efficacy of a NHP. Additionally, the NHPD is exploring the development of Abbreviated Labeling Standards which would contain allowable generalized claims, doses and routes of administration. The labeling standard would also indicate the evidence source (e.g. human in-vivo study) which would be required to be listed on the label. The addition of this evidence source appears to be the only component that separates a labeling standard apart from the current NHPD monographs. The NHPD is exploring the use of such generalized claims involving terms such as: “helps to”, “vitality”, “immune system stimulating”, “well being” and the use of “may” as in “may help to” although the first step is defining this terminology.

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