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Industry stakeholders suggested that industry input should be sought earlier in the evaluative process and that this process should be transparent.

Some comments expressed concerns that the proposed framework would not be cost-effective for FDA to implement.

In addition, comments were made suggesting that more discussion is needed on how the other approaches used to evaluate the safety of dietary supplements are or are not applicable in the proposed framework.

One comment stated that, while a good description of other approaches on the safety of botanicals was given, little attention was given to approaches used for vitamins, minerals, and other nutritional ingredients.

Prioritization Scoring System

Comments about the sorting matrix used in the priority-setting process to categorize ingredients are described below.

Concerns were raised over the complexity of the scoring system and whether FDA has enough resources to implement the proposed system.

A few stakeholders expressed concerns that the quantitative nature of the scoring system may give the false impression of numerical precision.

Furthermore, several industry stakeholders were concerned that the numerical scoring system for prioritization may be misused in legal cases against manufacturers.

It was also mentioned that the scoring criteria needed to be more clearly defined in the report to reduce subjectivity and variability.

Monographs

Comments were made suggesting that more guiding principles on how to develop the monographs are needed.

It was also suggested that the monographs should be considered to be in “draft” form until public input can be made.

One industry stakeholder suggested that FDA and not the advisory committee described in the report should develop conclusions for the monographs. It was suggested that FDA should base its conclusions on the advisory committee’s recommendations about the data.

Comments were also expressed over the extensive nature of the draft prototype monographs developed as part of this document. Some questioned whether FDA has the resources to develop monographs that are as extensive as the examples developed.

Expertise Needed

Several comments were received indicating that particular expertises needed to be added to the suggestions for who should be included in an



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