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health. New drugs are subject to premarket approval, yet DSHEA excludes all dietary supplements from this requirement despite the fact that they may possess biological activities similar to those found in medications, and survey data demonstrate that dietary supplements are used by consumers for medicinal purposes. Further, under the provisions of DSHEA, FDA has no authority to require the collection or reporting of specific safety data from dietary supplement manufacturers or distributors after their products are made available for sale to the public.

It is very challenging to carry out the mandate of DSHEA given the limitations it imposes on the quantity and quality of the currently available scientific data related to the safety of dietary supplement ingredients. One of the key premises of DSHEA is that history of use is evidence of safety when applied to dietary supplements; as indicated in Chapters 4 and 6, there are significant scientific problems with this assumption.

In line with these findings, members of the scientific and medical community have strongly advised that the regulatory mechanisms for monitoring the safety of dietary supplements, as currently defined by DSHEA, be revised. The constraints imposed on FDA with regard to ensuring the absence of unreasonable risk associated with the use of dietary supplements make it difficult for the health of the American public to be adequately protected.



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