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prehensive safety evaluation will generate an additional workload for the responsible staff at FDA. For the Framework to be effective, adequate resources must be available to FDA to collect and analyze available information.

  • Adverse Event Reporting:

    • DSHEA should be amended to require that a manufacturer or distributor report to the FDA, in a timely manner, any serious adverse event associated with use of its marketed product of which the manufacturer or distributor is aware.

    • FDA should continue to work with the Poison Control Centers as a source of adverse event reports, and sufficient resources to support this activity should be provided.

    • FDA should increase efforts to inform health care professionals and consumers that they should use the MedWatch adverse event reporting program to report adverse events associated with the use of dietary supplement ingredients.

    • FDA MedWatch toll-free telephone number should be provided on product labels to facilitate reporting of adverse events.

Reports of adverse events are an important source of information by which FDA becomes aware of potential risks to public health from exposure to dietary supplement ingredients. It has been estimated that FDA receives reports of less than 1 percent of all adverse events associated with dietary supplements. While spontaneous adverse event reports have recognized limitations, they have considerable strength as potential warning signals of problems requiring attention, making monitoring by FDA crucial.

  • To initiate the 75-day premarketing review period, both the distributor and manufacturer should be required to provide FDA with all available data, both favorable and unfavorable, regarding the safety of the product.

  • When the formulation or processing of a dietary supplement ingredient is changed, it should be considered a new dietary ingredient and subject to regulatory oversight as such.

Many dietary supplement ingredients on the market today have new formulations and are produced through very different processes than related dietary supplement ingredients in traditional usage, or even other dietary supplement ingredients bearing the same name. This may result in markedly different bioactive substances of potential harm and very different kinetics (e.g., absorption, distribution in the body, metabolism, and excretion).

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