According to the FDA, the product label on a supplement must include what information?
For the purposes of reporting an adverse event to the FDA, [ dietary supplements are products intended to supplement the diet and include one or more of the following ingredients:
Herbs or other botanicals
Any dietary substance for use by man to supplement the diet by increasing total dietary intake
Any concentrate, metabolite, constituent,
or extract or any combination of any ingredient listed above.
Who Must Report
The manufacturer, packer, or distributor of a dietary supplement marketed in the United States whose name appears on the label of the supplement is required to report serious adverse events.
According to the law, a dietary supplement label must include contact information (the domestic address or phone number) for the supplement’s manufacturer, packer, or distributor. The law refers to this entity as the “responsible person.” ]
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