H.R.3377 - Dietary Supplement Access and Awareness Act108th Congress (2003-2004)
|Sponsor:||Rep. Davis, Susan A. [D-CA-53] (Introduced 10/28/2003)|
|Committees:||House - Energy and Commerce|
|Latest Action:||06/02/2004 Sponsor introductory remarks on measure. (CR H3663) (All Actions)|
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Summary: H.R.3377 — 108th Congress (2003-2004)All Bill Information (Except Text)
Introduced in House (10/28/2003)
Dietary Supplement Access and Awareness Act - Amends the Federal Food, Drug, and Cosmetic Act to require reports to the Secretary of Health and Human Services by: (1) manufacturers and processors of dietary supplements respecting dietary supplement product listing (including labeling, ingredient, and discontinuance information); and (2) manufacturers and distributors of dietary supplements respecting serious adverse experiences resulting from a supplement's use (requires manufacturer or distributor investigation of such occurrence).
Authorizes the Secretary to require a manufacturer to: (1) provide postmarket surveillance if there is a reasonable possibility of a supplement causing adverse health consequences; and (2) demonstrate that a supplement is not adulterated if the Secretary has reasonable grounds for believing that a supplement may be adulterated (permits distribution during such demonstration period unless determined to be an imminent public health hazard, and requires a final determination of adulteration by the Secretary). Deems a supplement as adulterated for noncompliance with such safety demonstration provisions.
Authorizes the Secretary to make a determination that a dietary supplement may pose a significant risk to individuals under the age of 18, and prohibit (as misbranded while held for sale) the supplement's sale to such individuals.
Includes among prohibited acts failure to comply with the requirements added by this Act (other than safety demonstration requirements). Extends inspection authority to records, controls, and facilities related to a determination of supplement adulteration.
Directs the Secretary to carry out dietary supplement education programs for health care professionals and consumers.