To amend the Federal Food, Drug, and Cosmetic Act to require that manufacturers of dietary supplements register with the Food and Drug Administration, to require the submission to such Administration of reports on adverse experiences regarding such supplements, and for other purposes.
Requires any dietary supplement manufacturer, packer, or distributor to initially report to the Secretary any serious adverse reactions to a supplement, to investigate the reaction, and to report any additional information obtained to the Secretary. Sets forth additional requirements for manufacturers.
Grants the Secretary authority to enter and inspect any factory, warehouse, or establishment in which dietary supplements are manufactured, processed, packed, or held, for introduction into interstate commerce, or to enter and inspect any vehicle being used to transport or hold such supplements in interstate commerce.
Deems a food (includes dietary supplements) misbranded if its label does not contain the toll-free telephone number, and the address of the Internet site, maintained by the Secretary for purposes of the medical product reporting program (MedWatch or any successor program).
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Sponsor introductory remarks on measure. (CR E218-219)
Referred to the Subcommittee on Health.
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