What does S.3546 do?

The bill would require manufacturers and distributors of dietary supplements to submit to the Food and Drug Administration (FDA) any report they receive of a serious adverse event associated with a dietary supplement. They must include with each such report a copy of the label on or within the retail packaging of the supplement in question. In addition, the bill requires manufacturers to include on the label of all dietary supplements an address or phone number where reports of serious adverse events can be sent. The same requirements are imposed on the makers of non-prescription drugs.

What types of adverse events have to be reported?

The reporting requirement is limited to the kind of information FDA really needs - reports of death, a life-threatening experience, hospitalization, a persistent or significant disability or incapacity, or a congenital anomaly or birth defect associated with a dietary supplement or non-prescription drug.

Why is S.3546 needed?

Although the FDA has a system to receive voluntary reports of problems with dietary supplements and a mandatory system that covers some non-prescription drugs, there is no requirement for mandatory reporting for all these products as there is with prescription drugs and medical devices. While dietary supplements have a long record of safety, such a mandatory system will allow consumers the assurance that public health officials are on top of any emerging, serious safety problems so they can take immediate action.

What record keeping requirements are included in S.3546?

The bill requires manufacturers to keep reports of all adverse events they receive, serious and non-serious, for six years, and allows FDA to inspect these records. It also sets a 15- day time limit for manufacturers and distributors to give FDA the serious reports they receive.

How will S.3546 impact the roles and responsibilities of states and others in this area?

States will continue to work with the FDA on safety concerns. The bill makes clear that states may continue to enter into agreements with FDA to secure the information contained in any serious adverse event reports submitted. The new, mandatory, Federal reporting requirement would replace a patchwork of state requirements, providing greater uniformity and preventing duplicative or inconsistent reporting requirements. Voluntary programs like Poison Control Centers would be preserved.

Will the bill result in a large increase in serious adverse events reported?

There is no reason to believe that S.3546 will result in a large increase in reported serious adverse events. Dietary supplement companies receive very few serious adverse events reports, which demonstrates the strong safety record of these products.

What’s to stop competitors from submitting false reports to damage other companies?

S.3546 specifically prohibits the deliberate filing of a false adverse event report to a manufacturer
or to the FDA.

Does submission of an adverse event report legally constitute an admission by a company that there was a problem caused by its product?

No, S. 3546 clearly states that the submission of any adverse event report in compliance with the law shall not be construed as an admission that the dietary supplement involved caused or contributed to the adverse event.

How will FDA use the reports it receives?

The FDA will use reports of serious adverse events to more quickly identify potential problems,
like product contamination, adulteration, tampering, bioterrorism or ingredient safety issues.

How will the bill impact consumers’ access to their dietary supplements?

Consumers’ access will not be affected by S.3546. Consumers will benefit from the more rapid identification of any product problems.

What is the status of the bill?

S.3546 was introduced by a bipartisan group of Senators including Senators Hatch, Harkin, Durbin, Enzi and Kennedy. It is supported by a broad coalition of consumer and industry groups. It was unanimously approved by the Senate Health, Education, Labor and Pensions Committee on June 28, 2006. Its supporters are working towards passage by the full Senate before the Senate’s August recess.