Dietary Supplement and Nonprescription Drug Consumer Protection Act
Latest action. Became public lawWhat a bill becomes when enacted, numbered by Congress and order of enactment: Public Law 119-4 is the 4th law of the 119th Congress.Read the full definition (opens a new tab) No: 109-462.
(This measure has not been amended since it was reported to the Senate on September 5, 2006. The summary of that version is repeated here.)
Dietary Supplement and Nonprescription Drug Consumer Protection Act - (Sec. 2) Amends the Federal Food, Drug, and Cosmetic Act to require a manufacturer, packer, or distributor whose name appears on the label of a nonprescription drug or dietary supplement marketed in the United States to: (1) submit to the Secretary of Health and Human Services within 15 business days any report of a serious adverse event associated with use of such drug or supplement in the United States; (2) submit within 15 business days any related medical information that is received within one year of the initial report; (3) maintain records related to each report for six years; and (4) permit inspection of such records. Allows a retailer whose name appears on the label as a distributor to authorize the manufacturer or packer to submit the required reports so long as the retailer directs all reported adverse events to such manufacturer or packer.
Requires the Secretary to develop systems to ensure that duplicate reports of a serious adverse event are consolidated.
Allows the Secretary to establish an exemption from such reporting that would have no adverse effect on public health.
Considers a serious adverse event report to be: (1) a safety report that may be accompanied by a statement, which shall be included in any public disclosure of the report, that denies that the report or the records constitute an admission that the product involved caused or contributed to the adverse event; and (2) a record about an individual and a medical or similar file the disclosure of which violates the Freedom of Information Act unless all personally identifiable information is redacted.
Provides that the submission of any adverse event report shall not be construed as an admission that the drug or supplement involved caused or contributed to the adverse event.
The summary continues for 5 more paragraphs. Read it in full on Congress.gov
Written by analysts at the Congressional Research Service and published on Congress.gov, not by Civibrief. Summarized at the "Public Law" stage on December 22, 2006. It describes the bill, it is not the legal text.
Where is it in the process, and what happens next?
This bill has been enacted. It is law.
The record's latest action, on December 22, 2006: Became Public Law No: 109-462.
Has anyone actually voted on it?
No. No roll call in this Congress cites this measure. That is the ordinary outcome: most measures never reach a recorded floor vote, and a committee ends most of them simply by not acting.
A vote is not the only thing that happens to a measure. Hearings, markups, and referrals are all recorded actions, and none of them is a vote of the full chamber.
Who is behind it?
ORRIN HATCH (R-UT) introduced it on June 21, 2006, and 5 members have since signed on as cosponsors.
They come from both major parties: 3 Democrats, 2 Republicans.
Cosponsoring is a formal signature on the text. It is not a commitment to vote for the measure, it does not bind anyone's party, and a long list of cosponsors is a measure of attention rather than of prospects.
Every answer above is assembled from this measure's own record on Congress.gov and from published counts of what Congress has passed before. Civibrief does not predict outcomes and takes no position on any measure.
Vote history
- SenatePassed
- HousePassed
- PresidentSigned into law