A bill to amend section 412 of the Federal Food, Drug, and Cosmetic Act, relating to requirements for infant formulas.

Summary

Amends the Federal Food, Drug, and Cosmetic Act to revise infant formula manufacturer distribution recordkeeping requirements. Revises regulatory authority to: (1) require the Secretary of Health and Human Services to prescribe quality control regulations (under current law such prescription is discretionary); and (2) require regular independent audits and predistribution testing of each batch of formula. Requires the application notifying the Secretary of changes in formulation or processing to be made before distribution (rather than before processing as provided under current law) and to include full testing reports and records. Requires a manufacturer to notify the Secretary of nutritional inadequacy, adulteration, or misbranding of formula whether or not such discrepancies present a risk to human health and to immediately start a recall.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

No timeline events have been ingested for this record yet.

Votes

No vote records are attached yet.

Versions

No version snapshots stored. Document URLs remain at the source.

Documents

1 official file

• Introduced in Senate

  summary · EN · 24 January 1985

  Open at official source

Sponsors

No sponsors or actors listed by the source.

Related records

No cross-record relationships stored yet.