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FDA Notice: Comment Request on Dietary Supplement Labeling Notification Collection

A US Federal Register notice from the FDA seeks public comment on a proposed information collection tied to rules requiring supplement manufacturers, packers or distributors to notify the agency about certain label statements. It is a notice, not a final rule. [1]

Automatic summary · not editorially reviewed

The key findings

  1. The FDA notice was published in the Federal Register on 19 December 2024. [1]

  2. The notice allows 60 days for public comment under the Paperwork Reduction Act. [1]

  3. The regulation requires supplement manufacturers, packers or distributors to notify the FDA about certain label statements. [1]

The source at a glance

Jurisdiction
US
Authority
Health and Human Services Department; Food and Drug Administration
Document type
Notice
Record type / format
Notice (Federal Register)
Scope / context
US dietary supplement manufacturers, packers or distributors subject to the notification regulation; the general public is invited to comment.
Summary based on
Official regulatory document
Original publication
December 19, 2024

FDA notice on supplement label notification collection

This is a notice from the US Department of Health and Human Services and the Food and Drug Administration (FDA), published in the Federal Register on 19 December 2024. It announces an opportunity for public comment on a proposed collection of information. Under the Paperwork Reduction Act of 1995, federal agencies must publish notice of each proposed collection, including extensions of existing collections, and allow 60 days for comment.

Supporting source [1]

What the notification requirement covers

The notice solicits comments on the information collection provisions of a regulation. That regulation requires the manufacturer, packer or distributor of a dietary supplement to notify the FDA that it is marketing a product bearing, on its label or in its labeling, a statement provided for in the Federal Food, Drug, and Cosmetic Act. The notice concerns this notification procedure, not an evaluation of any product.

Supporting source [1]

Status, date and official edition caveats

The publication date is 19 December 2024, but a publication date is not necessarily an effective date. A notice is not a final rule. The web/API rendition is an informational resource, not the official legal edition; the linked official PDF on GovInfo should be verified, along with later amendments, before relying on legal requirements. This source alone does not determine a product's compliance or current legal status.

Supporting source [1]

How to interpret this

Document summary; not a determination of current law. Based only on the agency abstract and metadata; the full document was not reviewed. A notice is not a final rule, and a publication date is not necessarily an effective date.

Based on the cited official document. Its jurisdiction, document type and effective date matter; a proposal or notice is not a rule already in force.

Source & supporting passages

[1]
Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling: Notification Procedures for Statements on Dietary Supplements

Health and Human Services Department; Food and Drug Administration · federalregister.gov · December 19, 2024

Read the quoted passagesIn the language of the original source
  1. Finding 1 ↑

    Publication date: 2024-12-19
  2. Finding 2 ↑

    to allow 60 days for public comment
  3. Finding 3 ↑

    notify us that it is marketing a

AI-assisted summary with linked source passages. No independent editorial or clinical review.

Our editorial method

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