Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act | Guideline Explorer

Description

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.

Scope & Applicability

Product Classes

3

Dietary Supplement

Products containing dietary ingredients intended to supplement the diet; The final product category for which the NDI is intended.

Infant Formula

The primary product category covered by the guidance; Essential food product that is the sole source of nutrition for many infants.

Nonprescription Drug

Over-the-counter human drug products marketed without an approved application; Over-the-counter drug product marketed without an approved application

Stakeholders

6

Manufacturer

Entity responsible for submitting NDINs

Packer

Entity whose name appears on the label

Distributor

Entity responsible for submitting NDINs

Responsible Party

food firms that are responsible parties as defined in the statute

responsible person

Entity required to submit serious adverse event reports; The manufacturer, packer, or distributor whose name appears on the label; The individual or entity required to submit and maintain records of serious adverse events.

retailer

Any person, government, or entity who sells tobacco products to individuals for personal consumption; Entity subject to No-Tobacco-Sale Orders and compliance requirements.

Regulatory Context

Attributes

3

15 business days

Timeframe for submitting reports to FDA

six years

Duration for which records must be kept

Manufacturer Report Number

Unique identifier used to link reports and follow-ups

Identified Hazards

Hazards

1

Serious Adverse Health Consequences

Risk associated with reportable food

Related CFR Sections (3)

21CFR107.240§ 107.240 Notification requirements.
(a) Telephone report. When a determination is made that an infant formula is to be recalled, the recalling firm shall telephone within 24 hours the appropriate Food and Drug Administration district office listed in § 5.115 of this chapter and shall provide relevant information about the infant formuRead full regulation →
21CFR1.3§ 1.3 Definitions.
(a) Labeling includes all written, printed, or graphic matter accompanying an article at any time while such article is in interstate commerce or held for sale after shipment or delivery in interstate commerce.Read full regulation →
21CFR101.5§ 101.5 Food; name and place of business of manufacturer, packer, or distributor.
(a) The label of a food in packaged form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor.Read full regulation →

Related Warning Letters (3)

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Fagron Group B.V.
2022-06-28
Unapproved New Drugs/Misbranded
Prollergy Corporation/Ready Set Food
2020-10-20
CGMP/Dietary Supplement/Adulterated/Misbranded
Hawaii Pharm LLC
2020-05-05