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FDA Regulation of Product Label with Expiration Dates

Jun 06, 2022

The United States Food and Drug Administration develops and administers regulations under authority granted by laws passed by Congress that apply to food, drugs, cosmetics, biologics, radiation-emitting electronic products, and medical devices.

Manufacturers generally apply date labels at their discretion and for a variety of reasons.

The most common is to inform users and consumers of the date up to which they can expect the product to retain its desired quality.

While manufacturers are prohibited from placing false or misleading information on a label, they are not required to obtain agency approval of the voluntary quality-based date labels they use or specify how they arrived at the date they’ve applied.

It's important for users and consumers and the U.S. Food and Drug Administration (FDA) regulation expiration dates must strictly be adhered to; it is the law.

This guidance informs you to learn about expiration date label requirements for certain FDA-regulated products.

  • Supplements

Must expiration dating be included on the label of dietary supplements?

No. However, a firm may include this information if it is supported by valid data demonstrating that it is not false or misleading.

  • Cosmetics

There are no regulations or requirements under current United States law that require cosmetic manufacturers to print expiration dates on the labels of cosmetic products, but cosmetic firms have a responsibility for the safety of products.

Cosmetic labeling must be truthful and not misleading. Products intended to affect the structure or function of the body, or for a therapeutic purpose, such as treating or preventing disease, are subject to regulation as drugs.

Learn details : Cosmetics Labeling Guide

  • Drugs

Drug expiration dates reflect the time period during which the product is known to remain stable, which means it retains its strength, quality, and purity when it is stored according to its labeled storage conditions. Certain drugs are exempt; with no dosage limitations that are stable for at least three years not require an expiration date.

  • Homeopathic drug products shall be exempt from requirements.

  • Allergenic extracts that are labeled "No U.S. Standard of Potency" are exempt from the requirements.

  • New drug products for investigational use are exempt from the requirements, provided that they meet appropriate standards or specifications as demonstrated by stability studies during their use in clinical investigations. Where new drug products for investigational use are to be reconstituted at the time of dispensing, their labeling shall bear expiration information for the reconstituted drug product.

FDA regulations require drug applicants to provide stability testing data with a proposed expiration date and storage conditions when they submit an application for FDA approval of their drug. This testing is designed to provide confidence that the product will meet the applicable standards of strength, quality, and purity.

  • Medical Devices

The general labeling requirements for an expiration date of medical devices FDA does not require. If a certain component of a device is not useful past a certain date, FDA may require to print expiration dates on the labels.

In general, Whenever the label of a medical device includes a printed expiration date, date of manufacture, or any other date intended to be brought to the attention of the user of the device, the date must be presented in the following format: The year, using four digits; followed by the month, using two digits; followed by the day, using two digits; each separated by hyphens.

For example, January 2, 2014, must be presented as 2014-01-02.

FDA label compliance plays a significant role in FDA registration.

Any label that fails in complying with FDA regulation can cause legal issues.

Provision Consulting Group offers FDA compliance label review service.

Experience the best FDA approval directions and solutions!

If you have questions about FDA regulation of medical devices

or importing of medical devices to the United States,

Office 1-909-493-3276


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