Author

Anna Benevente

Director of Labeling, Ingredient and Product Review

Do I Need to Label My Products with Expiration Dates?

Jun 6, 2022

U.S. consumers often look for expiration dates when deciding if a product is safe to consume or use. Dates appear on many products, but the U.S. Food and Drug Administration (FDA) does not regulate most of these dates, so their meaning is based on the manufacturer’s interpretation. Products that do not require dates could include dates that indicate when the manufacturer thinks the quality will diminish, and do not necessarily indicate that a product is unsafe past that date.

However, FDA does regulate expiration dates on certain products more stringently. Even within the same industry, date requirements may vary according to product. Those requirements may include adherence to a particular format.

Get assistance with FDA compliance.

Registrar Corp’s Regulatory Specialists can help review your product’s label for FDA compliance.

For more information, call us at +1-757-224-0177, email us at info@registrarcorp.com, or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livechat.

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Does your product need an expiration date? Read on to learn about expiration date label requirements for certain FDA-regulated products.

Food

FDA does not generally require manufacturers to include an expiration date on a food product’s label. Firms can choose to include an expiration date on a label voluntarily if they wish to inform consumers of the time frame a product can be expected to maintain quality and flavor.

If a manufacturer chooses to apply a date label, the label can not include false or misleading information. The date does not need to be approved since it is an estimation of quality, and firms do not need to provide justification for how they chose the date.

Federal law does not require expiration dates on most food, though regulations at the state level may require dates on certain foods.

However, FDA does require infant formula labels to contain an expiration date. Manufacturers must include a “Use By” date on infant formula and must confirm the date to be an accurate indication of how long the product will be of an acceptable quality, retaining no less than a minimum amount of all listed nutrients.

Supplements

FDA does not require dietary supplement labels to include an expiration date, but manufacturers may include one provided the information is not misleading.

Cosmetics

Currently, federal law does not require cosmetic manufacturers to print expiration dates on the labels of cosmetic products. Manufacturers will often include a “period after opening” (PAO) symbol on the packaging to indicate how long a consumer should use the product, but this is voluntary.

Drugs

FDA requires drugs to bear a label that includes an expiration date on both the inner and outer package. The date must indicate 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; homeopathic drugs and those with no dosage limitations that are stable for at least three years are not required to bear an expiration date.

Drug manufacturers must determine a drug product’s expiration date through stability testing data that demonstrates the product meets applicable standards of strength, quality, and purity during the proposed time period and according to the proposed storage conditions.

Medical Devices

Generally, FDA does not require most medical devices to bear a label indicating an expiration date. If a certain component of a device is not useful past a certain date, FDA may require the label to indicate that date.

Both sterile and nonsterile in vitro diagnostic devices are required to include an expiration date or some other indication of the device’s quality at the time of use.

If a device’s label includes an expiration date, the manufacturer should conduct stability testing to determine the time period the device is fit for its intended use when stored according to the label’s instructions. The expiration date, date of manufacture, or any other date to get the user’s attention, must include the year, date, and month in the following format: yyyy-mm-dd.  For example, February 6, 2019, must appear on the label as 2019-02-06. A device may be exempt from this formatting regulation if it is a combination product that properly bears a National Drug Code (NDC) number or an electronic product for Radiological Health (which is subject to date of manufacture formatting regulations for electronic medical devices).

Get assistance with FDA compliance.

Registrar Corp’s Regulatory Specialists can help review your product’s label for FDA compliance.

For more information, call us at +1-757-224-0177, email us at info@registrarcorp.com, or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livechat.

Get Assistance

Author


Anna Benevente

Director of Labeling, Ingredient and Product Review

Highly regarded as a top expert on FDA labeling regulations, Anna Benevente continues to educate companies on existing regulations and updates from U.S. FDA for food and beverage, cosmetic, drug, and medical device products. She has researched thousands of products to determine whether they meet the FDA requirements for compliance. In addition, Ms. Benevente has conducted multiple seminars for trade and customs broker associations.

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