Product Warning Labeling Requirements in the United States

Warning labels are mandatory for a wide range of products sold in the United States. This guide provides an overview of several warning labeling requirements applicable to consumer products, chemicals, and packaging materials.

Which products require warnings in the US?

Various regulations set warning labeling requirements for products sold in the United States. Some warning labelling requirements can be found in regulation texts, while others are contained in ASTM or UL standards which are incorporated by reference.

The following checklist can serve as a useful methodology for assessing of your products require warning labels:

✅ Identify relevant product regulations (US federal and US state legislation)

✅ Is your product subject to children’s product safety rules?

✅ Is your product subject to general use product safety rules?

✅ Do these contain warning labeling requirements?

✅ Are any ASTM or UL standards incorporated by reference?

✅ Can you find any waring labeling requirements in the relevant standards?

✅ Are you selling products in California?

California Proposition 65 set warning labeling requirements for products that may contain substances

✅ Are you selling in any US state which mandate bag suffocation warning labels?

Examples can be found below:

• California
• New York
• Massachusetts
• Virginia
• Rhode Island

Note that warning labels are intended to inform consumers of product safety hazards that cannot be entirely eliminated by implementing applicable regulatory requirements and safety standards. Warning labels are not an acceptable substitute for ensuring that your product is fundamentally safe.

Further, warning labels should not contradict the intended use of the product.

Toys and children’s products

Toys and other children’s products are subject to various children’s product safety rules mandating warning labels. These include small part warnings and other product-specific warnings.

ASTM F963-23

16 CFR part 1250 applies to toys and mandates compliance with ASTM F963-23. This standard, in turn, contains graphical and written warnings for particular types of toys and associated risks.

Note: Additional product safety standards incorporated by reference also contain warning labels.

Small parts

16 CFR Part 1500.19 contains several warnings applicable to small parts for various types of toys. Examples of warnings can be found below:

Warning	Required for
	Toys and games that contain small parts (unless exempted in 16 CFR Part 1500.19)
	Latex balloons Toys and games that contain a latex balloon
	Small ball intended for children three years of age or older
	Toys and games intended for children who are at least three years old but less than eight years of age that contain a small ball
	Marbles intended for children three years of age or older
	Toys and games intended for children who are at least three years old but less than eight years of age that contain a marble

Product hazards

Certain children’s product safety rules set warnings relevant to specific product types. For example,16 CFR Part 1241- Safety Standard for Crib Mattresses contains various warning labels for crib mattresses. An example can be found below:

Learn more

Small Parts Regulations and Warnings in the United States: An Overview

Warning Labeling Requirements for Children’s Products in the United States

General-use products

Products covered by general use product safety rules are also subject to warning labeling requirements. Note that many of the rules are the same as those applicable to children’s products. The difference is that general-use products are defined as non-children’s products.

Examples of such warning labels can be found in the table below.

Warning	Product safety rule
	Part 1263 – Safety Standard for Button Cell or Coin Batteries and Consumer Products Containing Such Batteries
WARNING: This mattress set may be subject to a large fire if exposed to an open flame. It was manufactured in accordance with a physician’s prescription and has not been tested under the Federal Standard for the Flammability (Open-Flame) of Mattress Sets (16 CFR part 1633).	Part 1633 – Standard for the Flammability (Open Flame) of Mattress Sets
	Part 1213 – Safety Standard for Entrapment Hazards in Bunk Beds
WARNING: Contains Lead. Dried Film of This Paint May Be Harmful If Eaten or Chewed	Part 1303 – Ban of Lead-Containing Paint and Certain Consumer Products Bearing Lead-Containing Paint
WARNING: To reduce the risk of injury to persons—Only enable [+] feature when installed with sectional door.”, where + is the unattended operation closing function, or “WARNING: To reduce the risk of injury to persons—Do not use this device with one-piece doors or swinging doors.	Part 1211 – Safety Standard for Automatic Residential Garage Door Operators
	Part 1205 – Safety Standard for Walk-Behind Power Lawn Mowers

Learn more

Which Products Require a General Certificate of Conformity (GCC)?

California Proposition 65 warnings

A California Proposition 65 warning is necessary when you believe or are aware that your products may expose consumers to any of the listed chemicals. Testing is generally necessary to ensure that your product do not need a warning.

Even though there are different types of warnings, all warnings should include:

• The warning symbol (yellow triangle with exclamation mark)
• A signal word (e.g. “WARNING:”)
• Warning content

You find a list of warnings in the guidance page “Sample Warnings and Translations For Businesses” published on www.p65warnings.ca.gov.

Here are some examples of warning contents, taken from the above page:

Warning type	Warning content
Consumer Product Exposure Warnings: For listed carcinogens	This product can expose you to [name of chemical], which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.
Consumer Product Exposure Warnings: For listed reproductive toxicants	This product can expose you to [name of chemical], which is known to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.
Consumer Product Exposure Warnings: For exposures to listed carcinogens AND reproductive toxicants	This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause cancer, and [name of one or more chemicals], which is [are] known to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.

Learn more

California Proposition 65 Guide for US Importers & Amazon Sellers

Bag Suffocation Hazards

Several US states mandate bag suffocation warnings on polybags. These must generally be printed on the bag and meet certain requirements concerning size and placement.

Here is an overview of some of the US states which mandate bag suffocation warnings:

• California
• New York
• Massachusetts
• Virginia
• Rhode Island

Note that Amazon also requires that companies selling in the United States use plastic bags with bag suffocation warnings.

Learn more

Bag Suffocation Warning: US State & Amazon Seller Requirements

Warning placements

Warning labels are often affixed to the product, packaging, and printed instruction booklets. Note that certain regulations set specific requirements for both placement and the methods that must be used to affix warning labels.

For example, 16 CFR Part 221 sets the following warning labeling placement requirements for sling carriers:

5.7.3 Warning labels that are attached to the fabric with seams shall remain in contact with the fabric around the entire perimeter of the label, when the sling is in all manufacturer recommended use positions.

FAQ

Do ASTM standards set warning requirements?

Yes, many ASTM standards contain both graphical and written warning labels. ASTM standards incorporated by reference are mandatory, which means that compliance with any warning labeling requirements is also mandatory.

Do UL standards set warning requirements?

Yes, warning labels can be found in various UL standards, such as UL 4200A. As mentioned, warning labels contained in standards that are incorporated by reference are mandatory.

Can we use warnings if our product does not meet US standards?

No, warning labels are not meant to serve as shortcuts enabling companies to sell products that fail to meet mandatory safety standards. If anything, warning labels fill the safety gaps that cannot be entirely avoided.