The packaging is not child resistant as required by the Poison Prevention Packaging Act. The pain and itch relief cream contains lidocaine, posing a risk of poisoning to young children.
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Children's products are subject to a set of federal safety rules, called children's product safety rules. Determining how your product is classified enables you to identify correctly the set of children’s product safety rules applicable to your product. The law defines a "children's product" as a consumer product designed or intended primarily for children 12 years of age or younger.
The Commission passed an interpretative rule with further explanation and examples. Additionally, this page offers a series of frequently asked questions (FAQs) that summarize the rule and provide examples of the differences between children’s products and general use products. The bottom half of these FAQs are devoted to certain product-specific examples on areas such as board games, jewelry, and science kits.
What is a Children's Product?
The law defines a "children's product" as a consumer product designed or intended primarily for children 12 years of age or younger. In determining whether a consumer product is primarily intended for a child 12 years of age or younger, the following factors will be considered:
- A statement by the manufacturer about the intended use of the product, including a label on the product, if such statement is reasonable.
- Whether the product is represented in its packaging, display, promotion, or advertising as appropriate for use by children 12 years of age or younger.
- Whether the product is commonly recognized by consumers as being intended for use by a child 12 years of age or younger.
- The Age Determination Guidelines (pdf) issued by the Commission staff in September 2002, and any successor to such guidelines.
You can find the law in section 108(e) of the Consumer Product Safety Improvement Act of 2008 (CPSIA) (Public Law 110-314), and you can find the Commission's interpretative regulation at 16 CFR part 1200 (pdf).
What is a "General Use Product"?
General use products are consumer products that are not designed or intended primarily for use by children 12 years of age or younger.
Some products may be designed or intended for use by consumers of all ages, including children 12 years old or younger. Such products would be considered "general use products."
If a consumer older than 12 years of age is as likely, or more likely, to interact with a product than a child 12 years of age or younger, then the product would probably be considered a general use product, depending upon how the product is viewed, using all of the four factors above. Products used by children 12 years of age or younger that have a declining appeal for teenagers are likely to be considered children's products.
Why is this important?
Determining how your product is classified enables you to identify correctly the set of consumer product safety standards applicable to your product.
Children's products are required to undergo third party testing and to have a written Children's Product Certificate (CPC) demonstrating compliance. Here is the full list of rules requiring the issuance of a CPC.
Certain general use products subject to mandatory consumer product safety rules are required to undergo testing or be subjected to a reasonable testing program and have a written General Certificate of Conformity (GCC) demonstrating compliance. Here is the full list of rules requiring the issuance of a GCC.
Do you have an example to help explain the difference between general use and children’s products?
Yes. The Commission has provided the example of a pen as a product that is usually intended for consumers older than 12 years of age. Therefore, a pen is generally considered a general use product, even though children 12 years of age or younger may write with the same pen. However, if the same pen is decorated or embellished with certain features that might appeal to a child, such as childish themes or features with play value, then the pen may be considered, but would not necessarily be deemed, a children's product.
Further evaluation would be required, and other factors, such as whether the physical characteristics of the pen (e.g., size and color) and the likelihood that any additional decorations or novelty items associated with the pen would be equally appealing to consumers younger than and older than 12 years of age would be evaluated to determine whether the product was likely designed and intended primarily for children.
For example, a simple ball point pen bearing an elementary school's name, without any other decorations, is likely to appeal to anyone (i.e., students, teachers, parents) associated with the school. A pen with a silly head on the top, not associated with any particular mass media (and not sold in toy stores), may have just as much appeal to adults as children. Pens with puzzle features that allow the user to take them apart and reconfigure the design also are likely to appeal to children and adults alike, but would not likely be considered children's products because they are not primarily intended for children. An expensive gold pen may be used mainly by adults even if it is embellished with a character themed emblem traditionally associated with childhood.
Additional product-specific examples are provided in the interpretative rule and discussed further below.
Products that specifically are not intended for children 12 years of age or younger, for example cigarette lighters, candles, fireworks, and products with child-resistant packaging, are not considered children's products.
Can I simply label my product to ensure that it is not considered a children's product?
No. The Commission will certainly consider any label on the product and what it says about the age of the intended user but such a label is but only one of the factors we will consider. Any label on a product must be reasonably consistent with the expected use patterns for that product.
What if my product can be used by children 12 years of age or younger, but the product is not necessarily designed or intended primarily for that age group?
Your product may be a general use product if it is not designed or intended primarily for children 12 years of age or younger. (The Commission considers inclusion of the word primarily in the law to be important and helpful in distinguishing a "general use product" from a "children's product.")
When a child touches or interacts with a product, such as an adult stereo or a television, the product is still considered a general use product because it was not intended primarily for children 12 years of age or younger.
What if I state that my product is intended for consumers age 9 and up-does that automatically make my product a children's product?
No. Children between 9 and 12 years of age have advanced cognitive and motor skills and a greater ability to care for their belongings. Certain products for children of this age may also be suitable, equally likely, or more likely to be as appealing to consumers age 12 and up. Certain products that meet these criteria, depending on the facts and circumstances, may be treated as general use products. Some examples are provided in the Product-Specific FAQs below.
What exactly about the product's packaging, display, promotion, or advertising will be considered by the Commission?
The types of product representations can be expressed (such as product advertising declaring that the product is for use by children 12 years of age or younger) or implied (such as product advertising showing the product being used by young children). These representations may be found in packaging, text, illustrations, or photographs depicting consumers using the product, instructions, assembly manuals, or advertising media used to market the product.
The prominence, conspicuousness, or other emphasis given to each portrayal of a product's uses or intended users on packaging or in advertising media can be weighted differently according to which images or messages are the strongest and most obvious to the consumer at the point of purchase. For example, labeling in large, high contrast letters on the front of a package sends a stronger message than block letters in a small box on the package's side panel.
The Commission may also consider the kind of store (e.g., toy goods or sporting goods) and the in-store physical shelf location, if known, in determining whether a product is designed or primarily intended for children 12 years of age or younger. This analysis is not store-by-store, but it is conducted as a general market analysis.
Who determines whether the product is a children's product or a general use product?
The Commission decides whether a product is a children's product. The manufacturer, however, has a significant amount of control, through its design, packaging, representations, marketing, and advertising, in influencing how a product would likely be evaluated using the four factors (see the first question above). People who are unsure whether a product is a children's product are urged to err on the side of caution and ensure that the product meets all applicable children's product safety rules. In uncertain situations, you may also contact the Commission's Office of Compliance for a staff ruling on how a product would likely be classified. However, manufacturers should be cautioned that the Commission, as a quasi-judicial body, always retains the power to supersede any staff determination at any time.
In making a determination, the Commission will consider the manufacturer's statement of intended use and will also consider the product's reasonably foreseeable use. A manufacturer is expected to know its product and what a child using the product might reasonably be expected to do with the product.
Are there common elements to the four factors set forth above?
Yes. For example, decorations with childish themes that invite the use of the product by children 12 years of age or younger may cut across all four factors. The embellishments and decorations, depending on individual circumstances, may be enough to "transform" what would otherwise be a general use product into a children's product.
Additional elements include:
-Small sizing of a product that would make the product uncomfortable for average adults;
-Exaggerated features (large buttons, bright indicators) that simplify the product's use;
-Safety features that are not found on similar products intended for adults;
-Colors commonly associated with childhood (pinks, blues, bright primary colors);
-Decorative motifs commonly associated with childhood (such as animals, insects, small vehicles, alphabets, dolls, clowns, and puppets);
-Features, like cartoons, which do not necessarily enhance the product's utility but contribute to its attractiveness to children 12 years of age or younger; and
-Play value (i.e., features primarily attractive to children 12 years of age or younger that promote interactive exploration and imagination for fanciful purposes, including whimsical activities lacking utility for accomplishing mundane tasks; actions performed for entertainment and amusement).
The more characteristics of this type that a product has, the greater the likelihood exists that the product may be considered to be a children's product.
Is a children's product necessarily something that the child uses"?
Generally, yes. The Commission's policy is that a children's product is something "for use" by a child. For example, a toy, a potty seat, an article of clothing, and a backpack are all items that a child "uses" and that would likely be considered children's products, if the product met the four criteria above. In the case of the article of clothing and the backpack, the sizing of the product and the themes and decorations depicted on the products would likely play a part in determining whether the product is a children's product.
However, certain children's products may not necessarily require direct physical interaction to be considered a children's product. For example, products such as infant mobiles, lamps, clocks, and rugs with nursery themes that are designed for children's rooms and that have features designed to appeal to children and that may entice or invite children to use them or physically interact with them, could lead to a determination that a product is a children's product. Consideration of the other four factors must be undertaken as well. A complete analysis of the individual product would be required.
Does a children's product include products that are intended to be used "with" children?
The Commission has clarified that products, such as diaper bags, that are intended to be used with children by the parent or caregiver, are general use products and are not considered children's products. A children's product is one that is intended for use by children. In this example, the diaper itself would be considered a children's product, whereas the diaper bag would not. Products that are for use by children are those with which they will interact or have direct physical contact, such as the diaper itself.
Is "size" a factor in determining whether a product is a children's product?
Yes, size is often one of many factors used in determining whether product is a children's product.
Size is particularly relevant in certain product areas, such as sporting equipment, musical instruments, and science equipment, for which children 12 years of age or younger may often use equipment sized for people of all ages. The use of the equipment sized for people of all ages by children 12 years of age or younger does not convert that equipment into a children's product, even in situations where the equipment is specifically marketed or rented to schools and other educational settings for marching bands, science labs, and sporting events.
However, beyond the educational environment, youth-size musical instruments, science equipment, and sporting equipment may lead to a determination that the subject product be considered as a children's product, if it satisfies the other four factors.
Is "cost" a factor in determining whether a product is a children's product?
Cost may be a factor if the product is very expensive and is unlikely to be provided to a child. However, there is no specific rule on cost, and each case is examined on its own facts.
Adult collectibles, which are distinguished by their relatively high cost, limited production, intricate detail, fragility, and often, placement in a display case, can be distinguished from children's collectibles. Certain model trains that meet the criteria just described are one example of an adult collectible, on which the Commission provided guidance. At the same time, some collectibles are not necessarily high cost items and cost will remain one of several factors the Commission will use to make its determinations.
How do you know whether a product is commonly recognized by consumers as being primarily intended for a child?
To assess whether a product is commonly recognized by consumers as being primarily intended for a child, a manufacturer should evaluate the reasonably foreseeable uses of a product to determine how the product will be perceived and used by consumers of that product. Manufacturers could also refer to sales data, market analyses, focus groups, or other marketing studies for their analyses of consumer perceptions of their products.
I don't make toys. Do the Age Determination Guidelines (pdf) still apply in determining whether my product is a children's product?
Yes, the Age Determination Guidelines (pdf) issued by Commission staff in September 2002, were mandated by Congress as one of the four factors for use in determining whether a consumer product is primarily intended for a child 12 years of age or younger.
Age grading is an important task for manufacturers to undertake in order to ensure that their products are safe and developmentally appropriate for the targeted audience. The Guidelines generally describe the characteristics that appeal to children and the activities they are able to perform throughout childhood. Thus, the Guidelines can be used to make age determinations of any product, whether it is a toy or another article intended for use by children. The Guidelines provide information about social, emotional, cognitive, and physical development during childhood, and about specific product categories. This information also applies to many products that are not specifically mentioned in the Guidelines.
Are home furnishings and fixtures considered children's products?
Home furnishings and fixtures, like children's furniture sets or children's beanbags, which are designed or intended primarily for children 12 years of age or younger, are decorated or embellished with childish themes, are sized for children, have play value, or are marketed to appeal primarily to children, are considered children's products.
However, most home furnishings and fixtures are usually not considered children's products, unless they meet the criteria above. Some examples of general use products in this category-even when these items are found in children's rooms or schools-include: rocking chairs, shelving units, televisions, digital music players, ceiling fans, humidifiers, air purifiers, window curtains, tissue boxes, clothing hooks and racks. This also applies to most seasonal decorations, even if those decorations may appeal to children.
Does the Commission distinguish between adult jewelry and jewelry intended for a child 12 years of age or younger?
Yes. Jewelry intended for children is sized, themed, and marketed for children. Other factors to consider include: cost, play value, marketing, packaging, promotion, appearance (color, texture, material, and the level of realism), and dexterity required for wearing. Moreover, Commission staff also distinguishes between children's jewelry and toy jewelry using the factors described above. Toy jewelry would be subject to the federal toy safety standard in addition to the requirements for children's products.
Although certain characteristics of adult jewelry may be attractive to children, the level of attraction alone does not transform a piece of general use, adult jewelry into children's jewelry.
Are board games considered children's products?
The Commission has determined that traditional board and table games, like chess, checkers, backgammon, playing cards, or Chinese checkers are commonly recognized as equally attractive to children and adults because the level of difficulty increases or decreases, depending on the player's skill. Versions of these games, and similar games commonly considered by consumers to appeal to a general audience, are not considered children's products.
However, if a manufacturer adds features to the game or its packaging that make it more attractive to or suitable for children, then the game could be considered a children's product rather than a general use product. Specifically, where a product, such as a board game, exists in junior and regular versions, the junior version likely would be considered a children's product, and the regular version would not. For games with small parts, sharp points and edges, and other similar characteristics for children ages less than 9 years old then the game should be considered a children's product. For games intended for an audience of 9-year-olds and older, please see the prior question on products for children ages 9 to 12 years old.
Are CDs and DVDs considered children's products?
Generally, CDs and DVDs designed or intended primarily for use by consumers older than 12 years of age are considered general use products.
CDs and DVDs could be considered children's products if applying the four statutory factors leads to such a determination. However, the Commission also recognizes that many CDs and DVDs will be considered general use products even if children 12 years of age or younger find them appealing.
Are media players and electronic devices considered children's products?
Generally, no. However, such players or devices could be considered children's products if they are embellished or decorated with childish themes, are sized for children, or are marketed to appeal primarily to children.
What about science kits or other "kits" designed and primarily intended for children 12 years of age or younger-are they considered "children's products"?
Using the four-factor analysis set forth above, if it is determined that the "kits" are designed and primarily intended for children 12 years of age or younger, then all elements included in the kit are considered "children's products," and they must comply with the standards. For example, a paper clip, ordinarily a general use item, included in a "magnet kit," would be considered a children's product when it is part of the kit. When manufacturers use component parts or materials not otherwise intended for children and they repurpose those parts or materials as components in their children's products, those manufacturers become responsible for ensuring compliance with children's product safety standards.
Are art materials and craft kits considered "children's products"?
Art materials, including art and craft kits, sized, decorated, and marketed to children 12 years of age or younger, such as crayons, finger paints, and modeling clay, would be considered children's products.
Crafting kits and supplies that are not specifically marketed to children 12 years of age or younger likely would be considered products intended for general use.
(All art materials, whether or not designed or intended primarily for children, must comply with the Labeling of Hazardous Art Materials Act (LHAMA), codified at 16 CFR § 1500.14(b)(8), which requires that art materials be properly labeled if they may present a chronic adverse health effect.
Please see our art materials guidance page here: www.cpsc.gov/artmaterials.
Are books and magazines considered "children's products"?
The same principles that apply to art materials and crafts apply to books and magazines. The age guidelines provided by librarians, education professionals, and publishers are helpful for this particular class of products.
Can multiple products packaged together contain a general use product and a children's product?
Yes. The Commission provides the example of a stuffed animal packaged with a candle. While the candle is not a children's product, the stuffed animal might be considered a children's product because the manufacturer should expect that the recipient will likely provide the stuffed animal to a child and use the candle themselves.
This communication has been prepared for general informational purposes only and is based upon the facts and information presented. This communication does not, and is not intended to, constitute legal advice and has not been reviewed or approved by the Commission, and does not necessarily represent their views. Any views expressed in this communication may be changed or superseded by the Commission.
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