Regulations last checked for updates: Apr 27, 2025

Title 16 - Commercial Practices last revised: Apr 23, 2025
§ 1242.1 - Scope, purpose, application, and exemptions.

(a) Scope and purpose. This part, a consumer product safety standard, prescribes requirements intended to reduce the risk of death and injury from hazards associated with nursing pillows, as defined in § 1242.2.

(b) Application. Except as provided in paragraph (c) of this section, all nursing pillows that are manufactured after April 23, 2025, are subject to the requirements of this part.

(c) Exemptions. The following products are exempt from this part:

(1) Maternity pillows, as defined in § 1242.2,

(2) Sling carriers, as defined in 16 CFR part 1228, and

(3) Soft infant and toddler carriers, as defined in 16 CFR part 1226.

§ 1242.2 - Definitions.

Caregiver attachment means a portion of the product that is not an infant support surface and is intended to secure the nursing pillow to the caregiver. A caregiver attachment may comprise components including, but not limited to, straps, buckles, or latches.

Caregiver opening means the surface of the nursing pillow, excluding the caregiver attachment, intended to fit against the caregiver's torso during use. This surface is typically, but not necessarily, crescent-like in shape.

Conspicuous means visible to the caregiver while placing the product in the manufacturer's recommended use position on or against the caregiver's body.

Infant restraint system means a portion of a product intended to secure or hold an infant in place on the product. These typically take the form of straps or harnesses that are secured by the caregiver.

Infant support surface means the manufacturer's intended support surface for the infant during nursing or feeding.

Maternity pillow, also known as a pregnancy pillow, means a large body pillow intended, marketed, and designed to provide support to a pregnant adult's body during sleep or while lying down.

Nursing pillow means any product intended, marketed, or designed to position and support an infant close to a caregiver's body while breastfeeding or bottle feeding, including any removable covers, or slipcovers, sold on or together with such a product. These products rest upon, wrap around, or are worn by a caregiver in a seated or reclined position.

Safety alert symbol means a symbol consisting of an exclamation mark surrounded by an equilateral triangle, or an equilateral triangle with a contrasting superimposed exclamation mark. The safety alert symbol precedes the signal word “WARNING,” or other signal word, in the signal word panel of a warning.

§ 1242.3 - General requirements.

(a) Lead in paints. All paint and surface coatings on the product shall comply with the requirements of 16 CFR part 1303.

(b) Small parts. There shall be no small parts, as determined by 16 CFR part 1501, before testing or liberated as a result of testing.

(c) Hazardous sharp edges or points. There shall be no hazardous sharp points or edges, as determined by 16 CFR 1500.48 and 1500.49, before or after testing.

(d) Removal of components. When tested in accordance with § 1242.5(b), any removal of components that are accessible to an infant while in the product or from any position around the product shall not present a small part, sharp point, or sharp edge as required in paragraphs (b) and (c) of this section.

(e) Permanency of labels and warnings. (1) Warning labels (whether paper or non-paper) shall be permanent when tested in accordance with § 1242.5(c)(1) through (3).

(2) Warning statements applied directly onto the surface of the product by hot stamping, heat transfer, printing, wood burning, etc. shall be permanent when tested in accordance with § 1242.5(c)(4).

(3) Non-paper labels shall not liberate small parts when tested in accordance with § 1242.5(c)(5).

(4) Warning labels that are attached to the fabric of nursing pillows with seams shall remain in contact with the fabric around the entire perimeter of the label, when the product is in all manufacturer-recommended use positions, when tested in accordance with § 1242.5(c)(3).

§ 1242.4 - Performance requirements.

(a) Firmness. When tested in accordance with § 1242.5(d), (e) and (f), the force required for a 1.00-in. (2.54 cm) displacement of the 3-inch (76.2 mm) diameter hemispheric probe (figure 1 to this paragraph (a)—3-in. head probe) at any measurement location shall be greater than 10.0 N (2.24 lb).

Figure 1 to Paragraph (a)—3-in Head Probe

(b) Infant containment. When tested in accordance with § 1242.5(g), the surfaces within the caregiver opening of the product shall not contact the 9-inch (230 mm) diameter head probe (figure 2 to this paragraph (b)—9-in. head probe) such that the probe is constrained within the caregiver opening and, when placed according to § 1242.5(g)(6), the probe must extend past the caregiver opening.

Figure 2 to Paragraph (b)—9-in. Head Probe

(c) Infant restraints. Nursing pillows shall not include any infant restraint system.

(d) Seam strength. When tested in accordance with § 1242.5(h), fabric/mesh seams and points of attachment shall not fail such that a small part, sharp point, or sharp edge is presented, as required in § 1242.3(b) and (c).

(e) Caregiver attachment strength. When tested in accordance with § 1242.5(i), material seams, points of attachment, and attachment components shall not fail, and shall create no hazardous conditions, such as small parts or sharp edges, as required in § 1242.3(b) and (c).

§ 1242.5 - Test methods.

(a) Test conditions. (1) Condition the product for 48 hours at 23 °C ±2 °C (73.4 °F ±3.6 °F) and a relative humidity of 50% ±5%.

(2) Secure the firmness fixture to a test base such that the 3-in. head probe (figure 1 to § 1242.4(a)) does not deflect more than 0.01 in. (0.025 cm) under a 10 N (2.2 lb) load applied in each orientation required in the test methods.

(b) Removal of components test method—(1) Equipment. For torque and tension tests, any suitable device may be used to grasp the component, provided that it does not interfere with the attachment elements that are stressed during the tests.

(2) Torque test. Gradually apply a 4 lb-in. (0.4 N-m) torque over 5 seconds (s.) in a clockwise rotation to 180 degrees or until 4 lb-in. has been reached. Maintain for 10 s. Release and allow component to return to relaxed state. Repeat the torque test in a counterclockwise rotation.

(3) Tension test. For components that can reasonably be grasped between thumb and forefinger, or teeth, apply a 15 lb (67 N) force over 5 s., in a direction to remove the component. Maintain for 10 s. A clamp such as shown in figure 1 to this paragraph (b)(3) may be used if the gap between the back of the component and the base material is 0.04 in. (0.1 cm) or more.

Figure 1 to Paragraph (b)(3)—Tension Test Adapter Clamp

(c)Permanency of labels and warnings. (1) A paper label (excluding labels attached by a seam) shall be considered permanent if, during an attempt to remove it without the aid of tools or solvents, it cannot be removed, it tears into pieces upon removal, or such action damages the surface to which it is attached.

(2) A non-paper label (excluding labels attached by a seam) shall be considered permanent if, during an attempt to remove it without the aid of tools or solvents, it cannot be removed or such action damages the surface to which it is attached.

(3) A warning label attached by a seam shall be considered permanent if it does not detach when subjected to a 15-lbf (67-N) pull force applied in the direction most likely to cause failure using a 3/4-in. (1.9 cm) diameter clamp surface. Gradually apply the force within a period of 5 s. and maintain for an additional 10 s.

(4) Adhesion Test for Warnings Applied Directly onto the Surface of the Product:

(i) Apply the tape test defined in Test Method B of ASTM D3359-23 (incorporated by reference, see § 1242.8), eliminating parallel cuts.

(ii) Perform this test once in each different location where warnings are applied.

(iii) The warning statements will be considered permanent if the printing in the area tested is still legible and attached after being subjected to this test.

(5) A non-paper label, during an attempt to remove it without the aid of tools or solvents, shall not fit entirely within the small parts cylinder defined in 16 CFR part 1501 if it can be removed.

(d) Infant support surface firmness test method. Perform the following steps to determine the infant support surface firmness of the product as received from the manufacturer.

(1) Conduct tests at three locations on the surface to be tested, with 3 in. (7.62 cm) or more separation: maximum thickness perpendicular to the test surface and two other locations most likely to fail. When selecting these locations, the edge of the probe shall not extend beyond the edge of the product. If the design or size of the product is such that the edge of the probe must extend beyond the edge of the product, the probe shall be centered over as much of the test surface as possible.

(2) Lay the product, with the infant support surface facing up, on a test base that is horizontal, flat, firm, and smooth.

(3) Prevent movement of the product in a manner that does not affect the force or deflection measurement of the product surface under test. Provide no additional support beneath the product.

(4) Orient the axis of the 3-in. head probe (figure 1 to § 1242.4(a)) perpendicular to the test surface and aligned with a force gauge and parallel to a distance measurement device or gauge. Zero the force gauge.

(5) Using a lead screw or similar device to control movement along a single direction, advance the probe onto the product and set the deflection to 0.0 in. when a force of 0.1 N (0.02 lb) is reached.

(6) Continue to advance the head probe into the product at a rate not to exceed 0.1 inch per second and pause when the force exceeds 10.0 N (2.24 lb), or the deflection is equal to 1.00 in. (2.54 cm).

(7) Monitor the force and wait for it to stabilize, meaning the force has not changed more than 0.1 N (0.02 lb) for at least 30 s. If, after the force stabilizes, the deflection is less than 1.00 in. and the force is 10.0 N or less, repeat paragraphs (d)(6) and (7) of this section.

(8) Record the final force and deflection amounts.

(9) Repeat the infant support surface firmness tests on any other infant support surface and in all manufacturer-intended configurations that could affect the infant support surface, such as the folding or layering of parts of the product.

(e) Inner wall firmness test method. For nursing pillows with a caregiver opening, perform the steps in paragraphs (d)(1) through (8) of this section on the inner wall of the caregiver opening, and perform the following, to determine the inner wall firmness as received from the manufacturer. Repeat the inner wall firmness tests in all manufacturer-intended configurations that could affect the inner wall firmness.

(f) Product conditioning firmness test method. Following the firmness testing in paragraphs (d) and (e) of this section, perform the following steps to determine the product firmness after conditioning.

(1) Launder and dry the product according to the manufacturer's instructions.

(2) Repeat paragraph (d) of this section.

(3) Repeat paragraph (e) of this section.

(g) Infant containment test method. (1) Lay the product, with the infant support surface facing up, on a test base that is horizontal, flat, firm, and smooth.

(2) For nursing pillows with a caregiver attachment, unsecure and move the caregiver attachment away from the caregiver opening.

(3) Place the 9-in. head probe (figure 2 to § 1242.4(b)) inside the caregiver opening such that the flat bottom of the probe rests on the test surface and the probe's perimeter contacts the innermost surface of the caregiver opening.

(4) If the inner wall of the caregiver opening contacts the outwardly facing portions of the probe, or the inner wall interferes with placing the probe down, the caregiver opening is considered to constrain the probe. See figure 2 to this paragraph (g)(4). Do not include in the assessment any contact with a caregiver attachment.

Figure 2 to Paragraph (g)(4)—Infant Containment, Example

(5) With the probe at the position contacting the innermost surface within the caregiver opening, determine if any portion of the probe extends beyond a line projected across the outside limits of the caregiver opening.

(6) Slide the probe horizontally out of the caregiver opening to the outside of the nursing pillow. Determine if the probe is constrained by the inner wall of the caregiver opening contacting the outwardly facing portions of the probe. See figure 2 to paragraph (g)(4) of this section. Do not include in the assessment any contact with a caregiver attachment.

(7) For nursing pillows with a caregiver attachment, adjust and secure the caregiver attachment to the minimum length allowed by the product and repeat paragraphs (g)(3) through (g)(5).

(h) Seam strength test method. (1) Equipment shall include clamps with 0.75 in. (1.9 cm) diameter clamping surfaces capable of holding fabric and with a means to attach a force gauge. Figure 3 to this paragraph (h)(1), or equivalent. The force gauge must have an accuracy of ±0.5 lb (2.2 N).

Figure 3 to Paragraph (h)(1)—Seam Clamp

(2) Clamp the fabric of the nursing pillow on each side of the seam under test with the 0.75 in. clamping surfaces placed not less than 0.5 in. (1.2 cm) from the seam.

(3) Apply a tension of 15 lb (67 N) evenly over 5 s. and maintain for an additional 10 s.

(4) Repeat the test on every distinct seam and every 6 in. (15 cm) along each seam.

(i) Caregiver attachment strength test method. (1) Any suitable clamping devices with means to attach a force gauge with accuracy of 0.5 lb (1.2 N) may be used. The clamping surfaces shall grasp across the entire width of the strap or attachment element.

(2) Support the nursing pillow to resist the pull forces and release the buckle, clasp, or other fastener of the caregiver attachment.

(3) Clamp one side of the attachment or strap of the nursing pillow not less than 0.5 in. (1.2 cm) from the attachment to the nursing pillow.

(4) Apply a tension of 20 lb (89 N) evenly over 5 s. and maintain for an additional 10 s.

(5) Repeat the test on the other side of the attachment or strap.

(6) Join the buckle, clasp, or other fastener of the attachment or straps.

(7) Clamp both sides of the attachment or straps across the buckle, clasp, or other fastener, one on each side and not less than 0.5 in. (1.2 cm) from the fastener.

(8) Apply a tension of 20 lb (89 N) evenly over 5 s. and maintain for an additional 10 s.

§ 1242.6 - Marking and labeling.

(a) Each product and its retail package shall be marked or labeled clearly and legibly to indicate the following:

(1) The name, place of business (city, state, and mailing address, including zip code), and telephone number of the manufacturer, distributor, or seller.

(2) A code mark or other means that identifies the date (month and year as a minimum) of manufacture.

(3) The marking or labeling in paragraphs (a)(1) and (2) of this section are not required on the retail package if they are on the product and are visible in their entirety through the retail package. When no retail packaging is used to enclose the product, the information provided on the product shall be used for determining compliance paragraphs (a)(1) and (2). Cartons and other materials used exclusively for shipping the product are not considered retail packaging.

(b) The marking and labeling on the product shall be permanent.

(c) Any upholstery labeling required by law shall not be used to meet the requirements of this section.

(d) Warning design for product:

(1) The warnings shall be easy to read and understand and be in the English language at a minimum.

(2) Any marking or labeling provided in addition to those required by this section shall not contradict or confuse the meaning of the required information or be otherwise misleading to the consumer.

(3) The warnings shall be conspicuous and permanent.

(4) The warnings shall conform to sections 6.1 through 6.4, 7.2 through 7.63, and 8.1 of ANSI Z535.4-2011, (incorporated by reference, see § 1242.8), with the following changes.

(i) In sections 6.2.2, 7.3, 7.5, and 8.1.2, replace “should” with “shall.”

(ii) In section 7.6.3, replace “should (when feasible)” with “shall.”

(iii) Strike the word “safety” when used immediately before a color (for example, replace “safety white” with “white”).

Note 1 to paragraph (d)(4).

For reference, ANSI Z535.1, American National Standard for Safety Colors, provides a system for specifying safety colors. See note 1 to § 1242.8(b) for ANSI contact information.

(5) The safety alert symbol and the signal word “WARNING” shall be at least 0.2 in. (5 mm) high. The remainder of the text shall be in characters whose upper case shall be at least 0.1 in. (2.5 mm), except where otherwise specified.

Note 2 to paragraph (d)(5).

For improved warning readability, avoid typefaces with large height-to-width ratios, which are commonly identified as “condensed,” “compressed,” “narrow,” or similar.

(6) The message panel shall meet the following text layout requirements.

(i) The text shall be left-aligned, ragged-right for all but one-line text messages, which can be left-aligned or centered.

Note 3 to paragraph (d)(6)(i).

Left-aligned means that the text is aligned along the left margin, and in the case of multiple columns of text, along the left side of each individual column. See figure 1 to this paragraph (d)(6)(i) for examples of left-aligned text.

Figure 1 to Paragraph (d)(6)(i)—Examples of Left-Aligned Text Note 4 to figure 1 to paragraph (d)(6)(i).

The text shown for these warnings is filler text, known as lorem ipsum, commonly used to demonstrate graphic elements.

(ii) The text in each column should be arranged in list or outline format, with precautionary (hazard avoidance) statements preceded by bullet points. Multiple precautionary statements shall be separated by bullet points if paragraph formatting is used.

(7) An example warning in the format described in this section is shown in figure 2 to this paragraph (d)(7).

Figure 2 to Paragraph (d)(7)—Example of Warning

(e) Warning statements. Each product shall have warning statements. The text must address the warnings as shown in figure 2 to paragraph (d)(7) of this section.

Note 5 to paragraph (e).

“Address” means that verbiage other than what is shown can be used as long as the meaning is the same or information that is product-specific is presented.

(f) Package warnings. (1) The warnings and statements are not required on the retail package if they are on the product and are visible in their entirety through the retail package. Cartons and other materials used exclusively for shipping the product are not considered retail packaging.

(2) Each product's package shall have warning statements to address the following, at a minimum, as specified in paragraphs (d)(1) and (2) and (4) through (6) of this section:

(i) Do not use for sleep.

(ii) Do not use in sleep products like cribs, bassinets, or play yards.

(3) Each product's retail package shall address the manufacturer's recommended weight, height, age, or developmental stage or combination thereof of the infant.

(4) Warnings, statements, or graphic pictorials on the product and package shall not indicate or imply that the infant may be left in the product without an adult caregiver in attendance.

§ 1242.7 - Instructional literature.

(a) Instructions shall be provided with the product and shall be easy to read and understand and shall be in the English language at a minimum. These instructions shall include information on assembly, maintenance, cleaning, and use, where applicable.

(b) The instructions shall include all warnings specified in § 1242.6(e).

(c) The instructions shall address the following additional warnings:

(1) Read all instructions before using this product.

(2) Keep instructions for future use.

(3) Do not use this product if it is damaged or broken.

(4) Instructions shall indicate the manufacturer's recommended maximum weight, height, age, developmental level, or combination thereof, of the infant for whom the nursing pillow is intended. If this product is not intended for use by a child for a specific reason, the instructions shall so state this limitation.

(d) The cautions and warnings in the instructions shall meet the requirements specified in § 1242.6(d)(4) through (6) of this section, except that sections 6.4 and 7.2 through 7.6.3 of ANSI Z535.4—2011, need not be applied. However, the signal word and safety alert symbol shall contrast with the background of the signal word panel, and the cautions and warnings shall contrast with the background of the instructional literature.

Note 1 to paragraph (d).

For example, the signal word, safety alert symbol, and the warnings may be black letters on a white background, white letters on a black background, navy blue letters on an off-white background, or some other high-contrast combination.

(e) Any instructions provided in addition to those required by this section shall not contradict or confuse the meaning of the required information or be otherwise misleading to the consumer.

Note 2 to paragraph (e).

For additional guidance on the design of warnings for instructional literature, please refer to ANSI Z535.6, American National Standard: Product Safety Information in Product Manuals, Instructions, and Other Collateral Materials. See note 1 to § 1242.8(b) for ANSI contact information.

§ 1242.8 - Incorporation by reference.

Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by reference (IBR)material is available for inspection at the U.S. Consumer Product Safety Commission and at the National Archives and Records Administration (NARA). Contact the U.S. Consumer Product Safety Commission at: the Office of the Secretary, U.S. Consumer Product Safety Commission, 4330 East-West Highway, Bethesda, MD 20814, phone (301) 504-7479, email: [email protected]. For information on the availability of this material at NARA, go to: www.archives.gov/federal-register/cfr/ibr-locations. or email [email protected]. The material may be obtained from the following sources:

(a) ASTM International (ASTM), 100 Barr Harbor Drive, P.O. Box CB700, West Conshohocken, Pennsylvania 19428-2959; phone: (800) 262-1373; website: www.astm.org.

(1) ASTM D3359-23 Standard Test Methods for Rating Adhesion by Tape Test, approved February 1, 2023; § 1242.5(c).

(2) [Reserved]

(b) National Electrical Manufacturers Association (NEMA), 1300 17th St. N, Arlington, VA 22209; phone: (703) 841-3200; website: www.nema.org.

(1) ANSI Z535.4-2011(R2017), American National Standard for Product Safety Signs and Labels, ANSI-approved October 20, 2017 (ANSI Z535.4-2011); §§ 1242.6(d).

(2) [Reserved]

Note 1 to paragraph (b).

NEMA standards are also available from ANSI, which provides a free, read-only copy of the standard at https://ibr.ansi.org/Standards/nema.aspx. American National Standards Institute (ANSI), 25 West 43rd Street, 4th Floor, New York, NY 10036, USA, telephone: (212) 642-4900, www.ansi.org.

§ 1242.9 - Severability.

The provisions of this part are separate and severable from one another. If any provision is stayed or determined to be invalid, it is the Commission's intention that the remaining provisions shall continue in effect.

authority: 15 U.S.C. 2056a
source: 89 FR 85414, Oct. 25, 2024, unless otherwise noted.
cite as: 16 CFR 1242.2