Products Liability Law Daily Wrap Up, STATUTORY AUTHORITY—BABY PRODUCTS—D.D.C.: Safety statement regarding weighted baby blankets not sufficiently supported by record; case remanded to CPSC, (Sep 29, 2026)

By Leah S. Poniatowski, J.D.

The manufacturer established that the issue was reviewable, but CPSC’s basis for its decision was not clear enough to support a ruling.

In a lawsuit filed by a manufacturer of weighted baby blankets and swaddles against the Consumer Product Safety Commission (CPSC) for publishing a statement that the products were dangerous, the federal district court for the District of Columbia determined that there was not adequate evidence in the record to support the statement and ordered the matter be remanded to the CPSC in order to further investigate and explain the reasons for publishing the statement. Accordingly, the parties’ motions for summary judgment were both denied (Dreamland Baby Co. v. CPSC, No. 24-3277 (RC) (D.D.C. Sept. 25, 2026)).

Background. Dreamland Baby Co. manufactures weighted baby sleep products, including blankets, bags, and swaddles. The weighted products are produced using a quilted fabric design that “evenly distribute[s]” a “gentle weight.” Dreamland launched its company in 2019 and, in addition to selling over a million products, has donated the weighted sleep swaddles to over 250 neonatal intensive care units across the country.

Safe to Sleep. To facilitate reducing the risk of Sudden Infant Death Syndrome (SIDS) or Sudden Unexplained Infant Death (SUID), the public Safe to Sleep Campaign was launched as a collaboration among federal agencies and private organizations to keep consumers informed and protected. The CPSC, the National Institutes of Health (NIH), and the Centers for Disease Control (CDC) participate in the campaign.

In 2022, the American Academy of Pediatrics (AAP), a private organization, published its updated report on the topic of infant sleep safety as part of its effort to help reduce infant death during sleep. Although the AAP stated that “no studies have documented the safety of weights for infants in an unobserved, nonclinical sleep environment,” the organization advised that any weighted object, including blankets, sleepers, and swaddles, “not be placed on or near the sleeping infant.” It was the first time these products were deemed “not safe” by the organization. Following the AAP’s updated guidance, the NIH and CDC updated their websites to include the warning against using weighted sleep products.

ASTM standards. In addition to its collaboration on the Safe to Sleep campaign, the CPSC also works with numerous other stakeholders in developing voluntary standards for products with ASTM International, a non-profit organization. Under the Consumer Product Safety Act, the CPSC must “rely upon voluntary... standards” whenever such voluntary standards would “eliminate or adequately reduce the risk of injury addressed” and “substantial compliance” with these standards is likely.

Beginning in 2021, CPSC and several stakeholders began developing a voluntary standard as part of the ASTM Subcommittee F15.19 on Wearable Infant Blankets. The subcommittee’s first draft voluntary standard was balloted in October 2023, but by mid-November, the CPSC notified the subcommittee that it was voting against the standard out of concern that wearable weighted blankets and swaddles were “included in the scope of the standard without an accompanying specification of maximum weight limits by age.” The CPSC recommended that the subcommittee further evaluate and share research, testing, and evaluation of those products as part of narrowing the scope of the standard.

In June 2023, the AAP president wrote a letter to the CPSC chair and the ASTM committee chair about the concern of developing a voluntary safety standard for weighted infant sleep products. The president acknowledged that there was nothing in peer-reviewed scientific literature evaluating the safety of weighted sleep products in unmonitored settings, but emphasized that this should not be considered proof that the products do not cause harm. The president warned that AAP had a clear policy against use of weighted infant sleep products and therefore opposed development of voluntary standards.

The CPSC provided the subcommittee “the most comprehensive data possible” in July 2024, which reflected 167 incidents over the span of the years 2011 to 2024. Within the data provided by the CPSC, there were five deaths within the roughly twelve incidents involving weighted products.

Guidance adoption. In November 2023, the CPSC held a meeting to discuss the Fiscal Year 2024 Opening Plan, which included the consideration of amending the Plan to propose a rule addressing the risks of weighted infant products and align the CPSC’s guidance with that of the CDC and NIH. An updated draft amending the “Safe Sleep” page on its website to warn against using weighted infant sleep products was circulated among CPSC senior staff, and was later approved. The website posted the warning “Don’t use weighted blankets or weighted swaddles*.” The footnote stated “NIH.gov and CDC.gov.”

Litigation. In July 2024, Dreamland sent a formal request to the CPSC to retract the warning not to use weighted blankets or swaddles. Dreamland asserted that the statement was inaccurate or misleading because it was not based on the CPSC’s own findings, analysis, or data. Dreamland also contended that the CDC and NIH also did not base their warnings on any data or evidence, only on the “perceived lack of safety data.”

The CPSC replied that the retraction request was denied following a vote, and that under applicable law, the CPSC may “reference complementary information on other federal websites as long as such information is accurate and not misleading.” Additionally, the CPSC asserted that it complied with internal agency clearance processes before making the statement public, and that cross-linking to other agencies’ guidance was within the CPSC’s policy as well as consistent with its reliance on recommendations by the AAP.

The CPSC updated the footnote to clarify that the guidance was “based on information from” CDC and NIH, and readers were urged to check the websites of those agencies for “more information.” Dreamland filed a lawsuit under the Administrative Procedure Act (APA) for declaratory and injunctive relief to stop the CPSC and the other named agencies from unfairly maligning weighted infant sleep products.

The CPSC and related agencies filed a motion to dismiss, which was granted to all but the issue of the arbitrary and capricious claim. Dreamland and the agencies filed for summary judgment on that sole claim.

Analysis. As an initial matter, the federal district court concluded that the CPSC statement was reviewable per the APA. The APA permits judicial review of “final agency action.” According to case law, an agency’s action is “final” if it marks the consummation of the agency’s decision making process and the action determines rights or obligation, or from which legal consequences will flow. In the case at bar, the denial of Dreamland’s retraction request was a final agency action. The request unfurled the agency’s regulatory obligation to evaluate whether the information it posted was inaccurate or misleading.

Relatedly, the court was satisfied that the CPSC complied with clearance procedures when it decided to post the information about weighted infant sleep products. However, the court held that compliance was not sufficient—the CPSC must also “offer a satisfactory explanation for its action.”

In order to meet the requirements of the applicable federal regulation, CPSC must provide the reasons for its denial of the retraction request. The administrative record in the present case was not clear as to whether the CPSC’s decision was based on the data reflecting infant fatalities associated with use of the weighted sleep products or “blind reliance on the CDC and NIH,” the court stated. The court agreed that the twelve deaths in comparison with the 3.5 million products sold did not indicate that the products were dangerous. Further, the CPSC’s comment to the ASTM subcommittee indicated that certain weighted infant sleep products could be safe with an adequate standard in place.

Regardless, the CPSC was obligated under Directive 1450.2 to “assure that information disclosed to the public is accurate,” which the court construed to mean that the CPSC examine the available data in order to evaluate whether it is inaccurate or misleading even if it complied with a policy allowing cross-linking to other federal agencies.

The current record did not provide sufficient information for the court to make a grounded ruling and, accordingly, the court remanded the case to the CPSC for further investigation or explanation as to why it decided to publish the statement on its website and deny Dreamland’s request to retract the statement. The parties’ motions for summary judgement were therefore both denied.

The case is No. 24-3277 (RC).

Judge: Contreras, R.

Attorneys: Kara McKenna Rollins (New Civil Liberties Alliance) for Dreamland Baby Co. David Harvill Hixson, U.S. Department of Justice, for Consumer Product Safety Commission, Richard Trumka, Jr., Health and Human Services, Centers for Disease Control and Prevention and National Institutes of Health.

Companies: Dreamland Baby Co.; Consumer Product Safety Commission; Health and Human Services; Centers for Disease Control and Prevention; National Institutes of Health

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