UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
DREAMLAND BABY CO., :
:
Plaintiff, : Civil Action No.: 24-3277 (RC)
:
v. : Re Document Nos.: 23, 25
:
CONSUMER PRODUCT SAFETY
COMMISSION, et al., :
:
Defendants. :
MEMORANDUM OPINION
DENYING PLAINTIFF’S MOTION FOR SUMMARY JUDGMENT; DENYING DEFENDANT’S CROSSMOTION FOR SUMMARY JUDGMENT
I. INTRODUCTION
Dreamland Baby Co. (“Dreamland”) makes and sells weighted sleep blankets, bags, and
swaddles for infants and children. In November of 2024, the company filed suit against the
Consumer Product Safety Commission (“CPSC” or “Commission”); former CPSC
Commissioner Richard Trumka, Jr., in his official capacity; the Department of Health and
Human Services (“HHS”); and two HHS sub agencies, the Centers for Disease Control and
Prevention and the National Institutes of Health (collectively, “Defendants”). Dreamland seeks
declaratory and injunctive relief to stop Defendants from unfairly maligning weighted infant
sleep products, including those produced and sold by Dreamland. Compl. ¶¶ 1–11, ECF No. 1.
On September 26, 2025, this Court granted Defendants’ motion to dismiss Dreamland’s
complaint as to all counts except Count Four, which asserts an arbitrary and capricious claim
under the Administrative Procedure Act against the CPSC. See Dreamland Baby Co. v. CPSC,
No. 24-cv-3277, 2025 WL 2758476, at *6 (D.D.C. Sept. 26, 2025). Now before the Court are
Dreamland’s motion for summary judgment and CPSC’s cross-motion for summary judgment as to Count Four. Upon review of the administrative record, for the reasons set forth below, the
Court denies the parties’ cross-motions for summary judgment and remands the case to the
agency for further investigation or explanation.
II. BACKGROUND
A. Statutory and Regulatory Background
In 1972, Congress enacted the Consumer Product Safety Act (“CPSA”), 15 U.S.C.
§ 2051 et seq., in order “to protect the public against unreasonable risks of injury associated with
consumer products.” 15 U.S.C. § 2051(b)(1). Through the CPSA, Congress established the
Consumer Product Safety Commission, conferring “broad powers” on the agency to “conduct
research and investigations of consumer products,” “collect, analyze, and disseminate product
safety information,” and “establish comprehensive and effective regulation over the safety of
unreasonably hazardous consumer products.” Honeywell, Inc. v. CPSC, 582 F. Supp. 1072, 1074
(D.D.C. 1984) (citation omitted); see also 15 U.S.C. §§ 2051(b), 2053.
The CPSA requires the Commission to follow certain procedures, codified at 15 U.S.C.
§ 2055, whenever it makes public disclosures relating to consumer product safety. Under
Section 2055(b)(1), before the CPSC may publicly disclose information about a consumer
product that “will permit the public to ascertain readily the identity of [a] manufacturer,” it must
“take reasonable steps to assure” that the information is “accurate” and the disclosure “fair.” Id.
§ 2055(b)(1). The CPSC must also allow the manufacturer “a reasonable opportunity to submit
comments to the Commission in regard to such information.” Id. Additionally, Section
2055(b)(6) requires the CPSC to “establish procedures designed to ensure” that publicly
disclosed “information that reflects on the safety of a consumer product or class of consumer
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products . . . is accurate and not misleading,” regardless of whether the manufacturer’s identity is
readily ascertainable. Id. § 2055(b)(6).
The CPSC has implemented the latter requirement through its internal clearance process,
titled “Clearance Procedures for Providing Information to the Public” and otherwise known as
Directive 1450.2. See U.S. Consumer Prod. Safety Comm’n, Directive Sys. Order No. 1450.2,
Clearance Procedures for Providing Information to the Public (Jan. 16, 2003),
https://www.cpsc.gov/s3fs-public/pdfs/blk_media_1450.2.pdf [https://perma.cc/62LA-7JSH];
see also J.A., Admin. R. (“A.R.”) at 519–28 (“Directive 1450.2”), ECF No. 31. Under Directive
1450.2:
Clearance means a careful review and written approval of the information to
be disclosed by each Assistant or Associate Executive Director (AED) (or
delegate) whose area of responsibility is involved in the disclosure in order
to eliminate inaccurate or misleading statements. No information shall be
disclosed until approved as set out in this directive.
Directive 1450.2 § 7(a). Directive 1450.2’s “procedures apply to any release of information
initiated by the Commission, including information disseminated on the agency’s web site.” Id.
§ 1(a). The CPSC also maintains a policy on linking to nongovernment and other government
websites, known as the “Linking Out Policy” and set forth in Appendix B to Directive 1450.2,
which permits the Commission to “crosslink to content on federal and state government websites
and Social Media Sites, provided that the content complements safety information issued by the
agency and is related to the agency’s mission.” A.R. at 529–30.
Finally, the CPSA provides a mechanism for the CPSC to retract inaccurate or misleading
disclosures. Under Section 2055(b)(7), “[i]f the Commission finds that . . . it has made public
disclosure of inaccurate or misleading information which reflects adversely upon the safety of
any consumer product or class of consumer products,” it “shall, in a manner equivalent to that in
which such disclosure was made, take reasonable steps to publish a retraction of such inaccurate
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or misleading information.” 15 U.S.C. § 2055(b)(7). As CPSC regulations establish, the
Commission may retract information on its own initiative or upon the written request of a third
party, such as a manufacturer. 16 C.F.R. §§ 1101.52(a)–(b). A written request must include,
among other things, “[a] statement of the specific aspects of the information the firm believes are
inaccurate or misleading,” “[a] statement of the reasons the firm believes the information is
inaccurate or misleading,” and “[a]ny additional data or information the firm believes is
relevant.” Id. § 1101.52(c). The CPSC must act “expeditiously” on such requests and “promptly
notify the requester in writing of its decision on request for retraction,” along with “the reasons
for the Commission’s decision.” Id. §§ 1101.52(d)–(e).
B. Factual Background
Plaintiff Dreamland Baby Co. “develops, designs, produces, and sells infant and toddler
products, including weighted sleep sacks and swaddles.” A.R. at 324. Its products feature a
quilted fabric design that allows a “gentle weight” to be “evenly distributed” throughout the
product. Id. at 295. Since its founding in 2019, Dreamland has sold over a million products and
donated weighted sleep swaddles to over 250 neonatal intensive care units across the United
States. Id. at 320–22. Dreamland’s arbitrary and capricious claim against the CPSC is based on
the agency’s 2023 publication of a statement on an agency webpage warning the public not to
use “weighted blankets or weighted swaddles.” Id. at 433. As described below, in publishing
this statement, the CPSC adopted similar guidance from other federal agencies and private
organizations.
1. AAP’s 2022 Infant Sleep Recommendations
The CPSC participates in the Safe to Sleep Campaign, a public effort to “educate
caregivers, healthcare provides, and service providers . . . about ways to reduce the risk of
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Sudden Infant Death Syndrome (SIDS) and other sleep-related causes of Sudden Unexplained
Infant Death (SUID).” Id. at 9. Fellow Safe to Sleep Campaign collaborators include other
federal agencies, such as the National Institutes of Health (“NIH”) and the Centers for Disease
Control (“CDC”), and private organizations like the American Academy of Pediatrics (“AAP”).
Id. The Campaign’s education efforts are “in accordance with the current safe infant sleep
recommendations from the AAP Task Force on SIDS.” Id. at 10. Campaign collaborators
therefore agree to “[w]ork collaboratively to develop and revise messages, materials, and
strategies for the campaign, with the goal of providing consistent information about safe infant
sleep and, as permitted by law and organizational policy, promote campaign messages, materials,
and resources.” Id. at 12.
In June of 2022, the AAP released a report sharing updated recommendations for
reducing infant deaths in the sleep environment (“AAP’s 2022 Infant Sleep Recommendations”).
Id. at 19, 23–24, 30–32. For the first time, the AAP advised that “[w]eighted swaddle clothing or
weighted objects within swaddles are not safe and therefore not recommended,” id. at 24, and
recommended that “weighted blankets, weighted sleepers, weighted swaddles, or other weighted
objects not be placed on or near the sleeping infant,” id. at 23. In support of the latter
recommendation, the AAP cautioned that “no studies have documented the safety of weights for
infants in an unobserved, nonclinical sleep environment.” Id. at 575.
Sometime after AAP’s 2022 Infant Sleep Recommendations were issued, NIH and the
CDC updated webpages providing “safe sleep” guidance from the agencies to the public to
include warnings against using weighted infant sleep products. See id. at 487–96 (NIH); id. at
497–503 (CDC). The NIH webpage, for example, stated that “[t]hings in the sleep area can pose
dangers for [a] baby, especially if they are . . . weighted (e.g., weighted blankets, weighted
5
swaddles).” Id. at 488–89. Meanwhile, the CDC webpage advised that “[p]roducts labeled as
weighted—including weighted sleepers, swaddles, sleep sacks, and blankets—are not safe for
infants.” Id. at 500.
2. ASTM International Subcommittee on Wearable Infant Products
CPSC also participates, alongside various government entities, manufacturers, and
private organizations, in efforts to develop voluntary standards for consumer products in
connection with non-profit ASTM International. For context, although the CPSA empowers the
Commission to promulgate mandatory consumer product safety standards, the agency must
instead “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. 15 U.S.C. §§ 2056(a)–(b). Since July of 2021, CPSC staff have worked with
public and private stakeholders in a new ASTM International subcommittee—Subcommittee
F15.19 on Wearable Infant Blankets—to develop a voluntary standard for wearable infant
products. A.R. at 1, 393–94.
In October of 2023, the Subcommittee’s first draft voluntary standard was balloted. Id. at
394. In mid-November, however, the CPSC informed the Subcommittee that it was voting
against the standard due to concerns that “weighted wearable infant blankets and swaddles
[were] included in the scope of the standard without an accompanying specification of maximum
weight limits by age.” Id. at 278. The Commission encouraged the Subcommittee to “review all
scientific research on weighted products” and “conduct and share research, testing, and
evaluation on weighted products” in order to “set[ ] a standard as soon as possible to ensure
unsafe products are precluded from the market.” Id. at 279.
6
As the balloting process continued, the CPSC periodically provided the Subcommittee
with incident reports and summaries of incidents involving weighted and non-weighted infant
sleep products. See, e.g., id. at 5–8, 72–99, 396–412, 550–55. On July 1, 2024, the agency
provided the Subcommittee with “the most comprehensive data possible,” detailing 167 incidents
from 2011 to early 2024. Id. at 397. “To facilitate the [S]ubcommittee’s work of identifying
addressable hazard patterns,” CPSC staff categorized each incident based on product type and
whether the product was weighted. Id. at 398. The CPSC’s data showed at least twelve
incidents involving weighted products, including five deaths. Id. at 396–412 (rows 64, 80, 112,
114, 130, 137, 141, 145, 148, 155, 156, and 160).
3. June 2023 AAP Letter
On June 15, 2023, the President of the AAP wrote to the then Chair of the CPSC,
Alexander Hoehn-Saric, along with the Chair of ASTM’s F15 Committee on Consumer
Products, to express the AAP’s “concerns about the possible development of a voluntary safety
standard for weighted infant sleep products.” Id. at 106–07. The AAP observed that its most
recent recommendations for safe sleep included a warning against using such products, as “[t]he
evidence available at this time does not indicate that weighted swaddle products are safe.” Id. at
106. Specifically, the AAP explained that there was “no evidence in the peer-reviewed scientific
literature evaluating the safety of weighted sleep products on typical, healthy infants” and
“nothing published regarding their use in an unmonitored setting.” Id. at 107. Furthermore,
“[e]ven preliminary, non-peer-reviewed data under discussion in ASTM proceedings suggest
these products are associated with concerning reductions in oxygen saturation levels in infants.”
Id. Despite “[a] lack of substantial evidence about the possible harms of weighted sleep
products,” the AAP cautioned that this “should not serve as evidence that [weighted products] do
7
not cause harm.” Id. “[G]iven the AAP’s clear policy regarding the danger of weighted infant
sleep products,” the AAP President indicated that the AAP “oppose[d] the development of any
voluntary standard for these products.” Id. at 106.
4. CPSC Adopts NIH and CDC Guidance
On November 8, 2023, the CPSC met to discuss its Fiscal Year 2024 Opening Plan. Id.
at 256. Among other things, the Commission considered an amendment to the Plan to “initiate
rulemaking and issue a proposed rule to address risks associated with weighted infant blankets,
sleepers, and swaddles and align the Commission’s safe sleep guidance with [CDC] and [NIH]
guidance for weighted products.” Id. at 257. Although the Commission voted not to adopt the
amendment—purportedly because CPSC staff had “not conduct[ed] the research necessary to
draft a notice of proposed rulemaking in 2024”—then Commission Chair Hoehn-Saric stated that
the CPSC was planning to update its safe sleep guidance to incorporate advice from the CDC and
NIH. Id. at 255 (19:59–20:54).
That same month, CPSC staff initiated the clearance procedures contemplated in
Directive 1450.2 to add language to its “Safe Sleep” webpage recommending against the use of
weighted blankets and swaddles. Id. at 290. On November 27, 2023, a draft update was
circulated to CPSC senior staff for review and comment. Id. Reviewers from Safety Operations
and the Office of Hazard Identification & Reduction, as well as the General Counsel, Executive
Director, and Director of Communications, confirmed their approvals of the draft by November
30, 2023. Id. An email notification from that date indicates that the “Agency Clearance” form
for the “weighted blanket language addition” was “successfully completed and approved.” Id.
(citation modified). Shortly thereafter, CPSC updated its “Safe Sleep” webpage to state: “Don’t
8
use weighted blankets or weighted swaddles*.” Id. at 433. Further down, an asterisk footnote
stated simply “NIH.gov and CDC.gov.” Id.
5. CPSC Denies Dreamland’s Retraction Request
On July 23, 2024, Dreamland invoked 16 C.F.R. § 1101.52(b) to send a formal request to
the CPSC for retraction of the agency’s statement advising the public not to use weighted
blankets or swaddles (“CPSC Statement”), which Dreamland claimed was “inaccurate or
misleading.”1 See A.R. at 416–30. Dreamland argued that the CPSC Statement was misleading
because “consumers, particularly parents, expect that when the Commission makes statements
about or recommendations regarding the safety of a product or a class of products that the
Commission is doing so based on its own findings, analysis, and data.” Id. at 422. Yet,
according to Dreamland, the Statement was “not spoken from a place of either evidence or data”
but “instead relie[d] on references to statements” by NIH and the CDC. Id. Dreamland thus
argued that the CPSC’s “statement misleads consumers into believing that its recommendation is
backed by the Commission’s findings, analysis, and data when it is not.” Id. Moreover,
Dreamland maintained that the Statement was inaccurate because “neither CDC nor NIH based
their statements on any data or evidence specific to weighted swaddles or blankets but relied
only on a perceived lack of safety data” and because the CPSC did not corroborate the other
agencies’ statements. Id. at 423.
1
Dreamland also requested that the CPSC retract statements made by former Commissioner Richard Trumka “maligning weighted swaddles and blankets.” A.R. at 417. The CPSC reached a deadlocked vote regarding whether to retract Commissioner Trumka’s statements, lacking a majority needed to take action. Although Dreamland claims that the CPSC’s refusal to retract Commissioner Trumka’s statement violated the APA, this Court explained in its prior memorandum opinion that this claim lacks merit because, as Dreamland “appear[ed] to concede,” the “deadlocked vote was not final agency action.” Dreamland Baby Co., 2025 WL 2758476, at *6.
9
On August 30, 2024, the CPSC sent Dreamland a letter informing it that the agency had
voted to deny the retraction request. Id. at 512–14. The Commission noted that it had
“determined that the CPSC Statement is not barred by [§ 2055(b)(7)],” which “allows the CPSC
to reference complementary information on other federal websites as long as such information is
accurate and not misleading.” Id. at 513. The CPSC also asserted that “[i]n adding the CPSC
Statement to the CPSC website, Commission staff cleared it for public disclosure pursuant to its
internal agency clearance process, found in Directive 1450.2” Id. Furthermore, the CPSC
“disagree[d] with Dreamland’s assertion . . . that the references to the NIH and CDC guidance
are per se inaccurate or misleading unless CPSC independently corroborates them.” Id. Instead,
the CPSC maintained, “consideration of and crosslinking to other agencies’ guidance is
consistent with the CPSC’s Linking Out Policy.” Id. Finally, the CPSC noted that this guidance
in question came from the Safe to Sleep campaign, whose “safe sleep guidance has reflected the
recommendations of the AAP . . . since 2000, and that “[t]his reliance on AAP is made clear on
the NIH website.” Id. at 514.
Although the Commission voted not to retract the CPSC Statement, it informed
Dreamland that it had decided to “provide further context for the [Statement’s] crosslinks to
content from NIH and CDC” by making a “slight modification” to the asterisk footnote in the
Statement. Id. at 514. Whereas previously the footnote had directed readers to “NIH.gov and
CDC.gov,” it thereafter read: “This guidance is based on information from the Centers of
Disease Control and the National Institutes of Health. Please go to CDC.gov and NIH.gov for
more information.” Id. at 532.
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III. LEGAL STANDARD
The Administrative Procedure Act (“APA”) requires courts to “hold unlawful and set
aside agency action, findings, and conclusions found to be . . . arbitrary, capricious, an abuse of
discretion, or otherwise not in accordance with law.” 5 U.S.C. § 706(2)(A). “Although Federal
Rule of Civil Procedure 56 provides the ordinary summary judgment standard, it is well
established that, in cases involving review of final agency action [under the APA], the standard
set forth in Rule 56 does not apply because of the limited role of a court in reviewing the
administrative record.” Cognitive Pro. Servs. Inc. v. U.S. Small Bus. Admin., 254 F. Supp. 3d 22,
32 (D.D.C. 2017) (citation modified). On a motion for summary judgment in an APA case,
“[t]he entire case on review is a question of law, and only a question of law.” Marshall Cty.
Health Care Auth. v. Shalala, 988 F.2d 1221, 1226 (D.C. Cir. 1993). “Under the APA, it is the
role of the agency to resolve factual issues to arrive at a decision that is supported by the
administrative record, whereas the function of the district court is to determine whether or not as
a matter of law the evidence in the administrative record permitted the agency to make the
decision it did.” Cognitive Pro. Servs. Inc., 254 F. Supp. 3d at 32 (citation modified). In other
words, summary judgment in APA cases “serves as the mechanism for deciding, as a matter of
law, whether the agency action is supported by the administrative record and otherwise
consistent with the APA standard of review.” Landmark Hosp. of Salt Lake City v. Azar, 442 F.
Supp. 3d 327, 331 (D.D.C. 2020) (citation omitted).
The parameters of a district court’s authority to decide whether an agency acted in
violation of the APA are set forth in the APA itself. Cognitive Pro. Servs. Inc., 254 F. Supp. 3d
at 32. As described, “[t]hat statute requires reviewing courts to set aside agency action that is,
inter alia, ‘arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with
11
law.’” Id. (quoting 5 U.S.C. § 706(2)(A)). “[W]hen evaluating agency actions under this
standard, a court must be satisfied that the agency has ‘examine[d] the relevant data and
articulate[d] a satisfactory explanation for its action including a rational connection between the
facts found and the choices made.’” Id. (quoting Motor Vehicle Mfrs. Ass’n of U.S. v. State
Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983)). “Review by this Court under the APA is
generally limited to the administrative record that was before the agency when it reached its
decision.” Zemeka v. Holder, 989 F. Supp. 2d 122, 128 (D.D.C. 2013).
Judicial review under the “arbitrary and capricious” standard is “‘highly deferential’ to
the agency’s decision and presumes that the agency action is valid.” Oceana, Inc. v. Ross, 920
F.3d 855, 863 (D.C. Cir. 2019) (quoting Ethyl Corp. v. EPA, 541 F.2d 1, 34 (D.C. Cir. 1976) (en
banc)). “A court simply ensures that the agency has acted within a one of reasonableness and, in
particular, has reasonably considered the relevant issues and reasonably explained the decision.”
Fed. Commc’ns Comm’n v. Prometheus Radio Project, 592 U.S. 414, 423 (2021). Even “a
decision of less than ideal clarity” must be upheld “if the agency’s path may be reasonably
discerned.” Motor Vehicle Mfrs. Ass’n of U.S., 463 U.S. at 43 (citation omitted). Still, a court
“may not supply a reasoned basis for the agency’s action that the agency itself has not given,”
id., or “affirm an agency decision on a ground other than that relied upon by the agency,” Manin
v. NTSB, 627 F.3d 1239, 1243 (D.C. Cir. 2011).
IV. ANALYSIS
The parties now cross-move for summary judgment on Count Four of the complaint. See
Pl.’s Mot. Summ. J. (“Pl.’s MSJ”), ECF No. 23-1; Defs.’ Cross-Mot. Summ. J. (“Def.’s XMSJ”), ECF No. 25-1. In that count, Dreamland alleges that the CPSC acted arbitrarily and
capriciously, in violation of the APA, when it published the CPSC Statement on weighted infant
12
sleep products on its “Safe Sleep” webpage and when it later denied Dreamland’s request for
retraction of the Statement. Compl. ¶ 185. Below, the Court first addresses a preliminary issue:
whether the CPSC’s decision to publish the CPSC Statement is reviewable. In reviewing the
CPSC’s denial of Dreamland’s retraction request as the final agency action, the Court finds that
this decision is “[a] preliminary, procedural, or intermediate agency action” that is “subject to
review on the review of [a] final agency action.” 5 U.S.C. § 704. Next, the Court considers
whether the administrative record supports the CPSC’s publication of the Statement and denial
of Dreamland’s retraction request. Finding that it does not, the Court denies the parties’ crossmotions and remands the case to the CPSC for further investigation or explanation.
A. The CPSC Statement is Reviewable
The APA provides a right to judicial review of “final agency action for which there is no
other adequate remedy in a court.” Id. (emphasis added). Consistent with this rule, “[a]
preliminary, procedural, or intermediate agency action or ruling not directly reviewable is subject
to review on the review of the final agency action.” Id. “While the requirement of finality is not
jurisdictional, without final agency action, there is no doubt that [a plaintiff] would lack a cause
of action under the APA.” Soundboard Ass’n v. FTC, 888 F.3d 1261, 1267 (D.C. Cir. 2018)
(citation omitted). Two conditions must be met for an agency action to be “final.” Bennett v.
Spear, 520 U.S. 154, 177 (1997). “First, the action must mark the ‘consummation’ of the
agency’s decisionmaking process—it must not be of a merely tentative or interlocutory nature.
And second, the action must be one by which ‘rights or obligations have been determined,’ or
from which ‘legal consequences will flow.” Id. at 178 (first quoting Chi. & S. Air Lines, Inc. v.
Waterman S.S. Corp., 333 U.S. 103, 113 (1948); and then quoting Port of Bos. Marine Terminal
Ass’n. v. Rederiaktiebolaget Transatl., 400 U.S. 62, 71 (1970)).
13
In this case, although the CPSC does not dispute that its denial of Dreamland’s retraction
request was a final agency action, it argues that its earlier decision to publish the Statement on
weighted infant sleep products is not reviewable either as a final agency action or as a
“preliminary, procedural, or intermediate agency action” within the Commission’s retraction
proceeding. Def.’s X-MSJ at 10–19. The Court previously found, however, that “[e]ven if
CPSC’s statement is not final agency action, Dreamland is entitled to [review] because CPSC’s
decision not to retract its disclosure is final agency action subject to this Court’s review.”
Dreamland Baby Co., 2025 WL 2758476, at *6 (citation omitted). The Court declines CPSC’s
invitation to revisit this prior finding.
A recent decision from the District of Maryland—Keezio Grp., LLC v. CPSC, No. 25-cv1389, 2026 WL 1090957 (D. Md. Apr. 22, 2026)—supports the notion that, even if the CPSC
Statement is not a final agency action, it is reviewable as a “preliminary, procedural, or
intermediate agency action or ruling” under 5 U.S.C. § 704. In Keezio, a manufacturer of infant
and toddler sleep products challenged a CPSC press release that “advised consumers to stop
using Keez[i]o’s [infant mattresses] immediately due to a risk of ‘Serious Injury or Death from
Entrapment or Suffocation.’” 2026 WL 1090957, at *3. The district court found that the press
release was not a final agency action subject to APA review, including because it “did not
determine Keezio’s, nor any other party’s, ‘rights or obligations’” or “impose any ‘legal
consequences’ upon Keezio.” Id. at *5 (quoting Bennett, 520 U.S. at 178). As the district court
explained, despite Keezio’s allegations that the press release caused “significant downstream
effects,” including financial and reputational harm to the manufacturer, “such market-based
consequences” did not transform the press release into a reviewable agency action. Id. Still, in
declining to deem the press release a final agency action, the district court emphasized that
14
Keezio had failed to “invoke[ ] the available regulatory mechanism for seeking retraction” of the
press release pursuant to 16 C.F.R. § 1101.52(b). Id. at *6. “Had [Keezio] done so,” the district
court reasoned, “the process would have culminated in a formal Commission decision regarding
whether the disclosure was inaccurate or misleading.” Id.
Here, unlike in Keezio, Dreamland did file a formal request under § 1101.52(b) for CPSC
to retract the Statement on the “Safe Sleep” webpage. See A.R. at 416–503. In its request,
Dreamland provided specific reasons for which it believed that the Statement was inaccurate or
misleading. See id. That request triggered CPSC’s regulatory obligation “to determine whether
it had [in fact] disseminated inaccurate or misleading information.” Keezio, 2026 WL 1090957,
at *5; see also 16 C.F.R. § 1101.52(d)–(e) (obligating CPSC to act “expeditiously” on retraction
requests and “promptly notify the requester in writing of its decision on request for retraction”
along with “the reasons for the Commission’s decision”). To be sure, CPSC was also obligated
to “check for accuracy and fairness” before publishing the Statement. Keezio, 2026 WL
1090957, at *6; see also 15 U.S.C. § 2055(b)(6) (requiring CPSC to “establish procedures
designed to ensure” that publicly disclosed “information that reflects on the safety of a consumer
product or class of consumer products” is “accurate and not misleading”); 16 C.F.R. § 1101.1(c)
(noting that Directive 1450.2 establishes CPSC’s internal clearance procedures, as required
under § 2055(b)(6)). But now that CPSC has responded to Dreamland’s retraction request, a
“formal Commission decision” has been reached “regarding whether the [Statement] was
inaccurate or misleading.” Keezio, 2026 WL 1090957, at *6. Accordingly, even if the CPSC’s
initial clearance of the Statement “d[id] not mark the consummation of the agency’s
decisionmaking process,” that process has now produced a final decision, and the CPSC
15
Statement is therefore reviewable as a preliminary agency action upon review of the CPSC’s
denial of Dreamland’s retraction request.2
B. The Administrative Record Does Not Support the CPSC’s Actions
“A ‘fundamental’ requirement of administrative law is that an agency ‘set forth its
reasons’ for decision; an agency’s failure to do so constitutes arbitrary and capricious
government action.” Tourus Recs., Inc. v. Drug Enf’t Admin., 259 F.3d 731, 737 (D.C. Cir.
2001) (quoting Roelofs v. Sec’y of the Air Force, 628 F.2d 594, 599 (D.C. Cir. 1980)).
Dreamland contends that CPSC acted arbitrarily and capriciously when it cleared the CPSC
Statement and when it later denied Dreamland’s retraction request because the agency did not
disclose adequate reasons for either decision. Pl.’s MSJ at 18–21. Dreamland also argues that
the administrative record fails to establish that CPSC adequately followed its clearance
procedures, set forth in Directive 1450.2, in approving the CPSC Statement. Id. at 24–29. The
Court agrees only as to Dreamland’s first contention. Although there is no shortage of data in
the administrative record showing potential safety risks associated with weighted infant sleep
products, the overall record does not persuade the Court that the CPSC “articulate[d] a
2
The parties’ supplemental filings do not alter this conclusion. Dreamland relies on Center for Taxpayer Rights v. Internal Revenue Service, No. 26-5006, 2026 WL 2635380 (D.C. Cir. Sept. 8, 2026), to support its contention that the CPSC Statement itself is final agency action. See Pl.’s Notice Supp. Auth., ECF No. 32. There, the court considered an IRS procedure governing how the agency processed ICE requests for confidential taxpayer information. The court held, in relevant part, that the procedure was final because it was the IRS’s operative policy and itself bound agency officials by prescribing how they had to process those requests and limiting their discretion to reject them. Ctr. For Taxpayer Rts., 2026 WL 2635380, at *7–10. Here, the CPSC Statement is different: Unlike the procedure in Center for Taxpayer Rights, the Statement does not itself prescribe how CPSC officials must act or purport to constrain their discretion. And any requirements governing retraction arise from the CPSA and CPSC regulations rather than from the Statement itself. See Defs.’ Resp. Pl.’s Notice Supp. Auth. at 2– 3, ECF No. 33.
16
satisfactory explanation for [each] action including a rational connection between the facts found
and the choices made.” Motor Vehicle Mfrs. Ass’n of U.S., 463 U.S. at 43.
The Court first reviews the publication of the CPSC Statement. The administrative
record reflects that in early November of 2023, CPSC discussed, among other things, an
amendment to its Fiscal Year 2024 Opening Plan to initiate rulemaking and issue a proposed rule
to address risks associated with weighted infant sleep products. A.R. at 257. Although CPSC
rejected the amendment, then Chair Hoeh-Saric commented that CPSC was planning to update
the agency’s safe sleep guidance to incorporate advice on weighted infant sleep products from
NIH and the CDC. Id. at 255 (19:59–20:26). Later that month, an “Agency Clearance” form for
the “weighted blanket language addition” circulated among CPSC senior staff for review and
comment. Id. at 290. CPSC staff “successfully completed and approved” the form. Id. The
CPSC Statement was published shortly thereafter, warning the public not to use “weighted
blankets or weighted swaddles.” Id. at 433.
This record satisfies the Court that, in approving the CPSC Statement, the Commission
complied with the clearance procedures set forth in Directive 1450.2. As the CPSC observes, the
administrative record includes contemporaneous documentation of the agency’s adherence to
Directive 1450.2. See id. at 290 (noting that the “Agency Clearance” form was “successfully
completed and approved”). In any event, the Court had previously dismissed Dreamland’s claim
that the Statement “was not cleared under CPSC’s clearance procedures,” as Dreamland
“provide[d] no basis for this allegation and, regardless, it is unclear what procedure in Directive
1450.2 Dreamland believes the Commission was required, but failed, to take.” Dreamland Baby
Co., 2025 WL 2758476, at *7. Dreamland’s renewed attempt to reassert this argument fails. In
view of the “presumption of regularity [that] attaches to the actions of Government agencies,”
17
U.S. Postal Serv. v. Gregory, 534 U.S. 1, 10 (2001), as well as the absence of evidence here
undermining that presumption, the Court finds no basis to conclude that CPSC failed to follow
its clearance procedures.
But it is not enough that the CPSC complied with procedural requirements; the agency
further had to “offer a satisfactory explanation for its action.” Nat’l Ass’n for Home Care v.
Shalala, 135 F. Supp. 2d 161, 168 (D.D.C. 2001). The CPSC is correct that, in clearing the
Statement for publication, neither 15 U.S.C. § 2055(b)(6) nor Directive 1450.2 required it to
“memorialize a formal finding” that the Statement was accurate and not misleading. Def.’s XMSJ at 27; see also Danara Int’l, Ltd. v. CPSC, 549 F. Supp. 367, 375 (D.N.J. 1982) (“Section
[2055(b)(6)] is . . . solely a direction to the Commission to establish internal clearance
procedures.” (citation modified)); Directive 1450.2 § 7(a) (defining “clearance” to mean “a
careful review and written approval of the information to be disclosed”). But once Dreamland
filed a request under 16 C.F.R. § 1101.52(b) for retraction of the Statement, CPSC was required
to assess the merits of the request, render a formal decision on the request, and “promptly notify
[Dreamland] in writing” of “the reasons for the Commission’s decision.” 16 C.F.R.
§ 1101.52(e). The CPSC complied with these requirements, notifying Dreamland of its denial of
the retraction request on August 30, 2024. A.R. at 512–14. As set forth below, however, the
CPSC’s reasoning in the denial falls short under the applicable standard.
In its retraction request, Dreamland argued that the CPSC Statement is inaccurate and
misleading because, rather than basing its decision to publish the Statement on the CPSC’s “own
findings, analysis, and data,” the agency “relie[d] on references to [unsubstantiated] statements”
by NIH and the CDC. Id. at 422. In its prior memorandum opinion, the Court rejected
Dreamland’s contention that “Congress intended for CPSC to make product safety
18
determinations independently of the CDC, NIH, or AAP.” Dreamland Baby Co., 2025 WL
2758476, at *8. The Court also noted that the AAP’s 2022 Infant Sleep Recommendations, on
which the CDC and NIH guidance was in turn based, did not appear to be unsubstantiated, given
that the CPSC possessed “data involving multiple infant fatalities associated with weighted sleep
products.” Id. Nevertheless, the Court observed that “in the absence of an Administrative
Record, it [was] unclear whether the CPSC based its decision to publish and not retract the
Statement on this data, or on blind reliance on the CDC and NIH.” Id. (citation modified). The
administrative record is now before the Court. However, neither the CPSC’s retraction denial
nor other parts of the record give the Court greater insight into the basis for the CPSC’s decisions
to publish and not retract the Statement.
The administrative record shows that, after review by various senior CPSC staff, an
“Agency Clearance” form for the “weighted blanket language addition” to the “Safe Sleep”
webpage was “successfully completed and approved” in November of 2023. A.R. at 290. That
form is not in the record. Months later, in August of 2024, the CPSC denied Dreamland’s
request to retract the Statement. In its denial, the CPSC confirmed that “[i]n adding the CPSC
Statement to the CPSC website, Commission staff cleared it for public disclosure pursuant
to . . . Directive 1450.2,” whose procedures are “designed to comply with [the CPSA’s]
mandate” that disclosed information be “accurate and not misleading.” Id. at 513. But the
administrative record does not reveal why the CPSC believed the Statement is “accurate and not
misleading”—whether it was simply because the CDC, NIH, and AAP believed that weighted
infant sleep products were not safe, or because the CPSC itself also considered the relevant data
and concluded that such products were not safe.
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To be sure, the administrative record leaves little doubt that the CPSC was aware of
potential safety risks associated with weighted infant sleep products when it published the
Statement. For example, in June of 2023, the President of the AAP advised then Commission
Chair Hoehn-Saric and the President of the ASTM International Subcommittee on Wearable
Infant Products that “[e]ven preliminary, non-peer-reviewed data . . . suggest [weighted]
products are associated with concerning reductions in oxygen saturation levels in infants.” Id. at
107. Furthermore, in November of 2023, the CPSC voted against the Subcommittee’s draft
voluntary standard for wearable infant products due to concerns that this standard failed to
specify “maximum weight limits by age,” which raised safety concerns for weighted products.
Id. at 278-79. And in July of 2024—before the CPSC denied Dreamland’s retraction request—
the CPSC provided the Subcommittee with data showing at least twelve incidents involving
weighted infant sleep products, including five deaths. Id. at 396–412 (rows 64, 80, 112, 114,
130, 137, 141, 145, 148, 155, 156, and 160).
However, even if the administrative record shows that the CPSC possessed concerning
data regarding weighted infant sleep products, it does not reveal whether the CPSC ever made an
affirmative finding, based on such data or other data-driven considerations, that weighted infant
sleep products are, in fact, not safe. Such a finding is not self-evident to the Court. Dreamland
observes, for example, that over 3.5 million weighted infant sleep products have been sold since
2011. Pl.’s Opp’n to Def.’s X-MSJ at 19, ECF No. 27. If CPSC has identified only twelve
incidents involving such products,3 it does not necessarily follow that weighted infant sleep
3
Of course, the CPSC might well have more data showing further incidents involving weighted infant sleep products. But if that is the case, such data is not in the administrative record. And the record provides no indication that the CPSC based its decision to publish the CPSC Statement on similar data.
20
products are dangerous. Even the President of the AAP acknowledged that there was “[a] lack of
substantial evidence about the possible harms of weighted sleep products.” A.R. at 107.
Furthermore, although the CPSC voted against the Subcommittee’s first draft voluntary standard
for wearable infant products, the agency encouraged the Subcommittee to “set[ ] a standard [for
weighted products] as soon as possible to ensure unsafe products are excluded from the market.”
Id. at 279. This suggests that the CPSC believed that, with an adequate standard, certain
weighted infant sleep products could be safe. Of course, it is possible that the CPSC
nevertheless considered that, without such a standard in place, the potential risks associated with
weighted infant sleep products justified its categorical admonition to the public against using any
“weighted blankets or weighted swaddles.” Id. at 433. But if that was the CPSC’s view, the
administrative record does not reflect it. Cf. Motor Vehicle Mfrs. Ass’n of U.S., 463 U.S. at 43
(noting that the reviewing court “may not supply a reasoned basis for the agency’s action that the
agency itself has not given”).
Instead, the reasons the CPSC provided for its decisions to publish and not retract the
Statement focused on the agency’s adherence to internal clearance procedures and the fact that,
under the CPSA, Directive 1450.2, and the Linking Out Policy, the Commission was
“allow[ed] . . . to reference complementary information on other federal websites as long as such
information is accurate and not misleading.” Id. at 508–09. However, although the CPSC
emphasized that the Statement mirrored NIH and CDC guidance and ultimately “reflected the
recommendations of the AAP Task Force on SIDS,” id. at 509, the agency did not explain why it
believed that the Statement was accurate and not misleading.4 Needless to say, the basis for the
4
The administrative record does, however, show that the CPSC adequately explained that the source for the Statement was NIH and CDC guidance. Although the CPSC initially attributed the Statement in an asterisk footnote to “NIH.gov and CDC.gov,” it modified the
21
CPSC’s belief cannot simply have been that the Statement reflected the guidance of other federal
agencies. At minimum, the CPSC had to “review” the NIH and CDC guidance “to eliminate
inaccurate or misleading statements.” Directive 1450.2 § 7(a).5 And although the Linking Out
Policy allows the CPSC to crosslink to content on federal government websites “provided that
the content complements safety information issued by the agency and is related to the agency’s
mission,” A.R. at 530, the Court does not read this policy as eliminating the Commission’s
incessant obligation under Directive 1450.2 to “assure that information disclosed to the public is
accurate.” Directive 1450.2 § 1(b). The Court thus believes that, in the present context, the
CPSC was required to examine the data available to it in determining whether the Statement is
inaccurate or misleading. Cf. Def.’s X-MSJ at 22–23 (observing that Directive 1450.2 § 7(a)(1)
“allow[s] for statements to be supported by” either “data in the Commission’s files” or
“data . . . in currently applicable literature” (citation omitted)).
Because the administrative record offers no indication as to whether CPSC did so, the
Court remains unable to “assess whether the CPSC examined the relevant data and articulated a
satisfactory explanation for its action including a rational connection between the facts found and
the choice made.” Dreamland Baby Co., 2025 WL 2758476, at *8 (citation modified). “If the
record before the agency does not support the agency action . . . the proper course, except in rare
footnote in response to Dreamland’s retraction request to read: “This guidance is based on information from the Centers of Disease Control and the National Institutes of Health. Please go to CDC.gov and NIH.gov for more information.” A.R. at 532. To the extent Dreamland is arguing that the Statement is misleading because it insufficiently identifies the CDC and NIH guidance as the source for the Statement, the Court rejects that argument.
5
The CPSC appeared to suggest to Dreamland that the agency was not required to “independently corroborate” the “references to the NIH and CDC guidance.” A.R. at 513. To the extent the CPSC is arguing that it can publicly disclose information reflecting on the safety of consumer products without following Directive 1450.2’s procedures if such information is referenced on other federal government websites, the Court disagrees.
22
circumstances, is to remand to the agency for additional investigation or explanation.” Fla.
Power & Light Co. v. Lorion, 470 U.S. 729, 744 (1985). “In such circumstances, the agency
must first be afforded an opportunity to articulate, if possible, a better explanation.” Banner
Health v. Price, 867 F.3d 1323, 1356 (D.C. Cir. 2017) (citation modified). The Court sees no
reason to depart from this course here. Therefore, this case is remanded to the CPSC for further
investigation or explanation regarding its decisions to publish the CPSC Statement and to deny
Dreamland’s request to retract the Statement.
V. CONCLUSION
For the foregoing reasons, Plaintiff’s Motion for Summary Judgment (ECF No. 23) is
DENIED and Defendant’s Cross-Motion for Summary Judgment (ECF No. 25) is DENIED.
This case is remanded to the Consumer Product Safety Commission for further investigation or
explanation regarding its decisions to publish the CPSC Statement and to deny Dreamland’s
request to retract the Statement. An order consistent with this Memorandum Opinion is
separately and contemporaneously issued.
Dated: September 25, 2026 RUDOLPH CONTRERAS
United States District Judge
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