DREAMLAND BABY CO. v. CONSUMER PRODUCT SAFETY COMMISSION, et al.
Civil Action No.: 24-3277 (RC)
UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA
September 26, 2025
RUDOLPH CONTRERAS, United States District Judge
Re Document No.: 6
GRANTING IN PART AND DENYING IN PART DEFENDANTS’ MOTION TO DISMISS
I. INTRODUCTION
Dreamland Baby Co. (“Dreamland“) makes and sells weighted sleep blankets, bags, and swaddles for infants and children. Dreamland filed this suit in November 2024 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 of its sub-agencies, the Centers for Disease Control and Prevention (“CDC“) and the National Institutes of Health (“NIH“) (collectively, “Defendants“). The Complaint seeks declaratory and injunctive relief for (1) violations of the Administrative Procedure Act (“APA“),
II. BACKGROUND
A. Statutory and Regulatory Background
In 1972, Congress passed the Consumer Product Safety Act (“CPSA“) in response to growing concerns that “consumer products which present unreasonable risks of injury” were readily accessible to the public, and that existing regulatory frameworks were “inadequate” and potentially “burdensome to manufacturers.”
The CPSA requires the CPSC to follow certain procedures when making public disclosures relating to consumer product safety.
In addition, the CPSA requires the CPSC to “establish procedures designed to ensure” that the “public disclosure of information that reflects on the safety of a consumer product or class of consumer products ... is accurate and not misleading,” regardless of whether a manufacturer‘s identity is readily ascertainable.
Directive 1450.2 “describe[s] the clearance procedures to be used when initiating the public disclosure of information that reflects on the safety of consumer products” when the “release of information [is] initiated by the Commission, including information disseminated on the agency‘s web site, regardless of whether the information disclosed would enable the public to ascertain readily the identity of a manufacturer or private labeler.” Directive 1450.2 § 1.a. Appendix B to this Directive establishes the Commission‘s “Linking Out Policy,” which permits the CPSC to “crosslink to content on federal and state government websites and Social Media
The CPSA also provides a mechanism for retraction of inaccurate or misleading disclosures: “If 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, or the practices of any manufacturer ... 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 or misleading information.”
B. Factual and Procedural Background
Dreamland designs, manufactures, and sells weighted sleep products for infants. Compl. ¶¶ 41–50. These products use a “quilted fabric design which allows weight to be evenly distributed throughout the product.” Id. ¶ 49. Dreamland compares the “gentle pressure provided” by its weighted sleep bag to “placing a slice of bread or American cheese on an infant‘s chest.” Id. ¶ 50. Dreamland has sold over one million of these products in the past six years. Id. ¶¶ 42, 48.
“Since 1994, HHS and several of its subagencies, including NIH and CDC, have participated in the Safe to Sleep® campaign and its precursor, the Back to Sleep® campaign.” Id. ¶ 51. The campaign aims to reduce sleep-related infant deaths, including those caused by sudden infant death syndrome (“SIDS“). Id. ¶ 52. The Eunice Kennedy Shriver National
On June 21, 2022, the AAP updated its safe sleep guidelines, for the first time advising against the use of weighted infant sleep products, such as swaddles and blankets. Id. ¶¶ 54–56. Though the AAP noted a “single crossover randomized nonblinded trial of 16 infants” that “found no adverse events when a 1-pound weighted blanket was placed on each infant for 30 minute observed episodes,” the AAP based its recommendation on the fact that “no studies have documented the safety of weights for infants in an unobserved, nonclinical sleep environment.” Id. ¶¶ 57–58 (quoting Rachel Y. Moon, MD, FAAP; Rebecca F. Carlin, MD, FAAP; Ivan Hand, MD, FAAP, Evidence Base for 2022 Updated Recommendations for a Safe Infant Sleeping Environment to Reduce the Risk of Sleep-Related Infant Deaths (June 21, 2022), https://doi.org/10.1542/peds.2022-057991).2
Subsequently, the Safe to Sleep campaign, as well as the CDC and NIH, updated their messaging to reflect the AAP‘s revised guidance. Id. ¶¶ 60, 62–63. NIH amended its safe sleep materials to state that “[t]hings in the sleep area can pose dangers for baby, especially if they are: . . . Weighted (e.g., weighted blankets, weighted swaddles).” Id. ¶ 62. Similarly, the CDC revised its guidance to assert that “[p]roducts labeled as weighted—including weighted sleepers, swaddles, sleep sacks, and blankets—are not safe for infants.” Id. ¶ 63. “Neither agency provides the basis for its respective determination.” Id. ¶ 65.
Despite the Commission‘s decision, Trumka released a public statement the same day asserting that weighted infant sleep products are “concerning” hazards and chastising his fellow Commissioners for failing to adopt his amendment. Id. ¶ 72. Thereafter, Trumka continued to make public statements on the CPSC website and his social media channels warning against such products, including a January 26, 2024 post on X.com that linked to a Washington Post article that specifically named Dreamland and its line of weighted infant sleep products. Id. ¶¶ 87–91; Ex. 1 at 30, ECF No. 1-1. Additionally, Trumka sent letters to, and met with, various retailers and urged them to stop selling these products. Compl. ¶¶ 92–96. “The letters to retailers also included a hyperlink to a product search for weighted infant sleep products, which necessarily identified Dreamland‘s products, as they were for sale and searchable on retailers’ websites at the time.” Id. ¶ 109. Dreamland was provided no advanced notice of Trumka‘s statements, and alleges that his statements caused retailers to stop selling Dreamland‘s products. Id. ¶¶ 97, 99.
Sometime after the November 8, 2023 meeting, CPSC updated the “Safe Sleep – Cribs and Infant Products” page within the “Safety Education” portion of its website to include the
“On July 1, 2024, CPSC staff submitted updated incident data to the ASTM International (“ASTM“) subcommittee overseeing the voluntary standard for wearable blankets and swaddles, the ASTM F15.19 subcommittee. The data was provided to aid the ASTM subcommittee considering the potential hazards associated with such wearable blankets and swaddles.” Id. ¶ 83. The data identifies 167 incidents related to wearable infant blanket products, weighted and non-weighted, between January 1, 2011 and April 10, 2024. Id. ¶ 84. The dataset included five fatalities associated with weighted infant sleep sacks and swaddles, but the task group members who reviewed the data “found no pattern among the 13 incidents (deaths + injuries) involving weighted sleep products.” Id. ¶ 86.
In response to CPSC‘s website update and Commissioner Trumka‘s public campaign, Dreamland submitted a formal retraction request to the Commission on July 23, 2024. Id. ¶ 100; Ex. 1. The request sought the removal of the CPSC website‘s Safe Sleep guidance and Commissioner Trumka‘s individual statements, arguing that both were “inaccurate or misleading” and cast Dreamland‘s products in an unfairly negative light. Compl. ¶¶ 100–05.
On August 30, 2024, the CPSC formally responded. Id. ¶ 111; Ex. 2, ECF No. 1-2. Regarding the statement on CPSC‘s website, the Commission voted 3-0-2 to deny retraction, with two Commissioners abstaining. Ex. 2 at 2. The accompanying letter explained that the CPSC Safe Sleep statement was permitted under the CPSA and had been cleared “for public disclosure pursuant to [CPSC‘s] internal agency clearance process, found in Directive 1450.2.” Ex. 3 at 3, ECF No. 1-3. The CPSC further clarified that cross-references to CDC and NIH materials were permissible and complied with Appendix B of Directive 1450.2, and explained that the citations to those agencies’ websites had been updated to better identify their source. Id. at 3–4. Lastly, the Commission explained that the challenged guidance was derived from the Safe to Sleep campaign—a longstanding public health initiative involving the CPSC, NIH, CDC, and partners such as the AAP. Id. at 4. The CPSC noted that the campaign has consistently incorporated AAP‘s recommendations since 2000, and that the NIH has clearly described this collaboration on its website. Id.
With respect to Commissioner Trumka‘s public disclosures, the Commission‘s vote deadlocked at 2-0-2, lacking a majority needed to take action. Compl. ¶ 128. The two Commissioners who voted against retraction explained that (1) none of the statements contained Dreamland‘s name, (2) the challenged statements were neither inaccurate nor misleading, and (3) Trumka was not prohibited from requesting, in his own capacity, voluntary actions that retailers could disagree with or ignore. Ex. 6 at 2, ECF No. 1-6. Commissioner Trumka had recused himself, and Commissioners Feldman and Dziak had again abstained. Ex. 2 at 2. The abstaining Commissioners expressed their view that the process in the matter had been
In November 2024, Dreamland filed its Complaint seeking declaratory and injunctive relief. Compl. Counts 1, 4, and 5 allege that the CPSC violated the APA,
In January 2025, Defendants moved to dismiss the Complaint under Rules 12(b)(1) and 12(b)(6). Mot. to Dismiss, ECF No. 6; Defs.’ Corrected Mem. in Supp. Mot. to Dismiss (“MTD“), ECF No. 8-1. In their motion, Defendants argue that the CPSC statement on its website and deadlocked vote on retracting Commissioner Trumka‘s statements were not final agency actions, and that Dreamland fails to state an APA claim related to CPSC‘s decision not to retract its Safe Sleep guidance. MTD at 1–2. Defendants further argue that Counts 2 and 3 fail to state an ultra vires claim because the Complaint does not plausibly allege that the challenged statements by Trumka, NIH, or CDC violated any clear statutory authority. Id. at 2. Defendants
In May 2025, while the parties were briefing this motion, President Trump fired Commissioners Boyle, Hoehn-Saric, and Trumka without cause. Boyle v. Trump, No. 25-cv-1628, 2025 WL 1677099, at *1 (D. Md. June 13, 2025). Though a United States District Court granted those Commissioners a permanent injunction that reinstated them to their positions, see id. at *14–15, in July 2025, the Supreme Court stayed that order pending disposition of the appeal, Trump v. Boyle, 145 S. Ct. 2653, 2654 (2025). As a result, those Commissioners are no longer serving on the CPSC. See Reply in Supp. of Defs.’ Mot. to Dismiss (“Defs.’ Reply“) at 19, ECF No. 16. Defendants’ motion is now fully briefed, and ready for this Court‘s consideration. See Pl.‘s Mem. in Opp‘n (“Pl.‘s Opp‘n“), ECF No. 15; Defs.’ Reply.
III. LEGAL STANDARDS
“Federal courts are courts of limited jurisdiction,” and courts “presume[] that a cause lies outside this limited jurisdiction.” Kokkonen v. Guardian Life Ins. Co. of Am., 511 U.S. 375, 377 (1994). When deciding a motion to dismiss for lack of subject-matter jurisdiction under
To survive a motion to dismiss for failure to state a claim under
IV. ANALYSIS
The Court first analyzes Dreamland‘s APA claims against the CPSC (Counts 1, 4, and 5), followed by Dreamland‘s ultra vires claims against the HHS, NIH, CDC, and Trumka (Counts 2 and 3), and lastly Dreamland‘s constitutional claims against Trumka and the CPSC (Counts 6 and 7). Ultimately, the Court concludes that only one of Dreamland‘s claims survive Defendants’ motion to dismiss—Dreamland‘s arbitrary and capricious claim brought under the APA. Dreamland fails to state a claim that CPSC exceeded its statutory authority or failed to follow required procedures. The Court is unable to say the same, however, for Dreamland‘s arbitrary and capricious claim, which will require review of the Administrative Record in this case that has not yet been filed. The Court further concludes that Dreamland fails to meet the high bar required to state an ultra vires claim based on any clear statutory violation, and that it lacks standing to pursue constitutional claims that are no longer viable after three CPSC Commissioners have been removed. For the reasons discussed below, the Court grants Defendants’ motion as to all claims but Dreamland‘s arbitrary and capricious claim.
A. APA Claims
The parties raise the preliminary issue of whether there has been a final agency action ripe for judicial review. Under the APA, courts may review “final agency action for which there is no other adequate remedy in a court.”
Here, Dreamland‘s APA claims challenge the CPSC‘s publishing of its Safe Sleep guidance advising against the use of weighted blankets or swaddles, its decisions not to retract that statement, and its deadlocked vote on retracting Trumka‘s individual statements. See Compl. ¶¶ 148, 157, 176–79, 185, 187, 190–93. Defendants argue that the CPSC statement and deadlocked vote on Trumka‘s statements were neither “agency action” nor “final” within the meaning of the APA. MTD at 13–21. Plaintiffs appear to concede in their opposition brief that the deadlocked vote was not final agency action. See Pl.‘s Opp‘n at 14, 27. And Defendants do not contest whether CPSC‘s denial of Dreamland‘s retraction request was a reviewable final agency action. See Defs.’ Reply at 2. Thus, the parties dispute only whether CPSC‘s Safe Sleep statement on its website advising against the use of weighted blankets and swaddles was a final agency action. See id.; Pl.‘s Opp‘n at 14–19. But the Court need not decide this issue to resolve the present motion—as Plaintiffs explain, “[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.” See Pl.‘s Opp‘n at 14, 33, 36. On this point, the parties appear to agree, so the Court proceeds to analyze Dreamland‘s various APA claims
1. Excess of Statutory Authority
The APA provides courts with authority to “hold unlawful and set aside agency action . . . found to be . . . in excess of statutory jurisdiction, authority, or limitations, or short of statutory right.”
Here, Defendants argue that the “CPSC statement plainly falls within the agency‘s broad authority to disseminate product safety information.” MTD at 22. Dreamland responds that the CPSC failed to take required procedures—based in part on “an order of operations problem” where it relied on other agencies—before making its statement on weighted infant sleep products, and thus acted beyond its statutory authority. Pl.‘s Opp‘n at 13. But Dreamland fails to identify which procedures the CPSC was statutorily required, but failed, to take.
The Complaint cites provisions related to promulgating product safety standards under
As Defendants explained to Dreamland in the August 30, 2024 retraction denial letter, “Commission staff cleared [the statement] for public disclosure pursuant to [CPSC‘s] internal agency clearance process, found in Directive 1450.2.” Ex. 3 at 3. That Directive specifically allows for crosslinking to other agencies’ guidance “provided that the content complements safety information issued by the agency and is related to the agency‘s mission.” Directive 1450.2, App. B, Ex. 5 at 3. Though Dreamland alleges that CPSC‘s “statement was not cleared under CPSC‘s clearance procedures,” Dreamland provides 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. See Compl. ¶ 119. To the extent Dreamland argues that “[t]he Clearance Procedures also require the cleared statements to be supported by ‘data in Commission files,‘” Pl.‘s Opp‘n at 33, 35, Dreamland omits that the procedures also allow for statements to be supported by “data . . . in currently applicable literature,” that is, outside the Commission‘s files. Directive 1450.2 § 7.a.(1)(a).
Dreamland also faults CPSC for “ignor[ing] that it was without any data or evidence supporting its” statement. Pl.‘s Opp‘n at 22; see also Compl. ¶ 81. But that allegation is contradicted by Dreamland‘s own allegations, including data documenting five fatalities and eight injuries involving weighted sleep products. Compl. ¶¶ 84–86. Accepting those allegations
2. Arbitrary and Capricious
Under the APA, courts have authority to “hold unlawful and set aside agency action . . . found to be arbitrary” or “capricious.”
Dreamland further argues that CPSC blindly relied on CDC and NIH guidance, which was in turn based on “AAP‘s unsubstantiated recommendation.” See id. at 34–35. As mentioned above, Dreamland alleges that the AAP lacked any data or studies on the safety risks of weighted infant sleep products when it promulgated its revised guidance, on which the Safe to Sleep campaign relied. See Compl. ¶¶ 54–60. If there were no evidence of safety risks associated with weighted infant sleep products, then Dreamland‘s position would be logical, as consensus amongst health agencies based on nothing more than a data-less echo chamber and blind cross-linking would seemingly be arbitrary. But the face of Dreamland‘s Complaint refutes the absence of evidence—particularly the CPSC data involving multiple infant fatalities associated with weighted sleep products. See Compl. ¶¶ 84–86. As Defendants note, Dreamland “acknowledges that the data set revealed double-figure incidents—defined as ‘deaths + injuries’ involving weighted sleep products.” Defs.’ Reply at 17 (quoting Pl.‘s Opp‘n at 36). And Dreamland argues the CPSC had access to this data at least as early as December 2023. See Pl.‘s Opp‘n at 36.
Dreamland challenges not just the conclusion CPSC reached, but whether it acted arbitrarily and capriciously in reaching that decision. Without the Administrative Record, the Court is unable to make that determination at this juncture. See Swedish Am. Hosp., 691 F. Supp. 2d at 89 (“[T]he plaintiff is challenging not only the administrative decision, but also the process that led to that decision. The court is unable to assess the merits of these arguments without considering the administrative record.“); Dist. Hosp. Partners, L.P. v. Sebelius, 794 F. Supp. 2d 162, 173 (D.D.C. 2011) (denying motion to dismiss arbitrary and capricious APA claim
3. Without Required Procedures
Judicial review under the APA also provides courts with authority to “hold unlawful and set aside agency action . . . found to be . . . without observance of procedure required by law.”
Directive 1450.2 § 7.h(1) defines a joint project as “any project where an outside group, with some degree of CPSC involvement, produces any audio, visual, internet, written or other material or program for the public.” Directive 1450.2 § 7.h(1), Ex. 4 at 9 (emphasis added). But Dreamland‘s entire case is built around its view that CPSC “adopted” the NIH‘s determination and merely “inferr[ed] that [weighted infant sleep products] are unsafe” without making its own product safety determination. See Pl.‘s Opp‘n at 1, 34. Because Dreamland does not allege that CPSC was involved in the production of NIH‘s statement, its argument that CPSC had to clear NIH‘s statement under rules applying to Joint Projects fails. As a result, the Court will dismiss Count 5.
B. Ultra Vires Claims
The Court next considers Dreamland‘s claims against the HHS, CDC, NIH, and Trumka alleging ultra vires actions. An ultra vires claim “is available where (i) there is no express statutory preclusion of all judicial review; (ii) there is no alternative procedure for review of the
1. Against the Public Health Agencies
Dreamland has failed to allege that the NIH, CDC, or HHS violated any clear and mandatory statutory prohibition. Dreamland‘s entire argument is premised on its “key contention” that “CPSC, and only CPSC, is authorized by statute to make consumer product safety determinations in the first instance.” See Pl.‘s Opp‘n at 22–23. But what statute clearly prohibits the NIH and CDC from speaking on matters of consumer product safety related to
Dreamland acknowledges that, “[u]nlike most ultra vires challenges, which concern an agency‘s error regarding its own statutory authority, this case requires the Court to resolve an ultra vires challenge based on agencies arrogating the authority expressly provided to another agency under a different statute.” Pl.‘s Opp‘n at 23–24. But Dreamland offers no legal support for this abnormal theory of an ultra vires claim. See id. at 22–27.
As Dreamland‘s Complaint concedes, the Public Health Service Act (“PHSA“) “empowers HHS to develop, support, and maintain programs addressing sudden unexpected infant death and sudden unexpected death in childhood.” Compl. ¶ 162; see
In fact, Dreamland gives the game away when it argues that “it is questionable that CDC‘s and NIH‘s determinations even meet the requirements of the PHSA.” See Pl.‘s Opp‘n at 26. Because HHS, CDC, and NIH have not “plainly act[ed] in excess of [their] delegated powers and contrary to a specific prohibition in the statute that is clear and mandatory,” Count 2 must be dismissed. See Fed. Express, 39 F.4th at 763 (quoting Nyunt, 589 F.3d at 449).
2. Against Commissioner Trumka
Dreamland‘s ultra vires claim against Trumka starts out on better footing, as Dreamland identifies a statute Trumka allegedly violated,
Section 2055(b)(1) provides in relevant part:
[N]ot less than 15 days prior to its public disclosure of any information obtained under this Act, or to be disclosed to the public in connection therewith . . . the Commission shall, to the extent practicable, notify and provide a summary of the information to, each manufacturer or private labeler of any consumer product to which such information pertains, if the manner in which such consumer product is to be designated or described in such information will permit the public to ascertain readily the identity of such manufacturer or private labeler, and shall provide such manufacturer or private labeler with a reasonable opportunity to submit comments to the Commission in regard to such information. . . . The Commission shall take reasonable steps to assure, prior to its public disclosure thereof, that information from which the identity of such manufacturer or private labeler may be readily ascertained is accurate, and that such disclosure is fair in the circumstances and reasonably related to effectuating the purposes of this Act.
Here, Dreamland alleges that “Commissioner Trumka‘s public statements, letters, and social media posts . . . allowed the public to readily ascertain its identity because the statements included citations to a news article that specifically identified Dreamland and searches that
Though the Court agrees with Dreamland that Trumka did not merely repeat CPSC‘s statement, Pl.‘s Opp‘n at 28, and is skeptical of Defendants’ arguments that linking to another previously published source that specifically identifies a manufacturer would never trigger
C. Constitutional Claims
Dreamland brings two constitutional claims: one against Trumka alleging he is impermissibly biased, in violation of the Fifth Amendment‘s due process clause, and one against the CPSC based on its for-cause removal protection for Commissioners. As discussed above, all of the relevant Commissioners have now been removed from the CPSC and are no longer serving. See Defs.’ Reply at 19. Consequently, the Court concludes it lacks subject-matter jurisdiction over these claims.
1. Due Process Claim
To the extent Defendants previously argued that Dreamland‘s claims of future imminent harm by Trumka were speculative, Dreamland‘s risk of future harm is now virtually non-existent. See id.; MTD at 38. Dreamland‘s Complaint seeks “[a] permanent injunction enjoining Commissioner Trumka from participating in any future CPSC actions, including votes, regarding Dreamland‘s weighted infant sleep products and the class of weighted infant sleep products generally.” Compl. at 43. Dreamland alleged that this relief was justified because “[i]t is obvious from [Trumka‘s] statements and actions that he has clearly formed a strong negative impression of this class of products and is incapable of an unbiased consideration of actions affecting these products in the future.” Id. ¶ 206. In its opposition brief, Dreamland argued that “[a]s long as Commissioner Trumka is a member of the Commission, he still wields power that can continue to harm those protected interests,” and that “there is nothing stopping him” from causing harm in the future. Pl.‘s Opp‘n at 39–40. Dreamland later argues that “Commissioner Trumka‘s removal from the Commission would obviate the ongoing harm he poses to Dreamland because of his clear bias against it and weighted infant sleep products.” Id. at 45. The Court agrees. Because Trumka no longer serves as a Commissioner, Dreamland lacks standing to seek prospective injunctive relief related to his service. Accordingly, Count 6 must be dismissed.
2. For-Cause Removal Challenge
To the extent Dreamland seeks prospective relief based on
* * *
In sum, the Court agrees with Defendants that Dreamland has failed to state an APA claim against the CPSC based on agency action taken in excess of statutory authority or without required procedures. The Court also concludes that Dreamland failed to state an ultra vires claim against the other Defendants. And because President Trump has removed Commissioner Trumka and the other Commissioners who voted against Dreamland on its retraction request, Dreamland lacks standing to bring its constitutional claims against Trumka in his official capacity and against the CPSC based on the for-cause removal provision of the CPSA. Thus, the Court grants Defendants’
V. CONCLUSION
For the foregoing reasons, Defendants’ Motion to Dismiss (ECF No. 6) is GRANTED in part as to Counts 1–3 and 5–7, and DENIED in part as to Count 4. An order consistent with this Memorandum Opinion is separately and contemporaneously issued.
Dated: September 26, 2025
RUDOLPH CONTRERAS
United States District Judge