Paternalism and Product Safety:

The Consumer Product Safety Commission’s Approach toward Infant Nursery Products

The Consumer Product Safety Commission (CPSC) regulates consumer products to protect Americans from unreasonable risks of product-related injury.1 15 U.S.C. § 2051(b)(1). Created in 1972 by the Consumer Product Safety Act, this independent agency is authorized to adopt and enforce mandatory standards for consumer products, as well as to work with industries to develop voluntary product standards.2 “Who We Are – What We Do for You,” Consumer Product Safety Commission, accessed October 25, 2024, https://www.cpsc.gov/Safety-Education/Safety-Guides/General-Information/Who-We-Are—What-We-Do-for-You. If the CPSC determines that a product presents one or more unreasonable risks of injury and that no feasible safety standard would adequately protect consumers, the agency may ban that product through regulation.3 15 U.S.C. § 2057. Products not banned through regulation may be recalled by the CPSC if they present a “substantial product hazard.”4 15 U.S.C. § 2064.

The agency enforces 17 federal consumer-product safety laws, has adopted rules and regulations for 163 categories of products and substances, and has jurisdiction over $1.6 trillion in consumer products (as of 2021).5 “Statutes,” Consumer Product Safety Commission, accessed October 25, 2024, https://www.cpsc.gov/Regulations-Laws–Standards/Statutes; “Regulations, Mandatory Standards and Bans,” Consumer Product Safety Commission, accessed November 14, 2024, https://www.cpsc.gov/Regulations-Laws–Standards/Regulations-Mandatory-Standards-Bans; Government Accountability Office, “What Is the Consumer Product Safety Commission, and How Does It Protect Consumers from Hazards?,” WatchBlog, March 5, 2021, https://www.gao.gov/blog/what-consumer-product-safety-commission,-and-how-does-it-protect-consumers-hazards. In fiscal year 2023, the CPSC conducted an estimated 958 inspections, surveillance activities, and recall-effectiveness checks at businesses for compliance with its laws and regulations. In the same year, the agency pursued over 300 voluntary recalls of 97 million units of consumer products. The agency’s e-commerce surveillance team additionally completed more than three million platform screenings that led to the removal of over 59,800 product units from online stores.6 Consumer Product Safety Commission, Annual Performance Report Fiscal Year 2023, March 11, 2024, https://www.cpsc.gov/s3fs-public/FY-2023-APR-comp.pdf.

This research in brief looks at the CPSC’s regulation of nursery products, such as cribs, baby mattresses, bassinets, infant carriers, and high chairs.7 Consumer Product Safety Commission, “Durable Infant or Toddler Products,” accessed May 20, 2025, https://www.cpsc.gov/Business–Manufacturing/Business-Education/Durable-Infant-or-Toddler-Products. The CPSC’s regulatory goal, preventing defective products from harming infants, is worthwhile. Yet the CPSC’s own data show that, by far, most product-related injuries and deaths among infants are caused by consumers’ misuse of nursery products, not by the products themselves. The data also show that the types of misuse are common to all nursery products, yet the CPSC targets only certain products for elimination. All this suggests that the agency’s focus on products with no real defects is not the most effective way to increase infant safety.

This research in brief analyzes agency data on nursery products to answer the following question: Is the CPSC spending its resources in the most effective way to protect infants and young children? To do so, this brief reviews a case in which the CPSC went after a product with no objective defects and then examines the CPSC’s data on injuries and deaths associated with nursery products. Next, it explores the unintended consequences of the CPSC’s approach, including impacts on innovation and child safety. Finally, this brief suggests that to better serve its goals of reducing injuries and deaths, the agency should not attempt to reduce all risk but rather direct more of its resources toward educating parents about product misuse, which is the leading cause of product-related infant injury and death.

Leachco, Inc. v. Consumer Product Safety Commission

In February 2022, the CPSC filed an administrative complaint against Leachco, Inc. The CPSC alleged that three infant deaths were “associated with” Leachco’s infant lounger, called the Podster. The deaths resulted from sleep-related misuses that the Podster’s labels and instructions explicitly warn against, a fact the CPSC acknowledges. One infant was placed in a crib with a Podster and left unsupervised for over 90 minutes, another for 45 minutes. The third was in an adult bed with her parents, a Podster, bedding, and pillows.8 “Small Family Business Battles Arbitrary Prosecution for Baby Pillow,” Pacific Legal Foundation, accessed October 29, 2024, https://pacificlegal.org/case/cpsc-due-process-leachco/.

Instead of acknowledging that misuse and accidents may occur, however, the CPSC accused Leachco of selling a defective product. The agency alleged that the Podster presented a “substantial product hazard” and demanded that Leachco recall all units and provide refunds.9 “Small Family Business Battles,” Pacific Legal Foundation.

Leachco denied the allegations and defended itself in the CPSC’s administrative tribunal. It also objected to the administrative process itself, which entails an in-house prosecution rather than a review by an independent court. Accordingly, in August 2022, Leachco filed suit against the CPSC in federal court, arguing that the administrative proceedings against the company violate its constitutional right to due process of law and the constitutional separation of powers. This challenge was unsuccessful, as the US Supreme Court declined to hear the case in January 2025. In the administrative hearing, Leachco succeeded before the administrative law judge, but the CPSC’s enforcement lawyers have appealed to the CPSC’s commissioners.10 “Small Family Business Battles,” Pacific Legal Foundation.

For consumers of nursery products, the CPSC’s actions portend the loss of a popular and safe product: Leachco had sold 180,000 Podsters since the product’s introduction in 2009, and no injury or death has resulted from its proper use.11 “Small Family Business Battles,” Pacific Legal Foundation; Consumer Product Safety Commission, Memorandum Opinion and Initial Order Denying Relief Sought in the Complaint, July 3, 2024, https://www.cpsc.gov/s3fs-public/pdfs/recall/lawsuits/abc/148-CPSC_Docket_No_22-1_In_the_Matter_of_Leachco_Inc_ALJ_Decision.pdf. For Leachco, the potential recall portends great cost: forgone revenue, litigation expenses, and a damaged reputation.

Misuse as Defect

The CPSC’s targeting of Leachco’s Podster may be explained by the agency’s incentives. The CPSC can facilitate the recall or ban of a product without much publicity, but if the CPSC fails to remove a product that is later associated with an infant’s death, the agency will likely face heightened scrutiny. The agency is thus incentivized to avoid blame.

This kind of incentive has been observed in another public health agency, the US Food and Drug Administration (FDA). One study finds that the FDA is “overly conservative” in approving drugs and therapies for the deadliest diseases for fear of approving harmful or ineffective drugs.12 Leah Isakov, Andrew W. Lo, and Vahid Montazerhodjat, “Is the FDA Too Conservative or Too Aggressive?: A Bayesian Decision Analysis of Clinical Trial Design,” Journal of Econometrics 211, no. 1 (2019): 117–36. It is therefore reasonable to inquire whether the CPSC employs a similarly overcautious approach toward nursery products.

Consider the CPSC’s claims against Leachco. The CPSC has not banned the Podster or any other infant lounger through regulation. In its administrative action to recall the Podster, the CPSC had to establish that the Podster had a “product defect,” which “because of the pattern of defect, the number of defective products distributed in commerce, the severity of the risk, or otherwise…creates a substantial risk of injury to the public.”13 15 U.S.C. § 2064(a)(2).

Many of these terms are not defined in the Consumer Product Safety Act, but the CPSC has issued “interpretive” rules to fill in the gaps.14 16 C.F.R. § 1115.4. Under well-established law, interpretive rules are not binding on the public. The CPSC, however, treats them as binding. Through its interpretive rules, the CPSC allows itself to consider any factors that the agency deems relevant when identifying a substantial product hazard. Most importantly here, the CPSC never identified any objective design or manufacturing defect with the product itself. Instead, using its “interpretive” rules, the agency claimed that the Podster was defective because it was “reasonably foreseeable” that parents and caregivers might ignore the Podster’s warnings and misuse it.15 “Small Family Business Battles,” Pacific Legal Foundation.

As Leachco discovered, the CPSC has used these rules to claim broad discretion to determine whether a product presents a substantial product hazard. The CPSC declared that consumer misuse could, by itself, render a product defective. In other words, product “defects” can include no defects at all—just the potential for or evidence of misuse, in the CPSC’s judgment. Such an approach could be applied to every product on the market.

Nursery Product Reports

Although the CPSC ultimately targets products, products themselves are not the biggest threat to infant safety, and the agency knows this.

Each year, the CPSC publishes a report, Injuries and Deaths Associated with Nursery Products among Children Younger than Age Five. The injuries are reported annually, while the death statistics are calculated using the three most recent years’ data. For example, the 2024 report averages total deaths from calendar years 2019, 2020, and 2021.16 “Toys and Children Products,” Consumer Product Safety Commission, accessed November 14, 2024, https://www.cpsc.gov/Research–Statistics/Toys-and-Childrens-Products.

These reports include the number of emergency department-treated injuries and deaths that are “associated with” nursery products (cribs, cradles, etc.). Accordingly, the CPSC’s reports not only identify the types of products most commonly associated with injuries and deaths, they also describe the “hazard patterns” (how injuries typically occur), distinguishing between (a) associated products that were themselves faulty and (b) associated products that the consumer misused.17 “Toys and Children Products,” Consumer Product Safety Commission. These reports show that not all injuries and deaths associated with products are caused by those products. Rather, many injuries and deaths occurred merely in the presence of the various products.

For example, in each year from 1998 to 2023, falls were the leading cause of nursery product-related injuries of children younger than five. The high-chair category was associated with the most injuries each year from 2015 to 2023 and has been a top-five category each year since 1998.18 “Toys and Children Products.” Research on injuries involving high chairs has shown that the majority of children who fall do so after climbing or standing in the chair, suggesting that proper use and supervision would prevent most if not all such injuries.19 Nationwide Children’s Hospital, “New Study Finds 24 Children a Day are Treated in U.S. Emergency Departments for High Chair-Related Injuries,” news release, December 9, 2013, https://www.nationwidechildrens.org/newsroom/news-releases/2013/12/new-study-finds-24-children-a-day-are-treated-in-us-emergency-departments-for-high-chair-related; Elizabeth C. Powell, Edward Jovtis, and Robert R. Tanz, “Incidence and Description of High Chair-Related Injuries to Children,” Ambulatory Pediatrics 2, no. 4 (2002): 276–78.

Furthermore, several CPSC reports state, “the hazard patterns above indicate that while a nursery product was involved, many of the fatalities were not directly caused by failures in the product,”20 Risana T. Chowdhury, Nursery Product-Related Injuries and Deaths among Children under Age Five (Washington, DC: Consumer Product Safety Commission, 2008). whereas other reports state, “the hazard patterns described indicate that although a nursery product was involved, many of the fatalities were associated with how the product was used, including putting the product in a hazardous situation, and/or using it in a hazardous manner.”21 Ted Yang, Injuries and Deaths Associated with Nursery Products among Children Younger than Age Five (Washington, DC: Consumer Product Safety Commission, 2022).

The most recent report, released in August 2024, highlights “unsafe sleep environments” as the leading cause of both injuries and deaths associated with nursery products over the period from 2019 to 2021. Unsafe sleep environments are the result of parents’ and caregivers’ adding soft bedding, pillows, blankets, or some combination of those items to sleep products that should be bare—in other words, product misuse.22 Consumer Product Safety Commission, “New CPSC Report Shows Unsafe Sleep Environments Are Leading Cause of Injuries and Deaths with Nursery Products,” news release no. 24-365, September 19, 2024, https://www.cpsc.gov/Newsroom/News-Releases/2024/New-CPSC-Report-Shows-Unsafe-Sleep-Environments-Are-Leading-Cause-of-Injuries-and-Deaths-with-Nursery-Products.

Cribs and Mattresses

In each three-year period from 1992 to 2021, the cribs and mattresses category was associated with the most deaths of children younger than five.23 “Toys and Children Products,” Consumer Product Safety Commission. Starting with the three-year period from 2002 to 2004, every CPSC report delves into the hazard patterns that the agency believes led to nursery product-related deaths. These patterns are most observable in the data presented for deaths related to cribs and mattresses.

Deaths associated with cribs generally fall into two categories: deaths due to product defects and deaths due to product misuse.24 The CPSC breaks down deaths associated with cribs into three causal categories: (1) “a cluttered sleep environment” or extra bedding, (2) “the presence of hazardous crib surroundings,” and (3) “a range of hazards associated with the crib.” Because data for each category are not always available, this section combines the first two categories under “product misuse,” while the third category is a high estimate of “product defects.” Ted Yang, Injuries and Deaths Associated with Nursery Products among Children Younger than Age Five (Washington, DC: Consumer Product Safety Commission, 2024), 10–11. According to CPSC data, product misuse caused a majority of crib-related deaths of children younger than five in each three-year period from 2002 to 2021. Over this period, product misuse was responsible for an average of 82 percent of crib-related fatalities, compared with 18 percent caused by product defects.

The proportion of deaths due to product misuse has grown consistently from its low of 62 percent in the years 2004–2006 to its high of 91 percent in the years 2019–2021, an increase of 47 percent. Meanwhile, the share of deaths due to product defects has fallen by 76 percent during this time, from a high of 38 percent in the years 2004–2006 to a low of 9 percent in the years 2019–2021.25 “Toys and Children Products,” Consumer Product Safety Commission.

Figure 1. Percentage of Crib-Related Deaths Due to Product Defects and Product Misuse, 2002–2021

Note: “Product defects” refer to deaths due to “a range of hazards associated with the crib,” and “product misuse” refers to (a) deaths due to “a cluttered sleep environment” and (b) deaths due to “the presence of hazardous crib surroundings.”

Source: “Toys and Children Products,” Consumer Product Safety Commission, accessed November 14, 2024, https://www.cpsc.gov/Research–Statistics/Toys-and-Childrens-Products; Ted Yang, Injuries and Deaths Associated with Nursery Products among Children Younger than Age Five (Washington, DC: Consumer Product Safety Commission, 2024), 10–11.

For as long as the CPSC has reported data on the causes of product-related infant deaths,26 Data on the number of infant deaths by product category go back to at least 1992, but data on the causes and hazard patterns of product-related infant deaths only go back to 2002. most crib-related fatalities have resulted from product misuse, not from product defects. As figure 1 shows, the disparity has increased in recent years. Product defects accounted for less than 10 percent of total crib-associated fatalities in each of the last four reports, whereas product misuse accounted for more than 90 percent.

The increased proportion of crib-related deaths from product misuse could be attributed to the CPSC’s removal of faulty cribs from the market. According to the agency’s public recall database, crib recalls climbed to 14 products in 2008 and reached a peak of 20 in 2010. In all other years, crib recalls were in single digits.27 “Recalls and Product Safety Warnings,” Consumer Product Safety Commission, accessed November 14, 2024, https://www.cpsc.gov/Recalls”. But these peaks came after, not before, the divide in fatality trends between product defects and product misuse began growing. Many of these recalls were of drop-side cribs, which were banned in 2011.28 Consumer Product Safety Commission, “CPSC Approves Strong New Crib Safety Standards to Ensure a Safe Sleep for Babies and Toddlers,” news release no. 11-074, December 17, 2010, https://www.cpsc.gov/Newsroom/News-Releases/2011/CPSC-Approves-Strong-New-Crib-Safety-Standards-To-Ensure-a-Safe-Sleep-for-Babies-and-Toddlers.

Other Nursery Products

These trends are not unique to cribs. Three other nursery-product categories have consistently been among the top five most associated with infant fatalities: bassinets and cradles, playpens and play yards, and infant carriers and car seat carriers. Data are less available for these categories, and the CPSC describes the prevalence of their hazard patterns using words such as “majority,” “most,” “some,” and “few” instead of quantifying percentages. In every three-year period from 2002 to 2021, most deaths of children under five associated with these categories were caused by product misuse, not product defects.

For bassinets and cradles, most deaths in each report were the result of extra bedding used in the product. A few were the result of product defects or hazardous surroundings.29 “Toys and Children Products,” Consumer Product Safety Commission.

For playpens and play yards, a few deaths were the result of faulty products, but most were the result of asphyxiation from added bedding, positional asphyxia from wedging between the mattress and the side of the product, strangulations or suffocations due to a hazardous environment in or around the product, or suffocation on bedding.

For infant carriers, most deaths were the result of strangulation in the restraint straps or the hazardous placement of the infant in the carrier. The rest were the result of carriers tipping over when placed on nonrigid surfaces.30 “Toys and Children Products.”

Meanwhile, nursery product-related deaths of children younger than five have increased over the same period (see figure 2). For crib-related deaths, the average annual figure per 100,000 rose by 15.7 percent from the years 2002–2004 to the years 2019–2021. During this time, average annual deaths per 100,00 associated with bassinets, playpens and play yards, and infant carriers increased by 272.3 percent, 140.5 percent, and 47.0 percent, respectively. Lastly, deaths per 100,000 associated with all nursery products rose by 91.8 percent from the years 2002–2004 to the years 2019–2021, increasing each three-year period since 2012–2014.31 “Toys and Children Products”; Federal Reserve Bank of St. Louis, “Population, Total for United States,” last updated July 2, 2024, https://fred.stlouisfed.org/series/POPTOTUSA647NWDB.

Figure 2. Percentage Change in Infant Deaths per 100,000 across Product Categories, 2002–2021

Source: “Toys and Children Products,” Consumer Product Safety Commission, accessed November 14, 2024, https://www.cpsc.gov/Research–Statistics/Toys-and-Childrens-Products; Federal Reserve Bank of St. Louis, “Population, Total for United States,” last updated July 2, 2024, https://fred.stlouisfed.org/series/POPTOTUSA647NWDB.

Nursery product-related deaths have increased, and the majority of deaths related to these categories have been due to consumers’ misusing the nursery products.

Regulation’s Effects on Innovation and Safety

Risk is inherent in all products and in life. According to the Centers for Disease Control and Prevention, there were about 3,700 sudden unexpected infant deaths in the United States in 2022, 1,040 of which were from accidental suffocation and strangulation in bed.32 “Data and Statistics for SUID and SIDS,” Centers for Disease Control and Prevention, September 17, 2024, https://www.cdc.gov/sudden-infant-death/data-research/data/index.html.

The statute authorizing the CPSC’s authority seems to account for inherent risk, tasking the agency with protecting people from “unreasonable risks of injury associated with consumer products.”33 15 U.S.C. § 2051(b)(1). Acting against unreasonable risks is different than acting against any risk. But the CPSC’s recent actions reveal an incoherent approach—targeting certain products, like Leachco’s Podster, for elimination because of infant-sleep hazard patterns, while documenting those same hazard patterns for more ubiquitous products like cribs, bassinets, and high chairs. As a result, the CPSC attempts to eliminate any risk for certain nondefective products by removing them from the market; this attempt, though, invites more risk to children through moral hazards and forgone innovation.

If consumers believe the CPSC will protect them from all potentially dangerous products, consumers may fail to recognize the greater risk that stems from their own actions. As a result, parents may spend less time supervising their children, heeding warnings, or paying attention to safe and correct product use.

As professors Jonathan Klick and Gregory Mitchell argue, “the negative learning and motivational effects of paternalistic regulations” often have long-run costs that offset short-run gains.34 Jonathan Klick and Gregory Mitchell, “Government Regulation of Irrationality: Moral and Cognitive Hazards,” Minnesota Law Review 90, no. 6 (2006): 1625. These long-run costs include moral hazards, which “arise because paternalistic regulations reduce an individual’s motivation to act deliberately and carefully.”35 Klick and Mitchell, “Government Regulation of Irrationality,” 1626. By diverting attention from the importance of proper product use and truly defective products, the CPSC’s paternalism could increase the risks of child injury and death.

Burdensome regulation of nursery products may also disincentivize innovation, which can harm consumers by preventing life-improving products from being created. Scholars have found that a 10 percent increase in industry-specific regulation is correlated with a 0.5 percent reduction in the total number of firms and with a 0.6 percent reduction in employment among small firms.36 Dustin Chambers, Patrick A. McLaughlin, and Tyler Richards, “Regulation, Entrepreneurship, and Firm Size,” Journal of Regulatory Economics 61, no. 2 (2018): 108–34.

Complying with regulations has a cost, and while large firms may be able to comply with the CPSC, smaller firms may be driven out of business or fail to launch. Fewer firms means less competition, reducing the incentive for remaining firms to improve quality and safety. Reduced innovation limits consumer choice and may increase consumer risk. As policy analyst Adam Thierer writes in his book Permissionless Innovation, despite the best of intentions, “Trying to preemptively plan for every hypothetical worst-case scenario means that many best-case scenarios will never come about. That is, the benefits that accompany the freedom to experiment will be sacrificed if fear paralyzes our innovative spirit.”37 Adam Thierer, Permissionless Innovation: The Continuing Case for Comprehensive Technological Freedom (Arlington, VA: Mercatus Center at George Mason University, 2016), 82. When the government tries to prevent any possible risk, there are unintended consequences and trade-offs, such as the products never created and the alternative risks that emerge.

Because risk is inherent in life, a policy goal of eliminating risk is unattainable. A zero-risk goal also ignores the reality that the relevant trade-off is not between the risk of using a particular product and a baseline level of zero risk. All action involves risk, including the risk of forgone alternatives. For example, if infant loungers like the Podster are banned, caregivers will seek alternatives. They may instead use regular pillows, blankets, or other products not designed for infants, presenting greater risk to their children. As economist and parent Emily Oster writes, “People face trade-offs. No option is perfect or without downsides.”38 Emily Oster, “Understanding Risk, Living with Uncertainty,” ParentData, last updated December 17, 2024, https://parentdata.org/understanding-risk-living-with-uncertainty/. Policymakers must acknowledge these trade-offs.

Recommendations

The cause of most product-related infant injuries and deaths is product misuse, not product defects. But with its sweeping discretion to regulate product misuse as a defect, even when nothing is objectively wrong with a product, the CPSC can punish manufacturers for conduct beyond their control. Ultimately, Congress has the power, either by amending the Consumer Product Safety Act or through other legislation, to define terms such as “product defect” that remain statutorily undefined. Doing so could reduce vast agency discretion and establish more objective standards for determining substantial product hazards.

Additionally, while the CPSC cannot control consumer behavior, it can control its own discretion, investigation, reporting, and messaging to properly inform consumers of the real risks posed by their actions. The agency can thus allow and encourage innovation while fulfilling its mission of reducing product-related injuries and deaths by focusing more on consumer education and sharing accurate data and information with parents and consumers so they can use it to inform their behavior. Informing the public about the frequency and dangers of product misuse could save more lives than recalling or banning products that lack objective defects.

Acknowledgments

The authors thank Jacob Fishbeck for his helpful feedback and contributions to this brief.

Sources

[1]   15 U.S.C. § 2051(b)(1).

[2]   “Who We Are – What We Do for You,” Consumer Product Safety Commission, accessed October 25, 2024, https://www.cpsc.gov/Safety-Education/Safety-Guides/General-Information/Who-We-Are—What-We-Do-for-You.

[3]   15 U.S.C. § 2057.

[4]   15 U.S.C. § 2064.

[5]   “Statutes,” Consumer Product Safety Commission, accessed October 25, 2024, https://www.cpsc.gov/Regulations-Laws–Standards/Statutes; “Regulations, Mandatory Standards and Bans,” Consumer Product Safety Commission, accessed November 14, 2024, https://www.cpsc.gov/Regulations-Laws–Standards/Regulations-Mandatory-Standards-Bans; Government Accountability Office, “What Is the Consumer Product Safety Commission, and How Does It Protect Consumers from Hazards?,” WatchBlog, March 5, 2021, https://www.gao.gov/blog/what-consumer-product-safety-commission,-and-how-does-it-protect-consumers-hazards.

[6]   Consumer Product Safety Commission, Annual Performance Report Fiscal Year 2023, March 11, 2024, https://www.cpsc.gov/s3fs-public/FY-2023-APR-comp.pdf.

[7]   Consumer Product Safety Commission, “Durable Infant or Toddler Products,” accessed May 20, 2025, https://www.cpsc.gov/Business–Manufacturing/Business-Education/Durable-Infant-or-Toddler-Products.

[8]   “Small Family Business Battles Arbitrary Prosecution for Baby Pillow,” Pacific Legal Foundation, accessed October 29, 2024, https://pacificlegal.org/case/cpsc-due-process-leachco/.

[9]   “Small Family Business Battles,” Pacific Legal Foundation.

[10]  “Small Family Business Battles,” Pacific Legal Foundation.

[11]  “Small Family Business Battles,” Pacific Legal Foundation; Consumer Product Safety Commission, Memorandum Opinion and Initial Order Denying Relief Sought in the Complaint, July 3, 2024, https://www.cpsc.gov/s3fs-public/pdfs/recall/lawsuits/abc/148-CPSC_Docket_No_22-1_In_the_Matter_of_Leachco_Inc_ALJ_Decision.pdf.

[12]  Leah Isakov, Andrew W. Lo, and Vahid Montazerhodjat, “Is the FDA Too Conservative or Too Aggressive?: A Bayesian Decision Analysis of Clinical Trial Design,” Journal of Econometrics 211, no. 1 (2019): 117–36.

[13]  15 U.S.C. § 2064(a)(2).

[14]  16 C.F.R. § 1115.4.

[15]  “Small Family Business Battles,” Pacific Legal Foundation.

[16]  “Toys and Children Products,” Consumer Product Safety Commission, accessed November 14, 2024, https://www.cpsc.gov/Research–Statistics/Toys-and-Childrens-Products.

[17]  “Toys and Children Products,” Consumer Product Safety Commission.

[18]  “Toys and Children Products.”

[19]  Nationwide Children’s Hospital, “New Study Finds 24 Children a Day are Treated in U.S. Emergency Departments for High Chair-Related Injuries,” news release, December 9, 2013, https://www.nationwidechildrens.org/newsroom/news-releases/2013/12/new-study-finds-24-children-a-day-are-treated-in-us-emergency-departments-for-high-chair-related; Elizabeth C. Powell, Edward Jovtis, and Robert R. Tanz, “Incidence and Description of High Chair-Related Injuries to Children,” Ambulatory Pediatrics 2, no. 4 (2002): 276–78.

[20] Risana T. Chowdhury, Nursery Product-Related Injuries and Deaths among Children under Age Five (Washington, DC: Consumer Product Safety Commission, 2008).

[21] Ted Yang, Injuries and Deaths Associated with Nursery Products among Children Younger than Age Five (Washington, DC: Consumer Product Safety Commission, 2022).

[22] Consumer Product Safety Commission, “New CPSC Report Shows Unsafe Sleep Environments Are Leading Cause of Injuries and Deaths with Nursery Products,” news release no. 24-365, September 19, 2024, https://www.cpsc.gov/Newsroom/News-Releases/2024/New-CPSC-Report-Shows-Unsafe-Sleep-Environments-Are-Leading-Cause-of-Injuries-and-Deaths-with-Nursery-Products.

[23] “Toys and Children Products,” Consumer Product Safety Commission.

[24] The CPSC breaks down deaths associated with cribs into three causal categories: (1) “a cluttered sleep environment” or extra bedding, (2) “the presence of hazardous crib surroundings,” and (3) “a range of hazards associated with the crib.” Because data for each category are not always available, this section combines the first two categories under “product misuse,” while the third category is a high estimate of “product defects.” Ted Yang, Injuries and Deaths Associated with Nursery Products among Children Younger than Age Five (Washington, DC: Consumer Product Safety Commission, 2024), 10–11.

[25] “Toys and Children Products,” Consumer Product Safety Commission.

[26] Data on the number of infant deaths by product category go back to at least 1992, but data on the causes and hazard patterns of product-related infant deaths only go back to 2002.

[27] “Recalls and Product Safety Warnings,” Consumer Product Safety Commission, accessed November 14, 2024, https://www.cpsc.gov/Recalls”.

[28] Consumer Product Safety Commission, “CPSC Approves Strong New Crib Safety Standards to Ensure a Safe Sleep for Babies and Toddlers,” news release no. 11-074, December 17, 2010, https://www.cpsc.gov/Newsroom/News-Releases/2011/CPSC-Approves-Strong-New-Crib-Safety-Standards-To-Ensure-a-Safe-Sleep-for-Babies-and-Toddlers.

[29] “Toys and Children Products,” Consumer Product Safety Commission.

[30] “Toys and Children Products.”

[31] “Toys and Children Products”; Federal Reserve Bank of St. Louis, “Population, Total for United States,” last updated July 2, 2024, https://fred.stlouisfed.org/series/POPTOTUSA647NWDB.

[32] “Data and Statistics for SUID and SIDS,” Centers for Disease Control and Prevention, September 17, 2024, https://www.cdc.gov/sudden-infant-death/data-research/data/index.html.

[33] 15 U.S.C. § 2051(b)(1).

[34] Jonathan Klick and Gregory Mitchell, “Government Regulation of Irrationality: Moral and Cognitive Hazards,” Minnesota Law Review 90, no. 6 (2006): 1625.

[35] Klick and Mitchell, “Government Regulation of Irrationality,” 1626.

[36] Dustin Chambers, Patrick A. McLaughlin, and Tyler Richards, “Regulation, Entrepreneurship, and Firm Size,” Journal of Regulatory Economics 61, no. 2 (2018): 108–34.

[37] Adam Thierer, Permissionless Innovation: The Continuing Case for Comprehensive Technological Freedom (Arlington, VA: Mercatus Center at George Mason University, 2016), 82.

[38] Emily Oster, “Understanding Risk, Living with Uncertainty,” ParentData, last updated December 17, 2024, https://parentdata.org/understanding-risk-living-with-uncertainty/.

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