This Article contends that food and drug law has fallen short in safeguarding and advancing children’s health. The Food and Drug Administration’s (FDA’s) mission is to protect and promote public health, and children’s health is an integral part of that. This Article uses the feminist legal method of “asking the woman question” to examine how food and drug law has impacted issues related to children’s health. To better address children’s health, this Article argues that FDA should create a children’s health office to actively identify, assess, monitor, and address issues impacting children in and across all the major FDA-regulated product categories—food, drugs, biologics, devices, cosmetics, and tobacco products.
Recent high-profile issues involving Food and Drug Administration (FDA)-regulated products have highlighted FDA’s limitations and shortcomings when it comes to protecting and promoting children’s health. Formula shortages, baby foods reported to contain heavy metals, children’s cosmetics reported to contain asbestos, drug shortages, and youth e-cigarette use are only a few examples of recent issues involving FDA-regulated products that may threaten children’s health.
Addressing children’s needs is essential to FDA’s ability to fulfill its mission of “[p]rotecting and [p]romoting [p]ublic [h]ealth.” Public health aims to “fulfill[] society’s interest in assuring conditions in which people can be healthy.” Children comprise about 22% of the United States population, and health during childhood impacts adult health. “[Children’s] health is the public’s health,” and we all have a stake in it.
Despite the importance of FDA-regulated products to children’s—and society’s—well-being and FDA’s mission, FDA has frequently addressed issues surrounding children’s health in a piecemeal fashion by product category. Moreover, where FDA has used a broader, more comprehensive approach, it has frequently focused on drugs, biological products (biologics), and medical devices and excluded food, cosmetics, and tobacco products. This Article argues that there is a need to examine the impact of FDA regulation on children across all the product categories, which may help FDA better anticipate, avoid, respond to, and move beyond specific issues to advance children’s health.
To do this, this Article examines how federal food and drug law impacts children. Drawing on feminist legal scholarship and methods, it asks a series of questions modeled on the “woman question” to examine how this area of law impacts children. It asks if children have been left out of consideration. Using examples from each of the six major FDA-regulated product categories—food, drugs, biologics, devices, cosmetics, and tobacco products, this Article answers that question affirmatively. It then asks how that omission might be corrected and what difference it would make to do so. Ultimately, this Article argues that FDA needs an office of children’s health devoted to actively identifying, assessing, monitoring, and addressing issues impacting children in and across all product categories.
This Article proceeds as follows: Part I considers how the term “children” has been defined and explains how this Article uses it. Part I then discusses the legal scholarship and methods that provide the framework for this examination of food and drug law. After a brief discussion of children and the development of food and drug law, Part II uses examples from each of the major FDA-regulated product categories to argue that FDA regulation has failed to fully consider children’s needs to the detriment of children’s health. Part III then asks how that omission might be corrected. It considers how focused attention to food and drug law’s impact on children’s health matters might advance FDA’s mission. Part III also explores potential models for a children’s health office, including FDA’s Office of Women’s Health (OWH) and Office of Minority Health and Health Equity (OMHHE), and the Environmental Protection Agency’s (EPA’s) Office of Children’s Health Protections (OCHP).
This Article focuses on the impact of food and drug law on “children.” While the lay, legal, and medical definitions of “child” differ somewhat, this Article focuses on persons from birth up to age eighteen, which, for simplicity, it refers to as “children.” Where possible, this Article specifies the children to which it is referring. Accordingly, it sometimes uses other terms, such as babies, infants, toddlers, and teens, to refer to subgroups of children.
Where this Article cites a specific source, it tries to adopt the source’s terminology and explain how it is defined. For example, FDA often uses the term “pediatric” when discussing children’s health, however, the meaning of “pediatric” varies. While the definition of “pediatric” overlaps with this Article’s definition of “children,” it is not coterminous as it is used to refer to patients younger than seventeen as well as patients up to twenty-one.
In the United States, there were approximately 72.5 million children aged zero to seventeen in 2022. These children were roughly equally divided among the three age groups: zero to five (approximately 22.4 million children), six to eleven (24.2 million), and twelve to seventeen (25.8 million), with slightly more children in the older groups. There were slightly fewer female (approximately 35 million or 49%) than male children (approximately 37 million or 51%). Children are more ethnically and racially diverse than adults, with 49% of children white, non-Hispanic, 26% Hispanic, 14% Black, non-Hispanic, 6% Asian, non-Hispanic, and 6% non-Hispanic “[a]ll other races” in 2022. In addition, children are more likely to live in poverty than those over age eighteen. More than one in seven (or 15.3% of) children lived in poverty in 2021, with younger children and children of color being more likely to live in poverty than older children and white, non-Hispanic children.
Children are a vulnerable population. Children are still developing and differ from adults in important ways relevant to food and drug law. For example, “[c]hildren are at greater risk from environmental hazards than adults because they have different and unique exposures, . . . different responses to risks that are exacerbated by longer life expectancy[, and] . . . critical windows of vulnerability that have no parallels in adult physiology.” Pediatric patients “are not just small adults.” Diseases may have different clinicopathological features in children compared to adults, and some adult-onset conditions (e.g., type 2 diabetes and hypertension) may be rooted in childhood lifestyles. Children may react differently to medicines than adults, and medicines may alter children’s future outcomes.
Congress and FDA have required and sought to incentivize pediatric research. Children are cognitively different from adults. “They lack the autonomy and [decisionmaking] capacity to ethically and legally consent to participate in research and to understand and assume” research risks. There are also “inequalities of power between” children and adults. Accordingly, Congress, the Department of Health and Human Services (HHS), and FDA have taken measures to protect children as human subjects. But children are also vulnerable because historically, children’s health issues have been understudied, and there would be no appropriately evaluated therapeutic products for them without pediatric research. “Clinical investigations involving children are essential for obtaining data on the safety and effectiveness of medical products in children and to protect children from the risks associated with exposure to medical products that may be unsafe or ineffective.” Children also may be vulnerable due to factors or characteristics beyond their age, such as gender, sex, race, socioeconomic status, and other factors.
This Article uses “the child question” to examine how food and drug law impacts children. Asking the child question is rooted in feminist legal methods, specifically, “asking ‘the woman question.’” The exact phrasing of the woman question varies, but at its heart, it highlights the gendered impacts of aspects of the law that may “otherwise appear to be neutral or objective.” For example, Katharine T. Bartlett has framed the woman question as: “[H]ave women been left out of consideration? If so, in what way[?] [H]ow might that omission be corrected? [And w]hat difference would it make to do so?” Scholars and commentators have used the question to examine rules and practices in various legal areas, including health-related ones.
As framed by Barbara Bennett Woodhouse, the child question, like the woman question in which it is rooted, is several questions. Woodhouse reworks the woman question to ask: “How have children’s experiences and values been left out of the law? . . . . [And i]n an ideal world, what would the life situation of children look like and how could law play a role in bringing this ideal world about?”
As a feminist legal method, “asking the woman question” draws attention to the laws, policies, and practices that stand in the way of women and “members of other excluded groups” flourishing. By asking about the effect of the law on women and members of other excluded groups, the woman question seeks to examine “other bases of exclusion” and “overlapping forms of oppression.” It seeks to account for the fact that, among other things, race, ethnicity, sexual orientation, and class intersect with gender and shape women’s experiences.
Asking the child question is consistent with––and inextricably intertwined with––asking the woman question. This Article asks the child question to examine how food and drug law impacts children as a vulnerable and excluded group. For clarity, this Article refers to this as asking the child question, although, asking about vulnerable groups is asking the woman question. Ultimately, asking the woman question should not solely be viewed as a means of promoting women’s flourishing but also as a tool for expanding human flourishing more broadly, including for children. As Woodhouse has written, “building a world in which children flourish is integral to the project of building a world in which women flourish, and vice versa.” Accordingly, improving food and drug law for children may improve it for women and other adults.
On its face, the woman question does not ask about girls, i.e., children. The focus on women, i.e., adults, excludes them. Nevertheless, to comprehensively analyze gender, one must account for how gender and age intersect and shape girls’ and women’s experiences. “Full equality” of women cannot be achieved without considering girls’ experiences.
Women’s and children’s fortunes are often closely intertwined. Almost half of all children are female, and children become adults, including women. Girls’ use of and exposure to FDA-regulated products may impact their health as adults. For example, exposure to lead through FDA-regulated products can lead to long-term adverse health effects. In addition, food and drug law’s limitations for children may negatively impact women who disproportionately do the work of caring for them.
Asking the child question is not without limitations. Using “children” as a category, like using “women,” is too general and risks essentialism. Asking how food and drug law impacts children fails to account for differences between neonates and adolescents, for example.
Many intersecting factors shape food and drug law’s impact on children. Accordingly, when this Article discusses children, it tries to indicate to which children it refers, though even referring to specific categories may still be too general. At the same time, focusing on the impact of food and drug law on children is also too specific, as the products regulated by FDA may pose dangers and risks or offer benefits to all who use and consume them, not just children. Nevertheless, this Article asks the child question about food and drug law to advance this area for children and everyone who was once a child.
This Part provides examples of how tragedies and other issues impacting children have shaped food and drug law’s development. It then asks the child question about food and drug law to show that this area has fallen short in protecting and promoting children’s health.
FDA’s power to regulate drugs, biologics, devices, food, cosmetics, and tobacco products primarily derives from the Federal Food, Drug, and Cosmetic Act (FDCA) and the Public Health Service Act (PHSA), as amended. FDA’s authority varies significantly by product category. While drugs and biologics require premarket approval/licensure, only some devices and tobacco products and one subcategory of food (food additives) do, and approval is not required for cosmetics.
Historically, tragedies involving children and FDA-regulated products have shaped the development of food and drug law. For example, Congress passed the 1902 Biologics Control Act after nearly two dozen children died of tetanus after receiving a contaminated antitoxin or vaccine. Public outrage following “the death of nearly [100] children” who had taken “an antibiotic sulfanilamide . . . containing a highly toxic diethylene glycol,” helped prompt the enactment of the 1938 FDCA. Moreover, the 1962 Drug Amendments were passed “partly in response to the reported teratogenic effects of Thalidomide,” a drug that caused severe congenital abnormalities in children whose mothers took it during pregnancy. FDA did not allow thalidomide’s pending new drug application to become effective in the United States. However, it was marketed elsewhere, and “approximately 10,000 children were born with phocomelia,” which “causes the upper or lower limbs of [a] child to be underdeveloped or missing.”
More recently, when Congress enacted the Tobacco Control Act in 2009, it found that “[r]educing the use of tobacco by minors by [50%] would prevent well over 10,000,000 of today’s children from becoming regular, daily smokers, saving over 3,000,000 of them from premature death due to tobacco-induced disease.”
In addition, outbreaks of foodborne illnesses, including a 2008–2009 multistate salmonella outbreak linked to peanuts, led Congress to enact the Food Safety Modernization Act (FMSA) in 2011. Foodborne illnesses may disproportionately impact children. For example, CDC indicated that the median age of the 714 people reported to be infected in the salmonella outbreak was sixteen, “mean[ing] that half of [the] ill persons [were] younger than 16.” Accounts of child victims of foodborne illnesses were used to garner support for the FSMA. The testimony drew on images of “very young” victims of foodborne illness, “[t]he archetype of a nurturing mother preparing food for her children,” and “promising li[ves] felled before [their] time.”
More recently, concerns about cosmetic safety for children may have helped advance cosmetic reform and enactment of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Following “reports of contamination, like the 2017 reports of asbestos contamination in certain cosmetic products sold by Claire’s and Justice retailers,” retailers which specifically cater to children, FDA’s Commissioner and Center for Food Safety and Applied Nutrition (CFSAN) Director highlighted the limits of FDA’s authority, noting that “[t]o significantly shift the safety paradigm of cosmetics in the U.S., [they] would need to work with stakeholders, including Congress, to modernize the outdated regulatory framework [for cosmetics] that the FDA ha[d] been operating under for more than 80 years.” Senator Murray, who originally introduced the Modernization of Cosmetics Regulation Act of 2022 as part of the Senate version of the Food and Drug Administration Safety and Landmark Advancements Act of 2022, noted concerns about the safety of children’s cosmetics.
However, food and drug law still falls short in protecting and advancing children’s health.
This Section employs the child question to show how drug, biologics, and device law has fallen short in protecting and advancing children’s health.
FDA’s mission is to “protect[] the public health by ensuring the safety, efficacy, and security of human . . . drugs, biological products, and medical devices” and to “advanc[e] the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products . . . to maintain and improve their health.” Protecting and advancing children’s health is undoubtedly part of that mission.
How a product is categorized is important because what a product is determines how, if at all, FDA will regulate it. While the drug, biologic, and device definitions encompass medical uses of these products, they are not limited to these uses (e.g., tanning beds (devices) used for non-medical uses). The drug, device, and biologic categories include the most highly regulated FDA-regulated products. Drugs and biologics are subject to premarket approval requirements. Some devices—i.e., most Class III (“high risk”) devices—also require premarket approval. Generally, approval requires the product’s sponsor to show FDA that the product is “safe” and “effective” with well-controlled clinical trial results.
Asking the child question about the off-label use of drugs reveals the limitations of food and drug law in this space. Off-label use is the use of an approved product for an unapproved use, for example, in pediatric patients.
Conducting clinical research involving children can be more challenging than research involving adults because, among other things, it involves different ethical and regulatory considerations. Children are a vulnerable group, and Congress, HHS, and FDA have sought to protect them in the research context. However, children are also vulnerable because if products are not studied for and with children, there will not be appropriately evaluated therapeutic products for them. Congress and FDA have tried to address issues posed by these vulnerabilities. The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act of 2003 (PREA) seek to foster pediatric studies. Under the BPCA, FDA can issue a written request for submission of a pediatric study or studies that “may produce health benefits,” but completion of the studies is voluntary. In contrast, the PREA requires pediatric assessments and molecularly targeted pediatric cancer investigations for covered drug and biologics applications.
Despite Congress and FDA’s efforts to increase the availability of appropriately studied—and labeled—products for children, “there is still a significant lack of both pediatric-specific drug information and governmental approvals for on-label pediatric prescribing.” Many drugs, biologics, and devices are used off-label in children. Just because a product is used off-label does not mean that its use is “improper, illegal, contraindicated, or investigational.” Nevertheless, off-label use may expose children to risks and adverse outcomes; at times, the results have been tragic.
As a result of the lack of pediatric approvals, drugs are often used off-label in children. Many drugs and biologics lack “adequate pediatric prescribing information.” One review noted that the high use of off-label medications in children is a worldwide phenomenon and that “the incidence of off-label use is higher among younger populations, especially neonates.” Studies have also found “a high incidence of off-label medication prescriptions” and use in children in the United States.
The lack of labeling for children may mean that a drug is used “with limited information about . . . dosing, effectiveness, and side effects.” Extrapolation of dosing from adult studies may “result in under or overdosing of a medication and the associated risk of therapeutic failures or adverse events.” The use of drugs that “have not been appropriately studied in pediatric populations” may lead to “inappropriate doses,” “unforeseen adverse events,” or a lack of therapeutic benefit. Medical devices are also often used off-label in children due to the lack of devices approved or cleared for pediatric indications, which may similarly lead to suboptimal performance.
Asking the child question about drug shortages also reveals limitations of the current law and policy. A “drug shortage” is a period “when the demand or projected demand for the drug within the United States exceeds the supply of the drug.” While “drug shortages can pose a significant public health threat” that can impact adults and children, shortages of pediatric products “are especially concerning because children constitute a uniquely vulnerable and . . . underserved population.” The causes of pediatric drug shortages are complex, but “the decreased amount of quality pediatric data (or FDA-approved indications for pediatric use)” discussed in the prior Section may put pediatric patients “at particular risk of harm due to drug shortages.” Studies have documented negative impacts of drug shortages on pediatric patients, including cancer patients.
While the COVID-19 pandemic has contributed to drug shortages, drug shortages and their challenges pre-date the pandemic. As of July 10, 2023, FDA’s Drug Shortage Database listed thirty-two pediatric drugs in shortage, including a form of an antibiotic that is widely used to treat bacterial respiratory infections in children (amoxicillin oral powder for suspension), several “essential chemotherapy drugs critical to the care of children with cancer,” and parenteral nutrition products. One analysis found that “[o]f the 19 essential pediatric oncology drugs, 14 (74%) have experienced one or more shortages since 2016,” and “[t]he average duration of the shortage is . . . over 40 months.”
The President, Congress, and FDA have taken steps to prevent and mitigate drug shortages. The FDA Safety and Innovation Act (FDASIA) requires drug manufacturers to report the discontinuance or interruption of the production of lifesaving drugs to FDA. It also requires FDA to report annually to Congress on drug shortages and to “establish a task force to develop and implement a strategic plan for enhancing the Secretary’s response to preventing and mitigating drug shortages.” The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) expanded the requirements for manufacturers to report permanent manufacturing discontinuances and interruptions to FDA and required them to create and implement redundancy risk management plans to mitigate the potential for drug shortages. It also required drug registrants to report the amount of listed drugs and biologics they manufactured.
Many efforts to prevent and mitigate drug shortages are not pediatric-specific, although there have been efforts to address specific shortages impacting pediatric patients. For example, the only specific mention of children that FDA made in its 2022 report to Congress was that the agency “noticed an increase in demand for certain drugs used to treat COVID-19 and other infectious diseases, especially in children.”
Pediatric drug shortages may present different issues than other shortages because children are a vulnerable population and “often have more limited options for medications than adults.” Moreover, drug shortages may impact the most vulnerable children and families more intensely.
Asking the child question about benefit-risk assessments in the context of FDA regulatory decisionmaking highlights the limits of the current regulatory frameworks in assessing the impacts of products on children’s health. To gain approval, sponsors must demonstrate that their drug or biologic is safe and effective. Safety and effectiveness have been defined and assessed in relatively narrow ways: “[T]he standard for approval in the [FDCA] . . . describes drug safety and effectiveness in terms of ‘the conditions prescribed, recommended, or suggested in the proposed labeling.’”
Asking the child question about opioid and COVID-19 vaccine regulation (drug and biologic regulation, respectively) helps highlight a broader set of considerations related to the benefits and risks of these products for children. First, asking about FDA’s opioid regulation shows how focusing on clinical trials’ relatively narrowly defined set of risks and benefits in the context of applications for regulatory authorization overlooks potential adverse effects. For example, parent and caregiver opioid abuse can have negative impacts on children’s health and welfare. Second, asking about FDA’s COVID-19 vaccine regulation shows how the risk-benefit assessment overlooks many of the ways vaccine access may have benefited school-aged children’s health and welfare in the context of school closures and quarantines. Together, these two examples reflect the limits of food and drug law when it comes to assessing products’ benefits and risks, protecting and promoting children’s health, and advancing FDA’s public health mission.
This discussion is not intended to suggest that weighing the broader potential impacts of opioid or COVID-19 vaccine regulation on children would—or even should—have changed the outcome of any specific FDA regulatory decision. Those assessments are beyond the scope of this Article. In addition, this discussion is not intended to suggest that the broader matters that it considers should supplant the review of the safety and effectiveness of a product as shown through preapproval clinical trials and described in the products’ approved labeling. Instead, this discussion seeks to demonstrate how asking the child question can help to focus attention on how existing regulatory frameworks and processes fail to consider products’ potential impacts on children’s health consistently and fully. Using a child-centered lens to examine regulatory decisionmaking in this context suggests additional factors that might be considered to better protect and promote children’s health. Finally, while FDA plays an important role in reducing the harms associated with prescription opioids and approving pediatric vaccines, the issues raised are complex and multifaceted, and FDA cannot solve them alone.
This analysis builds on Patricia J. Zettler, Margaret Foster Riley, and Aaron S. Kesselheim’s article, which argues that FDA should more “consistently” use a “‘public health’ basis for decision-making” and “incorporate[] population health information . . . . . .into its approval and withdrawal decisions in a systematic way” to better regulate drugs with a high potential for externalities. They argue that this “would effectively serve [the agency’s] mission.” In guidance, FDA has noted that
[i]n certain circumstances, FDA’s benefit-risk assessment incorporates broader public health considerations for both the intended target patient population and others. For example, in the review of drugs, including vaccines, to diagnose, prevent, or treat communicable diseases, risks related to disease transmission are important considerations. Similarly, for drugs identified as controlled substances, FDA’s benefit-risk assessment incorporates considerations such as risks related to misuse or accidental exposure in the intended population and in other populations who may have access to the drug.
The current analysis considers how asking the child question about FDA’s benefit-risk assessments highlights how the regulatory system fails to fully account for children’s health.
FDA is an important regulator of prescription opioids and plays a vital role in assessing and regulating their benefits and harms. In 2017, Commissioner Scott Gottlieb noted that among FDA’s “new actions” to address the opioid addiction epidemic was FDA’s “work to ensure drug approval and removal decisions are made within a benefit-risk framework that evaluates not only the outcomes of opioids when used as prescribed, but also the public health effects of the inappropriate use of these drugs.” Commissioner Gottlieb and then-Center for Drug Evaluation and Research Director Janet Woodcock stated that “[g]oing forward, FDA is working to incorporate the effects of decisions on public health into its benefit-risk framework in a more quantitative manner that will supplement and enhance the strong qualitative work that the agency already performs” and that “[b]y ensuring that FDA’s decision-making tools are properly matched to the reality of how opioids are used—and misused or abused—[FDA] can do more to confront the crisis.”
In addition, in 2019, FDA released for comment draft guidance on how it proposes to assess the broader public health effects related to opioids. FDA noted that the risks considered will include those to the patient’s household members, including children and teenagers. Asking the child question about FDA’s regulation of opioids is consistent with these efforts as it may help illuminate the risks opioids pose to children’s health. A fuller consideration of these risks may improve FDA’s regulatory decisionmaking.
For example, while opioids have not spared children from their direct effects, the impact that these drugs have had on children extend far beyond children who have taken them. In 2017, the number of children “who have [opioid use disorder] themselves or have accidentally ingested opioids” was estimated to be 170 thousand. Additionally “[a]pproximately 2 million young people were affected primarily by parental use” of opioids (i.e., “they were either living with a parent with opioid use disorder, had lost a parent to an opioid-related death . . . , had a parent in prison or jail because of opioids, or had been removed from their home due to an opioid-related issue”).
These adverse childhood experiences may negatively impact child health. For example, “[C]hildren of incarcerated parents, compared with their counterparts, are a vulnerable population who are disadvantaged across an array of health outcomes . . . . [They] are more likely to experience fair or poor overall health, a range of physical and mental health conditions, activity limitations, and chronic school absence.” In addition, “research on adult children . . . show[s] that parental incarceration is, indeed, associated with measures of physical health including fair or poor health, asthma, and obesity . . . .” Thus, asking the child question in the context of the opioid epidemic highlights some broader harms to children’s health that FDA might consider in its assessment of the risks of prescription opioids.
Asking the child question about COVID-19 vaccine regulation highlights the potential benefits of vaccines beyond those studied in trials, which focused on immune response and vaccine efficacy and served as the basis for authorization. The regulatory system is not currently structured to systematically account for the broader public health impacts of regulatory decisions, including on children. Examining the benefits and risks of vaccines through a child-focused lens suggests how a broader understanding of public health coupled with a fuller assessment of a product’s benefits and risks might better account for children’s health needs. By failing to weigh those potential benefits in assessing a vaccine’s risk-benefit profile, the current regulatory process fails to consider children’s needs fully.
This analysis is not intended to be a comprehensive analysis of pediatric COVID-19 vaccine development. It focuses on the Pfizer-BioNTech COVID-19 vaccine (Pfizer vaccine) because it was the first COVID-19 vaccine FDA authorized for emergency use. FDA issued the authorization for emergency use (EUA) on December 11, 2020, including for children ages sixteen and older. In addition, FDA also granted the Pfizer vaccine emergency use authorization for use in younger ages—ages twelve through fifteen years old (May 10, 2021), and five through eleven years old (October 29, 2021)—before other COVID-19 vaccines.
In early 2020, the Secretary of HHS made the determination and declaration necessary to permit FDA to issue an EUA for a COVID-19 vaccine under FDCA § 564. Under Section 564, a medical product, like a vaccine, can be authorized for use in an emergency if, “based on the totality of scientific evidence available to the Secretary, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that . . . the product may be effective in . . . preventing” the serious or life-threatening disease referred to in the declaration justifying emergency use authorization—here COVID-19. In addition, the Secretary must conclude that “the known and potential benefits of the product, when used to . . . prevent . . . such disease or condition, outweigh the known and potential risks of the product . . . .” And, there also must not be any “adequate, approved, and available alternative to the product for . . . treating such disease or condition.”
In the summer and fall of 2020, FDA issued guidance on developing and licensing COVID-19 vaccines. In Guidance, Development and Licensure of Vaccines to Prevent COVID-19, FDA stated that the “goal of development programs should be to pursue traditional approval via direct evidence of vaccine safety and efficacy in protecting humans from SARS-CoV-2 infection and/or clinical disease.” The endpoints that FDA discussed in the guidance, including “laboratory-confirmed COVID-19 or laboratory-confirmed SARS-CoV-2 infection,” were consistent with this. In a later guidance, Emergency Use Authorization for Vaccines to Prevent COVID-19, FDA provided additional information about safety and effectiveness information that sponsors should include in an EUA request. The guidance noted: “Issuance of an EUA requires a determination that the known and potential benefits of the vaccine outweigh the known and potential risks.” This would include “meeting the prespecified success criteria for the study’s primary efficacy endpoint . . . .” In sum, the analysis of benefits is focused on the endpoints of the clinical studies of the vaccine, as is traditionally the case.
FDA also addressed pediatric assessments in its guidance on COVID-19 vaccine development and licensure, stating that it was “important for developers of COVID-19 vaccines to plan for pediatric assessments of safety and effectiveness, given the nature of the COVID-19 public health emergency, and to help ensure compliance with the Pediatric Research Equity Act (PREA) (section 505B of the FD&C Act (21 U.S.C. 355c)).” It noted that developers should discuss “the prospect of direct benefit and acceptable risk to support initiation of pediatric studies” and “the appropriate design and endpoints for pediatric studies” in the context of specific development programs to ensure compliance with the regulations setting forth safeguards for children in clinical trials.
On March 11, 2020, the World Health Organization declared the novel coronavirus a pandemic. The first COVID-19 vaccine was authorized for emergency use eight months later on December 11, 2020. Based on publicly available data on COVID-19 cases in children in the United States as of December 10, 2020, children represented 12.2% of all reported cases (1,639,728 out of 13,462,337), 1.8% of hospitalizations (7,913 out of 445,394), and 0.06% of deaths (162 out of 249,442).
This discussion focuses on FDA’s Vaccines and Related Biological Products Advisory Committee’s deliberation because it provides a window into a review process in which public disclosure of certain information is limited. Advisory committees provide FDA independent expert advice and can “help the public understand the FDA’s expectations for the data needed to support the agency’s determinations about the safety and effectiveness of a product.”
On December 10, 2020, the advisory committee met to consider the safety and efficacy of the Pfizer/BioNTech vaccine and found that “based on the totality of scientific evidence available, the benefits of the . . . [v]accine outweigh its risks for use in individuals 16 years of age and older[.]” The advisory meeting discussion and the review panel documents reflect a process for evaluating benefits that is closely focused on efficacy as defined by the clinical trial endpoints.
FDA’s approach to evaluating COVID-19 vaccines for children is an example of how the regulatory system is not structured to fully account for the ways in which children’s health, welfare, and flourishing may be impacted by regulatory decisions. Briefing materials from the December meeting note that at the time there was not enough data to make conclusions about the safety and efficacy of the vaccine for children under sixteen years of age, and “[s]ome committee members expressed concerns about including adolescents 16 and 17 years of age in the indication for the vaccine because of the limited amount of safety and efficacy data available in this population.” For example, one member stated that they would have preferred an indication for eighteen years of age and older, noting that “16- and 17-year-old children . . . do not get very sick, seldom get hospitalized, and I’ll bet it’s a very small number of deaths.” Nevertheless, it was noted at another point during the meeting that “the broader impacts in children perhaps are not entirely clear until the full resumption of normal activities ensues . . . including in person education across all schools . . . .”
Indeed, early in the pandemic, many children were not attending school in person because of COVID-19. At one point, school closures impacted “at least 55.1 million students in 124,000 U.S. public and private schools.” One survey found that 89% of adults reported that in September 2020, “classes for their children [under age 18] had moved to a distance learning format using online resources . . . .” In December 2020, “approximately half of students in kindergarten through 12th grade attended school fully remotely . . . . with low-income, Black, and Hispanic groups the most likely to attend fully remote school.” While the full impact of COVID-19 school closures remains to be seen, research suggests that remote learning was not without significant costs for children and parents. Such costs may diminish children’s health and the impact may disproportionately fall upon children who are members of excluded groups.
CDC’s guidance regarding quarantine following COVID-19 exposure differed based on the exposed person’s vaccination status. In September 2021, an Overview of COVID-19 Quarantine for K-12 Schools from CDC indicated that “[p]eople who are not fully vaccinated and are determined to be a close contact of someone with COVID-19” should “quarantine (stay at home and away from other people) immediately for a period of 14 days from the date of their last exposure, unless they receive different instructions from their school official or a public health official.” In contrast, CDC stated that “[p]eople who are fully vaccinated . . . do not need to quarantine . . . .” The COVID-19 vaccine had only been authorized for emergency use in those twelve years and older at that time and the CDC’s vaccine provider agreement provided that “administering vaccines to individuals younger than the ages for whom the FDA has approved or authorized use is prohibited and risks repercussions to providers, including legal liability, loss of payment, and removal from the Covid‐19 vaccine program.” This effectively meant that children under twelve were subject to two-week quarantines. News reports from around this time suggest that many students were quarantined following close contact with someone with COVID-19. For example, approximately 17,000 students in Maryland public schools had been quarantined between the start of the school year and the end of September, 20,000 students in Mississippi were quarantined as of mid-August, and 87,000 students in South Carolina had been placed in quarantine by mid-September. One review found that studies of quarantine among children and adolescents, both pre-dating and during the COVID-19 pandemic, showed that quarantine had “considerable psychological impact” and “negative impact on [children and adolescents’] physical health, academics, and social network.” As Ami Harbin and colleagues wrote, a narrow conception of risk focused on the risks of infection and adverse vaccine effects in the context of pediatric vaccine development is problematic because “access to education is a fundamental component of child health” and “[c]hildren are harmed not only when they lack access to disease protection, but also by social and educational disruption, in addition to emotional, financial, social, and professional harms to their family units.”
On December 11, 2020, the day after the advisory committee meeting, FDA issued “the first emergency use authorization (EUA) for a vaccine for the prevention of . . . COVID-19 . . . in individuals 16 years of age and older.” The FDA review team, in assessing efficacy, similarly focused on whether the vaccine “may be effective in preventing . . . such serious or life-threatening disease or condition that can be caused by SARS-CoV-2” and found that it was reasonable to believe that it would be. It found that “the known and potential benefits of the vaccine outweigh the known and potential risks of the vaccine when used for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.” It listed “[r]eduction in the risk of confirmed COVID-19 occurring at least [seven] days after Dose 2 . . . [r]eduction in the risk of confirmed COVID-19 after Dose 1 and before Dose 2,” and “[r]eduction in the risk of confirmed severe COVID-19 any time after Dose 1” as “relative to placebo” as benefits. It also listed “potential benefits that could be further evaluated but are not necessary to support an EUA include prevention of COVID-19 in individuals with previous SARS-CoV-2 infection, prevention of mortality and long-term complications of COVID-19, reduction in asymptomatic SARS-CoV-2 infection and reduction of SARS-CoV-2 transmission.” The review team accordingly recommended an EUA be issued.
FDA did not authorize a COVID-19 vaccine for children under five until roughly a year and a half later. By that time (June 16, 2022), the number of reported child cases had climbed to a total of 13,624,605, representing 18.8% of all reported cases. Earlier that month, a total of 43,316 child hospitalizations and 1,055 child deaths had been reported.
As noted earlier, this discussion of FDA’s authorization of the vaccine is not intended to suggest that the broader impacts FDA’s regulatory decisions may have on children’s health should supplant the review of the safety and effectiveness a product as shown through clinical trials. But rather, it suggests that using a child-centered lens to examine regulatory decisionmaking in this context highlights matters that arguably ought to be considered to more fully account for children’s health, broadly understood, in product evaluations.
FDA’s tobacco product regulation has failed to account for children’s needs fully. Using FDA’s regulation of e-cigarettes as an example, this Section highlights how regulatory delays have hampered FDA’s ability to regulate e-cigarettes and protect youth from their risks. FDA’s regulation of e-cigarettes has been marked by significant delays during which youth e-cigarette use has increased substantially.
Youth e-cigarette use is concerning because e-cigarettes often contain nicotine, which is addictive. In addition, e-cigarettes pose potential dangers to young users, and youth that use e-cigarettes may have a higher risk of starting to smoke cigarettes. Youth smoking “can cause serious and potentially deadly health issues immediately and into adulthood.”
Congress enacted the Family Smoking Prevention and Tobacco Control Act (TCA) in 2009. The TCA gave FDA authority to regulate the manufacture, distribution, and marketing of tobacco products. The TCA established FDA’s Center for Tobacco Products (CTP). CTP’s mission, unlike those of FDA’s other product centers, focuses explicitly on “youth”: CTP’s mission includes “[t]o protect the public health of the U.S. population from tobacco-related death and disease by comprehensively regulating the manufacture, distribution, and marketing of tobacco products; educating the public, especially youth, about the dangers of using tobacco products . . . ” The products that CTP regulates, which include cigarettes, smokeless tobacco products, vapes, e-cigarettes, and other electronic nicotine delivery systems (ENDS), have a tremendous impact on children’s health.
In enacting the TCA, Congress sought to ensure FDA had the authority to address youth smoking. Congress found that “[t]he use of tobacco products by the Nation’s children is a pediatric disease of considerable proportions that results in new generations of tobacco-dependent children and adults” and that reducing tobacco use in minors would decrease premature deaths due to tobacco-induced disease and result in substantial health care savings.
The TCA did not specifically mention e-cigarettes. When Congress enacted the TCA, e-cigarettes were relatively new to the U.S. market, having “entered the U.S. marketplace around 2007.” They were also not as widely used as they would later be. Since 2009, e-cigarette use in the United States, including by youth, has increased substantially.
While the TCA did not explicitly mention e-cigarettes, it gave FDA authority to “deem[]” e-cigarettes subject to the TCA by regulation. Despite this, and despite a 2010 decision by the United States Court of Appeals for the District of Columbia holding that “FDA has authority to regulate customarily marketed tobacco products—including e-cigarettes—under the [TCA],” FDA did not propose regulations deeming e-cigarettes subject to the TCA until February 2014. It published final regulations in May 2016.
In the rule’s preamble, FDA announced a compliance policy for premarket review of newly deemed products (e.g., ENDS) that are “new tobacco products.” Such products are “required to obtain premarket authorization . . . through one of three pathways” (substantial equivalence, exemption from substantial equivalence, or premarket tobacco product application). FDA indicated it did not intend to enforce the premarket review requirements for twenty-four to thirty-six months. In announcing that decision, FDA discussed the products’ impact on children. FDA indicated it “received comments and new data regarding the effect of flavored tobacco products on youth and young adult use” and that it “understands that the appeal of flavors and use of flavored tobacco products have an important role in the initiation and continued use of tobacco products.” Nevertheless, while FDA had “determined that exercising enforcement discretion indefinitely could put youth and young adults at risk for tobacco-related death and disease,” it stated that extending the compliance dates would balance that with “emerging evidence that some adults may potentially use certain flavored tobacco products to transition away from combusted tobacco use.”
FDA later extended the compliance deadlines via guidance, resulting in an August 2022 date for non-combustible products. FDA also noted that, for new tobacco products not on the market on the effective date of the deeming regulations, it did not intend to enforce the premarket authorization requirement for applications pending review.
The American Association of Pediatrics, and others, sought to vacate the later guidance. The court hearing the action noted that the guidance did “not require manufacturers to submit their applications . . . for five or more years and announce[d] that the FDA will defer enforcement during that period.” The court ordered a deadline for submitting new applications for premarket authorization for new tobacco products on the market when FDA’s deeming rule took effect. The final court-ordered deadline was September 9, 2020, more than a decade after the TCA was enacted. The court also provided a one-year period (until September 9, 2021) during which products with timely-filed applications could stay on the market pending FDA’s review. In November 2021, the plaintiffs requested the court reopen the case and require that FDA provide regular status reports. They alleged that “FDA has not issued a single [Premarket Tobacco Product Application (PMTA)] decision on any of the products with the largest market share in the market as a whole or in the youth market” and that “FDA does not appear to have enforced the premarket review requirements against any product still awaiting a PMTA decision, including products with the greatest market share and those most used by youth.” The court issued a remedial order requiring FDA to submit regular status reports regarding the review of certain pending applications. As of December 31, 2022, FDA had taken action on 51% of those applications.
Since 2009, when Congress enacted the TCA, youth e-cigarette use in the US has increased substantially. From 2011 to 2015, which falls between the DC Circuit’s 2010 decision that FDA had the authority to regulate e-cigarettes and FDA’s 2016 deeming rule, e-cigarette use increased 900% among middle and high school students. In 2016 e-cigarettes were “the most commonly used form of tobacco among youth in the United States.” In 2019, 27.5% of high school students and 10.5% of middle school students indicated current e-cigarette use.
While recent data suggests that youth e-cigarette use has declined from 5.4 million in 2019 to 3.6 million in 2020, many children still use e-cigarettes. And most (8 out of 10) report using flavored e-cigarettes. Although prefilled pods or cartridges were the most commonly used e-cigarettes during the same period, disposable e-cigarette use increased 1,000% among high school students and 400% among middle school students. Of note, when FDA announced that it intended to prioritize enforcement against “any flavored, cartridge-based ENDS product (other than a tobacco- or menthol-flavored ENDs product)” in early 2020, it excluded “completely self-contained disposable products.” Disposable products saw significant increases in use in 2020 and became the most commonly used device type by middle and high school students in 2022. More recently, FDA has taken action regarding unauthorized disposable e-cigarettes.
Despite progress, much work remains: 3.08 million middle and high school students reported current use of any tobacco product, more than 2.5 million reported current use of e-cigarettes, and almost 85% of the e-cigarette users used flavored e-cigarettes.
This Section uses examples from FDA’s regulation of food to show how FDA food law has failed to account for the needs of children fully and, in so doing, has jeopardized their health. As with earlier sections, this Section is not intended to be a comprehensive analysis of the impact of FDA food law and policy on children but rather serves to highlight some limitations of FDA’s regulation of food by asking the child question.
Food is essential for children to live, grow, and flourish. Food is so important to the well-being of children that the government provides food assistance to low-income children through programs such as the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), the Supplemental Nutrition Assistance Program (SNAP), and the National School Lunch and Breakfast Programs.
FDA’s food mission is to “protect[] the public health . . . by ensuring the safety of our nation’s food supply.” The FDCA defines food broadly as “articles used for food or drink for man,” including chewing gum and “articles used for components of any such article.” This includes articles used in the way that people commonly use food, for taste, aroma, and nutrition, as well as subcategories of food, such as “food additives” and “dietary supplements.” There is no general premarket approval requirement for foods. Instead, FDA largely relies on its post-market authority—including its authority under the adulteration and misbranding provisions—to regulate food.
While food is essential for children to live, grow, and flourish, it may also present risks. For example, children may be harmed by the consumption of a food with microbial or inorganic contamination, they may suffer from obesity and diet-related diseases, and the negative environmental impacts of food production may harm them. Indeed, children may disproportionately bear the burden of many food-related risks. For example, foodborne illnesses disproportionately impact children. Children are “especially vulnerable to the[] carcinogenic and non-carcinogenic effects [of inorganic contaminates in foods].” Furthermore, food allergies are more common in children than adults.
Asking the child question about FDA and the 2022 infant formula shortage highlights how FDA law and policy fell short. Under the FDCA, infant formulas are “food.” Accordingly, the food laws apply to infant formulas, although there are also legal requirements specific to infant formula.
Infant feeding has important life-long health implications, and infant formula is the “sole source of nutrition” for many infants, a vulnerable population, “during a critical period of growth and development.” For example, most infants (54%) born in 2018 received formula by the time they were three months old. Accordingly, the infant formula shortage threatened children’s health. In addition, the shortage may have disproportionally impacted the most vulnerable infants as “[i]nfants in low-income families, infants of color, and infants living in rural communities are more likely to use formula . . . .” Infants in WIC are estimated to consume 56% of the infant formula in the United States. In addition, the recall that precipitated the shortage included lots of two hypoallergenic formulas.
In 2022, concerns about the safety of powdered infant formula led to an investigation following reports of Cronobacter illness in infants who had reportedly consumed formula manufactured at an Abbott Nutrition facility in Sturgis, Michigan, between September 2021 and February 2022. There were four reports of Cronobacter infections, which may have contributed to two infant deaths. On February 17, 2022, FDA warned consumers not to use certain infant formula products, and the manufacturer voluntarily recalled specific lots of formula manufactured at that facility. The company also temporarily stopped production at the facility. It later expanded the recall to other products. FDA alleged that the formula was adulterated because it was made under insanitary conditions at the facility. The company ultimately entered a consent decree, which allowed it to resume manufacturing powdered infant formula at the facility at issue, which it did in the summer of 2022.
The recall and temporary cessation of production set off an infant formula shortage, which COVID-19-related supply chain issues exacerbated. The formula industry “is highly concentrated” with just four companies accounting for almost the entire U.S. market, and Abbott constituting an estimated 58% of the market. FDA described the factors contributing to the shortage as “a ‘perfect’ storm resulting in the supply chain disruption in 2022 that affected the entire U.S. market.” The estimated out-of-stock rate reached 74% nationally at the end of May 2022.
While the factors contributing to the shortage were complex and would require an analysis beyond the scope of this Article, delays and structural challenges at FDA likely contributed. A former Deputy Commissioner in FDA’s Office of Food Policy and Response testified before a House Oversight Committee subcommittee, “With siloed groups in the FDA’s decentralized Foods Program, it is impossible for leaders . . . to have clear line of sight on what was happening or to set processes in place to help catch these critical public health concerns.” Following hearings on the shortage, Congress enacted provisions for “critical food[s],” including infant formula. It directed FDA to develop a national strategy on infant formula and the Secretary to establish an Office of Critical Foods within FDA’s CFSAN. In March 2023, FDA released an Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market.
Asking the child question about the regulation of lead, arsenic, cadmium, and mercury, often referred to as “heavy metals,” in food also highlights FDA’s limits in protecting and promoting children’s health. These metals and metalloid have been found in foods, including foods marketed for babies and young children and other foods they commonly eat (baby foods).
A U.S. House subcommittee, following reports of heavy metals in baby foods, requested information from seven of the largest US manufacturers—four responded. The report noted, “[i]nternal company test results obtained by the Subcommittee confirm that all responding baby food manufacturers sold baby foods tainted by high levels of toxic heavy metals.”
The presence of lead, cadmium, arsenic, and mercury in food results from their natural occurrence and human activity (e.g., mining, ore smelting, pesticides, and industrial and product uses). These substances have been linked and associated with health concerns, and children are particularly vulnerable. For example, there is no safe level of exposure to lead. Lead can damage the ability of children to learn and, at higher levels, damage “kidneys, blood, and nervous system” and cause “coma, convulsions, or death.” “[Y]oung children face the most danger from exposure to lead because their growing bodies are more prone to harm and [they] absorb lead more easily than . . . adults . . . .”
In 2021, to reduce children’s exposure to these contaminants from food, FDA released a multi-phase action plan, “Closer to Zero,” which is to culminate in final action levels for each element in baby foods. FDA has indicated that once it has published final action levels, it “will establish a timeframe for assessing industry’s progress toward meeting the action levels” and resume evaluating scientific data to determine whether to adjust the action levels.
However, FDA’s use of action levels to address contaminants in food has significant limitations. Action levels are not binding. They are “a level of contamination at which a food may be regarded as adulterated” under FDCA § 402(a)(1). FDA considers action levels in deciding whether to enforce the FDCA’s adulteration provision. Indeed, FDA is seeking “new authority [from Congress] to establish binding contamination limits in foods, including those consumed by infants and young children, via an administrative order process,” noting that it currently “has limited tools to help reduce exposure to toxic elements in the food supply.”
This is not the first time that FDA has proposed or used action levels for contaminants in food. FDA’s previous efforts have been subject to substantial delays. During delays, the risk assessments the action levels are based on may become outdated.
FDA’s efforts to reduce arsenic in certain foods are illustrative. There are two types of arsenic—organic and inorganic—both of which have been found in food, but current research suggests that inorganic arsenic is more toxic than organic. While FDA has indicated that the levels of inorganic arsenic that have been reported in food are “not a concern in terms of immediate toxicity at the levels seen in food,” they “may be a health concern when they are consumed long-term.” Long-term inorganic arsenic consumption is “associated with . . . cancer, skin lesions, cardiovascular disease, neurodevelopmental toxicity, adverse pregnancy outcomes, non-malignant lung disease, and diabetes.”
In July 2013, FDA announced draft guidance that proposed an action level for inorganic arsenic in apple juice. FDA did not finalize the non-binding guidance until almost a decade later in June 2023. Between the draft and final guidance, FDA “identified some apple juice samples with inorganic arsenic levels above 10 [parts per billion]”—the action level in the draft and final guidance—although FDA noted its “testing results reflect a trend in reductions in the amount of inorganic arsenic in apple juice.” In April 2016, FDA proposed an action level of 100 ppb for inorganic arsenic in infant rice cereal, stating that inorganic arsenic exposure early in life is associated with adverse neurological effects. FDA also noted that it “recognizes that infant rice cereal is a common ‘starter’ food for infants and notes that the American Academy of Pediatrics specifically encourages consumption of iron-fortified cereals for infants and toddlers.” FDA reported that sampling after the draft guidance showed that 76% of samples were at or below the proposed action level of 100 ppb, which means nearly a quarter exceeded it. FDA did not finalize the guidance and the 100 ppb action level, which are not binding, until August 2020.
To date, FDA has not proposed action levels for arsenic in baby foods, and a chart of FDA’s planned action items lists “develop action levels and submit draft guidance for interagency review” for 2024. FDA appears to have fallen behind the timeline it announced previously for its Closer to Zero action.
Thus, while FDA indicated in a recent press release that “protecting one of our most vulnerable populations, babies and young children, is among [its] highest priorities,” much remains to be done. Groups have critiqued the proposed action levels as being too limited, for example, expressing concern that “FDA did not set action levels for lead in [baby] snack foods like teething biscuits and puffs, which some tests have shown have higher lead levels than other baby foods” and that limits for some foods may not be strict enough.
FDA’s cosmetics mission is to “protect[] the public health . . . by ensuring the safety of . . . cosmetics,” which includes the safety of cosmetics marketed to and used by children. The FDCA defines cosmetics as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance,” as well as components of such articles. Cosmetics include shampoos, conditioners, body washes and cleansers, diapers and baby wipes, lotions, baby powders, and makeup.
Children are exposed to cosmetics, often from birth. For example, newborns are bathed with “liquid soap” before leaving the hospital following birth. The cosmetics that children use or are exposed to and the frequency of that exposure may differ, but cosmetic use on or by children is widespread. Thus, cosmetic safety implicates children’s safety.
Children’s cosmetic use and exposure also vary, for example, by age, gender, race, and ethnicity. In prior work, I examined cosmetics as a gendered product category often associated with women and argued that the risks that cosmetics may pose may disproportionately impact women. This Article builds on that work and considers the impacts of cosmetics on children, including girls. A higher percentage of teen girls use some categories of cosmetics than women ages eighteen to thirty-four. For example, one survey found that 77% of teen girls ages twelve to seventeen use nail polish/nail care products compared with 71% of women aged eighteen to thirty-four. Young girls often use these products as well, with one study finding that 45% of girls under five use nail polish. While boys use cosmetics, studies have found that a higher percentage of girls use them, and the types of cosmetics girls and boys use differ. For example, a significantly higher percentage of girls aged six to eight report using lipstick and lip gloss than boys the same age: 45% versus 5%. Additionally, usage of and exposure to cosmetics differ among children of different racial and ethnic groups. For example, in one survey, “almost half of the parents/guardians reported first application of chemical relaxers to their [Black daughter’s] hair between the ages of [four] and [eight].” Another survey found that a higher percentage of Hispanic teens aged nine to seventeen reported using beauty or personal care products than non-Hispanic white or Black teens.
Congress gave FDA the authority to regulate cosmetics in the 1938 FDCA. In late 2022, Congress enacted the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Cosmetics law had long lagged behind that of other FDA-regulated products, and MoCRA expanded FDA’s cosmetics authority. For example, it requires adverse event reporting, facility registration, and product listing. It also gave FDA mandatory recall authority over cosmetics, requires FDA to establish good manufacturing practice regulations for cosmetic facilities, and gives FDA access to cosmetic product records under certain conditions. MoCRA also requires that cosmetic manufacturers ensure that a cosmetic product has “adequate substantiation of safety” and that producers maintain reports supporting this. Safe is defined to “mean[] that the cosmetic product, including any ingredient thereof, is not injurious to users under the conditions of use prescribed in the labeling . . . or . . . as are customary or usual.” However, a product or ingredient will not be considered injurious “solely because it can cause minor and transient reactions or . . . skin irritations in some users.” MoCRA also includes labeling requirements as well as provisions concerning talc-containing cosmetics and perfluoroalkyl and polyfluoroalkyl substances (PFAS). While Congress has required that some FDA-regulated products be approved before they can be lawfully sold, there is no comparable requirement for cosmetics. Instead, even with MoCRA, FDA’s cosmetics regulation is largely post-market regulation, based on the FDCA’s adulteration and misbranding provisions.
When this Article was written, MoCRA—effective December 29, 2023—had not yet gone into effect. Accordingly, its effects and implementation remain to be seen. The issues discussed in this Article occurred before the Act was effective. While MoCRA makes some important changes to the law that will likely help FDA advance cosmetic safety, gaps will likely remain.
As discussed above, children may be uniquely vulnerable to toxins because of their small size, behavioral patterns, and rapid growth and development. These usage differences may have health implications. One challenge in the cosmetic area is that safety information is often limited and focused on short-term reactions rather than long-term health problems. MoCRA is unlikely to resolve this issue because it does not clearly require that cosmetic ingredients be tested for long-term health effects.
Cosmetics may contain toxic chemicals as ingredients or contaminants. For example, asbestos, lead, mercury, and other contaminants have been reportedly found in cosmetics. Questions have been raised about the safety of cosmetics ingredients, including diethanolamine (DEA) and DEA-related ingredients, parabens, phthalates, and nanomaterials.
Asking the child question about the regulation of contaminants in cosmetics highlights its limitations. Children may be exposed to lead by cosmetics. For example, FDA has warned consumers to avoid “traditional eye cosmetics containing kohl” as they may present a risk of lead poisoning in adults and children. FDA has issued draft guidance with a recommended maximum lead level in cosmetic lip products and externally applied cosmetics. Like FDA’s guidance on heavy metals in food, as guidance, it is not binding. And, like FDA’s guidance regarding arsenic in infant rice cereal and apple juice, it has been subject to substantial delay. When this Article was written, FDA had not finalized the 2016 draft guidance.
The issue of asbestos in certain talc-containing cosmetics highlights both the potential hazards that cosmetics can pose to children and some of the challenges FDA has faced ensuring safety of cosmetics. In 2017, FDA “became aware of reports of asbestos contamination in certain cosmetic products sold by Claire’s and Justice retailers.” Asbestos is a “known carcinogen” whose “health risks are well-documented.” FDA announced that four products tested positive for asbestos. Justice had recalled its product in 2017, and “FDA requested that Claire’s recall the [three other] products.” According to FDA, “Claire’s . . . refused to comply with the FDA’s request,” highlighting the limits of FDA’s cosmetic authority at the time. The company later recalled the product. MoCRA requires FDA to propose regulations “to establish and require standardized testing methods for detecting and identifying asbestos in tact-containing cosmetic products” and finalize such regulations within 180 days of the comment period, but it remains to be seen how FDA will implement those talc provisions.
There is a need for FDA to comprehensively examine the impact of its regulatory actions—and inaction—on children. To do so, this Article argues that as an initial step, FDA and Congress should create a children’s health office at FDA to work across product categories to assess the impact FDA’s regulatory actions have on children and to help ensure that children have not been left out of consideration in the pursuit of FDA’s mission. Where children have been left out, the office should work to correct that omission to protect and better promote public health.
While an office of children’s health would help elevate children’s issues at FDA, it is important to note that the agency alone cannot solve the issues related to the products it regulates and children’s health. Others, including the regulated industries, must also work to address these issues.
As an administrative agency, FDA derives its authority to regulate from Congress, and its limited authority may hinder its ability to respond to issues involving children and FDA-regulated products. For example, in FDA v. Brown & Williamson Tobacco Corp., the United States Supreme Court held that Congress had not given FDA the authority to regulate tobacco products. At issue in that case was FDA’s assertion of jurisdiction over tobacco products and its promulgation of “regulations intended to reduce tobacco consumption among children and adolescents.” The Court noted,
By no means do we question the seriousness of the problem that the FDA has sought to address. The agency has amply demonstrated that tobacco use, particularly among children and adolescents, poses perhaps the single most significant threat to the public health in the United States. Nonetheless, . . . an administrative agency’s power to regulate in the public interest must always be grounded in a valid grant of authority from Congress.
And even when FDA has jurisdiction over a product category, its authority may be limited in ways that hinder its ability to address issues involving children’s health. Forces and factors outside of FDA’s control, including resource limitations, may hinder FDA’s ability to address issues impacting children’s health. Nevertheless, this Article contends that creating an FDA office of children’s health would help the agency better address issues impacting children.
This Part considers how FDA’s OWH and OMHHE, and EPA’s OCHP might inform the creation of an FDA office of children’s health. Then, building on Part II, the current Part discusses how many issues involving children’s health and FDA-regulated products cut across product categories and involve therapeutic and non-therapeutic products. Accordingly, this Article contends it may benefit children’s health for FDA to undertake a broader examination of how food and drug law impacts children across product categories.
While there is not currently an office at FDA that focuses on how FDA-regulated products across the product categories impact children, there are offices focused on how FDA-regulated products impact other specific populations: OWH and OMHHE, which address issues involving products across the FDA-regulated product categories, could inform the creation of a children’s health office.
The Commissioner of Food and Drugs established OWH in 1994 within FDA’s Office of External Affairs. OWH was created “to facilitate [FDA] coordination and communication of women’s health issues and initiatives.” Its mission includes advising the Commissioner “on scientific, ethical, and policy issues relating to women’s health,” “coordinat[ing] efforts to establish and advance a women’s health agenda for the Agency,” “[p]romot[ing] the inclusion of women in clinical trials” and “completion of sex/gender analysis,” “[i]dentify[ing] and monitor[ing] the progress of crosscutting and multidisciplinary women’s health initiatives including changing needs, areas that require study, and new challenges to the health of women as they relate to FDA’s mission”; and serving as FDA’s “liaison with other agencies, industry, professional associations and advocacy groups” on women’s health. The Affordable Care Act (ACA) later codified the establishment of OWH within the Commissioner’s office. OWH’s work is not limited to a specific product category or categories. Instead, its work focuses on women’s health and includes all the major FDA-regulated product categories. The mission of a children’s health office could be modeled on that of OWH, except child-focused.
The ACA established the FDA’s OMHHE in 2010. Like OWH, its director reports directly to the Commissioner. OMHHE’s mission is “to promote and protect the health of diverse populations through research and communication of science that addresses health disparities.” While much of OMHHE’s work focuses on clinical trials and information about specific diseases, its work is broader. It aims to “strengthen FDA’s ability to respond to minority health concerns” and “promote health and safety communication to minority populations.” For example, it has provided consumers information about cosmetics and tobacco products.
OWH and OMHHE are outside the product centers and the Office of Regulatory Affairs, enabling them to work outside the confines of specific product categories and regulatory activities. The first director of FDA’s OWH, Ruth Merkatz, recalled in an oral history that the proposal for a women’s health office came up because “there were pieces [issues impacting women] all over the agency, but there wasn’t a central focus to try to bring them together in a cohesive manner.” The current situation concerning issues impacting children is similar. There are issues affecting children’s health across the agency, but there is no central structure to bring them together more cohesively. Indeed, even within a single product center, efforts to address children’s health issues may be fragmented.
In addition, while there are organizational structures within FDA that focus on children’s health issues, these structures are not set up to cut across the product centers and the divide between therapeutic and non-therapeutic products. As discussed in Part II, each product center deals with topics and issues that impact children related to specific categories of products. The Office of Pediatric Therapeutics (OPT) and the Division of Pediatric and Maternal Health (DPMH) also deal with topics and issues that impact children, but they focus on medical products. OPT, which is within the Office of the Commissioner, focuses on therapeutic products for pediatrics patients. Similarly, DPMH, within the Office of New Drugs and the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, focuses on drugs and biologics. Other organizational structures dealing with pediatric topics and issues are similarly focused. For example, the Pediatric Oncology Program works “to promote the development of safe and effective new drugs and biologics to treat cancer in children.” Moreover, the Pediatric Advisory Committee “[a]dvises on pediatric therapeutics, pediatric research, and other matters involving pediatrics for which [FDA] has regulatory responsibility.”
FDA could also look to EPA’s OCHP, within EPA’s Office of the Administrator, as a potential model. OCHP was created as part of EPA’s efforts to implement its National Agenda to Protect Children’s Health from Environmental Threats and Executive Order 13,045 on the Protection of Children from Environmental Health Risks and Safety Risks. OCHP’s goals include “reduc[ing] negative environmental impacts on children through involvement in EPA rulemaking, policy, enforcement actions, research and applications of science that focuses on prenatal and childhood vulnerabilities;” “protect[ing] children through safe chemicals management;” and “coordinat[ing] community-based programs to eliminate threats to children’s health where they live, learn and play.” OCHP’s aim is “to ensure that all EPA actions and programs address the unique vulnerabilities of children,” vulnerabilities which may also be relevant in the food and drug law context.
Asking the child question about FDA-regulated products shows how FDA has fallen short in protecting and promoting children’s health. It also helps demonstrate why a broader child-health-focused lens is needed to supplement FDA’s existing work in this area.
A crucial part of asking the child question is considering how those shortcomings might be corrected and what difference it would make. As a first step, this Article proposes the creation of a central office of children’s health at FDA within the Commissioner’s office to advise the Commissioner on matters related to children’s health outside of the silos of a specific product center or regulatory focus. This Article does not argue that a children’s health office should replace the existing organizational structures that focus on children’s health. Instead, it suggests a children’s health office should supplement and build on the agency’s current child-health-related work. Creating a children’s health office would not eliminate all the issues that hinder the agency’s ability to protect and promote children’s health, but it could help to advance its mission. The success of any such office would depend on several factors.
A central office focused on children’s health may help to reduce the fragmentation and increase the integration of FDA’s existing work related to children’s health, as many of the topics and issues involving children’s health and FDA-regulated products cut across product categories. For example, FDA has tried to prevent and ameliorate shortages of products in different categories—drugs, biologics, medical devices, and food (infant formula). Some of FDA’s learnings from its work addressing drug shortages could help the agency avoid or mitigate future shortages in other categories. Indeed, FDA Commissioner Robert M. Califf noted that “[r]ecommendations from the White House’s 100-day supply chain review report with regard to pharmaceutical and active pharmaceutical ingredient supply chain resiliency may prove insightful” in the context of the issues with the infant formula supply chain.
Another example of a crosscutting issue is how to reduce “heavy metals” (e.g., lead, arsenic, cadmium, and mercury) in FDA-regulated products. These metals have been found in cosmetics, foods, medical devices, drugs, and tobacco products, including products used by children. Exposure to heavy metals may harm children’s health.
As a third example, “accidental” ingestion of FDA-regulated products, including drugs, dietary supplements (foods), cosmetics, and tobacco products, by children results in many emergency department visits. For example, each year, there are an estimated 57,928 emergency department visits for children five and under for medication overdoses, and of those, 82.2% are from unsupervised ingestions. An estimated 4,877 emergency department visits are due to unsupervised ingestions of dietary supplements by children. An estimated 4,312 children under five are treated for a cosmetic-related injury, with ingestion accounting for approximately 76% of the exposures. An estimated 900 visits for children under five were due to ENDS liquid nicotine exposure with ingestion being the most common route of exposure (99.4%).
As a fourth example, issues related to addiction have arisen with drugs (i.e., opioids) and tobacco products (specifically nicotine)—as well as issues regarding how others’ (including parents and caregivers’) use of these products impacts children.
In addition, a children’s health office whose work is not limited to a specific product category or categories (e.g., therapeutic or medical products) may be beneficial because the lines between categories can be blurry, and so much is often at stake in how a product is categorized.
Furthermore, a children’s health office within the Commissioner’s office could increase the prominence of FDA’s children’s health work and play a crucial role in communicating science-based educational material to parents and caregivers about children’s health and FDA-regulated products. Indeed, in response to the infant formula shortage, FDA has said that it will “improve accessibility” of its education materials on its website. A child-focused office could help streamline and promote FDA’s message.
Despite the potential benefits of creating a children’s health office, it is also important to consider potential costs. FDA’s resources are limited, and creating a new children’s health office would have costs. Nevertheless, the increased coordination and integration that could result from a children’s health office could result in cost savings for FDA, due to possible synergies and efficiencies, for example. Furthermore, the potential for better health outcomes for children could result in substantial benefits, including cost savings.
FDA could possibly create a children’s health office administratively like it did initially with OWH. The Commissioner has the authority to approve first echelon reorganizations, which include offices, subject to the limitations discussed in FDA’s policy regarding organizational changes and HHS clearance. There are some exceptions to the Commissioner’s ability to approve such reorganizations, which require approval from the Secretary. FDA must formally notify Congress thirty days before a reorganization proposal is effective. Congress could also direct FDA to create an office of children’s health like it did when it directed FDA to create the OMHHE and when it codified the OWH.
FDA’s mission is to protect and promote public health, and children’s health is an integral part of that mission. Modifying the woman question to ask how food and drug law impacts children’s health shows how vital FDA regulation is to that health as well as the limitations of that regulation. Congress and FDA should create a children’s health office within the Commissioner’s office. The creation of a children’s health office at FDA would be consistent with Executive Order 13,045 on the Protection of Children from Environmental Health Risks and Safety Risks. A children’s health office may help FDA decrease fragmentation, increase integration, and better protect and promote children’s health. Failing to elevate children’s health issues at the agency may jeopardize FDA’s ability to advance its public health mission and may ultimately make the products that it regulates less safe and beneficial for us all.
Thanks to Jaqueline R. Fox, Peter Barton Hutt, and the Academy of Food Law & Policy’s Scholarship Workshop organizers and participants, including Sarah Everhart, Andrea Freeman, Jacqueline P. Hand, and Margot J. Pollans, for their comments and questions. Thanks also to Candle M. Wester for her research assistance, Lillian Bates for library access assistance, Susanne Anderson, Taylor Campbell, and Katelyn Moody for their excellent research assistance, Ashley Alvarado and Vanessa McQuinn for their administrative support, and the editors of the Administrative Law Review for their work. Jaime Harrison, thank you for your support!
