In the 1970s, a prominent actress sought to aid the resettlement of Vietnamese refugees by running a vocational training program, spurring a “butterfly effect” that would create the modern American nail salon. People who immigrated from Vietnam—beginning with the twenty women who received the actress’s manicure training—gradually and significantly transformed the nail salon industry. What once was an unaffordable and unattainable experience available only to elites blossomed into an “affordable luxury” for many Americans. As manicures, pedicures, and other nail design services become increasingly popular, customer demands continue to bolster the booming industry; in fact, between 2014 and 2019, the number of U.S. nail salons doubled. Even with strict government-imposed health and safety precautions at the height of the COVID-19 pandemic, nail salons have successfully rebounded to meet customer demands. Today, the brick-and-mortar nail salon industry is worth over $8 billion and is expected to continue to grow over the next decade.
But behind this veil of prosperity, nail salon technicians face occupational hazards from the nail products that they must use in the scope of their work. These products can contain dozens of chemical vapors. The effects of these harmful vapors are magnified by their day-to-day use for long hours in salon. As a result, nail technicians experience chemical exposure intensities 1,200 times that of the average American. They inhale ten times more flame-retardant and plasticizer chemicals than the average electronic-waste facility employee. Levels of cancer-causing chemicals in nail salons can even exceed those in auto garages. For many nail technicians, these chemical exposures manifest in short-term dermal and respiratory irritation. For others—including still unknown future victims—exposures manifest as long-term debilitating health outcomes like cancer, asthma, and reproductive issues. Today, Vietnamese-American nail technicians—the same population credited for forging the modern, archetypal American nail salon—experience up to twice the level of phthalates (reproductive toxicants) in their bodies compared to the general Asian-American population. The modern nail salon industry suffers from an “epidemic of health issues” caused by chemical exposures. The risks from those exposures are exacerbated because this workforce is largely comprised of women of Asian descent who immigrated to the United States with limited English-speaking proficiency and who experience a lack of access to “culturally and linguistically appropriate educational and outreach materials.”
Yet despite these risks, the industry continues to thrive. For many nail technicians, these exposures are just part of earning a living in an industry that appeals to their unique employment needs. Further, the nail salon industry comes with its own set of exploitative practices. Nail technicians are “frequently underpaid, overworked, and misclassified as independent contractors instead of employees.” Without the safety net of labor protections, nail technicians face barriers to issuing formal complaints and filing workers’ compensation claims over safety hazards in the workplace.
Occupational safeguards fall short of protecting nail technicians. While the Occupational Safety and Health Administration (OSHA) sets “permissible exposure limits” for chemical air contaminants found in nail salons, OSHA has recognized that the limits “are outdated and inadequate for ensuring protection of worker health.” Additionally, although OSHA recommends against using products that contain harmful chemicals in the workplace, it does not restrict nail salons from using products containing these ingredients. Ultimately, occupational guidance and regulations shift the burden of worker safety onto private nail salons, ninety percent of which are small businesses without designated safety personnel. This demonstrates a need for regulatory action at the source: the manicure products themselves. However, the level of cosmetic product oversight is grossly incongruent with the cosmetic industry’s success.
In 1938, Congress passed the Federal Food, Drug, and Cosmetic Act (FDCA) after years of industry resistance. In doing so, Congress intended to replace the 1906 Pure Food and Drug Act and, for the first time, enable federal oversight of cosmetics to safeguard consumers from dangerous beauty products. But the cosmetics regime soon proved to be insufficient in reining in dangerous products, and, over the next several decades, industry players successfully quashed numerous attempts to reform cosmetic ingredient safety. The cosmetics industry continues to reap the benefits of a weak regulatory landscape: since the 1970s, the industry has funded and controlled the “only panel tasked with determining the safety of individual cosmetic ingredients.” The industry’s self-regulation reveals a dismal truth for both consumers and salon workers: despite the beauty industry’s increasing use of chemicals in cosmetics, manufacturers today are still not subject to any Food and Drug Administration (FDA) pre-market ingredient review or approval.
Despite a recent legislative overhaul of the FDCA that altered the cosmetic regime for the first time in over eighty years, FDA still lacks the authority it needs to restrict the use of harmful chemicals in nail products. As studies of long-term effects of chemical exposures in the nail salon workplace remain few and far between, workplace protections continue to be underregulated; legislation and regulations must address manicure product safety to ensure that this vulnerable group is able to prevent debilitating health effects before it is too late.
Part I of this Comment examines the most pervasive nail product chemicals and their potential effects on occupational health. Part II evaluates how FDA’s rigid cosmetic framework limits the agency’s pre-and post-market authority and prevents it from addressing nail product safety issues through traditional enforcement powers. Part III analyzes the permissible extent of FDA rulemaking on nail salon product chemicals. Part IV analyzes how current trends in jurisprudence may affect FDA’s authority to protect professionals (rather than just consumers alone) from harmful chemicals in nail products. Part V examines recent cosmetic reform and discusses provisions necessary to protect nail technicians through ingredient review, using an Environmental Protection Agency (EPA) chemical ingredient reform as a blueprint. Part VI recommends two possible remedies through either legislative action or FDA rulemaking.
Each day at work, nail technicians can encounter dozens of chemical constituents in the products necessary to perform their jobs. The most notorious example of harmful nail product ingredients is the “toxic trio,” a combination of dibutyl phthalate, formaldehyde, and toluene. Like many other chemicals in nail care products, components of the toxic trio have been linked to a variety of negative health outcomes through inhalation and dermal contact. Formaldehyde is a nail polish hardening agent that causes difficulty breathing along with skin, eye, and nose irritation. Formaldehyde is also a known human carcinogen. The FDA-supported, industry-operated Cosmetic Ingredient Review (CIR) panel concluded in 2012 that formaldehyde is “safe in the present practices of use and concentration in nail hardening products,” despite acknowledging that at “high doses” formaldehyde can cause nasopharyngeal cancers—the report ignored potential long-term accumulations that technicians may experience.
Dibutyl phthalate (DBP) is a nail polish bonder that, in the short term, causes nausea and skin, eye, and nose irritation. In the long term, DBP is a reproductive toxin linked to birth defects and endocrine disruption in animals. However, based on research last updated in 2002, FDA did not find a “sound, scientific basis to support taking regulatory action against cosmetics containing phthalates.”
Toluene is an organic solvent added to nail polish for a smoother application. Toluene has also been linked to spontaneous miscarriages in occupationally-exposed women. The CIR panel last reviewed toluene in 2005, finding that “adverse effects occurred only at levels many times higher than those observed when people used nail polish.” The CIR panel did not consider toluene’s effects at levels that nail technicians experience—instead, it concluded that “high exposures . . . are not relevant to the use of toluene in cosmetic products.”
In attempts to market their products as “3-free,” some manufacturers substitute out the toxic trio for chemicals such as triphenyl phosphate (TPHP) and didiethylhexyl phthalate (DEHP). TPHP, a plasticizer and flame-retardant commonly substituted for DBP, has been linked to reproductive toxicity and endocrine disruption. DEHP, a chemical banned in the European Union, is a hormone disrupter and possible carcinogen.
Overall, few studies examine nail product chemical exposures and adverse health outcomes in nail technicians, resulting in limited scientific research on the subject. The shortage is partially due to a diversity problem: members of nail technicians’ ethnic and cultural community are not well-represented in the research community, so “the people who care about [nail technicians] most [are not] . . . involved in addressing the problems.” The shortage of studies fails to reflect the serious concerns nail technicians have relating to the negative health outcomes associated with exposures to chemicals in nail products.
In 1988, Le Thi Lam immigrated to the United States from Vietnam. Soon after becoming a nail technician, she developed asthma and a thyroid condition. Ailing and concerned about the chemical exposures from nail products, Lam left the nail salon industry, but she returned after failing to find another job. Years later, she learned that she had breast cancer.
After immigrating to New York from Nepal, Pabitra Dash became a nail technician. Her relatives told her that “for immigrants like [them], working in a nail salon was the best choice.” Dash worked in the nail salon for years, where she inhaled chemicals such as toluene and formaldehyde. She just “wanted to survive and eventually start a family”—instead, over the course of ten years, Dash suffered seven miscarriages.
Dr. Charles Hwu, an internist in Flushing, New York, routinely encounters a particular set of conditions affecting otherwise healthy young women:
They come in usually with breathing problems, some symptoms similar to an allergy, and also asthma symptoms—they cannot breathe . . . . Judging from the symptoms with these women, it seems that they are either smokers, secondhand smokers or asthma patients, but they are none of the above. They work for nail salons.
These stories are not unique, and these women are not alone. The limited medical studies that do exist illustrate a pervasive set of ailments distinctive to nail product chemical exposures, often finding that nail technicians suffer from respiratory, skin, and musculoskeletal issues as a result of exposure to the “laundry list” of chemicals they encounter daily.
Beyond the short-term ailments, studies hint at more insidious illnesses emerging from long-term exposure. Over a twenty-year exposure to manicure products nail technicians are over one hundred times more likely to develop leukemia due to formaldehyde exposures and are up to thirty-eight times more likely to develop mouth and throat cancer due to benzene exposures. By contrast, it is highly unlikely that nail salon customers will face exposure to a significant or harmful concentration of manicure product chemicals—after all, consumers only spend a fraction of the time in nail salons that technicians do. Therefore, special product safety considerations are needed to account for the exposure levels that nail technicians face.
FDA does not possess the requisite pre-market authority to regulate chemicals in nail care products. Unlike under the FDCA’s drug, device, or additive approval processes, manufacturers do not need ingredient approval from FDA before distributing cosmetics in interstate commerce. Rather, the cosmetics industry itself is responsible for pre-market safety assessment through the CIR panel, an industry-funded mechanism that examines voluntary, manufacturer-provided data to make non-binding conclusions regarding product safety. Since its inception in 1976, the CIR panel has only analyzed eleven to thirteen percent of all cosmetic ingredients and has only found eleven unsafe chemicals out of the 10,000 used in cosmetics. Additionally, some believe the industry-funded findings pose a conflict of interest and question the impartiality of the CIR panel. This ambivalence toward current ingredient safety determinations demonstrates a need for FDA to obtain its own independent ingredient review authority.
FDA could improve pre-market product safety but has failed to define testing or evidence requirements for safety substantiations. Under FDA’s regulations, ingredients in cosmetic products “shall be adequately substantiated for safety prior to marketing” or otherwise bear a warning label stating that “the safety of this product has not been determined.” FDA directs manufacturers to rely on “available toxicological test data” or conduct tests to assess ingredients and formulae for safety, but does not specify exactly what records manufacturers must provide to show such substantiation. As long as a scientist can “reasonably conclude” that the product is not harmful through its intended use or foreseeable misuse, manufacturers can market the product without the prescribed warning label, regardless of the kind of tests conducted or data provided. Cosmetic manufacturers are not required to provide specific research to demonstrate ingredient safety or share their safety information with FDA before distributing their products in commerce.
Recent developments could scale back FDA’s already limited pre-market oversight of cosmetics. In December 2022, Congress passed the Modernization of Cosmetics Regulations Act of 2022 (MOCRA) as part of the Consolidated Appropriations Act of 2023. MOCRA requires manufacturers to ensure there is “adequate substantiation of safety” of their cometic products. MOCRA defines an “adequate substantiation of safety” as tests or evidence that qualified scientific experts would believe are sufficient to support a “reasonable certainty” that a cosmetic product is safe under its “customary or usual” conditions of use.
Like existing FDA regulations, MOCRA does not specify the standards for tests that manufacturers must maintain or conduct to demonstrate safety. Rather, by providing that manufacturers need only demonstrate cosmetic safety under “customary or usual” usages—despite current FDA regulations requiring the additional consideration of “reasonably expected related uses”—MOCRA codifies an even weaker safety expectation for cosmetics in the market. Therefore, MOCRA “appear[s] to supersede” FDA regulations with reduced standards for cosmetic safety substantiations that manufacturers must provide prior to marketing. Ultimately, by failing to offer uniform testing and evidence standards for manufacturer safety substantiations, FDA effectively enables manufacturers to downplay the risks associated with certain chemical ingredients before marketing their cosmetics.
In the cosmetic labeling space, FDA derives authority from both the FDCA and the Fair Packaging and Labeling Act. Under both Acts, anything on or accompanying a cosmetic product’s package constitutes labeling. A cosmetic is misbranded if “its labeling is false or misleading in any particular,” and FDA may issue warning letters or, with assistance from the Department of Justice, seek injunctions or criminal penalties against manufacturers for introducing misbranded cosmetics into interstate commerce. Despite its authority to prohibit misbranded products in interstate commerce, FDA has not addressed common claims from nail care product manufacturers that feign product safety. Although MOCRA requires products intended for professional use to bear ingredient listings, users might rely on marketing claims instead of unwieldy and confusing ingredient lists.
Federal law provides that in determining whether a label is misleading, the agency will consider the extent to which the labeling “fails to reveal facts material . . . with respect to consequences which may result from the use of the article.” For example, FDA has utilized this provision in the cosmetic context before to find that a hair product containing methylene glycol, a liquid that becomes formaldehyde gas when heated, was misbranded because the manufacturer labeled it as “Formaldehyde Free.” Similar practices exist in the nail product industry. In 2012, the California Department of Toxic Substances Control sampled twenty-five different nail polish brands for the presence of the toxic trio. Out of the twelve products that claimed to be free of toluene, ten contained detectable concentrations of the chemical, and five of the seven products claiming to be free of DBP, formaldehyde, and toluene were falsely labeled. While this practice could make for a misbranding offense, other industry labeling practices raise novel concerns.
In addition to “free-of” claims, manufacturers also use “number-free” (n-free) labels that claim to exclude certain ingredients but consequentially shield the substitution of other harmful chemicals in their formulations. These claims, which can range from 3-free (free of three harmful chemicals) to up to “13-free” (free of thirteen harmful chemicals), may claim to be free of materials not traditionally even used in nail polish. Not only do different brands of nail products define label contents differently from one another, more recent n-free claims are often inconsistent with the list of ingredients excluded on previous labels of the same product. The lack of regulatory scrutiny applied to these inconsistencies blurs the line between acceptable, safe ingredients and unacceptable ingredients, subjecting nail technicians to potential harm.
While falsely claiming the absence of an ingredient on the cosmetic label violates misbranding regulations, it is unclear whether FDA may take a similar approach to nail product n-free claims and subsequent substitutions with other harmful chemicals. For example, while methylene glycol in hair products becomes formaldehyde, the same cannot be said for toxins such as TPHP, which is substituted for DBP. To address the ambiguity of labeling in light of the practice of “continual substitution of toxic chemicals for other toxic chemicals,” FDA should provide clear n-free chemical list definitions that include common substitutions known to be harmful to health. Without providing these definitions, FDA precludes consumer suits seeking to hold manufacturers accountable for misleading claims because courts are highly deferential to the agency’s interpretations of labeling terms. FDA is the agency best suited to prevent nail care product manufacturers from continuing to craft their own, inconsistent standards for safety claims.
Under the FDCA, a cosmetic is an article that is “intended to be . . . applied to the human body . . . for . . . beautifying . . . or altering the appearance.” Under the FDCA’s adulteration provisions, a manufacturer may not use “any poisonous or deleterious substance” that makes a cosmetic “injurious” when it is used as intended, meaning when it is used according to directions on the label, or in the usual or customary way. Introducing an adulterated product into interstate commerce may subject an individual or manufacturer to criminal penalties.
The FDCA’s “intended for use” scope in these definitions effectively precludes safety considerations for nail technicians. For nail care products specifically, FDA assumes that otherwise harmful ingredients are safe when used on the nails because “the nail is a barrier, which prevents absorption.” For nail products, an intended use does not encompass contact from inhalation or dermal absorption. However, nail technicians cannot escape exposures that fall outside of the intended-use scope. Due to this statutory rigidity, FDA appears powerless to act on chemicals in nail care products when such chemicals are harmful through uses that the statute does not consider but that naturally follow from it.
FDA has provided unclear interpretations for whether products containing chemicals exposed through unintended contact, such as under the conditions such products are used in the salon setting, are subject to adulteration actions. In 2011, FDA warned a manufacturer of hair smoothing products that its merchandise was adulterated because it contained harmful levels of formaldehyde gas, for which the “primary route of exposure . . . is through inhalation,” although the product’s intended use was not for salon workers or clients to inhale. Since FDA explored expanding on its interpretation of the statutory definition in the context of hair products “primarily for use by salon professionals in a salon setting,” there may be opportunities for the agency to act under its current adulteration authority. This ambiguous space requires clarification to unequivocally answer whether FDA can enforce adulteration provisions on harmful products with chemicals that nail technicians inhale or make dermal contact with during the application process and whether such contact is “customary or usual.”
Furthermore, a cosmetic is adulterated if “it consists in whole or in part of any filthy, putrid, or decomposed substance.” The statutory language of “putrid” and “filthy” connote acute, immediate risks rather than risks from the long-term exposures that nail technicians face. However, recent developments under MOCRA provide that FDA can “consider, as appropriate and available, the cumulative or other relevant exposure to the cosmetic product” in deeming that a cosmetic is adulterated because it has not been adequately substantiated for safety. Because this provision is both unprecedented and optional for FDA, it is unclear whether the agency will use it to address nail product safety. Otherwise, absent a meaningful showing of harmful long-term effects—a showing that can be difficult to demonstrate—cosmetics such as nail products could remain on the market despite containing ingredients that are hazardous when they accumulate.
FDA also affirmed that it can take action towards ingredients within its regulatory framework for cosmetics “based on reliable scientific information available” to it. However, it is unclear whether FDA can accept existing research on nail product safety as adequate “reliable scientific information” for it to pursue an adulteration action. Given that FDA has not provided the standards for the kind of information that surpasses the action standard, the extent of FDA’s ingredient review authority in this area necessitates more clarity.
Out of over 10,000 ingredients used in cosmetic formulations, FDA has only banned or restricted eleven ingredients that render cosmetics adulterated. Compared to the nearly 2,000 substances that the European Union has banned from cosmetics, the brevity of FDA’s restriction list demonstrates that the process of banning an ingredient in the United States is not straightforward. Even with evidence that an ingredient is harmful to human health, the road to banning a harmful ingredient is fraught with bureaucratic roadblocks and is vulnerable to leadership changes. Prior FDA attempts to ban harmful cosmetic ingredients demonstrate that FDA may abandon the efforts due to shifting priorities or other unrelated issues despite “dozens of complaints,” findings that an ingredient endangers salon workers, and scientists “mak[ing] the case for restricting” the use of an ingredient. Among the unclear regulations, manufacturer indifference, and institutional infighting, the true victims are the salon workers who remain at risk of harmful product effects until FDA bans chemical culprits.
Under the Administrative Procedure Act (APA), agencies may issue non-legislative, non-binding, procedural rules without undergoing the notice-and-comment process. Non-legislative rules allow agencies to efficiently explain ambiguous legislation, advise the public on how the agency proposes to exercise its discretion, or manage intra-agency affairs without engaging in cumbersome procedures. The Supreme Court clarified that “[a]n interpretive rule itself never forms the basis for an enforcement action[,]” and as such “does not impose any legally binding requirements on private parties.” Because informal guidance lacks the force of law, it would be impossible for such guidance to exact sweeping, meaningful change. Agencies also cannot use guidance to take significant action as that would undercut rulemaking requirements: even if an agency action falls into one of the three permissible categories of non-legislative rules, the action may still be subject to notice-and-comment rulemaking if it is “likely to have considerable impact on ultimate agency decisions” or if it will have a “substantive impact” on the rights of those under agency authority.
The notice-and-comment rulemaking process allows an agency to promulgate rules under its delegated legislative authority. Final rules promulgated under APA § 553 are binding. While FDA can achieve some change through rulemaking, it may be limited due to the rigid cosmetic statutory framework. Any rule that FDA promulgates must pass the review as defined by the Court in Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc. Chevron provides that generally, if Congress has not spoken on the matter, courts defer to the agency’s construction of the controlling statute as long as it is reasonable. Therefore, while FDA can promulgate rules to restrict the use of certain ingredients, it cannot exceed the bounds of its statutory authority.
FDA recognizes that it “does not have authority over the operation of salons or the practice of cosmetology,” and that such workplace safety issues fall under the jurisdiction of OSHA. Aside from the bounds of FDA’s enforcement and rulemaking authority in the cosmetic space, there remains a possibility that a court would deem FDA completely powerless to take action on safety issues specifically affecting the professional administration of a cosmetic, as opposed to the mere consumer use of one. While courts have not yet decided whether FDA possesses the authority to take on what is, at the root, an occupational hazard, current trends in jurisprudence suggest the Supreme Court might narrowly construe the enabling statutes of health and safety agencies.
The Supreme Court recently found that OSHA overstepped its statutory purview when it mandated COVID-19 vaccines in the workplace, going too far by addressing a hazard affecting individuals both inside and outside the workplace. As applied in the FDA context, a court narrowly construing the FDCA could similarly find that because OSHA has authority over workplace safety, FDA does not have the same authority to protect workers inside the workplace. This possibility would pose a significant hurdle to FDA’s authority to regulate nail products with special or specific consideration of technician safety.
In determining whether FDA has the authority to regulate nail care products in the occupational context, a court would likely review the issue under the Chevron doctrine. Under the first step, a court would examine whether Congress directly spoke on the question at issue, and if so, the court would give effect to Congress’s intent. For example, if Congress already enacted legislation on product and occupational safety in nail salons without delegating authority to FDA, then Congress would have evidenced its view that FDA does not have jurisdiction. This was the Supreme Court’s reasoning in FDA v. Brown & Williamson Tobacco Corp., where it held that FDA lacked authority to regulate tobacco products because Congress had previously passed legislation concerning tobacco without providing FDA with authority to regulate in that area, suggesting it did not intend for FDA to have such power. In response to the Court’s ruling, Congress explicitly delegated authority to FDA to regulate tobacco products and curb their harmful public health outcomes through the Family Smoking Prevention and Tobacco Control Act.
Whether FDA action on nail care products can survive the Supreme Court’s trend toward narrow construction relies on congressional support for FDA’s regulation in this area. Under step two of Chevron, if a court finds Congress has not directly spoken on the issue, it examines whether the agency’s construction is reasonable; if so, the Court will accept the agency’s interpretation. Although courts usually defer to the agency during this step, the Supreme Court’s recent constructions of health and safety actions present the risk that a court may disapprove of FDA’s action on professional exposure levels in the workplace as an impermissible overstep of the agency’s statutory bounds. To cement FDA’s rulemaking and enforcement powers over the effects of nail care products in the salon setting, Congress should directly and unequivocally express support for FDA authority in this context.
Advocates and lawmakers have attempted to update cosmetic safety standards for years, and in 2022, a reform effort successfully altered the nation’s cosmetics regime for the first time since 1938. Passed as part of a consolidated appropriations bill, MOCRA “emerged in the wake of heightened FDA and consumer attention toward the safety of cosmetic products” and boasts significant strides in FDA’s authority over cosmetics. These strides include providing FDA with mandatory recall authority, mandated facility registration and product listings, directives for FDA to promulgate guidelines dictating safe cosmetic manufacturing practices, and enforcement provisions that classify the failure to adhere to any of MOCRA’s requirements as adulteration or misbranding.
However, the Act did not go as far as imposing any pre-market review for cosmetics. And unlike in a prior reform effort, cosmetic ingredient review provisions are “notably absent”—Congress declined to grant FDA the authority to analyze specific cosmetic ingredients for safety under MOCRA. In choosing MOCRA as its vehicle for cosmetic reform, Congress fell short on implementing the ingredient review threshold necessary to protect nail technicians from harmful nail care product exposures. As a broad and ultra-encompassing category, cosmetics and accompanying regulations affect various intersectional groups and occupations in different ways. Nail technicians represent a distinctly vulnerable population due to factors such as minority status, workplace agency, and health literacy. To properly address these issues at the root, legislation must grant FDA the ability to conduct precautionary ingredient risk evaluations with special consideration of vulnerable populations such as nail technicians.
In 2016, Congress passed the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Chemical Safety Act), which amended the Toxic Substance Control Act (TSCA). The Lautenberg Chemical Safety Act requires the EPA to conduct safety reviews for chemical substances currently in the market, as well as new chemicals before they enter the market. Prior to the Lautenberg Chemical Safety Act’s amendments, the EPA’s authority over ingredient review under TSCA was as similarly limited as FDA’s current cosmetic regime. For example, the pre-amended TSCA required manufacturers to receive the EPA’s approval before chemicals could hit the market. However, the EPA could only review data generated by the manufacturers themselves. Similarly, FDA requires manufacturers to substantiate product safety before marketing but allows beauty manufacturers to test for safety in any way they choose. The pre-amended TSCA also presented a catch-22 wherein the EPA had to show a chemical’s potential harm before it could compel testing to determine whether the chemical posed an “unreasonable risk” to public health or the environment, despite not having ready access to safety data that manufacturers were not required to provide. Similarly, while the “burden is on FDA to prove that a particular product or ingredient is harmful when used as intended,” FDA cannot require manufacturers to share ingredient safety data with the agency. The key changes that the Lautenberg Chemical Safety Act implemented included toxicity review, risk-ranking and management, and consideration for vulnerable populations. The EPA may now require more toxicity testing before approving chemicals, must develop a screening process for all existing chemicals that ranks them according to their level of risk, and must consider feasible alternatives and vulnerable populations in its review.
Under the TSCA, the EPA lacks the authority to regulate chemicals distributed in commerce solely for use in cosmetics; however, it can regulate those same chemicals when they are meant to be used in other products. This is because the TSCA’s definition for “chemical substance” excludes substances that meet the definition of “cosmetic” under the FDCA. As demonstrated by the EPA’s power to review chemical components found in nail care products for non-cosmetic purposes, FDA requires a similar level of reform that emphasizes ingredient review. While not all-encompassing, the key aspects of the Lautenberg Chemical Safety Act address the elements necessary to analyze ingredient safety with considerations for the levels of exposure experienced by vulnerable populations. A similar regime at FDA would provide the agency with the authority to restrict harmful chemical exposures in manicure products.
Granting cosmetic ingredient review authority to FDA and increasing the agency’s resources is the most significant and important step toward reducing or eliminating harmful chemical exposures from nail care products. Mandated ingredient review would give FDA greater bandwidth to ensure it actually and effectively analyzes ingredients on the market for safety. Considering the EPA’s improved ingredient authority, Congress should utilize the key aspects of the Lautenberg Chemical Safety Act reform as a guide.
Congress must take on Lautenberg Chemical Safety Act-level reform to effectively push out harmful chemicals in manicure products that jeopardize occupational health. To do so, Congress should reconsider and pass the Safe Cosmetics and Personal Care Products Act (SCPCPA), last introduced in 2019. The SCPCPA, as last introduced, aimed to amend the FDCA and expand FDA’s regulatory powers over cosmetics. The major provisions of the SCPCPA mirrored those of the Lautenberg Chemical Safety Act; they include toxicity review, risk-ranking and management, and consideration for vulnerable populations.
In terms of toxicity review, the SCPCPA sought to provide resources to FDA and mandate it immediately add twenty ingredients to a priority assessment list (PAL) for review, after which it would be required to assess ten ingredients annually until it reviewed all cosmetics chemicals under the “reasonable certainty of no harm” safety standard defined in the Act. Given that MOCRA does not currently mandate annual ingredient reviews, this provision would constitute a meaningful shift towards safer ingredients on the market. When considering which chemicals to place on the PAL, FDA would not only need to consider scientific evidence linking the chemical to harmful health effects, but also prioritize chemicals that disproportionately impact a certain racial, ethnic, or occupational community. Including this language would bring nail product chemical safety into the forefront, as these chemicals unfairly harm the nail technician profession—a profession comprised mainly of women who immigrated to the United States. This mandate would also significantly expand ingredient reviews, currently left up to manufacturers to conduct.
If reintroduced, the SCPCPA would also establish a heightened safety standard that requires cosmetics to present “a reasonable certainty of no harm . . . and protects the public from any known or anticipated adverse health effects associated with the cosmetic or ingredient.” The SCPCPA further defines a “reasonable certainty of no harm” as one in which “the likely level of exposure . . . presents not more than a one in a million risk for any adverse health effect in any vulnerable population.” FDA currently uses a “reasonable certainty of no harm” safety standard for cosmetic color additives, which require pre-market approval.
Applying the “reasonable certainty of no harm” safety standard to cosmetics would require manufacturers to either completely remove many of the existing chemicals that may adversely affect health or explore safer alternatives. The burden would fall on manufacturers, rather than FDA, to prove ingredient safety, increasing manufacturer accountability as well as the likelihood of obtaining better data concerning the long-term effects of nail product chemicals. Finally, using this safety standard, FDA can address nail product exposures that have higher impacts on nail technicians than on the average consumer.
The SCPCPA would also fast-track the ban of chemicals known to be harmful to nail technicians, which would be more expedient than an FDA-initiated ban for each individual chemical. Among a list of a dozen of the most toxic chemicals found in cosmetics, the SCPCPA would immediately ban the toxic trio. Additionally, some states have already enacted bans of chemicals such as DBP and formaldehyde in cosmetics sold in-state. As these state-specific bans are expected to significantly impact manufacturers who wish to sell in these states, Congress should take advantage of the opportunity to preserve these bans through federal law. Without doing so, federal preemption could threaten more stringent state requirements designed to protect professionals, such as nail technicians, and consequentially result in weaker nationwide cosmetic reform. The SCPCPA as currently written protects against this possibility because it does not contain a preemption clause.
In terms of risk-ranking, the SCPCPA would provide FDA with the authority to categorize cosmetic ingredients into “prohibited,” “restricted,” “safe without limits,” and “priority assessment.” Risk-ranking would aid the agency in prioritizing its resources toward the most harmful and pervasive chemicals, such as those in nail products.
Finally, the SCPCPA would address severe chemical hazard exposures affecting salon workers and communities of color and would do so by defining the cosmetic safety standard to take into account the level of exposure “in any vulnerable population,” as well as consider the “impact of cumulative exposure from all sources.” While MOCRA provides that FDA “may consider” cumulative exposures to cosmetic products when determining whether a cosmetic is safe, this consideration is permissive, so manufacturers are not required to consider the impact of cumulative exposures when substantiating their cosmetics for safety. On the other hand, the SCPCPA would require the consideration of cumulative exposures—under the SCPCPA’s standard, whether a nail product can be rendered safe would depend on its long-term impact on nail technicians under the conditions that the nail technicians typically work in, which includes working for long hours. The SCPCPA would also fund research into safer alternatives to the hazardous ingredients such as those found in nail care products.
The SCPCPA died in committee at the end of the 116th Congress. Several commentators have discussed the SCPCPA’s superiority over other cosmetic-reform bills in protecting against harmful occupational exposures, and some have argued that the SCPCPA should be re-introduced, noting the benefits the bill would provide to vulnerable populations, such as nail salon technicians.
Under the FDCA, whether “customary or usual” conditions of use may include occupational uses and exposures for the purpose of adulteration actions presents another area of statutory ambiguity. Current judicial interpretations of health and safety statutes further compound this uncertainty. FDA could take advantage of this ambiguity and argue that, because of the ubiquity of nail salons, applying nail polish has become a “customary” use of the product. The agency could then promulgate a rule that identifies occupational-specific consequences of nail product use as a condition of use that is subject to adulteration enforcement. However, it is unclear whether a court would read such a rule as contravening congressional intent. Although FDA has considered salon-setting uses within its product safety purview before, current judicial trends suggest that congressional action would be the most effective vehicle to cement FDA’s authority in this space.
As currently drafted, the SCPCPA contains a provision defining “professional use,” which, if passed, would clarify FDA’s authority to regulate “the application of a cosmetic to a human customer or client by an employee or contractor of a hair salon, nail salon, beauty salon, spa, or other [similar] establishment . . . .” However, the term only refers to FDA’s authority under the bill’s section concerning ingredient labels. Similarly, MOCRA defines professional use only in the labeling context. Therefore, if Congress reconsiders the SCPCPA, lawmakers should expand the Bill to include a provision that expresses Congress’ intent for FDA to regulate products as they relate to both consumers and those who apply the products, such as nail technicians. Alternatively, Congress could pass a standalone bill clarifying this authority to secure subsequent rulemaking power for FDA.
While congressional action would have the most potential to enact meaningful and sweeping reform, FDA can utilize its APA rulemaking authority and promulgate beneficial clarifications for existing, ambiguous regulatory language. These areas include defining the threshold for manufacturers’ self-determined safety substantiations, defining the level of information necessary to ban ingredients, and defining certain marketing claims. APA informal rulemaking is the most effective vehicle to address these issues because agencies cannot use guidance documents to take significant or binding action. By limiting the proposed rules to merely clarify how it plans to act under existing statutory language, FDA would lower the risk that it will run afoul of the APA.
FDA should define a threshold for information that supports an “adequate substantiation of safety”; while both FDA regulations and MOCRA mandate safety substantiations for cosmetics, neither specify any testing or evidence requirements for manufacturers to meet. One existing area of law that can serve as a model for cosmetic safety substantiation is the standard in FDA’s regulations of manufacturer self-determination of safety within the food additive approval regime. FDA currently requires that for an ingredient to be “generally recognized as safe” (GRAS) for use in food, the safety of food additive formulations must be supported by published, peer-reviewed scientific data. FDA should adopt this threshold for cosmetics to compel manufacturers to invest in methodic and thorough testing, or to find up-to-date and reliable data to adequately support ingredient safety before distributing their cosmetic products in the market.
One drawback of defining this standard through rulemaking is that FDA lacks the statutory authority to mandate regulated parties to submit safety data to the agency for review. However, FDA can employ a system similar to its food additive GRAS affirmation process through which manufacturers voluntarily send safety substantiations for FDA examination. From there, the agency can take no action or notify the manufacturer that the supporting data is insufficient. While the process is voluntary, it incentivizes manufacturers to go through FDA review rather than make their own GRAS declarations as they may risk retail loss if they fail to provide safety information. If this becomes the norm, nail products with formulations reviewed for safety by FDA may be more successful and prevalent in the market. Incentivizing manufacturers to share their cosmetic safety data with FDA would be especially beneficial in curbing the long-term effects of nail product chemical exposures, given FDA’s new authority to consider cumulative exposures in determining whether a cosmetic product has been adequately substantiated for safety.
Through rulemaking, FDA could also clarify the level of “reliable scientific information” required for the agency to ban or restrict a cosmetic ingredient. FDA can interpret this term to encompass published studies that suggest harm from exposures through elevated uses in common occupational settings, rather than evidence of acute reactions alone. As published studies denoting the harmful effects of nail salon product exposures already exist in the nail technician context, such an interpretation could better enable FDA to ban pervasive, toxic ingredients used in nail products.
Finally, FDA can use rulemaking to standardize the various n-free labeling claims to include specific chemical lists with common harmful substitutions such as TPHP, rather than chemicals not typically used in nail products. Standardizing such claims would improve technician awareness of the specific harm associated with certain chemicals in nail products. This practice would also keep manufacturers accountable by requiring them to truthfully provide safer alternatives. Standardized terms would notably benefit health-conscious nail salons seeking to protect both technician and consumer health.
Every day at work, nail technicians experience exposures to reproductive toxins, asthmagens, irritants, and potential carcinogens in the products essential to their job performance. While occupational risks in the nail salon industry may not constitute immediate physical dangers, chemical exposures at the levels nail technicians experience pose threats to long-term occupational health. However, FDA lacks adequate authority to regulate nail product safety in this context. Current statutory definitions, by design, exclude consideration of harmful chemical exposures that nail technicians experience.
FDA’s rulemaking can help to clarify existing protections as applied to nail technicians and will be easier than pursuing Congressional action. However, while FDA may pursue administrative rulemaking to set industry standards for pre-market safety substantiations and health-oriented labeling claims, the agency may face judicial-review barriers if it attempts to mandate industry action. Therefore, true effective reform relies on congressional action. To effectively rein in manicure manufacturers and protect nail technicians, Congress should re-introduce and adopt the SCPCPA, which would encompass major strides toward ingredient reform and would effectively ban or restrict dangerous chemicals found in manicure products.
I would be nothing without my family, my friends, and their unconditional support and encouragement. To the Administrative Law Review staff, thank for your commitment and invaluable editorial guidance. This Comment is lovingly dedicated to my parents, and especially to my mother, who has labored tirelessly as a nail technician for over twenty years. Because of your unwavering resilience and sacrifice, I can pursue my dreams, and for that, I am endlessly inspired and grateful—cảm ơn bố mẹ cho tất cả.
