By Amaya Gentry
In the United States, most cosmetics do not require the Food and Drug Administration (FDA) premarket approval before they are marketed.
The Federal Food, Drug, and Cosmetic Act FD&C Act defines cosmetics as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body… for cleansing, beautifying, promoting attractiveness or altering the appearance.” The FD&C Act prohibits adulterated or misbranded cosmetics, before they enter the market.
The Modernization of Cosmetics Regulation Act of 2022 , known as MoCRA, expanded FDA authority and established additional requirements intended to strengthen cosmetic product safety. MoCRA provides the FDA with new authorities, including access to certain records and authority to order mandatory recalls in specified circumstances.
It requires serious adverse-event reporting, facility registration and cosmetic product listing, and maintenance of records supporting adequate safety substantiation. Implementation dates and exemptions vary by requirement, so manufacturers and consumers should consult current FDA guidance.
Most cosmetic ingredients do not require individual FDA premarket approval, although manufacturers and responsible persons have legal obligations to ensure cosmetics are safe and properly labeled; MoCRA added an explicit requirement for adequate safety substantiation. FDA guidance states that, except for color additives and ingredients prohibited or restricted by regulation, manufacturers may use an ingredient if the finished cosmetic is safe under labeled or customary conditions of use and is properly labeled.
Research on hair products commonly used by Black women
Concerns about some hair products marketed to Black women have received increased attention because research has identified differences in product use and chemical exposure. A 2021 study in the Journal of Exposure Science & Environmental Epidemiology examined hormonal activity in six leave-in hair products commonly used by Black women, including a hair lotion, two leave-in conditioners, two hair oils and one root stimulator.
Researchers found hormonal activity in laboratory assays for all six products, though the type and magnitude of activity varied across products. The finding indicates the products interacted with hormone-related receptors in the tests; it does not establish that their use causes disease.
In a 2018 study published in Environmental Research, tested 18 products used primarily by Black women for 66 chemicals, including fragrances, phthalates and parabens. Researchers detected 45 chemicals that the study categorized as endocrine-disrupting or asthma-associated across the tested products.
Additionally, the researchers reported finding “cyclosiloxanes, parabens, and the fragrance marker diethyl phthalate (DEP) at the highest levels, and DEP most frequently.” The researchers reported that many target chemicals were not listed individually on labels; some fragrance components may be declared collectively as “fragrance” under federal labeling rules.
Phthalates are a family of chemicals used for different purposes, including making some plastics more flexible and, in some cases, helping fragrances last longer. Some phthalates have been associated with reproductive, developmental and endocrine effects in scientific research, including animal studies; risks depend on the specific compound, dose and route of exposure.
The FDA states that, based on currently available safety information, it does not have safety concerns about diethyl phthalate, or DEP, as it is currently used in cosmetics and fragrances.
Parabens are used for their antimicrobial and preservative properties. Parabens can show estrogen-like activity, although the FDA notes that studies have found that their estrogenic activity is substantially lower than that of naturally occurring estrogen. The FDA’s current position is that parabens have not been shown to be harmful as used in cosmetics, where they are generally present in small amounts.
In a 2017 commentary in the American Journal of Obstetrics & Gynecology, researchers Ami R. Zota and Bhavna Shamasunder wrote that “Women of color have higher levels of certain endocrine-disrupting chemicals, such as phthalates and parabens, in their bodies compared to white women, and these racial [and] ethnic differences are not explained by socioeconomic status.”
The commentary summarizes associations reported across studies; it does not establish that using a particular hair product causes these outcomes.
Zota and Shamasunder also wrote, ‘Exposure to one or more of these chemicals has been linked to endocrine disruption, cancer, reproductive harm and impaired neurodevelopment in children.” The FDA says it continues to monitor and review published research on cosmetic-ingredient safety.
How to evaluate ingredients in hair care products
Consumers can start with a product’s ingredient declaration. For consumer cosmetics sold at retail in the United States, ingredients generally must be listed by their common or usual names in descending order of predominance. Ingredients present at 1% or less and color additives may be listed in any order after ingredients present at more than 1%.
Consumers also may consult third-party databases, such as the Environmental Working Group’s Skin Deep database or CosDNA, to identify reported ingredients and review each service’s methodology. CodeCheck, an app that scans product barcodes and provides ingredient information and ratings, can be used to check labels and investigate ingredients found in hair care products.
These third-party tools do not replace FDA safety determinations or product-specific advice from a qualified health professional. They can help consumers see which ingredients are listed for particular products, although users should compare the results with the current package label and recognize that formulas can change. It is also important to note that different services use different rating methods.
Takeaways
The enactment of MoCRA has expanded federal requirements and FDA authority over cosmetics in the U.S. Research has raised concerns about exposure to certain chemicals in some hair products, although potential risk depends on the particular chemical, its concentration, frequency and route of exposure, and the evidence available for that use.
Studies have detected chemicals that researchers classify as endocrine-disrupting or asthma-associated in some products used by Black women, while the FDA says it does not have evidence that phthalates as used in cosmetics pose a safety risk, and it does not have information showing that parabens as used in cosmetics affect human health.
Ingredient declarations generally identify cosmetic ingredients but do not disclose concentrations, and they may list fragrance mixtures collectively rather than naming their individual components.
Consumers should also recognize that labels may list a fragrance mixture simply as “fragrance,” rather than naming each component.
Amaya Gentry has a bachelor’s degree in biology and has worked as a quality control chemist.
