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Few physicians consider cosmetics and related products relevant to their professional lives. Cosmetics, of course, are used to alter the body’s appearance, not its actual structure or function. However, the distinction between substances that only alter bodily appearance or aesthetics and medicinal compounds that affect the body’s structure or health (eg, wrinkle removal; prevention of gingivitis) is one the cosmetics industry and the US Food and Drug Administration (FDA) have struggled with for decades. As Paracelsus, the 16th-century Swiss physician and philosopher, observed, any substance applied to or in the body can cause harm, given the right circumstances.
The debate about regulation of the cosmetics industry to protect the public health has gone unresolved for more than a century. Unlike drugs and devices used for diagnosis and treatment, Congress has never required cosmetic manufacturers to obtain premarket approval before selling a new product (with the exception of color additives). Nor does any regulatory body evaluate claims about the safety or effectiveness of these products. The FDA’s role with regard to cosmetics is thus similar to that of police, who can act only if they become aware of something that gives them “probable cause” to investigate. The challenge for regulators is daunting: the global cosmetics industry is enormous, with an expected $265 billion in revenue in 2017.1 The Office of Cosmetics and Colors within the FDA’s Center for Food Safety and Applied Nutrition is tiny in contrast and, with a budget of around $13 million for Fiscal Year 2017,2 chronically underfunded, even considering its limited responsibilities and scope of authority.
In this issue of JAMA Internal Medicine, Kwa and colleagues3 provide an analysis of the adverse event reports submitted to the FDA regarding cosmetics and other personal care products. The information available has many deficiencies, none of which are the authors’ fault. Without a legal requirement for the cosmetics industry to collect or report adverse events or even register marketed products, the FDA must wait for clues to accumulate from voluntary reports suggesting that a product may not be as completely safe as presumed. For example, in 2007, toothpaste made in China that included diethylene glycol, a solvent related to conventional antifreeze, was found for sale in a few discount stores in the United States. The discovery was made possible because the FDA had been alerted to look for these products by other countries that had first recognized the adulteration problem.4 The need to wait for problems to declare themselves overtly before regulatory action can be initiated, as revealed by Kwa et al,3 raises important questions about cosmetic safety as well as the safety of health-related products in general.
History has repeatedly shown that when there is insufficient regulatory oversight, a few unscrupulous people or companies will exploit the vulnerable public for profit. Market forces may sometimes correct such lapses when consumer products are involved. The challenge, however, is considerably greater when consumer safety is at risk. The Pure Food and Drug Act of 1906 was the first federal attempt to regulate pharmaceuticals. Primarily mandating truth in labeling for food and drugs, the act did not require testing or evidence of safety, provided very little enforcement authority, and did not apply to cosmetics.5 Decades later, the S. E. Massengill Company in Tennessee started selling Elixir Sulfanilamide, which was prepared by dissolving the antibiotic in diethylene glycol. The pleasant-tasting liquid, which was targeted at children who could not or would not take pills, caused over 100 deaths before it was withdrawn from the market.5 The resulting public outcry led Congress to pass the Federal Food, Drug and Cosmetic Act (FFDCA) of 1938. Cosmetic regulation was included in that legislation because health risks from cosmetics, some quite serious, had also gained widespread public attention. For instance, the 1902 Sears Roebuck Catalogue advertised “Dr Rose’s French Arsenic Complexion Wafers,” which promised to convert even the “coarsest and most repulsive skin” to “an unrivaled purity of texture.”6 Prior to the Act of 1938, cosmetics containing toxic amounts of mercury, lead, carbolic acid, and even radium were widely available.7,8 The regulatory authority over cosmetics was primarily in requiring proper labeling and avoidance of marketing adulterated products (including those containing harmful ingredients or contaminants). Although FDA oversight of drugs and medical devices has been substantially strengthened by later legislation, the lack of similar enhancements for cosmetics means that the cosmetic industry remains largely self-regulated.
The Federal Food, Drug and Cosmetic Act “defines cosmetics by their intended use, 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.’”9 This definition encompasses products such as skin moisturizers, perfumes, lipsticks, eye and facial makeup, cleansing shampoos, hair colors, and deodorants.9 Similar products, if intended to treat or prevent disease or affect the body’s structure or function, are classified as drugs or devices, even if the primary motivation for use is cosmetic or aesthetic.9 Sunscreens are regulated as over-the-counter drugs because they are marketed to prevent sunburn and skin cancer.10
In the United States, attitudes toward governmental regulation have long reflected a strong element of ambivalence. We want to be safe and to be able to use products without injuring our health, but we do not want products to become more expensive or take longer to reach the market simply to clear regulatory hurdles that achieve no useful goals. For products that largely are very low-risk, can we depend on the less costly, less burdensome system of spontaneous adverse event reporting (passive surveillance) to guide policies and regulation of individual products?
Importantly, research shows that only a small fraction of all adverse events are reported to regulatory authorities, usually fewer than 10%, even when such reporting is required.11,12 Whether an event is reported may depend on the background of the person who observes or is affected by it, as well as whether concerns about a product have received widespread public attention. Thus, when serious adverse events are reported via passive surveillance, there is no credible way to calculate a valid denominator or understand how many events were not reported. Clearly, absence of evidence in this context should not be confused with evidence of absence (of adverse events). In the case of cosmetics, the absence of legal obligations for companies to relay customer complaints intensifies this problem. In the WEN case,13 described by Kwa et al3 and involving cleansing conditioner products, the company did not relay thousands of adverse event reports to the FDA. For products that are used routinely, small effects over time within large populations can be almost impossible to detect without active surveillance. Even when health risks are substantial, as with tobacco products, the path to identifying and interpreting those safety signals clearly enough to justify regulatory action is often long and tortuous. In an ideal world, sophisticated active monitoring approaches would complement—and perhaps eventually supersede—spontaneous adverse event reporting. For example, widely used internet and social media tools may offer novel ways for expeditiously collecting large amounts of data to yield a more complete picture of risks associated with commonly used products.
The FDA regulates approximately 20% of the US economy, with a remit that encompasses food, therapeutics, cosmetics, tobacco, and veterinary products. Legal frameworks debated in the political process, established by Congress, and interpreted through regulation and guidance, determine approaches to surveillance and active safety. For medical products, a consensus is emerging for moving beyond passive adverse event reporting and enabling active surveillance that allows manufacturers, clinicians, health systems, consumers, and patients to understand the balance of benefits and risks. Given that a substantial proportion of approved drugs have safety risks that are discovered only when the drug sees “real-world” use—despite rigorous testing that winnows most candidate drugs before reaching the market—it is not surprising that a sophisticated approach to monitoring drug safety has developed. This extensive postmarket system includes mandatory safety reporting and label updates as well as active surveillance using the FDA’s Sentinel System, which tracks drug use and outcomes in tens of millions of people.14 Biologic products, because of their complexity, also merit a high level of premarket assessment and postmarket surveillance. Although medical devices have a development pathway that requires less definitive premarket studies, the FDA and the device industry are building a comprehensive National Evaluation System for health Technology (NEST). This collaborative endeavor is intended to create an ecosystem of registries, claims data, and electronic health records to monitor benefit and risk throughout the lifecycle of products.15 Negotiations are well under way for a much-needed modernization of the FDA’s oversight system for over-the-counter drugs.16 Sunscreens offer a good example of why this modernization is needed: fundamental knowledge of their benefit and risk remain unknown for these products, including the degree to which potentially bioactive constituents of these products are absorbed into the circulation over a lifetime of use. For cosmetics—and for dietary supplements—the FDA’s oversight authority remains stuck at the levels established in 1938, nearly 80 years ago.
How might the FDA best regulate cosmetics? First, Congress should provide the agency with an adequate budget to fulfill its existing responsibilities, which it mandates. The FDA is vastly underresourced for even the very limited responsibilities it currently has for the safety of cosmetics. Second, Congress should require manufacturers to register marketed products. The FDA has a voluntary registration system for cosmetics. Without mandatory registration, however, the agency has no way to determine the universe of products to which consumers are exposed. Absent such data, the FDA’s task of discerning important safety signals with passive surveillance alone is prohibitively difficult. Finally, self-regulation of cosmetics is the current default policy. By borrowing innovations being developed for efficient, cost-effective active surveillance of drugs and devices, the oversight of cosmetics can be modernized without creating an inappropriately burdensome regulatory process. Using these new tools to collect and analyze the right kinds of empirical data, we can achieve the high levels of safety people in the United States have a right to expect.
Corresponding Author: Robert M. Califf, MD, MACC, Division of Cardiology, Department of Medicine, Duke University School of Medicine, 300 W Morgan St, Ste 800, Durham, NC 27701 (firstname.lastname@example.org).
Published Online: June 26, 2017. doi:10.1001/jamainternmed.2017.2773
Conflict of Interest Disclosures: Dr Califf was the Commissioner of Food and Drugs, US Food and Drug Administration (FDA), from February 2016 to January 2017. Prior to his appointment to the FDA as Deputy Commissioner for Medical Products and Tobacco in February 2015, Dr Califf received research grant funding from the Patient-Centered Outcomes Research Institute, the National Institutes of Health, the FDA, Amylin, and Eli Lilly and Company; research grants and consulting payments from Bristol-Myers Squibb, Janssen Research and Development, Merck, and Novartis; consulting payments from Amgen, Bayer Healthcare, BMEB Services, Genentech, GlaxoSmithKline, Heart.org–Daiichi Sankyo, Kowa, Les Laboratoires Servier, Medscape/Heart.org, Regado, and Roche; he also held equity in N30 Pharma and Portola. He currently receives consulting payments from Merck. Mr McCall is a salaried employee of the Duke Clinical Research Institute (DCRI) and has performed work for the FDA per contract through the DCRI. Dr Mark reports research grants from Eli Lilly & Company, Gilead, AstraZeneca, Bristol-Myers Squibb, Merck & Company, and Oxygen Biotherapeutics; paid work for the FDA; and consulting payments from Medtronic.
Califf RM, McCall J, Mark DB. Cosmetics, Regulations, and the Public Health: Understanding the Safety of Medical and Other Products. JAMA Intern Med. 2017;177(8):1080–1082. doi:10.1001/jamainternmed.2017.2773
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