Cosmetics Regulation: Where It Is and Where It May Be Going
On March 5, the U.S. Food and Drug Administration (FDA) simultaneously published its independent testing results confirming the presence of asbestos in certain cosmetic products sold by Claire’s and by the girls' apparel/accessories retailer Justice, and issued a safety alert warning consumers about three remaining Claire’s asbestos-contaminated products that were still on the market. One week later, after reportedly refusing to pull the identified products at FDA’s request, Claire’s announced a voluntary recall. These actions took place against the backdrop of over 11,000 ongoing civil cases against Johnson and Johnson alleging that the company knew about the presence of asbestos in its talcum powder for decades.
The Claire’s news demonstrated that asbestos-contaminated cosmetic and personal care products might not just be an isolated case of one company with a few bad actors—it might be larger in scope—and the week long standoff between FDA and Claire’s called widespread attention to the lack of regulatory oversight FDA has over the cosmetic industry. Unlike its enforcement authority over devices, for example, FDA had no power to force Claire’s to recall its products. Though FDA can pursue enforcement actions against, among other things, unsafe or contaminated cosmetic products already on the market, under current law FDA is essentially left with reacting to consumer complaints or after-the-fact safety testing. FDA made this concern known in its March 5 test results announcement, appealed to cosmetic manufacturers to help enhance product safety and expressed plans to seek modernization of the current regulatory framework for cosmetics which was developed in 1938.
How FDA Currently Regulates Cosmetics
An understanding of the current regulation of cosmetics and personal care products requires an understanding of the scope of what constitutes a cosmetic under the law. The Federal Food Drug and Cosmetic Act (FFDCA) 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 category includes not only make-up (lipstick, eye shadow, etc.), but other “personal care products” used by men, women and children (including those for hair care, skin care, nail care, makeup, perfumes and shampoo), so long as their intended uses are limited as noted above. Any additional therapeutic use could subject a product to another set of regulations, typically the drug requirements. For instance, FDA regulates cleansing shampoo as a cosmetic, but anti-dandruff shampoo is both a cosmetic and a drug because it is intended to cure, mitigate, treat or prevent a disease or condition of the body. Similarly, deodorants are cosmetics, but anti-perspirants are drugs. Claims on product labeling and even consumer perception can establish a product's intended use and, therefore, how FDA regulates that product, which can make a tremendous difference. For example, drugs either need to obtain FDA approval prior to commercialization or need to conform, for certain over-the-counter (OTC) products, to OTC drug monographs which, loosely speaking, are like recipe books that set forth dosage form, strength and other conditions under which certain active ingredients are generally recognized as safe and effective.
FDA regulation is minimal for products that are categorized only as cosmetics, especially compared to the regulation of product in the EU and other countries. For example, in 2013 the EU Cosmetics Regulationbecame effective, requiring manufacturers to take such steps as:
- Designating a responsible person located in the EU
- Registering their products and submitting certain information prior to placing them on the market
- Reporting product non-conformities that may pose risks to human health
- Maintaining a product information file
- Complying with good manufacturing practices (GMP)
- Conducting safety assessments that contain specified data
The EU regulations also include a list of more than 1,300 prohibited substances and hundreds of restricted substances, and places certain requirements on cosmetic distributors aimed to ensure safety and adverse event reporting. In addition, all cosmetic products must be registered in a centralized database.
On the other hand, in the U.S., under the FFDCA, manufacturers generally define how they test their products and ingredients for safety and choose whether to share their safety information with FDA. FDA does not have GMP regulations (only guidelines) for cosmetics, and registration with FDA for cosmetic manufacturers is voluntary, though some states require registration of cosmetic manufacturers and distributors. In fact, but for color additives and a few restricted ingredients, cosmetic manufacturers can use almost any substance in a cosmetic without FDA approval, though products that are harmful to health are considered adulterated.
Heightened awareness of this regulatory gap for cosmetics and personal care products in recent years has led to the introduction of various bills aimed at amending the FFDCA, including in 2017 the Personal Care Products Safety Act and the FDA Cosmetic Safety and Modernization Act, and in 2018 the Safe Cosmetics and Personal Care Products Act. All three of these bills would require cosmetic manufacturers to register with FDA, manufacture products in accordance with GMPs, and report adverse events, and would require FDA to review for safety certain ingredients used in cosmetic products. Two of the bills also would give FDA recall authority over cosmetic manufacturers and require them to submit cosmetic ingredient statements to FDA for each of their cosmetic products. In addition to these comprehensive reform bills, 2018 also saw the introduction of the Children’s Product Warning Label Act, which would require manufacturers of cosmetics marketed to children to demonstrate that they are free of asbestos or carry a warning label that the product has not been evaluated for asbestos contamination. All four bills were referred to committee with no further action.
Reinvigorated Interest in New Legislation
The Claire’s incident, however, seems to have reinvigorated interest in cosmetic legislation. On March 7, Senator Diane Feinstein reintroduced the Personal Care Products Safety Act, and on March 18, Representatives Debbie Dingell and Jan Schakowsky reintroduced the Children's Product Warning Label Act. Also on March 18, California lawmakers introduced the "Toxic-Free Cosmetics Act," which would ban sale of makeup in the state that uses 20 highly toxic chemicals, including asbestos, lead and formaldehyde, known to cause cancer or reproductive harm. This renewed activity, coupled with the fact that key industry players such as Johnson and Johnson, Revlon and the Personal Care Products Council have called for regulatory reform for cosmetics and personal care products, may provide the needed momentum. However, this issue is likely to take a backseat to other issues, such as drug pricing reform, and with the departure of FDA Commissioner Scott Gottlieb, it is unclear to what extent the new Commissioner will push cosmetics regulatory reform. That said, manufacturers and retailers may want to consider staking out their positions now on proposed actions that may affect their products before their products become the center of unplanned attention as a result of an emergent event.