Loyola University Chicago School of Law, J.D. 2019
The cosmetics industry, unknown to many, is essentially not regulated by a federal regulatory agency. Cosmetics technically fall under the purview of the Food and Drug Administration (“FDA”), but there are few requirements that manufacturers must comply with. The FDA only requires that manufacturers comply with several labeling regulations so companies can avoid listing a product’s total ingredients, and the FDA does not require manufacturers to report health complaints. The FDA instead relies on direct reports of adverse events from consumers, which has the potential to delay remedying a potentially dangerous situation. A study published in JAMA Internal Medicine found that between 2015 and 2016, the number of complaints of adverse health results related to cosmetic products more than doubled from the previous years. Additionally, the FDA only has the equivalent of six full-time inspectors to monitor three million shipments of cosmetics that come into the United States each year. Last year, inspectors only conducted tests on about 364 of those shipments, and 20 % of those shipment that were inspected led to adverse findings.
The law currently does not require the ingredients of cosmetics products, other than color additives, to be approved by the FDA prior to being released on the market. But there are laws and regulations that apply in the interstate commerce of cosmetic products. The two most inclusive laws pertaining to cosmetics are the Federal Food, Drug, and Cosmetics Act (“FD&C Act”) and the Fair Packaging and Labeling Act (“FPLA”). The FD&C Act defines cosmetics by their intended use and includes products such as skin moisturizers, perfumes, eye and facial makeup, cleansing shampoos, hair colors, and deodorants, among others, and includes those ingredients used in a cosmetic product, but the list does not include soap. The FDA establishes a fine line between a cosmetic product and a product intended for therapeutic use, such as treating or preventing disease or one that may affect the structure or function of the body. The FDA qualifies these products as drugs or medical devices and may be regulated as dietary supplements or consumer products and not as cosmetics. The FD&C Act does regulate cosmetic products by prohibiting the marketing of adulterated or misbranded products in interstate commerce. Under the current law, the FDA does not require that cosmetic products and ingredients need premarket approval, with the exception of color additives. Additionally, the FDA does not require specific tests to determine and demonstrate the safety of individual products or ingredients; instead it is on the manufacturers of cosmetics to determine that a product is ready for the marketplace. But if the FDA finds out that a product is not safe for the market, they can recall the product and inspect the cosmetic manufacturers.
Consumer Interests and Current Problems
As consumers are becoming more and more aware of the ingredients in the products that they are using and putting in their body, they are becoming increasingly frustrated with not only the manufacturers of these products, but also the FDA for not doing their part to regulate these products. In 2014, the FDA opened an investigation into Wen Hair products after they had received 127 complaints directly to their office in which customers alleged that the products resulted in skin irritation, and in some instances hair loss. But the FDA soon found that the company themselves had already received more than 21,000 complaints from consumers directly (these products are still currently on the market). It is worrisome that products exist in the marketplace that have received so many complaints, and that these manufacturers as receive little to no fallout. Dr. Steve Xu, in the department of dermatology at Northwestern University Feinberg School of Medicine, evaluated the more than 5,000 related health complaints that were submitted to the FDA between 2004 and 2016. The study found that the number of complaints from 2015 to 2016 increased from 706 to 1,591 and found that number of adverse events reported increased more than 300% over the twelve-year study. They found that it is a danger to the public that the FDA has yet to adopt stricter standards to ensure customers aren’t buying potentially harmful products. While the United States has adopted much stricter rules when it comes to drugs and pharmaceuticals than the European Union, the United States is lagging when it comes to cosmetics regulations. The EU bans more than a thousand chemicals while the United States only bans around ten. After multiple failed attempts for stricter regulations of cosmetics in the 1970s, this year Senator Dianne Feinstein and Senator Susan Collins proposed the introduction of a new bill: The Personal Care Products Safety Act (“PCPS Act”).
The proposed PCPS Act, introduced in May 2017, is the solution that many consumers, physicians, and safety experts have been waiting for. The proposed bill would amend the FD&C Act to ensure the safety of cosmetics. The bill would require that the FDA evaluate a minimum of five ingredients per year for safety, that they order recalls of questionably safe beauty products, and that they require products that include ingredients not suitable for children to be specially labeled. The new bill would also require manufacturers to provide the completed ingredient information for products both online and printed on labels and that the FDA could issue regulations on Good Manufacturing Practices, as they relate to beauty, among other additions. The bill also seeks to reverse the status of some ingredients, such as coal tar, which is found in certain hair dyes. Coal tar is a carcinogen, but current law prevents the FDA from banning this chemical for safety reasons; if a warning label is included on the product then it will be allowed on the market. Even though cosmetics are not currently heavily regulated, Dr. Xu still believes that “in general, cosmetics are very safe product class.” But the introduction of this kind of bill would only enhance the safety of cosmetic products on the marketplace and it would allow the FDA to learn more about the long-term health effects of cosmetics, which as stands remain largely unknown.