By Dianne Feinstein and Susan Collins
Originally published by JAMA Internal Medicine
Eliana Lawrence was a vivacious 10-year-old, quick with a smile. She had bright red hair, reminiscent of Little Orphan Annie, until it all fell out after using WEN shampoo just a few times.
When, as US Senators, we met with Eliana in 2017, she recounted how scared she was when her hair started falling out. She is still teased at school for bald spots that haven’t grown back—3 years later. And WEN by Chaz Dean Cleansing Conditioners remain on the market. After the US Food and Drug Administration (FDA) began investigating, the agency learned that the manufacturer had received 21,000 complaints of alopecia and scalp irritation. The FDA had only received 127.
The Personal Care Products Safety Act, the bill that we introduced in the 115th Congress in 2017, is a response to the problems with the current regulatory approach to cosmetics and personal care products in the United States, as illustrated by the example of Eliana Lawrence.
It might be assumed that the many consumer complaints about WEN would have triggered filings with the FDA and a mandatory recall. That has not been the case, however. At present, there is no legal requirement to report incidents like this to the FDA, and the agency has no recall authority. Congress has never updated the law governing the safety of personal care products, the Federal Food, Drug, and Cosmetic Act of 1938.
There is no other class of products so widely used in the United States with so little regulation, and the need for commonsense safety rules extends far beyond the case of WEN shampoo. As Robert M. Califf, the former FDA commissioner, and colleagues have noted, “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 lack of oversight is a broad threat to public health.
There is increasing evidence that daily, long-term exposure to certain chemicals, including phthalates, is linked to a range of health concerns from cancer to reproductive disorders. This includes some chemicals in personal care products that are absorbed through the skin. The effect on various groups of people must also be considered. For example, during pregnancy a fetus absorbs an even greater amount of chemicals that the mother is exposed to than the mother herself does. Formaldehyde has been suspected to cause cancer since 1981, and has been listed as a known human carcinogen by the National Toxicology Program since 2011. Nonetheless, formaldehyde is still found in hair-straightening salon products.
Parabens, widely used in everyday products, such as lotion and deodorant, have been found to accumulate in the body after long-term, low-dose exposure. Public concern has increased after parabens were found in the breast tissue of patients with breast cancer. Toluene, a chemical used in nail products, has been linked to a wide variety of health effects ranging from dizziness to liver and kidney damage.
Under current law, the FDA lacks the authority to review the ingredients in personal care products to determine whether they are safe. In the United States, only 11 substances are banned or restricted from use in these products. In contrast, the European Union and Canada have been reviewing ingredients in personal care products for decades. More than 1500 chemicals are banned or restricted from these products in Europe, and more than 800 are banned or restricted in Canada.
As a result, US companies that market personal care products largely determine their own safety standards. Companies use voluntary guidance from the Cosmetic Ingredient Review panel—an industry-funded panel—to help them decide whether to include certain ingredients. The FDA, however, has stated that if it had the ability to review cosmetic ingredients it might well reach different conclusions than this panel about the safety of certain ingredients.
The Personal Care Products Safety Act would establish an independent review process for ingredients used in personal care products in the United States. The FDA would be authorized to look at all available information on particular chemicals to determine whether they are safe and, if so, what the appropriate levels in products should be.
Independent review of ingredients by the FDA is critical. Some ingredients may be safe in certain quantities, and other ingredients may not be safe under any circumstances. Some ingredients may be safe for adults in one concentration and safe for children in a lower concentration.
Under the Act, the FDA would be required to review at least 5 chemicals or categories of chemicals per year, chosen based on input from consumers, medical professionals, scientists, and companies. The FDA would also look at cumulative and aggregate exposures to ingredients as part of their safety analyses whenever such data are available. The goal would be to ensure that findings reflect the latest knowledge regarding long-term, low-dose exposure risks. This is an important aspect of the review, as illustrated by concerns about the adverse health effects of long-term exposure to endocrine-disrupting chemicals.
Companies would still be able to adopt stricter standards than the FDA might require, for example, by using less of a particular ingredient or not using an ingredient at all. The FDA’s review process, however, would create a uniform safety standard for ingredients to which all companies would be required to adhere. The bill would require companies to register with the FDA, provide the agency with list of the ingredients in their products, and indicate the range of concentrations for each ingredient within specific products.
A June 2017 letter from FDA officials to Congressman Frank Pallone, the ranking Democrat on the House Energy and Commerce Committee, stated that nearly 29?000 companies from 181 countries export 3 million shipments of personal care products to the United States each year. Six FDA inspectors examine just 0.3% of these shipments. The bill would ensure that these thousands of companies disclose what is in millions of products.
Companies would be required to report adverse events to the FDA. The agency would also gain the authority to require warning labels when needed, such as for products not appropriate for children. For example, the recent analysis of adverse events reported to FDA showed that baby products had “significantly higher than average (35.0%) reports of serious health outcomes,” indicating a need for additional scrutiny of products marketed for babies and children.
The Act would require that companies post complete label information, including ingredients and product warnings, and thus help consumers make informed decisions about which products to use. And the FDA would be authorized to recall products that may cause serious harm. In 2017, a prominent national retail chain recalled makeup marketed to children and adolescent girls owing to reports that the product contained asbestos, which can cause cancer. If the company had not taken this step voluntarily, the FDA lacks the power to compel them to act.
The costs, including the FDA’s enforcement activities, would be funded through user fees paid by companies. For smaller companies, the bill also includes important flexibility and technical assistance.
Over the course of nearly a decade, we have developed the Personal Care Products Safety Act. We have incorporated feedback from the FDA, consumer advocates, public health experts, and companies large and small that market cosmetics and personal care products. As a result, the bill has broad support from health and consumer groups, and many companies, from some of the largest to small- and mid-size companies and several associations representing small businesses that market handmade cosmetics.
It might be surprising that companies would support a bill that subjects them to additional regulations and requires them to pay user fees. The industry officials we have spoken to, however, recognize that it is in their interest, as well as the interest of consumers, for the FDA to establish uniform rules that apply to all companies. It makes no sense for each company in a multibillion dollar industry to have to make its own determinations about minimum safety standards.
The commonsense proposals that the Act advances are long overdue, and Congress should act. Consumers deserve to know that the personal care products they and their families use every day are safe, and companies deserve clear standards and guidelines, and a modernized oversight system.