By Hadley Duncan

The American cosmetic industry rakes in north of $80 billion-a-year.  Despite the cosmetic industry’s size, the Food and Drug Administration’s (FDA) Office of Cosmetics and Colors only has an annual budget of $8 million dollars and a staff made up of less than 30 people to regulate this industry.  Additionally, the FDA’s only legal oversight of cosmetic companies comes from the Federal Food, Drug and Cosmetic Act passed in 1938.  The act has not been updated since 1938 and is a measly two pages that limits the FDA to only regulating adulterated or misbranded products, or falsely packaged products.  The act doesn’t require the FDA to recall potentially dangerous items or monitor the ingredients used in products, which leaves the cosmetic industry with incredible freedom to use whatever ingredients in its products.  Following consumer outcry and House and Senate members introducing bills to increase the monitoring of the cosmetic industry, the FDA has announced that it will be seeking consumer feedback via a survey in a process that may lead to allergen and ingredient labeling on cosmetic products in the United States. But is this enough?

Current Regulation

The FDA is currently very limited in what legal oversight they have over cosmetic companies.  They cannot require companies to submit safety data before they market a product, adhere to basic manufacturing standards, register with the FDA, report problems or adverse events that consumers tell them about.  The FDA cannot demand to inspect companies’ records when an incidents with one of their products occurs.   The FDA can only inspect facilities for visible defects.  Additionally, the FDA only has the ability to test less than 1% of the imported cosmetics, meaning it cannot ensure all products’ safety.

Due to the lack of regulation granted to the FDA, the cosmetic industry is left to self-regulate.  The Personal Care Products Council is an advocacy group that represents 600 companies within the cosmetic industry.  Despite setting up groups to self-regulate their industry these organizations are often criticized as being self-helping.  For example, there have been times when the panel’s conclusions have been significantly different to those of impartial government entities.  Furthermore, out of over 5,000 chemicals tested by the Personal Care Product Council’s panel only 11 have been found unsafe.

The limited regulation of the cosmetic industry has permitted the companies to continue to release products with harmful chemicals with little repercussion.  Studies continue to find products have ingredients known to have negative effects on humans.  The recent study from the U.S. National Library of Medicine found Oxybenzone, a product found in many sunscreens and lip balm, can lead to the production of human breast cancer cells.  Yet companies, including powerhouses like Johnson & Johnson, have continued to use this ingredient in their products. WEN, a hair care product, by Chaz Dean also has ingredients known to have negative effects on humans.  Despite thousands of complaints about the product, the FDA doing an investigation, and a $26 million payout to the affected consumers, the product continues to be sold.

Cosmetics have such a large role in many of our lives; the chemicals in these products need to be tested so the public is aware of any and all adverse short-term and long-term effects.  Members of both the House and Senate have responded to this need and have both introduced bills.  In May 2017, California Democratic Senator Dianne Feinstein and Maine Republican Senator Susan Collins introduced the Personal Care Products Act.  This Act would increase the FDA’s regulation of the cosmetic industry.  If passed, it would require the FDA to evaluate at least five ingredients per year, which would set a standard for companies, clear guidance on what can or cannot be used, and how much of each ingredient can be used.  The FDA would be also be allowed to recall products that are threats to consumer safety and require labeling of products with ingredients not suitable for children or those that should be professionally administrated.

Plans for Further Regulations

In October 2017, Utah Republican Senator Orrin Hatch introduced the FDA Cosmetic Safety and Modernization Act.  This bill also looks to increase the FDA’s regulatory power over the cosmetic industry by amending the Federal Food, Drug, and Cosmetic Act to include the FDA’s right to regulate ingredients in these products, monitor adverse reactions, and establish manufacturing practice standards.  Other bills introduced include one from Michigan’s Republican Representative Debbie Dingell which would mandate cosmetics marketed to children be free of asbestos.   Another bill introduced by Texas’s Republican Representative Pete Sessions called the Safe Cosmetic Modernization Act would increase the FDA’s regulation over the cosmetic industry and create new requirements for cosmetic manufacturers to follow.

In addition to these efforts, the FDA announced in 2018 that it would be conducting a consumer survey about allergens in cosmetics.  This survey comes as a continuation of the FDA’s 2015 research on allergens in cosmetics.  The research had the FDA contracting with Integrated Laboratory System, Inc. to review the 26 fragrances identified as an allergens by the European Union, and then later expanded to additional cosmetic ingredients.  According to FDA Commissioner, Dr. Scott Gottlieb, “Gathering information about consumer experiences with cosmetic products, especially adverse reactions such as irritated skin or an allergic reaction is critical,” and “[t]he information that the FDA collects through this survey is an important step in advancing a process for reducing exposure to allergens in vulnerable individuals.”

Plans to increase FDA regulations over the cosmetic industry are still very much in the early stages leaving the cosmetic companies to continue to be able to introduce unregulated products to the market.  As a 2017, a JAMA Internal Medicine article stated, “[b]etter cosmetic surveillance is needed given their ubiquity and lack of a premarket approval pathway. Unlike devices, pharmaceuticals, and dietary supplements, cosmetic manufacturers have no legal obligation to forward adverse events to the FDA.”  To protect the safety of consumers, there is a need for expedited and increased regulation on the cosmetic industry.  A survey is not enough, and immediate action needs to be taken.

Hadley Duncan is a 2L at Suffolk University Law School, Hadley attended Trinity College for undergraduate school, where she earned a degree in art history with a minor in entrepreneurship and won a NCAA D3 National Championship with her lacrosse team. Hadley hopes to practice as an in-house general counsel in Boston, MA.

Sources

https://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm623457.htm

https://www.mintz.com/insights-center/viewpoints/2171/2017-01-cosmetics-reform-activity-begins-115th-congress

https://www.mintz.com/insights-center/viewpoints/2017-11-surprise-cosmetic-reform-bill-appears-congress-bipartisan

https://www.feinstein.senate.gov/public/index.cfm/press-releases?ID=BF77F321-35AA-4F29-A5E4-FF321BF089F6

https://www.webmd.com/beauty/news/20180207/wen-case-spurs-call-for-beauty-product-regs

https://www.nytimes.com/2019/02/09/opinion/cosmetics-safety-makeup.html

https://www.allergicliving.com/2018/11/07/fda-set-to-launch-consumer-survey-on-allergens-in-cosmetics/

https://www.cnbc.com/2018/08/01/fda-begins-first-inquiry-of-lightly-regulated-cosmetics-industry.html

https://www.bloomberg.com/news/articles/2018-05-08/fda-mulls-more-resources-for-little-monitored-cosmetics-industry

Disclaimer: The views expressed in this blog are the views of the author alone and do not represent the views of JHBL or Suffolk University Law School.