PUBLISHED IN ISSUE 2 | FALL 2022
Transforming Cosmetic Safety in America: Using the European Union as an Example to REnovate the Authority of the FDA
Erika Almarza
Lone Star College - University Park
Erika is a current honors student at LSC-University Park seeking to pursue a Government major. Transforming Cosmetic Safety in America is her Honors Federal Government research. She analyzed the effectiveness of cosmetic regulations in preventing the circulation of potentially harmful chemicals in the cosmetics market. Currently, Erika is conducting new research for the 2022 Spring semester. In her personal life, she is a devoted Christian, with Jesus being the first thing in her life. She deeply loves her family, and in her free time she enjoys spending time outdoors and landscape painting.
The research analyzes the successful example of cosmetic regulations in the European Union in comparison to cosmetic guidelines of the Food and Drug Administration in the United States. The goal is to determine the effectiveness of US regulations in preventing potentially harmful chemicals from circulating in the beauty industry. The review of sources such as academic publications, FDA guidelines, or assembly bills aids in drawing a conclusion. The analysis concludes that the FDA currently lacks the authority to impose stronger cosmetic regulations under US law. Consequently, attempts by lawmakers to modernize the FDA authority might be unsuccessful due to the impact of solid regulations on cosmetic businesses. The research finishes by proposing the implementation of a federal program to relieve companies from the burden of conducting their safety research, benefitting society by modernizing the FDA authority, promoting safer cosmetic products, and new employment opportunities in the United States of America.
ABSTRACT
INTRODUCTION
The American market carried dangerous, toxic, and ineffective cosmetic products in the early 20th century. Cosmetics were widely unregulated, even though legislation regulated food and drugs. As a response and to raise awareness about the issue, authority figures from the Food and Drug Administration created a traveling exhibit known as the American Chamber of Horrors in 1933. The exhibit highlighted about 100 dangerous products which the FDA lacked authority to regulate. In 1936, Ruth deForest Lamb, Chief Education Officer of the FDA and a creator of the American Chamber of Horrors, adapted the exhibit into a book in which she stated that those tragedies happened because government officials had no power to prevent them. Consequently, President Roosevelt signed the Federal Food, Drug, and Cosmetic Act in 1938, which allowed the FDA to regulate medical devices and cosmetics. In the present day, the law still guides the FDA in regulating cosmetics.1
In the United States, the FDA oversees cosmetic regulations under the law. The FDA includes skin moisturizers, perfumes, makeup, shampoos, and deodorants in the definition of cosmetics. Current regulations ensure the safety of cosmetics by prohibiting the sale of adulterated or misbranded products. Therefore, manufacturers must comply with the guidelines to sell their products in the US market. Failure to comply will result in legal action from the FDA. Consequently, the guidelines ensure that manufacturers create products labeled with accuracy and free of poisonous or filthy ingredients,2 creating trust in the final US consumer.
Throughout the decades, scientific research has guided American manufacturers in creating cosmetics products to offer safe and innovative formulations. One example is California, which has taken steps to ensure that manufacturers do not include harmful ingredients in cosmetics marketed in the state.3 However, even though scientists have found many ingredients too hazardous to be included in personal care formulations, the FDA does not regulate them in cosmetic products since the organization lacks authority. Why does the FDA lack sufficient authority to enforce stronger regulations? Current legislation limits the role of the FDA in cosmetic regulation.4 A solution to the problem would include establishing new legislation in the United States to expand the authority of the FDA on cosmetics.
To further develop a solution, the research provides an insight into the regulations in the United States in contrast to the European Union, explaining the role and limitations of the FDA in the regulation of cosmetic products. Consequently, the research highlights the importance of strong regulations to ensure cosmetic safety. The research further expands on the impact that establishing stronger regulations would have on beauty companies. To achieve this purpose, the sources to be evaluated include the websites of the FDA, scholarly journals, articles of the media, and nonprofit organizations that further explain the issue. As further support for this argument, the Literature Review discusses the dangers of some cosmetic ingredients, benefits, and drawbacks of the current FD&C Act and briefly compares US regulations to those of the EU. The research overall contributes to the conversation of cosmetic regulations and the role of the FDA in cosmetic safety.
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1 “80 Years of the Federal Food, Drug, and Cosmetic Act.” U.S. Food and Drug Administration. July 11, 2018. https://www.fda.gov/about-fda/fda-history-exhibits/80-years- federal-food-drug-and-cosmetic-act.
2 "FDA Authority Over Cosmetics: How Cosmetics Are Not FDA-Approved but FDA- Regulated.” U.S. Food and Drug Administration. March 8, 2021. https://www.fda.gov/cosmetics/cosmetics-laws-regulations/fda-authority-over-cosmetics-how- cosmetics-are-not-fda-approved-are-fda-regulated.
3 “Assembly Bill No. 2762.” California Legislative Information. October 02, 2020. https://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=201920200AB2762.
4 "FDA Authority Over Cosmetics,” https://www.fda.gov/cosmetics/cosmetics-laws- regulations/fda-authority-over-cosmetics-how-cosmetics-are-not-fda-approved-are-fda-regulated.
LITERATURE REVIEW
Several scholars argue that the authority of the FDA is too limited in scope to ensure the safety of cosmetic products in the US market. Alison Dotta states in "The Foundation for New Cosmetic Safety Laws" that although the Food, Drug, and Cosmetics Act contains 829 pages of guidelines on drug regulation, the law only presents two pages regulating cosmetics. The law focuses on adulterated or misbranded cosmetic products, as the FDA prohibits their sale in the US market. Dotta further indicates that the FDA does not require premarket approval of cosmetics; therefore, manufacturers do not need to disclose ingredients or product formulations to the FDA.5 Brittany Stepp argues that manufacturers can decide whether or not to remove a product from the market since the FDA does not have the authority to issue recalls on harmful formulations. However, Stepp indicates that the FDA created a voluntary program in which cosmetic companies may register manufacturing practices and ingredients in the formulation of products, named the Voluntary Cosmetic Registration Program (VCPR). Stepp claims that the best information from the FDA about cosmetic safety relies on voluntary submission from manufacturers.6
Rebecca Kessler asserts that manufacturers are frequently requested to remove specific ingredients from their cosmetic product formulations. She reports that ingredients like diethyl phthalate (DEP), parabens, or triclosan are potential endocrine disruptors. Kessler indicates that parabens are among the most concerning chemicals used in the industry since manufacturers widely apply them as preservatives. However, Kessler notes in her research that the FDA conducted analyses on parabens and DEP and concluded there is no scientific basis for taking action. The FDA determines the safety of an ingredient through factors like quantity and exposure to the substance; many ingredients might be unsafe to swallow but safe for skin application. In response to the analyses of the FDA, Kessler argues that despite the confidence of the FDA in the safety of such ingredients, the exposure from repeated application of products containing such chemicals concerns industry experts. In her research, she suggests that companies choose to remove such substances linked to health problems to build trust with cosmetic consumers.7
In support of the argument for stronger FDA regulations, Dotta indicates that the cosmetic regulations in the European Union ban more than 1,300 substances in cosmetic formulations.8 Moreover, Thomas Galligan explains that companies must evaluate ingredients for safety before placing the products on the European market.9 Consequently, Scott Faber adds that ingredients like isobutyl paraben, mercury, and formaldehyde have been banned in the EU to ensure the safety of cosmetic products.10 Furthermore, Dotta notes that manufacturers must perform a "safety assessment"11 on products before market launch. Additionally, after the market launch, the manufacturer must recall the product if it does not comply with the standards.
Scholars argue that current FDA regulations cannot ensure the safety of cosmetics. To support the argument, Dotta explained that current regulations do not require cosmetic manufacturers to disclose formulation ingredients to the FDA. In contrast, the law focuses mainly on misbranded or adulterated products.13 Additionally, Stepp pointed that the FDA is not authorized to issue product recalls.14 Kessler notes that the FDA conducted analyses that concluded that scientific evidence was insufficient to take action. However, she argues that repeated exposure to products with potentially harmful ingredients may be a cause of concern.15 To reinforce the case for stronger FDA regulations, Dotta explains that the European Union bans 1,328 chemicals from product formulations.16 In their research, the experts point out the drawbacks of current regulations; however, the scholars do not focus on solutions to address the issue, except for Stepp. Nonetheless, the research of the scholars offers limited solutions at the legislative level.
The present research will focus on current legislation from the European Union and California as examples to address the gap in research. Further research is needed to suggest a solution to strengthen the FDA in addressing the problem of toxic ingredients in cosmetics. Consequently, the European Union and California may serve as examples of successful solutions for the safety of cosmetics in the country. The purpose of the research is to highlight the importance of solid regulations through legislation to ensure the safety of cosmetic products while taking into account the impact on companies in the United States of America.
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5 Dotta, Alison. “Chapter 314: The Foundation for New Cosmetic Safety Laws.” University of Pacific Law Review vol. 52 issue 2 (2021): pp. 417-418. Scholarly Commons (accessed October 21, 2021).
https://scholarlycommons.pacific.edu/uoplawreview/vol52/iss2/13/. 6
6 Stepp, Brittany. “You Don’t Know What’s in Your Shampoo, and Neither Does the
FDA: A Call for Change.” Drexel Law Review vol. 10 no. 1 (2018): pp. 278-304. Gale OneFile:
Health and Medicine (accessed October 21, 2021).
https://link.gale.com/apps/doc/A567549420/HRCA?u=nhmccd_main&sid=bookmark-
HRCA&xid=ea627343.
7 Kessler, Rebecca. "More Than Cosmetic Changes: Taking Stock of Personal Care Product Safety." Environmental Health Perspectives vol. 123 issue 5 (2015): pp. A123-A124. Gale in Context: Opposing Viewpoints (accessed October 21, 2021). https://doi- org.lscsproxy.lonestar.edu/10.1289/ehp.123-A120.
8 Dotta, Alison, “The Foundation for New Cosmetic Safety Laws.” p. 416, https://scholarlycommons.pacific.edu/uoplawreview/vol52/iss2/13.
9 Galligan, Thomas. “Study Highlights Importance of Cosmetic Ingredient Safety Tests.” Environmental Working Group. September 10, 2020. https://www.ewg.org/news- insights/news/study-highlights-importance-cosmetics-ingredient-safety-tests.
10 Faber, Scott. "The Toxic Twelve Chemicals and Contaminants in Cosmetics.” Environmental Working Group. May 5, 2020. https://www.ewg.org/the-toxic-twelve-chemicals- and-contaminants-in-cosmetics.
11 Dotta, “The Foundation for New Cosmetic Safety Laws.” p. 416, https://scholarlycommons.pacific.edu/uoplawreview/vol52/iss2/13/.
12 Dotta, “The Foundation for New Cosmetic Safety Laws.” p. 416, https://scholarlycommons.pacific.edu/uoplawreview/vol52/iss2/13/.
13 Dotta, “The Foundation for New Cosmetic Safety Laws.” pp. 417-418,
https://scholarlycommons.pacific.edu/uoplawreview/vol52/iss2/13/. 14
15 Kessler, “More Than Cosmetic Changes,” p. A124, https://doi- org.lscsproxy.lonestar.edu/10.1289/ehp.123-A120.
16 Dotta, “The Foundation for New Cosmetic Safety Laws.” p. 416, https://scholarlycommons.pacific.edu/uoplawreview/vol52/iss2/13/.
ANALYSIS
The present section of the work analyzes the factors that influence the safety of cosmetics in the United States and suggests solutions to improve the situation. The research begins by showing the current role of the FDA, including limitations on regulations. Then, the analysis describes the legislative efforts to address the gaps in the FDA authority. It is critical to underline that Congress has not enacted new bills to alter the role of the FDA, so the following section briefly explores factors that may influence the decision to impose stricter regulations. Furthermore, the research reviews successful examples of stronger regulations in the European Union and California, a leading state bringing change to safety standards in the United States. The analysis concludes by offering solutions to strengthen the role of the FDA while taking into account several issues that may impede reform. In essence, cosmetics in the industry are plagued with harmful ingredients, which the FDA lacks the authority to regulate because of US law;17 therefore, new legislation must allow the FDA to enforce stronger cosmetic regulations.
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The Current Role of the FDA on Cosmetic Regulations
The FD&C Act significantly limits the authority of the FDA in the present. The foundation of the problem is that legislation implemented the law in 1938,18 with the needs of the era in mind. The act mainly focuses on the misbranding and adulteration of cosmetics.19 Although the legislation strictly regulates color additives,20 it only bans eleven chemicals from cosmetic formulations.21 The current regulations enforce few requirements to ensure the safety of cosmetic products in the 21st century. Manufacturers are free to include several concerning ingredients in their formulations, as long as the final product is safe to use according to the instructions on the label.22
As a result, the FDA has limited means to ensure that manufacturers market safe cosmetic products. The organization cannot require premarket approval of products or cosmetic safety proof. Additionally, the FDA does not have the authority to issue recalls of harmful cosmetics. Manufacturers have the option of whether or not to recall a concerning product. The organization can take action to "remove adulterated or misbranded cosmetics from the market" through the Department of Justice, as the government can seize cosmetics that violate the law.23 Therefore, unless the products are misbranded or adulterated, the safety of cosmetics widely relies on the best practices of the manufacturer. Consequently, consumers rely on individual product research to choose cosmetics with high-quality formulations.
To address the gaps in federal cosmetic regulations, several lawmakers have introduced bills to renovate the authority of the FDA. The Personal Care Products Safety Act would allow the FDA to review individual cosmetic ingredients and issue recalls on harmful products even if manufacturers object.24 Another legislative effort includes the FDA Cosmetic Safety and Modernization Act, introduced in 2017. Some proposals of the act would require manufacturers to report adverse effects and establish good manufacturing practices.25 Furthermore, the Cosmetic Safety Enhancement Act of 2020 was introduced in December 2019. The bill would allow the FDA to require premarket submission of safety statements. Additionally, a safety assessment of products would be necessary.26 All the bills would address current problems in the cosmetic industry. Unfortunately, Congress has not completed the process to approve either bill.
No evidence supports a reason for Congress not to approve the new bills; however, one factor may impact the decision. According to The New York Times, even though some large companies may advocate for stronger regulations, several small companies may insist that stricter regulations would negatively impact them.27 In support of that argument, Jim Markham, founder of Pureology Serious Colour Care and contributor to The Hill, argues that small businesses rely on innovation to differentiate themselves from the competition in the beauty industry. Markham explains that increasing regulations may force small companies out of business.28 Small businesses are central to the economy. Without small beauty brands, large companies would dominate the cosmetics industry. It may lead to the creation of trusts or
monopolies, which would negatively impact the market as they may cause inflation, loss of innovation, and decline in product quality.29 This result would create the contrary effect the country would seek in the industry. A balance must exist between small and large companies; therefore, successful regulations must ensure the preservation of a balanced industry structure while still prioritizing the well-being of the population.
The Example of the European Union
One example that successfully enforces strong regulations to protect public health while boasting a thriving beauty industry is the European Union. As of 2020, the value of the European beauty industry reflects €76.7 billion in retail sales prices, the largest in the world.30 Undoubtedly, stronger regulations in the cosmetic industry may even promote industry growth, as consumers would develop a deeper trust in cosmetic companies, resulting in higher retail sales, brand innovation, and industry evolution.
The cosmetic guidelines of the European Union are practical and relevant. The regulations in the EU work under the REACH Act from 2006 (Registration, Evaluation, Authorization, and Restriction of Chemicals) and the Cosmetic Regulation, updated in 2009.31 Both acts work together to ensure the safety of cosmetic ingredients, good manufacturing practices, and the well-being of cosmetic consumers. They allow the European Union to enforce one of the most thorough cosmetic safety standards of the world.
The European Union enforces specific regulations. The EU requires companies to register their chemicals in a database. One critical concept that may benefit small businesses is the share of data between manufacturers, which reduces registration costs. Stepp explains that the REACH legislation is based on that all manufacturers and importers must jointly register information about substances. However, if Europe later finds such chemicals harmful or a safer alternative, they can revoke the permission. Subsequently, the EU requires adverse effect reports from manufacturers.32 Alternatively, the European Union prohibits cosmetic use of more than 1,300 potentially harmful substances. Regulations also require premarket approval of final products, including a safety assessment. If the products do not align with the standards, manufacturers must recall products from the market.33 Undoubtedly, the specific standards of the European Union continue to ensure that all the cosmetics marketed in its member countries are safe for the well-being of the population. The European standards are an excellent example of cosmetic safety guidelines worldwide.
Not only is the European Union a world leader in cosmetic safety, but it also leads the beauty industry in innovation. According to Cosmetics Europe, cosmetic products in Europe are leaders in innovation by selecting and developing the best ingredients, ensuring their safety for humans and the environment. Additionally, the European beauty industry seeks to meet factors such as age, gender, religious beliefs, climate, lifestyle, and the well-being of consumers. The article states that consumers want new, better, and safer products created by responsible companies.34 Such a mindset is the key to creating a thriving industry. A product created in Europe inspires trust in consumers, as European manufacturers ensure the creation of their products with high standards in mind.
Surprisingly, the innovation practices in Europe are quite simple. According to the article, European cosmetics focus on progressive innovation. They may renew products to meet the demands of consumers while improving formulas to create new results. Cosmetic Europe mentions that breakthrough innovations are rare, but the evolution of cosmetic technologies reflects the worth of years in progress. Europe prioritizes long-term innovation, which is a constant process.35 Brands may focus on creating the best product formulation with the cleanest ingredients. Consequently, innovation also comprises the creation of effective formulations with clean ingredients.
To constantly ensure that ingredients are effective and safe, the European Union appoints a large team of experts to the field. The beauty industry employs more than 28,000 scientists from microbiology, dermatology, toxicology, genetics, and chemistry to constantly research, create, and innovate cosmetic formulations. Also, Europeans employ more than 70 scientific innovation facilities for cosmetic research. In addition, Europe boasts a total expenditure of 2.35 billion euros in R&D.36 Therefore, the EU gathers the means to execute the highest quality standards in their cosmetic formulations. All those factors contribute to the establishment of Europe as the leader in the cosmetic industry.
Leading the Cause for Safer Cosmetics in America
With the right strategy, the United States may follow the example of the European Union to compete as a leader in the beauty industry. One American state leading the cause for safer cosmetics is California. In 2005, the state established the California Safe Cosmetics Act, requiring manufacturers to provide to the California Department of Public Health (CDPH) a list of suspected hazardous ingredients in cosmetics. Subsequently, the California Safe Cosmetics Program implements the act by making the information available to the public.37 Cosmetic consumers in the state may consult the list to decide whether or not they prefer to use cosmetics that include harmful ingredients. Although such regulations are practical, they lack factors to ensure the complete well-being of cosmetic consumers in California.
To establish complete cosmetic regulations, the Californian government passed Assembly Bill No. 2762 in September 2020.38 The bill is called the Toxic-Free Cosmetics Act,39 and the new legislation starts on January 1, 2025. It prohibits manufacturers from creating cosmetics that contain any of 24 chemicals banned by the act, "except under specific circumstances."40 The legislation bans ingredients that include formaldehyde, quartenium-15, mercury, dibutyl and
diethylhexyl phthalates, isobutyl and isopropyl parabens, and PFAS. Exceptions include the presence of unavoidable trace amounts of the ingredients. Additionally, the legislation states that the regulations are consistent with those enacted by the European Union.41 Consequently, all cosmetic manufacturers in 2025 that wish to market in California must adhere to the guidelines of the act. Therefore, many cosmetic products will cease to include such harmful ingredients in the formulation.
However, many cosmetic products currently in the market still contain harmful ingredients. Europe and California took steps to ban several ingredients from their cosmetics, but many American formulations still include such ingredients. Their adverse effects are related to cause congenital disabilities, hormone disruption, reproductive system damage, and even cancer, making such ingredients potentially hazardous. It is especially concerning because men, women, and children frequently use cosmetic products in their daily routines. The frequent exposure to the ingredients makes the population more vulnerable to adverse effects.42 Routine exposure to harmful ingredients may be noxious for human health. As a result, it is critical to protect the population by including stricter standards to ensure the safety of cosmetics.
The new Californian legislation would remove such harmful ingredients from the cosmetics market in the state and also potentially nationwide. Many cosmetic companies seek to establish themselves in California due to the proximity to technology, similar brands with shared values, and corporate talent.43 The legislation would require companies to create and market safer cosmetics starting in 2025.44 Many companies established in California would market not only in the state but also nationwide. Their products would no longer include potentially harmful ingredients. Therefore, the California legislation would indirectly impact the safety of cosmetics in the whole country.
The Impact of Clean Beauty
A concern may arise on the impact that stronger regulations may impose on manufacturers. Markham argues that if regulations are too strict, they can limit creativity in the cosmetics market.45 However, evidence suggests the contrary. Some new brands innovate by creating clean and effective products. According to Byrdie, "Nowadays, you can discover clean products everywhere, from your local drugstore to the fanciest boutiques."46 Undoubtedly, consumer expectations promote the creation of innovative, high-quality products. Innovation does not have to come at the cost of health, and safety must be the priority. Stronger regulations would ensure that such a standard applies to cosmetics in the whole market. According to Dotta, "No other industry governed by the FDA is as self-regulated as the U.S. cosmetics industry."47 If legislation changes the authority of the FDA, the administration can enhance its standards to ensure proper cosmetic regulation.
Many legislators have already taken the necessary steps to offer solutions that improve the safety of cosmetics. However, Congress has not completed the process to enact such bills at the federal level. Although the Californian act would improve the situation in 2025 at a state level,48 a nationwide solution does not exist yet. Furthermore, the suggestions could be improved to ensure complete results.
The following suggestions strengthen the current authority of the FDA for the well-being of the people. New legislation must follow the example of the successful European Union and California regulations. The modernized FDA standards should eliminate hundreds of harmful ingredients from product formulations, following the standard of the EU. Additionally, premarket review and approval of individual products would ensure the safety of cosmetics in the industry. This way, consumers would know exactly what to expect from those products.
To ensure that new regulations do not negatively impact small cosmetic businesses, the United States could create programs to assist companies in complying with new guidelines. First, the FDA should create a database, similar to the model of the European Union,49 where all providers of raw material and manufacturers would submit the data of individual ingredients and formulations. Each element would be introduced for a fee one time only, so manufacturers do not need to spend unnecessary funds on registering repeated ingredients to the platform. This platform would serve as a foundation for the FDA to review the safety of ingredients and formulations. As a result, the platform would remove the financial burden from companies to conduct scientific research on ingredients and formulations.
Furthermore, the US government could create a federal program that the FDA monitors for scientific research and innovation. The program would establish research facilities where scientists research, assess, and create ingredients and basic formulations for the cosmetic industry. Scientists from the chemistry, physics, biology, and medicine fields would determine the safety of cosmetic elements. Scientists would submit safety data to a database regulated by the FDA. Consequently, manufacturers may consult in the database which ingredients or formulations are preapproved by the FDA for implementation in cosmetics, as the federal program would already have attested their safety. Additionally, companies would be free to create new ingredients within the new FDA regulations. Companies would submit new ingredients for premarket safety assessment and approval to the federal research program for a fee. With the programs, manufacturers would be relieved from a significant burden to fund their scientific research and may better use the budget to formulate products with high-quality ingredients.
Such programs would benefit the well-being of the population and the American economy in several ways. Manufacturers would only use ingredients guaranteed to be safe. Consequently, safe cosmetic products would dominate the beauty industry in the United States. Public health would improve, as it would be less common for products to cause adverse health effects. Therefore, consumer trust improves, and cosmetic sales increase, benefitting the economy. With a higher product demand, the industry would additionally create new jobs. The federal program for scientific research and innovation would create the need for more professionals in science and medicine. It would increase the number of individuals pursuing higher education to enter such careers, as the field would grow. The country would create several employment opportunities around new guidelines. As the FDA would enforce more authority, the organization would create more employment positions to meet the new demands. Undoubtedly, the improvement of public health, the benefits for the economy, and the creation of new jobs are worth the efforts to regulate cosmetics.
New guidelines would create a modern, successful, innovative standard for the cosmetic industry in the US. Additionally, it would establish the United States as a cosmetic safety leader globally. This way, companies that wish to market in the United States must abide by the guidelines to ensure the safety of their products. Furthermore, the beauty industry market will evolve with the inclusion of safe formulations. It will create trust in consumers, which may lead to the promotion of sales. Therefore, the industry would grow. Finally, since the US market is prosperous, international companies will follow the guidelines to receive permission to market in the US. The final result would ensure that beauty companies implement more conscious manufacturing practices, modernizing the cosmetics industry worldwide.
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17 "FDA Authority Over Cosmetics,” https://www.fda.gov/cosmetics/cosmetics-laws- regulations/fda-authority-over-cosmetics-how-cosmetics-are-not-fda-approved-are-fda-regulated.
18 “80 Years of the Federal Food, Drug, and Cosmetic Act,” https://www.fda.gov/about- fda/fda-history-exhibits/80-years-federal-food-drug-and-cosmetic-act.
19 "FDA Authority Over Cosmetics,” https://www.fda.gov/cosmetics/cosmetics-laws- regulations/fda-authority-over-cosmetics-how-cosmetics-are-not-fda-approved-are-fda-regulated.
20 “Color Additives and Cosmetics: Fact Sheet.” U.S. Food and Drug Administration. May 16, 2019. https://www.fda.gov/industry/color-additives-specific-products/color-additives- and-cosmetics-fact-sheet.
21 "Prohibited & Restricted Ingredients in Cosmetics." U.S. Food and Drug Administration. August 24, 2020. https://www.fda.gov/cosmetics/cosmetics-laws- regulations/prohibited-restricted-ingredients-cosmetics.
22 "FDA Authority Over Cosmetics,” https://www.fda.gov/cosmetics/cosmetics-laws- regulations/fda-authority-over-cosmetics-how-cosmetics-are-not-fda-approved-are-fda-regulated.
23 "FDA Authority Over Cosmetics,” https://www.fda.gov/cosmetics/cosmetics-laws- regulations/fda-authority-over-cosmetics-how-cosmetics-are-not-fda-approved-are-fda-regulated.
24 "Feinstein, Collins Introduce Bill to Modernize Safety Standards for Personal Care Products." United States Senator for California Dianne Feinstein. June 17, 2021.
https://www.feinstein.senate.gov/public/index.cfm/2021/6/feinstein-collins-introduce-bill-to- modernize-safety-standards-for-personal-care-products.
25 "S.2003 - 115th Congress (2017-2018): FDA Cosmetic Safety and Modernization Act." Congress.gov. October 25, 2017. https://www.congress.gov/bill/115th-congress/senate- bill/2003.
26 "Text - H.R.5279 - 116th Congress (2019-2020): Cosmetic Safety Enhancement Act of 2019." Congress.gov. March 11, 2020. https://www.congress.gov/bill/116th-congress/house- bill/5279/text.
27 The Editorial Board. “Do You Know What’s in Your Cosmetics?” The New York Times. February 19, 2019. https://www.nytimes.com/2019/02/09/opinion/cosmetics-safety- makeup.html.
28 Markham, Jim. “FDA’s Cosmetics Regulations Hurt Small Business.” The Hill. August 18, 2016. https://thehill.com/blogs/pundits-blog/healthcare/291870-fdas-cosmetics-regulations- hurt-small-business?rl=1.
29 Amadeo, Kimberly. “What is a Monopoly?” The Balance. October 23, 2021. https://www.thebalance.com/monopoly-4-reasons-it-s-bad-and-its-history-3305945.
30 “Cosmetics and Personal Care Industry Overview.” Cosmetics Europe. Accessed
October 26, 2021. https://cosmeticseurope.eu/cosmetics-industry/. 31
Stepp, “You Don’t Know What’s in Your Shampoo,” pp. 278-304,
31 https://link.gale.com/apps/doc/A567549420/HRCA?u=nhmccd_main&sid=bookmark-
Stepp, “You Don’t Know What’s in Your Shampoo,” pp. 278-304,
32 https://link.gale.com/apps/doc/A567549420/HRCA?u=nhmccd_main&sid=bookmark-HRCA&xid=ea627343.
33 Dotta, “The Foundation for New Cosmetic Safety Laws.” p. 417-418, https://scholarlycommons.pacific.edu/uoplawreview/vol52/iss2/13/.
34 “Innovation and Future Trends in The Cosmetics Industry.” Cosmetics Europe. Accessed on October 31, 2021. https://cosmeticseurope.eu/cosmetics-industry/innovation-and- future-trends-cosmetics-industry/.
35 “Innovation and Future Trends,” https://cosmeticseurope.eu/cosmetics- industry/innovation-and-future-trends-cosmetics-industry/.
36 “Innovation and Future Trends,” https://cosmeticseurope.eu/cosmetics- industry/innovation-and-future-trends-cosmetics-industry/.
37 “California Safe Cosmetics Program.” California Department of Public Health. June 29, 2021. https://www.cdph.ca.gov/Programs/CCDPHP/DEODC/OHB/CSCP/Pages/About- CSCP .aspx.
38 “Assembly Bill No. 2762,” https://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=201920200AB2762.
39 Little, Susan. "Everything You Need to Know About California's Toxic-Free Cosmetics Act." Environmental Working Group. June 10, 2020. https://www.ewg.org/news- insights/news/everything-you-need-know-about-californias-toxic-free-cosmetics-act.
40 “Assembly Bill No. 2762,” https://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=201920200AB2762.
41 “Assembly Bill No. 2762,” https://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=201920200AB2762.
42 Little, "California's Toxic-Free Cosmetics Act," https://www.ewg.org/news- insights/news/everything-you-need-know-about-californias-toxic-free-cosmetics-act.
43 Rao, Priya. “Beauty & Wellness Briefing: Is L.A. Becoming The New Beauty capital of The World.” Glossy. May 4, 2021. https://www.glossy.co/beauty/beauty-wellness-briefing-is- los-angeles-becoming-the-new-beauty-capital-of-the-world/.
44 “Assembly Bill No. 2762,” https://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=201920200AB2762.
45 Markham, “FDA’s Cosmetics Regulations,” https://thehill.com/blogs/pundits- blog/healthcare/291870-fdas-cosmetics-regulations-hurt-small-business?rl=1.
46 McIntyre, Megan. “The Newbie’s Guide to The Best Clean Beauty Brands.” Byrdie. September 06, 2021. https://www.byrdie.com/best-clean-beauty-brands-5094580.
47 Dotta, “The Foundation for New Cosmetic Safety Laws” p. 418, https://scholarlycommons.pacific.edu/uoplawreview/vol52/iss2/13.
48 “Assembly Bill No. 2762,”
https://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=201920200AB2762. 49
Stepp, “You Don’t Know What’s in Your Shampoo,” pp. 278-304,
17
https://link.gale.com/apps/doc/A567549420/HRCA?u=nhmccd_main&sid=bookmark-
HRCA&xid=ea627343.
CONCLUSION
The current law that authorizes the FDA to regulate cosmetics is obsolete. The act was established in 1938,50 addressing the problems of the era. As a solution, new bills must modernize the authority of the FDA. Several lawmakers already took the initiative to seek reform. Unfortunately, Congress has not completed the process to enact new cosmetic legislation. The cause might be the impact that stronger regulations may impose on cosmetic companies51 and the economy. Subsequently, the research verifies that stronger regulations may benefit all parties; the example of the European Union employs strict guidelines to ensure the safety of cosmetics52 and boasts the most successful cosmetic industry in the world.53
The research argues that the United States can successfully establish stronger cosmetic regulations by employing the right strategy. For instance, the country can follow the example of California. The state passed strong laws to regulate cosmetics, ensuring the safety of formulations marketed in the state.54 Alternatively, California attracts companies to the state with several factors that benefit the industry.55 As a result, many beauty companies that seek to establish themselves in the state would follow the new guidelines, producing safer cosmetic formulations. Subsequently, such companies would market their products nationwide, created with strong standards in mind. To further support the claims that stronger regulations may benefit the economy, the research suggests that clean cosmetic products become successful in the market56 as they promote consumer trust. Many brands innovate by creating effective products with clean standards. The research concludes that stronger regulations would benefit the population, consumers, and the economy. It proves that Congress can establish laws that motivate companies to produce clean products and protect public health. The lack of new legislation approval does not rule the solutions as a failure. It only reflects the progress of the legislative process. To improve the solutions, the research suggested implementing a federal program to research ingredient safety to relieve companies from the burden of conducting the process by themselves.
The present research serves as a foundation for future scholars to find new ways to improve cosmetic regulations in the United States. The suggestions presented in the analysis would enhance the present regulations. Subsequently, future researchers may find a viable way to implement them. The result would create a positive impact on American society.
Modernized cosmetics standards would greatly benefit society. Regulations established more than 80 years ago are not sufficient to address the modern problems of cosmetic formulations. The most vital result of modernized cosmetic safety standards would be the improvement of public well-being. Cosmetics would lack many toxic ingredients; therefore, routine exposure to potentially harmful formulations would no longer impose a hazard to men, women, and children. Safer cosmetics would positively impact the health of citizens worldwide.
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50 Scott, "The Toxic Twelve Chemicals," https://www.ewg.org/the-toxic-twelve- chemicals-and-contaminants-in-cosmetics.
51 The Editorial Board, “Do You Know What’s in Your Cosmetics?” https://www.nytimes.com/2019/02/09/opinion/cosmetics-safety-makeup.html.
52 Dotta, “The Foundation for New Cosmetic Safety Laws” p. 416, https://scholarlycommons.pacific.edu/uoplawreview/vol52/iss2/13.
53 “Cosmetics and Personal Care Industry Overview,” https://cosmeticseurope.eu/cosmetics-industry/.
54 “Assembly Bill No. 2762,” https://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=201920200AB2762.
55 Rao, “Beauty & Wellness Briefing,” https://www.glossy.co/beauty/beauty-wellness- briefing-is-los-angeles-becoming-the-new-beauty-capital-of-the-world/.
56 McIntyre, “The Newbie’s Guide,” https://www.byrdie.com/best-clean-beauty-brands- 5094580.
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