There's More To Cosmetics Regulation Than Meets The Eye

A recent boost in cosmetics litigation, especially related to talcum powder, has reinvigorated a debate about the breadth of the U.S. Food and Drug Administration’s authority over cosmetic products and their ingredients.

The subject of the FDA and its action or inaction in regulation of cosmetics is being presented to countless courts and jurors in every recent cosmetic product liability action. While the debate is multifaceted, the majority of critiques all tend to be concentrated on one side of the issue.

Some litigants as well as commentators suggest that the FDA exerts no real regulatory authority over cosmetic ingredients. Others suggest that the lack of specific ingredient regulation and premarket approval makes cosmetic products inherently unsafe. A third camp claims that the FDA’s reliance on cosmetic industry self-regulation means that it has, in a sense, abandoned American consumers, who are now responsible for their own public health concerns.

But there is a contrarian view. Just because the FDA does not require premarket approval[1] of cosmetics does not mean the ingredients are completely unregulated. Nor does the lack of federal guidelines for tens of thousands of different cosmetic ingredients mean that the industry is completely sovereign.

Looking under the hood of the current regulatory framework reveals that the rules applicable to cosmetic ingredients may be more robust than some think. Examining what rules are actually in place, rather than focusing on perceived inadequacies, may give us a better understanding of the other side of the debate.

Specific Cosmetic Regulations

First, the FDA’s actual legal authority over cosmetics is different from its authority over other products regulated by the agency, such as drugs, biologics and medical devices. Cosmetic products and their ingredients are not subject to FDA premarket approval authority, with the exception of color additives.[2]

However, cosmetics do come under the purview of the FDA’s regulatory authority through two important laws: (1) the Federal Food, Drug, and Cosmetic Act, or FDCA, and (2) the Fair Packaging and Labeling Act, or FPLA.[3] The FDA may pursue enforcement action against companies which violate these laws.

The FDCA prohibits the adulteration and misbranding of cosmetics, and the introduction, receipt and delivery of adulterated or misbranded cosmetics into interstate commerce.[4] Cosmetics can be considered adulterated if they contain any poisonous substance, are packed under unsanitary conditions or are contaminated in a way that renders the product injurious to health.[5]

Second, the FDA has put together a list of prohibited and restricted ingredients it considers harmful in cosmetic products.[6] The list contains eight prohibited and two restricted ingredients.[7] As recently as 2015, the FDCA was amended to include the Microbead-Free Waters Act, which bans rinse-off cosmetics that contain intentionally-added plastic microbeads, effective Jan. 1, 2018.[8] While these restrictions are less prohibitive than the analogous regulations maintained by the European Union, which contain more than 1,000 banned ingredients, they are restrictions nonetheless.

Third, there are significant regulations relating to the labeling of ingredients in cosmetic and personal care products. Regardless of whether such products are manufactured domestically or imported, they must comply with FPLA labeling requirements.[9] These strict labeling standards are based on the FDA’s established definitions of drugs, cosmetics, shampoos and the like. A cosmetic is considered misbranded if:

• Its labeling/container is false or misleading;
• Its label does not include all required information; or
• The required information is not adequately conspicuous.[10]

Cosmetics that fail to comply with the FPLA are considered misbranded under the FDCA.[11] While these laws may not deal with the efficacy of particular substances, they do prevent deceptive packaging and labeling of ingredients that make their way into the households of U.S. consumers.

Fourth, there are targeted regulations and FDA approval requirements for certain ingredients.[12] Color additives, for example, are one of the most widely used types of ingredients in cosmetics. Color additives give consumers a wide range of options, from a rosy hue in blush to a purple shade of eyeliner. Essentially, these are dyes that can impart color when added to a cosmetic.[13] Color additives are subject to stringent regulations, including premarket approval, meeting requirements for identity stated in the Code of Federal Regulations, permissible concentration limits and certification of every individual batch of additives.[14]

Finally, it is important not to focus the entirety of the conversation on the FDA. There are other agencies and regulatory schemes that assist in the regulation of cosmetics. The Toxic Substances Control Act, or TSCA, regulates new and existing substances, many of which are found within personal care products.[15] While the TSCA does not regulate any products, it regulates substances that are used as ingredients in cosmetics.[16] 

A perfect example of this regulation at work is dibutyl phthalate, an ingredient in nail polish. Dibutyl phthalate is also a chemical solvent used in other industries; thus, it falls under the purview of the TSCA, and is subject to any testing and registration the act requires.[17] This is just one example of how the TSCA plays an important role in the regulation of personal care products.

Other ways in which cosmetics and their ingredients are regulated include FDA review of edible cosmetics,[18] requirements related to cosmetic shelf life[19] and the U.S. Department of Agriculture’s regulation of organic claims. There are many other similar examples. Critics who paint the cosmetic industry as being completely devoid of any regulation may not have paid attention to the breadth of rules and guidelines within the regulatory system.

Cosmetics Can Be Drugs — So Are There Crossover Regulations?

Those who point to a lack of regulation also might not have considered that a portion of the cosmetic industry falls under drug regulations. A cosmetic product may be subject to drug approval requirements depending on advertising assertions by the manufacturer.

The FDCA defines drugs, in part, as products intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease, and intended to affect the structure or function of the body of humans or other animals.[20] Some products meet the definitions of both cosmetics and drugs.

A common example is shampoo. Shampoo can be a cosmetic, because it is used to clean hair. But it can be considered a drug when it contains an ingredient used to treat dandruff. In such instances, the product must generally either receive premarket approval by the FDA through the New Drug Application, or NDA, process, or conform to a “monograph” for a particular drug category.[21]

Other cosmetic/drug combinations include toothpaste with whitening ingredients, deodorants that are also antiperspirants, makeup marketed with sun-protection claims, anti-acne products and anti-wrinkle creams. Under this standard, many cosmetic products sold in the U.S. may require premarket approval, depending on how they are marketed.

If Not Regulation, What About Guidance or Consumer Knowledge?

Critics of the current framework often say that the FDA’s reliance on the cosmetic industry to police itself and use safe ingredients puts the burden on consumers to protect their own health and safety. But one could argue that this is less a matter of abandoning consumers than of sharing responsibility.

There are tens of thousands of different cosmetic ingredients on the market, with new ones created every year. This being the case, from a FDA capacity and fiscal perspective, it seems impractical to require specific directives for every ingredient.

While there may not be specific regulations governing every facet of the cosmetic industry (nor could there be), the FDA can and does fill in gaps by issuing guidance, not only on specific cosmetic ingredients, but also on other subjects. These guidance documents have been issued on a variety of subjects, including lipsticks,[22] lead,[23] nanoparticles,[24] alpha hydroxy acids,[25] quality assurance programs[26] and good manufacturing processes.[27] Although they do not create or confer any rights for or on any person, the FDA’s guidance documents can be used by manufacturers to satisfy the requirements of the applicable statutes and regulations.

Further, modern-day consumers can be quite discerning in their consumption of personal care products. Some have a distaste for inorganic ingredients; some are hypersensitive or allergic to certain ingredients. Between the FDA, the Cosmetic Ingredient Review, the Personal Care Products Council and the Environmental Working Group cosmetics database, U.S. consumers have a vast amount of ingredient information at their fingertips. One could argue that the sheer volume of information available empowers consumers to take the initiative in the protection of their own health and safety, by familiarizing themselves with various ingredients, and with their own bodies’ reactions to those ingredients.

Petitions and Enforcement

Sometimes the FDA takes its cues from consumers and trade organizations. Ordinary citizens may submit petitions to the FDA asking the agency to determine that a cosmetic is adulterated, or that it contains a particular deleterious substance.[28] In response to such petitions, the FDA can issue new regulations, change or cancel a regulation, or take other action. The agency receives about 200 petitions annually.

In the cosmetic talc context, for example, the FDA responded to petitions in 1986, 1996 and 2008 which requested that the FDA require cosmetic talc products bear a label warning of a risk of asbestos contamination.[29] The FDA declined to require a warning label on cosmetic talc products or to make a determination that cosmetic talc was a deleterious substance.[30]

Outside of the talc context, the Consumer Federation of America petitioned the FDA to determine urocanic acid (at the time, a common cosmetic ingredient used as a skin-conditioning agent and as a sunscreen) an unsafe substance. The FDA denied such a petition after conducting a review of urocanic acid, and concluding that the scientific evidence did not establish it to be a deleterious substance. The FDA did, however, require that manufacturers of products containing urocanic acid provide notice on their labels that its safety has not been established.[31]

These petitions, and the FDA's responses, allow the agency to potentially address an unmet regulatory need concerning a particular substance, or to make a reactive prohibition of products already on the market. They also provide meaningful dialogue between consumers and regulated parties alike, allowing both groups insight into the FDA's positions on particular substances.

In addition to issuing responsive guidance on cosmetic ingredients pursuant to Section 704 of the FDCA, the FDA is authorized to conduct inspections of cosmetic firms at reasonable times, in a reasonable manner and without prior notice, in order to assure compliance with the applicable laws and regulations, to determine whether cosmetics are safe and properly labeled, and to identify possible health risks and other violations of the law.[32] Although the FDA does not have mandatory recall authority over products based on these inspections, they can request recalls of products from the marketplace.[33]

Conclusion

Not surprisingly, the debate over cosmetics regulation has spilled from the courtroom to Congress, with the introduction of the Personal Care Products Safety Act, the FDA Cosmetic Safety and Modernization Act and the Children's Product Warning Label Act. The passage of any of these bills would not only expand regulatory authority over cosmetics, but potentially affect every facet of the cosmetic industry, from sale, distribution and supply chains to manufacturing and marketing.

No matter the outcome of any of these bills, one thing is clear: At first blush, appearances can be deceiving. A true understanding of the breadth of cosmetic industry regulation requires a careful examination of the interplay between a variety of guidelines and directives, not just the text of the FDCA and FPLA.
 

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The opinions expressed are those of the author(s) and do not necessarily reflect the views of the firm, its clients, or Portfolio Media Inc., or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.

[1] The United States Federal Food, Drug, and Cosmetic Act § 721 (FDCA); FDA, FDA Authority Over Cosmetics, http://www.fda.gov/Cosmetics/ GuidanceComplianceRegulatoryInformation/ucm074162.htm.

[2] Id. 

[3] 21 U.S.C. Chapter 9; 15 U.S.C. Chapter 39.

[4] 21 U.S.C. Subchapter VI § 331(a)-(c).

[5] 21 U.S.C. §§ 361-363.

[6] C.F.R. §§ 700.11-700.35; see also https://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm127406.htm.

[7] Id.

[8] H.R. 1321, Microbead-Free Waters Act of 2015, 21 U.S.C. 301.

[9] See generally 15 U.S.C. Chapter 39.

[10] 16 C.F.R. 500, 501, 502, 503.

[11] Id.

[12] 21 C.F.R. § 70.3-70.55.

[13] 21 C.F.R. § 70.3(f).

[14] 21 U.S.C. 379e.

[15] 15 U.S.C. § 2601 et seq.

[16] See 15 U.S.C. § 2605.

[17] Dec. 17, 2014: EPA Significant New Use Rule under the Toxic Substances Control Act, Docket No. EPA-HQ-OPPT-2010-0573.

[18] See 21 C.F.R. § 101.93.

[19] See 21 C.F.R. § 211.

[20] 21 U.S.C. § 321(g).

[21] U.S.C. § 355 et seq.

[22] https://www.fda.gov/Cosmetics/GuidanceRegulation/GuidanceDocuments/ucm452623.htm.

[23] Id.

[24] https://www.fda.gov/Cosmetics/GuidanceRegulation/GuidanceDocuments/ucm300886.htm

[25] https://www.fda.gov/Cosmetics/GuidanceRegulation/GuidanceDocuments/ucm090816.htm.

[26] https://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm073841.htm.

[27] https://www.fda.gov/Cosmetics/GuidanceRegulation/GuidanceDocuments/ucm353046.htm.

[28] https://www.fda.gov/regulatoryinformation/dockets/ucm379450.htm.

[29] See FDA00003601-03; see also Letter from J.W. Swanson, Acting Associate Commissioner for Regulatory Affairs, FDA, to Philippe Douillet (July 11, 1986); Letter from S. Musser, Ph.D., Deputy Director for Scientific Operations Center for Food Safety and Applied Nutrition to S. Epstein, Cancer Prevention Coalition (April 1, 2014).

[30] Id.

[31] https://www.fda.gov/Cosmetics/GuidanceRegulation/GuidanceDocuments/ucm090816.htm.

[32] 21 U.S.C. § 374 (a)-(f).

[33] https://www.fda.gov/cosmetics/complianceenforcement/recallsalerts/ucm173559.htm.