We would like to express our gratitude to everyone who viewed our site. Welcome to another edition. legal lensWe discuss all things regulatory in the world of personal care products.
This month’s theme is something I’ve been thinking about for a while: “Clean Beauty.” This topic is a strange one to me. Because my personal concept of clean beauty includes using dry shampoo and lots of coffee, and (again) not passing out with makeup on.
Nevertheless, the “clean beauty” market, however defined, is expected to reach an estimated $11.6 billion by 2027. Clean beauty is big business. But what do we think of when we think of something as “clean,” “natural,” “green,” or “non-toxic”? And why do we know what’s in beauty products? Do they really care that much about whether they are there?
What is clean beauty?
My idiosyncratic views on doing the bare minimum when it comes to beauty aside, the concept of “clean beauty” has been around for a while. That’s the aesthetic that comes to mind when you see Sofia Coppola’s “The Virgin Suicides.” It’s refreshing, youthful, minimalist, and typically white. Products of the same type, synthetic ingredients and preservatives.
Over time, this concept evolved from an aesthetic to an ethos, appearing alongside concepts like “preservative-free,” “non-toxic,” and “all-natural.” This change is due to the growing environmental awareness among consumers and the increasingly unhealthy consumer culture of late capitalism, in contrast to products that eschew synthetic ingredients and preservatives in favor of naturally derived ingredients. It reflects the idea that there is.
Today, “clean” typically means products formulated without ingredients associated with human health or sensitivity issues, such as sulfates, parabens, added fragrances, and formaldehyde. Brands are also capitalizing on growing consumer demand for environmentally friendly products by adopting terms such as “natural,” “conscious,” “sustainable,” “green,” and “organic.” .
Given the ad hoc development of “clean beauty,” different brands and retailers have different standards for what constitutes “clean” based on different lists of banned ingredients and sustainability initiatives. It is important to remember that you are hiring. Few claims of “clean beauty” are built the same way. And many brands and retailers explain in detail (often on their websites) what “clean beauty” means.
Clean Beauty claims are regulated by the US FDA?
That’s a good question. Yes and no.
Under federal law, cosmetic products (clean or not) must not be considered incorrect brand name. And this is a term that needs a little unpacking.
Prior to 2022, the federal government regulated cosmetics under two primary statutes: the Federal Food, Drug, and Cosmetic Act of 1938 (FDCA), the Fair Packaging and Labeling Act (FPLA), and the regulations promulgating these two statutes. I did.
The FDCA defines cosmetics as products “scrubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for the purpose of cleaning, beautifying, enhancing attractiveness, or altering appearance.” There are no requirements for: Premarket approval.
However, once a cosmetic product enters interstate commerce (i.e., is available for sale in the United States), it must be safe and free from adulteration and misbranding when used by customers in accordance with the product label or customary instructions. It shouldn’t be.
Similarly, the Fair Packaging and Labeling Act (FPLA) requires cosmetic products offered for sale to be truthful and non-misleading to consumers and to disclose all ingredients. Products that are not FPLA compliant are considered misbranded under the FDCA and may be subject to enforcement action by the FDA.
Both the FDCA and FLPA define misbranding as false or misleading, lacking required information, in violation of various regulations, or that, for all intents and purposes, a reasonable consumer would be misled. It is defined as something that is sold in such a way that it
And for more than 50 years, through December 2022, the FDCA and FPLA have formed the basis of federal cosmetics regulation, even as the beauty industry has grown rapidly and required more comprehensive guidance.
In December 2022, Congress enacted the Cosmetic Regulatory Modernization Act (MoCRA). MoCRA significantly expands FDA’s rulemaking and enforcement authority with respect to cosmetics and creates significant new compliance obligations for manufacturers, packagers, and distributors of cosmetics sold in the United States.
For example, MoCRA imposes facility registration and product listing requirements, enhanced recordkeeping obligations, and new labeling requirements for adverse event contact information. MoCRA also provides regulations that address, among other things, the identification of fragrance allergens that must be disclosed on cosmetic labels in line with Good Manufacturing Practice (GMP), European Union and other international requirements, and standardized test methods for detection. The FDA is required to enact the following. Identification of asbestos in talc-containing products.
However, while the MoCRA significantly changes how the federal government regulates cosmetics distributed in the United States, it does not address or change the existing regulatory framework regarding cosmetic labeling and marketing issues. there is no. For example, “natural,” “clean,” “non-toxic,” and “safe.” Nor does it provide guidance on how much support brands need to make these claims.
so what can Do companies make claims about their products?
The FDA does not maintain a list of approved claims for cosmetic products. However, there are limits to what brands can say about their products on their labels and promotional materials, as well as guidance issued by other federal regulators.
Although the FDA does not define the term “natural” in cosmetic labeling and has not established a regulatory definition, the U.S. Department of Agriculture’s Agricultural Marketing Service (AMS) does not define what qualifies as “natural.” It provides companies with general principles for labeling cosmetics. All “green” and environmental marketing claims.
These principles include the inclusion of substances that are not chemically modified or obtained through natural biological processes.
Similarly, the FDA does not define or regulate the term “organic” as it applies to cosmetics or other personal care products. However, the United States Department of Agriculture (USDA) regulates the term “organic” as applied to agricultural products, so cosmetics must be composed of agricultural products and meet USDA standards for organic production, handling, processing, and labeling. Cosmetics can be used if possible. You are eligible to apply for organic certification under the U.S. Department of Agriculture’s National Organic Program Regulations and can make various organic claims depending on the percentage of organically produced ingredients in your product.
The Federal Trade Commission (FTC), which regulates cosmetic advertising under the FTC Act, has promulgated a Green Guide that provides companies with general principles regarding all “green” and environmental marketing claims. These principles include how consumers are likely to interpret certain claims and how brands can best qualify their claims to avoid consumer deception claims. .
The most recent update to the FTC’s Green Guide in 2012 includes guidance on certified use of products, as well as “environmentally friendly,” “degradable,” and “non-toxic” claims, especially if companies are It clearly states that. The claim must have “competent and reliable scientific evidence that the product, packaging, or service is non-toxic to humans and the environment.”
The FTC also takes action against brands to prohibit conduct that is unfair or deceptive, or what it considers to be false advertising that could mislead rational consumers or inform their purchasing decisions. You can also.
What are the legal risks associated with promoting clean beauty?
Although the federal government does not clearly define what “clean beauty” is from a regulatory perspective, beauty brands and retailers are still being accused of deceptive “clean” or She is facing intense scrutiny for allegedly claiming to be “natural.”
These lawsuits challenge claims that products are “clean,” “natural,” or “non-toxic,” and instead label them as synthetic ingredients or related to human health concerns such as hair loss, reproductive issues, etc. It claims to contain ingredients that can, in some cases, cause cancer.
Or, because the product contains synthetic ingredients, the product’s “clean” or “natural” label is false and/or misleading, and you purchase the product at a price you would not have otherwise paid. He claims to have been induced to do so.
For example, in 2023, plaintiffs claimed they were injured by hair products containing the fragrance ingredient Lilial, which has been linked to health hazards by the European Commission.
In addition, ingredients such as benzene and per- and polyfluoroalkyl substances (PFAS), widely used compounds that can be inadvertently present in consumer products due to their use in manufacturing processes or their presence in tap water. A class action lawsuit has been filed alleging that ingredients such as Increased.
Although courts agree on a clear definition of “clean beauty,” opinions may differ, and the level of success of a plaintiff in asserting a clean beauty claim depends on the specifics of the claim. It is important to remember that
Meanwhile, courts such as the U.S. District Court for the Northern District of New York have rejected class action consumer deception claims arising from “Clean Beauty” retail programs, holding that retailers must very clearly disclose the program’s standards. I concluded that it did. The retailer did not define “clean” to mean “all natural” or “free from synthetic ingredients.”
Meanwhile, courts such as the U.S. District Court for the District of Minnesota have taken a different position.
In a recent decision in September of this year, the court held that on the plaintiffs’ claims of statutory consumer fraud and common law fraud, negligent misrepresentation, breach of warranty, and unjust enrichment, reasonable consumers would He agreed to proceed with discovery as to whether there was a possibility of misunderstanding. Specifically, the plaintiffs allege that certain products considered “clean” under the program’s standards contain ingredients prohibited by the program or contain ingredients that are more harmful than the prohibited ingredients. insisted.
Given this lack of definitional clarity, it’s important to understand how beauty brands use terms like “clean,” “natural,” and “safe,” and in light of product ingredients and intended claims. The question remains whether a reasonable consumer would find those terms misleading.
So what do you get?
Beauty brands need to be aware of the potential liability risks of advertising products as “clean,” “natural,” or “safe.”
Regulatory enforcement risks are relatively low, but regulators may or non-toxic), we may specifically scrutinize claims published on the internet or in advertising. social media.
Meanwhile, the risk of private (and costly) litigation is increasing as plaintiffs focus on beauty and wellness products as an inexhaustible source of potential claims.
Whenever possible, beauty brands should:
- Consult with an attorney to approve claims, especially regarding ingredients that may be subject to scrutiny.
- Obtain third-party certification of “organic” ingredients and reference that certification in marketing and labeling.
- Stay tuned for evolving guidance in this area, including updates to the long-awaited Green Guide and litigation regarding various claims.
- Ensure consistency of claims and wording with marketers and social media influencers to ensure claims are true, not misleading, and properly substantiated.
- Language and context matter. Consider what you communicate to consumers, how you communicate it, and the value added by “clean” terminology.
Are clean beauty consumers looking for clear explanations and consistent standards of what clean beauty actually means? It’s in the eye of the beholder.
Have questions or suggestions? Contact Kelly at kabonner@duanemorris.com.
