The market for clean beauty is expected to reach an estimated $11.6 billion by 2027, but what “clean beauty” means is anyone’s guess. Given the lack of clear regulatory guidelines surrounding clean beauty, what are the legal and reputational risks associated with promoting products and services as “clean”?

What Is Clean Beauty?

The term “clean beauty” has evolved over the past 50 years, from the fresh-faced, no-makeup look to the growth of brands favoring naturally derived ingredients over synthetics.

Today, clean typically means products formulated without ingredients allegedly linked to human health or environmental issues like sulfates, parabens or formaldehydes. But, different brands have adopted different criteria based on lists of prohibited ingredients and sustainability commitments.

Brands also have capitalized on Gen Z’s demand for environmentally safe products by adopting terms like “natural,” “conscious,” “sustainable,” “green” or “organic.”

How Is Clean Beauty Regulated?

Traditionally, cosmetics were regulated under the Federal Food, Drug and Cosmetic Act of 1938 (FDCA) the Fair Packaging and Labeling Act (FPLA).

The FDCA defines cosmetics as, “articles intended to be rubbed, poured, sprinkled or sprayed on, introduced into or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness or altering the appearance.” This definition encompasses products as diverse as moisturizers, eye and facial makeup, shampoos and deodorants.

Under the FDCA, finished cosmetics typically did not require pre-market approval. But once they entered interstate commerce, they must be safe when used by customers in accordance with product labeling or customary usage, and not be misbranded or adulterated.

The FLPA required cosmetics marketed on a retail basis to consumers in interstate commerce to be truthful and not misleading, and to disclose all ingredients. Products that failed to comply with the FPLA were considered misbranded under the FDCA, and could result in enforcement action by FDA.

Together, the FDCA and the FLPA constituted the basis of federal cosmetics regulation for over 50 years, even as the beauty industry grew exponentially and required more comprehensive guidance.

Then, in December 2022, Congress enacted the Modernization of Cosmetics Regulation Act (MoCRA). MoCRA significantly expands FDA’s rulemaking and enforcement authority over cosmetics, and creates substantial new compliance obligations for manufacturers, packers and distributors of cosmetics intended for sale in the US.

For example, MoCRA imposes facility registration and product listing requirements, greater recordkeeping obligations, and new labeling requirements for adverse event contact information. MoCRA also requires the FDA to, among other things, enact regulations addressing good manufacturing practices (GMP), the identification of fragrance allergens that must be disclosed on cosmetics labels (in line with the EU and other international requirements), and standardized testing methods for detecting and identifying asbestos in talc-containing products.

While MoCRA represents a significant shift in the way the federal government regulates cosmetics distributed in the US, the new law doesn’t address or alter the existing regulatory framework for cosmetic labeling and marketing issues, such as defining or restricting the use of certain terms like natural, clean, nontoxic or safe. Nor does it provide guidance on how much support brands need to make these claims.

Related: How Greenwashing Actually Threatens Sustainability

What Can Companies Claim About Products?

The FDA does not have a list of accepted claims for cosmetics. However, there are limits to what brands can say about their products on their labels and in their promotional materials.

The FPLA requires that cosmetic labeling must be truthful and not misleading, and must disclose all ingredients.

The Federal Trade Commission (FTC), which regulates cosmetic advertising under the FTC Act, can also take action against brands to enjoin what it perceives as unfair or deceptive practices, or false advertisements that are likely to mislead a reasonable consumer in their purchasing decisions.

Legal Risks When Promoting Clean Beauty

Neither the FDA nor the FTC has defined the term “clean” for use in cosmetic labeling. Nevertheless, companies have faced scrutiny for allegedly deceptive “clean” or “natural” claims in the form of private lawsuits brought by consumers.

These lawsuits dispute claims that products are “clean,” “natural” or “nontoxic,” alleging instead that they contain synthetic ingredients, or ingredients allegedly linked to human health concerns like hair loss, reproductive issues or, in certain cases, cancer. Alternately, they allege that a product’s “clean” or “natural” labeling is false and/or misleading because the product contains synthetic ingredients, and that they were induced to purchase products they would not have otherwise purchased for prices they would not have otherwise paid.

Last year, plaintiffs claimed they sustained injuries from hair products that contain the fragrance ingredient lilial, which has been linked by the European Commission to adverse health issues. Additionally, class action lawsuits involving ingredients like benzene and per- and polyfluoroalkyl substances (PFAS)—a widely used class of compounds that is often inadvertently present in consumer goods because of their use in manufacturing processes or presence in water supplies—have increased.

How Spas Can Protect Themselves

Spas should be aware of the potential for liability for promoting services and products as “clean,” “natural” or “chemical free.” While the risk of regulatory enforcement is comparatively low, regulators may scrutinize “all or nothing” claims (e.g., "100% natural") or easily verifiable claims (e.g., "certified" organic or vegan), especially those publicized online.

Meanwhile, the risk for private (and costly) litigation is increasing as plaintiffs fixate on beauty and wellness as a source of risk.

Wherever possible, brands should:

• Consult with counsel to approve claims, particularly with respect to ingredients that are likely to draw scrutiny.
• Obtain third-party certification for vegan or organic ingredients, and refer to that certification in marketing and labeling.
• Ensure consistency of claims and language with marketers and social media influencers to ensure all claims are truthful, not misleading and adequately substantiated.

Remember: Language and context matter. Consider what is being communicated to consumers, how it is being communicated, and the value added through “clean” terminology.

Kelly A. Bonner, trial attorney with Duane Morris LLP, focuses on cross-jurisdictional and complex commercial disputes involving pharmaceutical, health-related retail and consumer branded products. Bonner is a frequent author on litigation risk and regulatory issues affecting businesses in the beauty and wellness industries.