In a world where consumers are more health-conscious and eco-friendly than ever, products containing artificial ingredients have become less attractive. Consumers are looking for natural alternatives, and the cosmetics industry is no exception. The recent boom of all-natural products has coincided with a rise in litigation. Like the food industry, cosmetic companies are learning that marketing products as “natural” comes with a price.
What Are “Natural” Cosmetics?
Pursuant to the Food, Drug and Cosmetic Act (FDCA), a “cosmetic” includes any article that is “intended to be rubbed, poured, sprinkled, or sprayed on, introduced into or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance. . . ”. 21 U.S.C. § 321(h)(i). While the definition of a cosmetic is clear, there is no clear definition of a “natural” cosmetic. The agencies that regulate marketing claims for cosmetic products —the U.S. Food & Drug Administration (FDA) and the Federal Trade Commission (FTC)—have not published regulatory definitions for the term “natural” that apply specifically to cosmetics.
Under the FDCA, a cosmetic is misbranded if “its labeling is false or misleading in any particular.” 21 U.S.C. § 362(a). But the FDA has not addressed whether claiming that a cosmetic is “natural” is “false or misleading.” And it is not likely to do so, because historically, the FDA has not taken action against a cosmetic manufacturer unless there is a safety issue (adulteration), or the manufacturer claims that the product affects the structure or function of the body, which changes the legal status of a product from a “cosmetic” to a “drug.” See 21 U.S.C. § 321(g)(1)(B)–(C) (2018). The closest the FDA has come to defining the term “natural” is in the context of food labeling. See FDA Requests for Guidance U.S. FOOD & DRUG ADMIN (interpreting natural to mean “nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in that food.”). The FDA sought comment from the public related to use of the term “natural” on food labeling, but the public is still waiting for the FDA’s response. See id.
Cosmetic company marketing claims are also subject to scrutiny by the FTC pursuant to the Federal Trade Commission Act, which prohibits unfair or deceptive acts or practices. While the FTC has also refrained from any formal definition of the term “natural,” it has addressed “all natural” claims for cosmetics and taken the position that they are appropriate only where they have “no artificial ingredients or chemicals.” In 2016, the FTC brought complaints against five cosmetic companies alleging they misrepresented cosmetic products as “all natural” or “100% natural,” because they contained synthetic ingredients. The FTC entered four consent orders that prevented the companies from, among other things, misrepresenting that their products are “natural” or “100% natural.” Notably, in announcing approval of the settlements, the FTC released its response to a public comment that implied the term “natural” should be regulated as forcefully as “all natural” claims, stating that the FTC “ha[d] [no] evidence that consumers necessarily interpret ‘natural’ to mean ‘all natural’ or no synthetic ingredients.”
Are “Natural” Claims Subject to United States Department of Agriculture Regulations?
Although one would not normally connect cosmetics with the Department of Agriculture, cosmetics may be subject to USDA regulation if they contain agricultural ingredients and are certified as organic. The National Organic Program in the Code of Federal Regulations contains a definition of “Nonsynthetic (natural)” substances, and specifically states that “nonsynthetic is used as a synonym for natural.” 7 C.F.R § 205.2 (2018). In 2016, the USDA issued guidance for determining whether a substance is natural, as opposed to synthetic. The guidance stated that a substance is natural if: (a) the “substance [is] manufactured, produced, or extracted from a natural source” (i.e. naturally occurring mineral or biological matter); (b) it has not “undergone a chemical change [i.e. a process (i.e. chemical reaction) whereby a substance is transformed into one or more other distinct substances] so that it is chemically or structurally different than how it naturally occurs in the source material”; or (c) “the chemical change [was] created by a naturally occurring biological process, such as composting, fermentation, or enzymatic digestion; or by heating or burning biological matter.” U.S. Dep’t of Agric., National Organic Program, NOP 5033-1, Guidance Decision Tree for Classification of Agricultural and Nonagricultural Materials for Organic Livestock Production or Handling (2016).
These threats to the cosmetic industry are not merely from regulatory agencies. Recently, the USDA’s definitions and guidance were used in support of a complaint alleging a cosmetic company’s “High Performance Naturals” claims were false and misleading under various state consumer protection statutes, because their skincare and beauty products contained synthetic ingredients (preservatives and emulsifiers). See Patora, et al. v. Tarte, Inc., No. 7:18-cv-11760-KMK (S.D.N.Y. filed Dec. 14, 2018). It is unclear how a court would respond to a challenge to the allegations, as the case was settled; however, it is likely that it will be tested in the future.