Synopsis: Unhappy with the FDA’s position on branding, Congressional representatives seek to define “natural” narrowly to limit its use in consumer advertising.
As the cosmetic industry moves on to new marketing lingo connoting healthier and safer cosmetics, including “clean beauty,” “sustainable,” “vegan,” and “pure,” New York Representative Sean Patrick Maloney introduced the Natural Cosmetics Act (the “Bill”) last week in the US House of Representatives. While the US Food and Drug Administration (FDA) has declined to define natural, through this legislation, Rep. Maloney seeks to define the terms “natural” and “naturally-derived ingredient” as used with personal care products. As Rep. Maloney pointed out in his announcement of the Bill, the FDA does not qualify false labeling of “natural” as misbranding, mainly because it is an unregulated and undefined term when used with cosmetics.
Recognizing consumers’ concerns, Rep. Maloney advocated, “[w]e’re talking about safety and health of millions of Americans who use these products. My bill will set the standard for ‘natural’ personal care products and do right by American consumers by putting transparency first.” Joining Rep. Maloney’s bill is Representative Grace Meng (also from New York), who stated, “[i]ncreasing protections, transparency and oversight of personal care products is desperately needed, and this legislation would go a long way towards ensuring strict standards for items claiming to be ‘natural.’” A number of leading brands in the dubbed “clean beauty” space have also joined Representatives Maloney and Meng in supporting passage of this new Bill.
Meanwhile, the FDA remains mum about formally defining “natural” for cosmetics despite its solicitation of comments from the public over three years ago. The FDA has a longstanding policy concerning the use of “natural” in human food labeling. In regulating food products, FDA has considered the term “natural” to mean that “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.” Similarly, the Federal Trade Commission has not acted on the term “natural” since 2016, when it approved four final consent orders against companies that allegedly misrepresented their personal care products as “All-Natural” or “100% Natural,” despite the fact that they contain man-made ingredients. Additionally, the National Advertising Division (NAD) has not addressed “natural” and “naturally” claims in cosmetics since 2016 when it recommended that a company discontinue use of these terms because the company’s labeling implied that the products were formulated without aluminum when in fact they contained aluminum.
Last year, then-FDA Commissioner Scott Gottlieb delivered a speech at the National Food Policy Conference in which he indicated that, just like other claims made on products regulated by the FDA, the “natural” claim must be true and based in science. At the same time, he recognized that there are wide differences in beliefs regarding what criteria should apply for products termed “natural” and some of those criteria are not based on public health concerns. In a letter addressed to Rep. David Valadao, dated December 19, 2018, Dr. Gottlieb added that the “FDA is actively working on this issue, and in 2019, FDA plans to publically communicate next steps regarding Agency policies related to ‘natural.’” These statements generally relate to food regulation and have not yet been followed by any formal action by the FDA.
Despite the rather dormant federal regulatory activity over “natural” advertising with cosmetics, class actions regarding misuse of the term “natural” continue to populate the federal docket. See, e.g., Yolanda Turner v. Trans-India Products, Inc., Case No. 19-cv-03422, pending in the E.D.N.Y. Courts who have addressed the issue of defining “natural” have found it means “an affirmative claim about a product’s qualities and is, therefore, not ‘an exaggeration or overstatement expressed in broad, vague, and commendatory language’” (Suarez v. California Nat. Living, Inc., No. 17 CV 9847 (VB), 2019 WL 1046662, at *7 (S.D.N.Y. Mar. 5, 2019)), and it is indicative of “the absence of synthetic ingredients” (Petrosino v. Stearn’s Prod., Inc., No. 16-CV-7735 (NSR), 2018 WL 1614349, at *7 (S.D.N.Y. Mar. 30, 2018)). But, courts are split as to whether “all natural” claims “are more within the conventional expertise of judges or whether they involve technical or policy considerations within the FDA’s particular field of expertise.” See de Lacour v. Colgate-Palmolive Co., No. 16-CV-8364 (RA), 2017 WL 6550690, at *2 (S.D.N.Y. Dec. 22, 2017). This consideration has caused some courts to stay litigation pending regulatory guidance, leading parties to settle instead of waiting in vain.
This House activity is yet another instance in which Congressional leaders are trying to keep up with regulating industry trends while the FDA lags behind. See, e.g., Senator Schumer’s call to action. Like vaping and CBD, we may see “natural” and “clean” resurface in the FDA’s priorities because of the safety concerns these marketing terms hold.