What You Need to Know Before Promoting Wellness Ingestibles

What You Need to Know Before Promoting Wellness Ingestibles
Beauty and wellness supplements are products designed to be consumed orally, contain vitamins, minerals, herbs or other botanically-derived ingredients, and cater to specific beauty concerns.

Beauty and wellness supplements for lustrous hair, glowing skin, healthy nails and holistic well-being are surging in popularity among Gen-Z beauty consumers. Recent litigation concerning the validity of brands’ science-based claims, combined with unclear guidance over what constitutes “clean” or “natural” beauty, have led to questions regarding best practices for promoting these products.

Here’s what spas need to know about promoting beauty and wellness supplements.

What Are Beauty and Wellness Ingestibles?

Beauty and wellness supplements, also known in retail parlance as “ingestible beauty” or “beauty from within,” are products designed to be consumed orally, contain vitamins, minerals, herbs or other botanically-derived ingredients, and cater to specific beauty concerns. They range from products as varied as biotin capsules for promoting thicker, longer hair, to collagen-infused gummies to reduce the appearance of wrinkles, to mood-boosting botanical powders for energy and stress (or at least the visible appearance of stress).

American consumption of beauty and wellness supplements was valued at $2.32 Billion in 2018 and is projected to reach $3.33 Billion by 2026. While this growth is driven in part by celebrity endorsements and social media influencers, post-pandemic consumers are increasingly turning to supplements as a way of not only looking good aesthetically, but feeling good from a whole-body wellness perspective. According to an online U.S. survey from The Benchmarking Company, from a total of 2,172 female shoppers, 76% of participants expect beauty brands to offer supplements to complement their topical offerings, while 77% of participants trust beauty brands to create safe, efficacious ingestibles.1

Beauty Supplement Regulation

Although beauty and wellness supplements are intended to address specific aesthetic concerns or improve overall wellness, except where they are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease, they are not subject to the same requirements as over-the-counter drugs by the U.S. Food & Drug Administration (FDA). Nor are they regulated as “cosmetics” under the Federal Food, Drug, and Cosmetic Act (FDCA), which defines cosmetics as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body,” rather than orally ingested.

Instead, beauty and wellness supplements are regulated as “dietary supplements” by the Dietary Supplement Health and Education Act (DSHEA), which amended the FDCA in 1994. Under DSHEA, “dietary supplements” are defined as products intended to supplement the diet and that bear or contain certain ingredients like vitamins, minerals, herbs or other botanicals or amino acids. The FDCA further requires that companies ensure their products meet safety standards for dietary supplements, are not otherwise adulterated or misbranded, and have labels that, among other things, contain nutrition information in the form of a supplemental facts label, and a statement identifying the product as a “dietary supplement” or similar descriptive term (e.g., “herbal supplement” or “calcium supplement”).

Under current federal law, dietary supplements do not require premarket approval by FDA for safety and effectiveness, or labeling approval, before they are sold to the public. However, the FDA has authority to take action against any adulterated or misbranded dietary supplement after it reaches the market. There are also certain requirements related to Dietary Ingredients and New Dietary Ingredients, as well as requirements that all product ingredients be generally recognized as safe.

Additionally, the Federal Trade Commission, which also regulates dietary supplements, requires that claims about the benefits and safety of dietary supplements be truthful, not misleading, and supported by science. Finally, depending on where the products are manufacturer and/or sold, dietary supplements are subject to a range of state laws.

Related: [Editor's Picks] 6 Spa Ingestibles for Holistic Wellness Support

Know The Risks

Although beauty supplements have proved popular with consumers, there are legal risks associated with promoting and selling beauty supplements. In recent years, consumers have sued manufacturers of biotin and/or collagen supplements, alleging that the supplements falsely claimed to support healthy hair and skin, without providing any demonstrable health benefits. Similarly, in a class action complaint filed in New York state court earlier this year, consumers alleged that the manufacturer of hair growth supplements falsely claimed that the products were “clinically proven” to increase the rate of hair growth and “physician formulated,” despite a lack of scientific evidence. A similar complaint was filed against the product’s retailer, which held exclusive distribution rights, in California state court on August 22, 2023.

In addition to lawsuits directed specifically at beauty and wellness supplement manufacturers, beauty companies in general have come under increasing fire with lawsuits, fueled in part by the rise of TikTok and other social media platforms. These lawsuits alleged that products marketed as “clean” or “natural” are misleading under state consumer protection statutes when, in fact, they contain synthetic chemicals, or ingredients that are otherwise inconsistent with how reasonable consumers interpret these terms.

Finally, in addition to costly litigation, there is the risk of regulatory enforcement against companies that make over-broad or unsubstantiated promotional claims. Both the FDA and FTC have issued warning letters to beauty manufacturers for “drug” claims, as well as over-broad or unsubstantiated claims, like promising to stimulate hair growth, reduce wrinkles, prevent aging and repair skin damage. Misleading or confusing advertising claims also could result in investigations or claims by state attorneys general.

The Need to Know

Companies should be aware of the potential for liability for promoting beauty and wellness supplements as “clinically proven,” “chemical-free,” “all natural,” or “scientifically formulated” (See Supplement Language Guide Sidebar).

While the overall risk of federal regulatory enforcement, absent a “drug” claim is low, government regulators will scrutinize “all or nothing” claims (e.g. “100% natural”) or easily verifiable claims (e.g. “certified” or “clinically proven”). Meanwhile, the risk for private litigation remains.

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.

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