Welcome to 2025! The holidays are over, the Legos are everywhere, and I’ve succumbed to a particularly virulent strain of Toddler Plague, which means you’re dying and unable to move, but you’re a mom, so you still have do everything you usually do, to and also not make that face like you’re auditioning for Nosferatu II.
Yep. That one.
In honor of January and the flu and the general …. [gestures broadly] -ish of it all, this month’s column is focused on wellness: The thing your most annoying friend hasn’t shut up about this month besides Dry January and that one time she went to St. Barth’s.
Wellness is a word that gets thrown around a lot, especially in recent years, and it’s one of those concepts where—much like the term “quiet luxury”—you’re not really sure what’s going on, but the vibes are great?
Wellness can encompass everything from meditation to yoga to facial massage tools to expensive stretchy pants, and products that promise glowing skin, gut health, body recovery, mood elevation, and holistic wellbeing are surging in popularity among consumers, particularly Gen Z consumers.
But turning to the cosmetics space, what kind of claims can products make with respect to promoting or enhancing wellness?
What do we talk about when we talk about wellness?
Setting aside what wellness means to you personally,¹ wellness means business. Big business, in fact.
The global wellness market is worth an estimated $1.5 trillion, with an expected 5-10% annual growth, and encompasses not just skin creams or supplements but each aspect of physical and mental health and fitness.
Practically speaking, this market includes products designed to improve personal health, like fitness and sleep trackers, fertility-boosting powers, sleep-enhancing pillow sprays stress-reducing essential oils, nutrition apps, skin care supplements, and meditation-oriented apps.
But taking a broader view, wellness and its distinct vocabulary (words like “clean, “organic,” natural,” “rejuvenate,” “harmonize,” “nontoxic,” and my personal favorite, “detox”) increasingly shapes the way consumers perceive products, rendering the act of consumption less about whether you want something and more about, will this product help you be a “better” version of yourself?
And what product can credibly claim to help you become a “better” version of yourself (read: a healthier, more mindful, more successful, more beautiful, and thinner version of yourself)?
How are wellness products regulated?
Because wellness is such a broad business, products designed to enhance or promote wellness may be regulated under varying levels of scrutiny.
The federal Food, Drug, and Cosmetic Act (FDCA) gives the US Food & Drug Administration (FDA) the authority to regulate the safety of food, drugs, medical devices, and cosmetics and protect the public from adulterated or misbranded products.
But whether a product is defined as food, drug, medical device, cosmetic, or something else, isn’t always easy to ascertain. The product’s intended use determines whether a product falls into a certain regulated category under the FDCA.
Now, we’ve talked a bit about how FDA defines cosmetics (“articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleaning, beautifying, promoting attractiveness, or altering the appearance” of the body). Among the products included in this definition are skin moisturizers, perfumes, lipsticks, cleansing shampoos, hair dyes, deodorants, and any substance intended for use as an ingredient in a cosmetic product.
Notably, MoCRA (discussed here) amended the FDCA to include a “cosmetic product,” which is defined as “a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product,” and applies to MoCRA’s amendments to the FDCA.
But FDA also has the authority to regulate drugs and medical devices:
- The FDCA defines a drug as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease,” and “articles (other than food) intended to affect the structure or any function of the body.”
- A product may be considered a medical device if it is “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagant, or other similar or related article, including any component, part, or accessory, which is … intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals,” or “intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man … and which is not dependent upon being metabolized for the achievement of its primary intended purposes.”
Determining a product’s intended use is the first step to determining what level of regulatory scrutiny FDA will impose and what federal laws and regulations govern a product.
FDA will determine a product’s intended use in several ways, including:
- Claims stated in product labeling, advertising, or other promotional materials;
- Consumer perception, which may be established by a product’s reputation in the marketplace; and
- Ingredients that cause a product to be considered a drug because they have a well-known therapeutic use.
Simple, right? No, not really.
FDA may consider certain products to be both cosmetics and drugs, meaning that they have more than one intended use (to beautify AND prevent disease or affect the structure and function of the body) and must comply with federal law governing both cosmetics and drugs.
This includes products like whitening toothpastes containing fluoride, antiperspirant deodorants, moisturizers, and cosmetics containing SPF or intended to treat acne.
As for devices, FDA has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 different specialties, or “panels.”
Each generic type of device is assigned to one of three regulatory classes based on the level of scrutiny needed to assure the safety and effectiveness of the device.
For example:
- A Class 1 device, which FDA considers to be the lowest potential risk to others, requires registration and listing with FDA, as well as proper labeling and compliance with regulatory controls.
- A Class II device, which FDA considers as posing a slightly higher risk or complexity than Class I devices, are subject to performance standards and labeling requirements. For non-exempt Class I and Class II devices for which a premarket approval application (PMA) is not required, companies must submit a 510(k) – a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device.
- A Class III device, which FDA considers the most complex devices with the highest risk to users, requires pre-market approval, and is subject to performance, testing, and accuracy regulations, as well as labeling requirements.
FDA also maintains guidance on low-risk products that promote a healthy lifestyle (general wellness products), which does not apply to products regulated by FDA as drugs, biologics, dietary supplements, foods, cosmetics, or combination products.
General wellness products are defined as products that:
(1) are intended for only general wellness use, as defined by FDA’s Guidance; and
(2) present a low risk to the safety of users and other persons.
A “general wellness use,” for purpose of the Guidance, is defined as “(1) an intended use that relates to maintaining or encouraging a general state of health or a healthy activity or (2) an intended use that relates to the role of a healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or conditions.”
General wellness claims may include:
- Claims to promote or maintain a healthy weight;
- Claims to promote relaxation or manage stress;
- Claims to improve mental acuity or focus;
- Claims to promote sleep management;
- Claims to physical fitness.
Some examples that FDA provides of general wellness products are exercise equipment, audio recordings, video games, software programs, and other products commonly available through retailers.
However, FDA will not consider a product to be a general wellness device if it makes specific claims to treat or diagnose diseases like anxiety disorders, eating disorders, or obesity.
So it’s important to know what kind of product you’re talking about when you’re talking about wellness products and to be aware of applicable FDA guidance for each product.
What about supplements?
Beauty and wellness supplements, also known in retail parlance as “ingestible beauty” or “beauty-from-within,” 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, 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.
Who else besides FDA regulates wellness claims?
In addition to FDA, the Federal Trade Commission, which also regulates promotional claims regarding cosmetics, dietary supplements, and, in some cases, medical devices, requires that claims about the benefits and safety of dietary supplements be truthful, not misleading, and supported by science.
The United States Consumer Product Safety Commission (CPSC) is an independent agency of the US government that oversees the safety of consumer products and maintains consumer product safety standards, including consumer wellness devices.
Finally, depending on where the products are manufactured and/or sold, wellness products may be subject to a range of state laws, including potential ingredient bans.
What are the risks associated with promoting wellness products?
Although wellness has proved popular with consumers, there are legal risks associated with promoting and selling products that claim to enhance or promote wellness.
For example, in recent years, consumers have sued supplements manufacturers, alleging that the supplements falsely claimed to support healthy hair and skin without providing any demonstrable health benefits or scientific evidence.
Similarly, consumers have sued skin care brands over claims that they were misled by the prominence of certain ingredients, i.e., collagen—a popular skin care ingredient—in products’ anti-aging promotional claims because the size of the product’s collagen molecules made them too large to penetrate the skin barrier, and thus, the product did not work the way consumers expected.
Additionally, beauty companies have continued to face scrutiny over claims that products marketed as “clean” or “natural” are misleading under state consumer protection statutes when, in fact, the products contain synthetic chemicals, water-based contaminants, or ingredients that are otherwise inconsistent with how reasonable consumers interpret these terms.
Finally, setting aside the risk of costly private litigation, there is the risk of regulatory enforcement against companies that make overbroad or unsubstantiated promotional claims.
Both the FDA and FTC have issued warning letters to manufacturers for “drug” claims, in which the product purports to affect the structure and function of the body or otherwise cure ailments, or overbroad or unsubstantiated claims, like promising to stimulate hair growth, reduce wrinkles, prevent aging, and repair skin damage.
Misleading or overbroad advertising claims could also result in investigations or claims by state attorneys general.
So, what are the takeaways?
This column is the start of a much longer conversation we’ll be having about wellness.
In the coming months, we’ll take a deeper dive into what claims have raised regulatory or legal scrutiny with respect to wellness, ranging from beauty supplements to med-aesthetic devices to fitness tracking to weight loss treatments to intimate wellness.
Nevertheless, companies should generally be aware of the potential for liability for promoting wellness products as “clinically proven,” “chemical-free,” “all natural,” or “scientifically formulated.”
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., “FDA-certified” or “scientifically proven”). Meanwhile, the risk of private litigation remains.
Wherever possible, companies should:
- Avoid making claims that products will repair, cure, or treat medical ailments or mental health concerns, or otherwise making “drug” claims. For example, promising to “promote hair growth” is a drug claim;
- Avoid making all-or nothing claims that a product is “all-natural,” “100% natural,” or “free from” any substance, especially where those substances can be found in water used to manufacture the product, or are present in the environment;
- Use caution in describing products as “clean,” “natural,” “conscious” or “healthy”. These terms are not defined by the FDA, and their precise contours are subject to ongoing litigation;
- Ensure that any specific promotional claims are supported by scientific evidence or studies;
- Stay current with relevant state and federal legislation, as well as federal guidance concerning marketing claims. For example, the FTC recently updated its “Green Guides” to help marketers avoid making environmental claims that mislead consumers, and requiring scientific substantiation for “non-toxic” claims;
- Ensure consistency of claims and language with marketers and influencers to ensure any product claims are truthful, not misleading, and adequately substantiated; and
- Consider asking regulatory counsel to review product labeling as well as advertising and promotional material (including web advertising and social media).
Questions or suggestions? Contact Kelly at kabonner@duanemorris.com.
¹ Full disclaimer – I am not exempt from the wellness economy. I am a full-fledged participant in the recovery soaks and the brightening serums and the immunity shots and the detox cleanses. As a reminder, this column is intended to be entertaining and educational. It is not peer-reviewed, should not be construed as legal or scientific guidance, does not purport to speak for any government regulatory agency, and offers no perspective on the clinical effectiveness of any products or practices described herein. I will say though, having someone else watch your kids so you can write this column … 10/10 stars.
