Welcome back to this month’s edition of Legal Lens, where we explore all things legal and regulatory affecting the personal care products industry.
Last month, we kicked off a series of articles doing a deep dive into wellness claims–what wellness means, in all its form; how wellness came to dominate the way we talk about mental, physical, spiritual, and stylistic health, and how the exponential growth of the wellness industry has outpaced clear regulatory definitions and guidelines.
This month, we’ll be tackling one of the more sensitive aspects of the wellness industry: intimate wellness.
Mom, just stop reading now.
The global market for intimate wellness products was estimated at $83.6B in 2023 and is projected to reach an estimated $115.1B by 2030, growing at an expected rate of 4.7%, according to recent market research reports.
Once hinted, or the topic of Cosmo headlines or awkward conversations with your mom while you were just trying to play with your one non-headless Barbie¹, post-Covid, the concept of intimate wellness has crossed well over into mainstream retail with headlining collaborations with major fashion and beauty retailers, and is expanding concepts of self-care for Gen Z consumers who are simultaneously more inclusive and willing to explore individual concepts of pleasure, while at the same time more discerning, and more likely to seek a curated and individualized experience.
With consumers increasingly focused on expanded definitions of self-care, the demand for intimate wellness products is only expected to grow. But, as always, there are legal risks surrounding what brands can claim or promise, and in particular, what brands can advertise when it comes to mentioning the unmentionables.
What is intimate wellness?
Intimate wellness is a broad term that encompasses everything from personal care products such as oils and exfoliants and personal hygiene products to smart vibrators and various toys to products intended to strengthen the pelvic floor and provide support to uterine, bladder, and bowel functions.
This can also include hormone-free dietary supplements or transdermal patches intended to enhance libido and promote vaginal health, lubricants to counter skin irritation and enhance sensual pleasure, to downloadable apps that address everything from low libido to tracking fertility or exploring more inclusive and individualized concepts of sexual desire, to encompassing holistic approaches to gynecological health and treating sexual discomfort.
How are intimate wellness claims regulated?
Intimate wellness products, like other personal care products, can be regulated in a few different ways.
The US Food and Drug Administration, which is tasked by the federal Food, Drug, and Cosmetics Act of 1938 with regulating cosmetics, drugs, and medical devices intended for sale in the United States, does not separately define intimate wellness products as a regulatory category.
Instead, the FDA regulates products based on their intended use.
For example:
- Cosmetics are defined as articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body … for the purposes of cleansing, beautifying, promoting attractiveness, or altering the appearance.
- Drugs, on the other hand, are defined as articles intended for therapeutic purpose, such as treating or preventing disease, or affecting the structure or function of the body.
- Medical devices are considered any instrument, implement, machine, or article … intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or any function of the body… and which does not achieve its primary intended purposes through chemical action within or on the body … and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
The FDA also regulates both finished dietary supplements and dietary ingredients and, as with cosmetics, drugs, and medical devices, has the power to take action against any adulterated or misbranded dietary supplements sold in the United States.
Products encounter varying levels of regulatory scrutiny depending on whether they are considered cosmetics, drugs, medical devices, or dietary supplements, and each impose varying obligations on manufacturers, packers, and distributors.
So what does this mean?
The FDA does not have a list of accepted claims for intimate wellness products or criteria on how much support brands need to make certain claims, such as scientific studies, customer surveys, or third-party certifications. However, there are limits to what manufacturers can claim on product labels.
The Fair Packaging and Labeling Act requires that various forms of product labeling must be truthful and not misleading and disclose all ingredients. Products that are required to comply and fail to comply with the FPLA are considered misbranded under the FDCA and can result in enforcement action by the FDA.
The Federal Trade Commission, which regulates product 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 and material to their purchasing decisions.
The United States Consumer Product Safety Commission (CPSC), which is an independent agency of the US government that oversees the safety of consumer products, maintains consumer product safety standards, including intimate wellness devices and toys.
Finally, depending on where the products are manufactured and/or sold, ingredients are subject to a range of state laws. Products also may be subject to various advertising rules or social media requirements that may restrict the promotion of so-called “adult products or themes,” depending on the language of the rule or data privacy laws—particularly with respect to confidential health, biometric, or fertility information.
What are the risks associated with intimate wellness claims?
Although intimate wellness products and treatments have proved popular with consumers, companies have faced legal scrutiny for allegedly deceptive or misleading claims with respect to products marketed as “all-natural,” “non-toxic,” “safe,” or pure.”
In recent years, a number of private lawsuits have been brought by consumers, disputing claims that products are “clean,” “natural,” or “nontoxic.” Instead, these complaints allege that the products contain synthetic ingredients or ingredients allegedly linked to human health concerns like reproductive issues or, in certain cases, cancer.
Alternatively, 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.
In addition to the risks posed by costly litigation, overbroad or unsubstantiated efficacy claims may incur regulatory scrutiny. Both the FDA and FTC have issued warning letters to consumer product manufacturers for “drug” claims, claiming that the product is intended to treat various medical conditions or affect the structure and function of the body, as well as overbroad or unsubstantiated claims that lack sufficient evidence that the products act as intended.
Misleading or confusing advertising claims also could result in investigations or claims by state attorneys general.
Brands should also be aware of potential data privacy risks, particularly in states like California, and the potential for serious penalties for the inadvertent collection and disclosure of confidential health information.
Finally, brands should be aware that as consumers under the age of 13 (“Gen Alpha” or “tweens”) increasingly embrace wellness content on social media, and, depending on where the brand promotes its products, may encounter regulations aimed at restricting the dissemination or promotion of “adult” content to under-age users.
Brands should also be aware that these restrictions may vary significantly depending on the state, and may be subject to change in the upcoming years.
So what are the takeaways?
As always, brands should be aware of the potential for liability when promoting intimate wellness products and treatments.
This particularly applies to claims that emphasize cleanliness, purity, or the inclusion of “all natural” ingredients, or that advertise on social media, and need to be aware of potential content restrictions.
How certain words are perceived—or in this case, misperceived—can be almost as costly as what brands intend them to mean.
Wherever possible, companies should:
- Exercise caution when making claims that promise to fundamentally alter or affect gynecological or mental health conditions, or clinically improve fertility.
- Substantiate claims that a product is intended to support or maintain bodily functions.
- Identify what, if any, consumer data is being collected, and determine whether the data is confidential or relates to medical conditions or reproductive issues. Consider consulting attorneys who specialize in data privacy or healthcare to determine whether any intimate wellness products collect or maintain this data.
- Stay current with relevant state and federal legislation, as well as federal guidance concerning marketing claims, particularly with respect to what can be marketed to teenagers or upcoming ingredient bans.
- Ensure consistency of claims and language to ensure any product claims are truthful, not misleading, and adequately substantiated; and
- Think critically about all advertising and labeling claims and consider what is being communicated to which consumers and in which states—particularly if those consumers may be under 18.
- Provide clear guidance to influencers about what can and cannot be said about products on social media, and ensure that any paid sponsorships are appropriately disclosed.
- 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.
¹This actually happened. It was as bad as you think.
