Welcome to this month’s edition of Legal Lens. Here we explore all of the legal and regulations that impact the personal care product industry.
Last month we kicked off a series of articles that delve deep into wellness claims. What does it mean in all of that form? How have we come to dominate the way we talk about mental, physical, mental and stylistic health and how exponential growth in the wellness industry surpasses clear regulatory definitions and guidelines?
This month we’ll be working on one more thing Sensitive Aspects of the wellness industry: intimate wellness.
Mom, stop reading now.
A recent market research report shows that the global market for intimate wellness products is estimated at $83.6 billion in 2023, reaching an estimated $115.1 billion by 2030, with a growth rate of 4.7%.
Once suggested, or topics of a nasty conversation with Cosmo headlines and moms, while you are about to play after your headless Barbie, Covid, and after Covid, the concept of intimate health has become mainstream retail along with major collaborations with major fashion and beauty retailers. At the same time, you are more likely to seek a more discernible, curated, individualized experience.
As consumers are increasingly focused on the expanded definition of self-care, demand for intimate wellness products is only expected to grow. But as always, there is a legal risk surrounding what a brand can claim or promise, especially what a brand can promote when referring to its mentation potential.
What is intimate health?
Intimate wellness is a broad term that covers everything from personal care products such as oils, exfoliants and personal hygiene products to a variety of toys and various toys for products intended to strengthen the pelvic floor and support the function of the uterus, bladder and intestines.
This can also include hormone-free dietary supplements or transdermal patches that are intended to enhance libido, enhance vaginal health, promote lubrication, counteract skin irritation, and enhance sensual pleasure.
How are intimate wellness claims regulated?
Intimate wellness products can be regulated in several different ways, like other personal care products.
The US Food and Drug Administration, appointed by the Federal Food, Drug and Cosmetics Act of 1938, which regulates cosmetics, drugs and medical devices intended for sale in the United States, does not define intimate wellness products separately as regulatory categories.
Instead, the FDA regulates products based on their intended use.
for example:
- Cosmetics are defined as articles intended to be washed, poured, sprayed, or sprayed, introduced or otherwise applied to the human body… for the purpose of purifying, glorifying, promoting appeal, or changing the appearance.
- On the other hand, drugs are defined as articles intended for therapeutic purposes, such as treating and preventing diseases, affecting body structure and function.
- Medical devices are considered devices, implementations, machines, or articles intended for use in the diagnosis, mitigation, treatment, or prevention of diseases or other conditions, with the aim of treating, mitigating, treating, or preventing diseases or other conditions, or for use in the diagnosis, mitigation, treatment, or prevention of diseases or other conditions, which are intended to affect the structure or function of the body.
The FDA also has the power to regulate both finished dietary supplements and nutritional content, and take action against fraudulent or false branded dietary supplements sold in the United States, as well as cosmetics, drugs and medical devices.
Products encounter different levels of regulatory scrutiny depending on whether they are considered cosmetics, drugs, medical devices, or dietary supplements, each of which places different 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 standards for support brands that require the support brands needed to make a particular claim, such as scientific research, customer research, and third-party certification. However, there are limits to what manufacturers can claim on product labels.
With fair packaging and labeling methods, various forms of product labeling are true and requires that all ingredients be misleading and not disclosing them. Products that comply with and do not comply with the FPLA are deemed to be misbranded under the FDCA and may take enforcement action by the FDA.
The Federal Trade Commission, which regulates product advertising under the FTC Act, may also take action against a brand and prohibits what it perceives as unfair practices or false advertising that are likely to mislead reasonable consumers and materials into a purchasing decision.
The U.S. Consumer Product Safety Commission (CPSC), an independent US government agency that oversees the safety of consumer products, maintains safety standards for consumer products, including intimate wellness devices and toys.
Finally, materials are subject to various state laws, depending on where the product is manufactured and/or sold. Products may also be subject to a variety of advertising rules or social media requirements that may limit the promotion of so-called “adult products or themes” depending on the language of the regulations or data privacy laws. This is especially true regarding confidential health, biometrics, or fertile information.
What are the risks associated with intimate wellness claims?
While intimate wellness products and treatments have proven popular with consumers, businesses face legal surveillance for deceptive or misleading claims about products sold as “all natural”, “non-toxic”, “safe”, or pure.
In recent years, many private lawsuits have been filed by consumers, challenging claims that products are “clean”, “natural” or “non-toxic.” Instead, these complaints argue that the product contains synthetic ingredients or ingredients that are allegedly related to human health concerns, such as reproductive issues and, in certain cases, cancer.
Alternatively, they claim that because the product contains synthetic ingredients, the “clean” or “natural” label on the product is false and/or misleading, and they are led to purchase products that they would not have purchased at a price they would otherwise not have paid.
In addition to the risks posed by costly litigation, overloading or unfounded validity claims may be subject to regulatory scrutiny. Both the FDA and the FTC issued warning letters to consumer product manufacturers for “drug” claims, claiming that the product is intended to treat a variety of medical conditions and affect the structure and function of the body.
Misleading or confusing advertising claims could result in an investigation or claim by the State Attorney General.
Brands should also recognize potential data privacy risks, and the potential for serious penalties for careless collection and disclosure of confidential health information, especially in states like California.
Finally, brands need to recognize that consumers under the age of 13 (“Gen Alpha” or “Tweens”) are increasingly accepting wellness content on social media, and they may encounter regulations aimed at limiting the spread or promotion of “adult” content to minors, depending on where the brand promotes its products.
Brands should also recognize that these restrictions may vary widely from state to state and may change over the next few years.
So, what is the takeaway?
As always, brands need to recognize the potential responsibility in promoting intimate wellness products and treatments.
This applies in particular to the claim that it should include cleanliness, purity, or “all natural” ingredients or promote it on social media and be aware of any potential content limitations.
How a particular word is perceived or in this case it is misunderstood – it can cost as much as the brand intends.
Whenever possible, businesses should:
- Be careful when making claims that promise to fundamentally alter or affect gynecological or mental health status or improve clinical fertility.
- Demonstrate the claim that the product is intended to support or maintain physical function.
- Identify what consumer data is being collected and determine whether the data is confidential or related to a medical condition or reproductive problem. Consider consulting with a data privacy or healthcare lawyer to determine whether an intimate wellness product will collect or maintain this data.
- Stay up to date with relevant state and federal laws and federal guidance on marketing claims, particularly regarding what can be sold for teenagers and future ingredient bans.
- Ensures consistency of claims and language to ensure that product claims are properly demonstrated rather than misleading. and
- Think critically about all advertising and labeling claims and consider which states are communicated with consumers, especially whether those consumers may be under the age of 18.
- Provides clear guidance to influencers about what you can’t say about your products on social media, ensuring that paid sponsorships are properly disclosed.
- Consider asking your regulatory lawyer to review product labeling, advertising and promotional materials (including web ads and social media).
Questions or suggestions? Please contact Kelly at kabonner@duanemorris.com.
¹This actually happened. That was as bad as you might think.
