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“Longevity” has quickly emerged as one of the most influential trends across the beauty, wellness and fitness space, attracting significant consumer interest, investment and media attention. While the trend presents significant opportunities for brands, it also raises complex questions around FDA regulation, claim substantiation, product liability and investor diligence.
In this Q&A, FDA Regulatory partner Kristen Klesh shares her perspectives on the legal and business considerations of the longevity market and the challenges companies face as they balance innovation, consumer demand and regulatory compliance.
As longevity becomes a major consumer trend, what should companies understand about longevity-related claims?
The first challenge is defining what “longevity” actually means. Unlike traditional anti-aging claims, which generally focus on reducing or correcting visible signs of aging, longevity is increasingly being marketed as a broader concept tied to preventive wellness, healthspan and slowing the biological processes associated with aging to live a longer, healthier life. For some brands, longevity products are described as addressing the “root causes” of aging rather than merely treating its symptoms.
From a legal and business perspective, the critical question is how consumers perceive and understand those claims. Is a longevity claim simply a statement about looking or feeling better as consumers age? Or does overarching messaging imply that a product can meaningfully influence age-related health outcomes, biological aging or even lifespan? The answer matters because consumer interpretation often drives regulatory risk, substantiation requirements and potential exposure to false advertising claims or other legal risk that can be impactful to the reputation of the brand and whether consumers can trust their products say what they claim.
How does FDA regulation intersect with longevity-focused products?
The mere use of the term “longevity” does not determine how, if at all, FDA will regulate the product. Rather, the FDA regulatory analysis turns on the specific claims being made, and in what context, along with the particular functions of the product.
For beauty, wellness, dietary supplement, food and device companies, longevity messaging can become more problematic when it suggests—expressly or implicitly—that a product can be used to prevent, treat or mitigate a disease, including the delay of age-related conditions or alterations of biological aging processes. The more a claim resembles a disease treatment, prevention or therapeutic benefit, the more likely it is to attract regulatory scrutiny and lead FDA to believe the product should be regulated as a drug or medical device subject to rigorous oversight. For topical cosmetic products, if a longevity claim suggests that the product alters the body at the physiological or biological level, beyond a superficial effect, FDA is also more inclined to regulate the product as a drug.
Companies should also be thinking carefully about the safety framework supporting longevity products. Whether the product is a topical, ingestible, wearable or technology-driven wellness service, businesses should ensure they have conducted appropriate testing and developed sufficient support for both product safety and performance claims before launch. This is key from a product liability perspective, in addition to FDA considerations.
What scientific evidence is needed to support longevity marketing claims?
Unlike claims tied to short-term product performance or superficial changes in appearance, demonstrating an impact on longevity, healthspan or biological aging may require more rigorous scientific data, including human clinical study data to meet the FTC’s “competent and reliable scientific evidence” standard for health-related claims, and if applicable, potential FDA premarket authorization requirements. Yet the time and costs associated with robust scientific research can be a significant hurdle to growing companies in the longevity space.
As a result, companies may aim to rely on third-party literature arising from emerging science, biomarker research, cellular health studies and other developing areas of aging research. The question then becomes whether such data adequately supports (i.e., translates to) the specific claims being made about the company’s specific product. From an advertising perspective, companies are not only required to substantiate their express claims but also any reasonable implications that consumers may take away from the messaging.
This is particularly important given the continued rise of consumer class actions targeting false advertising in health, wellness and beauty claims, in addition to FDA and FTC scrutiny. “Longevity” may be a new marketing term, but the legal standards governing advertising and claim substantiation remain the same. To help reduce regulatory and litigation scrutiny, companies should ensure that all express and implied longevity-related claims are backed by adequate substantiation and also align with FDA labeling requirements for the product.
What risks should brands and investors be considering as the longevity market grows?
Longevity products or services face a broad range of legal and business risks. These include potential product liability exposure in the absence of robust safety data, consumer fraud and false advertising litigation, competitor challenges and, in some cases, questions regarding whether certain personalized health offerings resemble the “practice of medicine” subject to state-specific licensure requirements and restrictions on the corporate practice of medicine.
Investors should be paying close attention to these issues as capital continues to flow into longevity-focused startups and consumer brands. In addition to evaluating the underlying technology or scientific platform, diligence should include a careful review of claim substantiation, regulatory positioning, safety data, compliance processes and litigation risk. In an increasingly crowded marketplace, strong science and compelling marketing may help generate attention, but sustainable growth often depends on whether a company’s claims can withstand regulatory and legal scrutiny.
How can companies responsibly participate in the longevity trend?
The goal for most companies is less about avoiding the longevity conversation but to engage in it thoughtfully and strategically. It’s extremely important for businesses to engage legal teams well versed in the nuances of the beauty, health and wellness space early and throughout the life cycle of the development of the product or service to ensure the claims accurately reflect the available scientific evidence, establish appropriate safety support and account for how consumers are likely to interpret marketing messages geared toward aging and longevity.
As longevity continues to evolve from a scientific concept into a mainstream consumer category, companies that prioritize substantiation, transparency and compliance will likely be best positioned to capitalize on the opportunity while minimizing regulatory and litigation risk.
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Partner