No Immunity: Why Wellness and Longevity Brands Can Get Sued Before the FDA Ever Calls

• Wellness is big business. The FDA says the supplement market is worth more than $60 billion, with as many as 100,000 products. About 3 in 4 Americans take a supplement.

• Longevity is the next frontier. Shoppers want more than feeling good today. They want to add healthy years to their lives, also called “healthspan.” That goal is driving demand for supplements, test kits, wearables, and telehealth programs built around healthy aging.

• More wellness and longevity brands want in. Companies that already sell test kits, run telehealth platforms, or offer other wellness products are adding supplements to their lineups. Investors are watching closely, too.

• A new case to watch. On September 25, a New York shopper filed a proposed class action against Vive Organic, Inc., a Sacramento-based maker of wellness shots (Briceno v. Vive Organic, Inc., S.D.N.Y.). The suit says labels like “Immunity Boost” and “Doctor Crafted” promised more than the science shows. The case is new, and the claims are unproven.

• The lesson: Lawsuits can arise without FDA involvement. Consumer class action lawyers may scrutinize product labels through a lens similar to that used by regulators, and sometimes with even greater scrutiny.

• Why lawsuits can move first: The FDA mostly steps in after a product is already for sale. In fact, most supplements can be launch without the FDA even knowing. That leaves room for private lawsuits to get there first.

• It is not just supplements. The same is true for other wellness and longevity products the FDA oversees. You do not need an FDA Warning Letter to get sued. Recent class actions have targeted claims about weight loss, brain support, immunity, and nutrition — with no FDA action first.

• The FDA starts with your promise. It looks at the overall message your label, website, ads, and images send about what your product will do.

• Mostof its work happens after launch. Many wellness products reach shelves without FDA sign-off. The FDA then checks labels and websites for claims that go too far.

• Hints count, not just words. The FDA says a product name or picture can make a claim on its own.

• The claims question: is there adequate support? The FDA expects “competent and reliable scientific evidence” for applicable claims, and disclaimers may not resolve concerns surrounding an otherwise unsupported claim. Consumer lawyers ask the same questions. Under state false-advertising laws, they ask “would an ordinary consumer likely be deceived by the messaging on your product label? Does the science support your advertising about the product?” Claims that potentially lack support are a common target for class action lawsuits seeking millions of dollars in alleged damages.

• Why the overlap? Plaintiffs’ lawyers borrow the regulator’s playbook. They point to FDA rules, public health sources, and perceived gaps in a company’s evidence. So, they don’t need to wait for the FDA to act.

• Switching categories? Supplements, test kits, and telehealth services each have their own FDA rules. The regulatory treatment of claims can differ across supplements, test kits, and telehealth services. 

The overlap: Because regulators and plaintiffs’ lawyers may examine many of the same issues, claim substantiation can play an important role in both regulatory compliance and consumer litigation risk.

Five Areas That Can Draw Scrutiny

1. Labels, packaging, and websites. Words and images across product materials may contribute to the overall message conveyed about a product, including whether that messaging suggests disease-related benefits.

2. Support for product claims. Terms such as “boost,” “clinically supported,” or “research backed” can raise questions about the scientific evidence supporting those representations.

3. Expert branding. Statements such as “doctor crafted” may create expectations about physician involvement and the role those professionals played in developing a product.

4. The broader marketing package. Product names, images, website copy, social media, and influencer statements can all contribute to the claims consumers take away from a product.

5. Regulatory and litigation exposure. Product claims can raise distinct issues under FDA requirements and consumer protection laws, making the same marketing language relevant in both regulatory and private litigation contexts.

The wellness and longevity market is full of possibility. As the wellness and longevity market continues to expand, product claims and the science supporting them are likely to remain an important area of regulatory and litigation scrutiny. ArentFox Schiff’s Food, Drug, Medical Device & Cosmetic group and consumer class action teams monitor developments affecting wellness and longevity brands across the product life cycle. For questions about these issues, contact the authors.