Megan Robertson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Diagnostics World News, in "Trendspotting: Precision Diagnostics, Artificial Intelligence, Data Management, Collection."
Following is an excerpt:
FDA scrutiny of marketing claims, particularly challenges to the line between general wellness claims and clinical claims, will continue (and possibly increase) into 2026: In 2025, we saw an uptick of FDA enforcement activity targeting products’ intended uses based on statements on the companies’ websites and social media platforms, including not only public Warning Letters but also more private direct inquiries. In the device and diagnostics space, this enforcement largely hit companies marketing mobile applications and testing kits for lifestyle and wellness-related purposes. Similarly, many dietary supplement businesses fielded questions from FDA as to whether their promotional activity crossed the regulatory line into drug claims. The promulgation and wide adoption of digital marketing, coupled with the social pressures to promote accessible general wellness practices to the public, promises to draw more attention from FDA in its efforts to ensure these products are in line with its safety and effectiveness pillars.
