Health Law Advisor

The Trump Administration continues to pursue a policy of AI dominance, which began with its January 23, 2025 executive order to remove “barriers” to Artificial Intelligence (“AI”) innovation to promote “human flourishing, economic competitiveness and national security.” On December 11, 2025, the Administration issued another executive order announcing a policy to remove state law impediments to adopting a “minimally burdensome national standard” for AI development and use.

On December 11, 2025, the U.S. Food and Drug Administration (“FDA”) announced in a letter to the dietary supplement industry that it is actively considering requests to amend its dietary supplement labeling regulation at 21 C.F.R. § 101.93(d), which governs placement of the disclaimer required for structure/function claims under the Dietary Supplement Health and Education Act of 1994 (“DSHEA”).

The regulation currently requires the DSHEA disclaimer—which states that the product has not been evaluated by FDA and is not intended to diagnose, treat, cure, or prevent disease—to appear on each panel of a product label where a qualifying structure/function claim is made.

Based on its initial review, FDA indicated that removing the “each panel” requirement would be consistent with the DSHEA, could reduce label clutter and unnecessary costs, and would align with the agency’s historical enforcement posture, noting that the requirement has rarely, if ever, been enforced. FDA further stated that, absent significant concerns, it is likely to propose formal rulemaking to amend the regulation.

The U.S. Court of Appeals for the First Circuit recently provided important clarity—and welcome relief—for clinical laboratories facing False Claims Act (“FCA”) allegations based on a lack of medical necessity for processing tests ordered by a physician. In a case of first impression, United States ex rel. OMNI Healthcare, Inc. v. MD Spine Solutions LLC,[1] the First Circuit held that clinical laboratories may rely on an ordering physician’s determination that lab tests billed to Medicare are medically necessary. The First Circuit held that laboratories need not second-guess a physician’s certification absent red flags or suspected improper conduct. While the First Circuit’s decision does not relieve clinical laboratories of their existing obligation under the FCA to ensure they are not submitting a false claim to government payors, it provides much-needed clarity for clinical laboratories across the country on what constitutes the knowing submission of false claims to the government and highlights several practical takeaways for managing compliance risk.