Commercial Litigation Update

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.

Do plaintiffs’ attorneys smell blood in the water? A raft of class-action suits recently initiated against dietary supplement manufacturers, alleging deceptive practices in the sale of fish oil products, suggests that they might.

These suits, filed in California federal courts (a favorite jurisdiction for the plaintiffs’ bar), are nearly identical in that they allege that the manufacturers’ fish oil products do not actually contain fish oil. To date, plaintiffs’ class action lawyers have already targeted well-known dietary supplement products, such as Dr. Tobias ...