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.

As the dietary supplement industry continues to draw attention from Congress, state attorneys general, and class action lawyers, now comes another state law trying to prohibit the sale of over-the-counter (“OTC”) dietary supplements that target weight loss and muscle building to minors – this time, in New Jersey.

On October 28, 2024, by a majority vote of 56 to 17, with four abstentions, the New Jersey General Assembly passed Assembly Bill No. 1848, which, if it goes into effect, will prohibit the sale or delivery of OTC diet pills, weight loss, and muscle building supplements to minors, unless the minor is accompanied by a parent or guardian. Bill No 1848 is an exemplar of efforts intended to combat the misuse and abuse of these products and the potential causal relationship between these dietary supplements and eating disorders. Violators, including employees of retail establishments, may face a civil penalty of not more than $750.

The legislation sets forth that:

“no person, firm, corporation, partnership, association, limited liability company, or other entity shall sell, offer to sell, or offer for promotional purposes, either directly or indirectly by an agent or an employee, any over-the-counter diet pull or dietary supplement for weight loss or muscle building to a minor under 18 years of age, unless the minor is accompanied by a parent or guardian.”

Epstein Becker Green Lawyers Anthony Argiropoulos, Theodora McCormick, William Gibson, and Maximilian Cadmus Argue for Amicus Curiae New Jersey Doctor-Patient Alliance

On August 25, 2022, the New Jersey Supreme Court issued on an important decision in Mirian Rivera v. The Valley Hospital, Inc., (A-25/26/27-21)(085992)(085993)(085994), reaffirming the exceedingly high bar for punitive damages claims in medical malpractice cases in New Jersey. This is an important decision for healthcare providers as it provides them with broad protection from punitive damages claims (which are not covered by malpractice insurance) that are really negligence or gross negligence claims in disguise.

Creative and aggressive plaintiffs’ lawyers are forever on the hunt for new theories under which to bring potentially lucrative class action lawsuits utilizing plaintiff-friendly state consumer protection statutes (with California being the most favored forum). The dietary supplement industry has been in the plaintiffs bar’s cross-hairs for more than a decade now. As the case law has evolved and developed, supplement companies have had notable success fighting these suits. Just last week, Judge Miller in the Southern District of California tossed a proposed class action ...