What regulatory actions has the FDA taken against deceptive dietary supplement marketing in the last five years?
Executive summary
In the past five years the FDA has primarily used letters to industry, public warnings coordinated with the Federal Trade Commission (FTC), and rulemaking/guidance activity to push back on deceptive dietary‑supplement marketing, while leaving much of direct advertising enforcement to the FTC; the agency has also signaled regulatory changes to labeling requirements such as the DSHEA disclaimer and moved forward on New Dietary Ingredient (NDI) procedures and related rulemaking that affect what can be marketed as a supplement [1] [2] [3] [4] [5].
1. Warning letters and joint FDA–FTC public actions against illegal or deceptive products
The FDA has publicly warned companies—and in coordinated actions with the FTC—about illegal, unapproved, and deceptively marketed products, including a recent joint FDA–FTC warning targeting firms selling unapproved opioid‑cessation supplements that make unlawful health claims, demonstrating that the agency still uses public enforcement communications to deter dangerous or deceptive claims [1].
2. Letters to industry and reconsideration of the DSHEA disclaimer requirement
The agency has issued formal letters to the dietary‑supplement industry about labeling compliance and explicitly opened the door to amending the DSHEA disclaimer requirement—announcing it is considering a regulatory amendment to reduce where the disclaimer must appear on product panels—an administrative action aimed at clarifying labeling obligations that also affects how claims are presented and perceived by consumers [2] [6] [7].
3. Rulemaking and regulatory agenda that reshape what may be marketed
Through its Unified Regulatory Agenda and forthcoming rules, the FDA has signaled plans to publish proposed rules on ingredients and definitions that determine whether particular substances can lawfully be sold as supplements; although specifics remain pending, such rulemaking changes have direct consequences for marketing claims because they clarify whether products qualify as dietary supplements under the FD&C Act and therefore what claims require premarket review or are prohibited [4].
4. Guidance and procedural clarifications affecting enforcement posture (NDI process and labeling guidance)
The FDA has finalized and updated guidance related to the New Dietary Ingredient notification process and other labeling practices—moves that tighten the administrative process for bringing new ingredients to market and give the agency clearer bases to declare products adulterated or misbranded when manufacturers fail to comply, thereby creating documentary and procedural grounds for later enforcement against deceptive presentations [3].
5. Deference to FTC on advertising enforcement, but active coordination where public health risks arise
Statutorily and in practice the FTC retains primary authority over advertising and “truth in advertising,” yet FDA repeatedly coordinates with the FTC on enforcement when supplements make health or disease claims or present safety risks; agency statements and industry analyses make clear that both agencies treat influencer and social‑media content as within enforcement scope, increasing regulatory pressure on how efficacy or health benefits are marketed online [8] [5].
6. Legal and practical limits of FDA action—and plaintiffs’ use of FDA docs in private suits
Congressional and legal analyses show FDA lacks a premarket approval regime for most supplement efficacy claims and that courts sometimes treat FDA standards as background rather than dispositive, which limits direct FDA suppression of certain commercial speech; nonetheless, FDA warning letters, guidance, and classification decisions have been used by plaintiffs in private class actions alleging deceptive labeling, meaning FDA administrative steps can indirectly fuel litigation even when full regulatory remedies are constrained [9] [10].
7. Competing agendas and the enforcement landscape going forward
Industry and trade groups push for clarifying and often narrower FDA controls (for example, easing the DSHEA disclaimer to reduce “label clutter”), while consumer‑protection advocates and courts press for stronger policing of implied health claims and influencer marketing; law‑firm and industry analyses predict continued FDA–FTC coordination and litigation risk around influencer content, origin and “clean” claims, and ingredient classification as the agencies refine guidance and rulemaking through 2026 [7] [5] [4].
Limitations: reporting reviewed here documents FDA letters, guidance, coordination with the FTC, and regulatory agenda items, but does not provide a comprehensive docket of every FDA enforcement action in the last five years; specific enforcement counts, individual warning‑letter texts, and case outcomes fall outside the available sources and were not asserted here [1] [2] [3] [4].