What FTC or FDA actions in the past five years targeted supplements marketed for nerve pain or cognition, and what refund outcomes followed?
Executive summary
In the last five years the Federal Trade Commission has repeatedly pursued companies marketing products — including dietary supplements and at least one nerve‑pain device — with unsupported claims about cognition and pain, extracting settlements and ordering consumer refunds; the FDA has participated mainly through warning letters and coordination under an interagency liaison, while issuing guidance to clarify marketing rules [1] [2] [3]. Refunds and consumer payments have ranged from the mid‑hundreds of thousands to multi‑million dollar recoveries, but distribution depends on court settlements and claims administration timelines [1] [4] [5].
1. FTC crackdowns on "cognitive improvement" supplement marketers — what happened and why
The FTC has publicly announced multiple enforcement actions against firms that advertised dietary supplements as reversing memory loss, preventing dementia or otherwise improving cognition without competent scientific evidence; for example, the agency reported mailing 27,174 refund checks totaling over $551,000 to buyers of deceptively marketed “cognitive improvement” supplements [1], and earlier actions returned more than $750,000 via 16,596 checks to consumers who purchased NeuroPlus and BioTherapex, supplements advertised with unsupported claims about Alzheimer’s, dementia and memory improvement [4]. The FTC’s broader posture — reflected in updated Health Products Compliance Guidance — stresses that health‑related advertising must be supported by competent and reliable scientific evidence and that the agency will treat misleading supplement claims as deceptive advertising subject to enforcement [3] [6].
2. Pain‑treatment claims: supplements, devices, and larger monetary recoveries
Enforcement work has not been limited to cognition: the FTC has targeted products marketed for pain relief and “healthy aging,” securing refunds and judgments against marketers of supplements purporting to treat pain and against makers of devices claiming clinical pain relief. The agency announced sending refund payments exceeding $1.1 million to consumers who bought three supplements deceptively marketed as pain or age‑related treatments [2] [7]. Separately, the FTC obtained large monetary redress in cases involving a nerve‑stimulation device — agreeing to at least $4 million and orders to stop deceptive claims for the Quell device, and in a related action announced refunds to NeuroMetrix (maker of Quell) consumers totaling nearly $3.9 million for false advertising about chronic pain relief [1] [5].
3. FDA’s role: warning letters, liaison with FTC, and limits of authority
The FDA’s visible posture in these matters has been to issue warning letters to companies selling unapproved products that make drug‑level claims and to work with the FTC under a formal liaison agreement that coordinates responsibilities — the FDA oversees labeling and product approval matters while the FTC focuses on advertising claims — but the liaison does not bar the FTC from acting on labeling claims in advertising contexts [1] [3]. The agencies’ coordination has strengthened enforcement reach: press releases note joint warning letters to seven companies, and the FTC guidance explains the two agencies’ complementary but distinct legal frameworks [1] [3].
4. Refund outcomes: scale, mechanisms, and practical limits
Refund results have varied by case: some FTC matters produced multiclass or mass mailings of checks (e.g., 16,596 checks >$750,000; 27,174 checks >$551,000), other cases produced lump‑sum recoveries payable through claims processes (more than $1.1 million in another pain/aging supplements matter), and device litigation produced the largest consumer redress with roughly $3.9–$4 million tied to Quell/NeuroMetrix [4] [1] [2] [5]. How much individual consumers receive depends on the settlement terms, number of claimants and administrative distribution; the FTC’s press notices specify totals and numbers of checks or anticipated mailings but individual payouts are set by claim administrators and case orders [1] [2] [4].
5. Caveats, gaps and what reporting does not show
Public releases and trade reporting document many FTC settlements and some joint FDA actions, but the available sources do not provide exhaustive lists of every enforcement action in the past five years nor detailed claim‑by‑claim payout amounts to individual consumers; furthermore, some coverage conflates devices with supplements even though legal treatment differs (FTC device settlements versus supplement advertising cases) and media summaries may emphasize headline dollar totals over procedural details [1] [5] [3]. The FTC’s Health Products Compliance Guidance and related press releases are the clearest public statements of strategy and outcomes, while the FDA’s actions appear more often as warning letters and coordination rather than stand‑alone refund orders in these materials [3] [1].