How can consumers report adverse reactions or request recalls for dietary supplements sold online?
Executive summary
Consumers who experience adverse reactions to dietary supplements should stop using the product, seek medical care, and report the event to the FDA through the Safety Reporting Portal or MedWatch so regulators can track signals and potentially remove dangerous products from the market [1][2]. Manufacturers, packers, and distributors are legally required to forward serious adverse event reports to FDA and keep records, and while FDA can investigate and ask for voluntary recalls, it generally lacks premarket approval authority over supplements and relies on postmarket reporting and industry cooperation [3][4][5].
1. How to report an adverse reaction — first actions and the Safety Reporting Portal
If a supplement is suspected of causing a serious reaction, immediately stop using it, seek medical care, and submit a safety report through the FDA Safety Reporting Portal (SRP) or use MedWatch for serious events; the SRP is the primary electronic channel FDA directs consumers and health professionals to use for dietary supplement complaints [1][6][7]. The SRP guides reporters to include key information such as product name, lot number, label, timing of the event and medical outcomes; including a copy of the product label improves FDA’s ability to follow up and analyze trends [7][8].
2. Reporting to the manufacturer, retailers, and what they must do
Consumers and health professionals may also report adverse events directly to the product’s manufacturer, packer, or distributor using the domestic contact information on the supplement label, and firms that receive serious adverse event reports are required by law to investigate and submit those reports to FDA—typically within 15 days for serious events—while maintaining records for years [5][3][7]. Retailers listed as distributors on labels can contractually delegate reporting responsibilities to manufacturers, but the chain of information should flow from consumer to firm to FDA as mandated by the Dietary Supplement and Nonprescription Drug Consumer Protection Act [9][4].
3. How to request a recall and what FDA can actually do
A consumer who believes a product should be recalled should notify FDA via the SRP/MedWatch and complain to the manufacturer; FDA may open an investigation and can ask a company to conduct a voluntary recall, publish warnings, seize adulterated products, or take other enforcement actions—but FDA generally does not have premarket approval power for supplements and often relies on voluntary recalls and postmarket enforcement [10][11][4]. Public enforcement actions, warning letters, and recall notices for dietary supplements are posted by FDA and can follow CAERS signals or targeted inspections [10][8].
4. How FDA uses reports and the system’s limits
Adverse event reports feed into FDA databases such as CAERS and help the agency identify safety signals and possible enforcement actions; even single reports can trigger investigations that protect other consumers if they reveal dangerous products or adulterants [8][12]. However, oversight bodies have documented limitations: incomplete reports can prevent FDA follow-up, the public database may lack evaluations, and experts have recommended stronger mandatory reporting and registries to improve detection and trend analysis [13][8].
5. What reporters should include and follow-up expectations
Reporters should provide identifiable information about the injured person, product identifiers (name, lot/UPC, label), timing and clinical details, and any medical records—this increases the chance FDA or the manufacturer can follow up for clarification, and manufacturers are required to send follow-up information when they obtain new medical details [7][4]. After filing, expect FDA to enter reports into CAERS and to use them alongside manufacturer reports and inspections to evaluate risks, but do not expect an immediate recall unless evidence supports urgent action [8][10].
6. Alternative pathways and when to involve others
If harm is serious or criminal (forged labels, intentional adulteration), consumers and clinicians can alert state public health agencies or file complaints with the FDA Human Foods Program; healthcare professionals play a crucial role in reporting and documenting adverse events to bolster the public-health response [1][14]. Given regulatory gaps noted by the HHS Office of Inspector General and academic reviews, consumer reports remain one of the clearest levers for prompting investigation and possible removal of unsafe supplements from the market [13][11].