21 CFR 111.560 requires dietary supplement manufacturers to establish and follow written procedures for receiving, reviewing, and investigating consumer complaints. The complaint handling system is both a cGMP requirement and the front line of the brand's adverse event reporting and product safety surveillance.
The Written Procedure Requirement
Under 21 CFR 111.560, the manufacturer must establish written procedures for consumer complaints that include:
How complaints are received (phone, email, mail, online forms, social media)
How they are documented (the information captured in the complaint file)
How they are reviewed to determine whether they may indicate a cGMP failure
When a formal investigation is required
How the investigation is conducted and documented
How the investigation outcome is reviewed by a qualified individual
The written procedure must be followed — having a procedure that isn't actually used doesn't satisfy the regulation.
What Must Be Documented for Each Complaint
Under 21 CFR 111.570(b)(3), each consumer complaint record must include:
The name and contact information of the complainant (if provided)
The name of the dietary supplement and the lot or batch number (if provided or if the product can be identified)
The date the complaint was received
The nature of the complaint — what the consumer reported
Any action taken in response, including investigation results
Any follow-up communications with the consumer
When Investigation Is Required
Under 21 CFR 111.560(b), a formal investigation must be conducted when a complaint involves:
A possible failure of the dietary supplement to meet any of its specifications
A possible contamination, mix-up, or mislabeling
A serious adverse event — see interaction with adverse event reporting below
Any condition that could cause or has caused a health risk to consumers
A complaint that a tablet was a different color than expected — and no health concern is raised — may not require a formal investigation. A complaint that a consumer became ill after taking the supplement and required medical attention requires both an investigation and likely an adverse event report.
Consumer Complaints and Adverse Event Reporting
Consumer complaints are the primary intake mechanism for identifying serious adverse events (SAEs) requiring mandatory FDA reporting under the Dietary Supplement and Nonprescription Drug Consumer Protection Act (21 CFR Part 111 Subpart P).
A consumer complaint that describes any of the following outcomes triggers the SAE reporting clock:
Death
Life-threatening experience
Inpatient hospitalization
Persistent or significant disability or incapacity
Congenital anomaly or birth defect
Medical or surgical intervention to prevent one of the above
The 15 business day clock for SAE reporting begins when the manufacturer receives the complaint — not when it concludes the complaint is related to the product. The complaint handling system must be designed to flag SAE-qualifying language immediately upon receipt.
Social Media, Marketplace, and Third-Party Complaints
FDA's interpretation of the complaint handling requirement extends to consumer communications received through any channel, including:
Amazon reviews or seller messages
Social media posts and direct messages on brand-owned pages
Communications forwarded from retailers or distributors
Third-party review platforms
A consumer who posts on Instagram that they were hospitalized after taking a supplement has potentially submitted a complaint (and an SAE report). Brands with social media monitoring should have a triage protocol for routing flagged communications to the complaint handling system.
The complaint handling procedure should specify who is responsible for monitoring social media and marketplace channels, how flagged communications are transferred to the complaint file, and what constitutes a complaint vs. general product feedback.
Investigation Process
When an investigation is required, 21 CFR 111.560(b) requires:
Review of the complaint by a qualified individual
Examination of relevant batch production records, testing records, and distribution records
Determination of whether a cGMP failure occurred or whether the batch meets specifications
Corrective action if a cGMP failure is identified
Documentation of the investigation findings and outcome
The investigation must be completed in a timely manner — the regulation does not specify a deadline, but unreasonable delay in completing investigations is itself a compliance gap.
Recordkeeping Requirements
Under 21 CFR 111.570(c), all complaint records must be:
Retained for 1 year after the product's expiration date or 2 years from the date of distribution, whichever is longer
For SAE-related complaints: retained for 6 years (the longer SAE-specific retention period under the adverse event reporting rules)
Made available to FDA upon request during inspection
Complaint files are among the first records FDA reviewers request during facility inspections.
How Truli Helps with Consumer Complaint Compliance
Multi-channel complaint capture: Truli monitors product mentions across social media, marketplace channels, and direct consumer contacts and routes flagged communications to a centralized complaint file
SAE triage flagging: Truli surfaces complaint language indicating serious adverse events — hospitalization, medical intervention, severe symptoms — for immediate compliance team review and SAE reporting workflow initiation
Investigation tracking: Truli tracks open complaint investigations and alerts when investigations are approaching or exceeding reasonable completion timelines
Complaint file management: Truli maintains organized, searchable complaint records meeting the applicable retention requirements (1–2 year standard, 6 years for SAE-related)
Related Regulations
21 CFR Part 111 — Supplement cGMP — Full cGMP framework for dietary supplements
FDA Adverse Event Reporting for Supplements — SAE reporting requirements triggered by complaint intake
DSHEA — Statutory framework within which complaint and safety obligations operate
Frequently Asked Questions
Do we need to investigate every complaint?
No — investigation is required when the complaint may indicate a cGMP failure or could reflect a product safety issue. A complaint that a supplement smells different than expected may warrant inquiry but not a formal investigation unless the odor change suggests a quality defect. A complaint that a consumer had a severe reaction requires a formal investigation and likely an SAE report.
We received a complaint from Amazon through our seller central account. Does that count?
Yes. Complaints received through marketplace channels — Amazon, Walmart, DTC platforms — are consumer complaints under 21 CFR 111.560. Your complaint procedure must specify how marketplace complaints are captured and routed into your complaint system.
A customer left a 1-star review saying our product "made them sick." Is that an SAE?
It depends on the severity of the illness described. A vague "made me sick" without description of hospitalization or medical intervention does not automatically qualify as a serious adverse event. However, the complaint must be captured in your system, and your SAE triage procedure should include a step for following up with consumers who report illness to determine whether the outcome meets the SAE definition.
A note from Truli: Truli is not a law firm, and this article does not constitute or contain legal advice or create an attorney-client relationship. When determining your obligations and compliance with respect to relevant laws and regulations, you should consult a licensed attorney.
Last updated: April 2026. Reflects 21 CFR 111.560 as of April 2026. Book a demo to see how Truli monitors supplement cGMP compliance.
