Last Updated: May 7, 2026
1. Purpose
This policy establishes the procedures for reporting adverse events, product safety concerns, and product quality complaints to Company. Timely and accurate reporting is essential for consumer safety and regulatory compliance. Practitioner is required to report all events described below, regardless of whether a causal relationship with the Product has been established.
2. Definitions
Serious Adverse Event
A health-related event associated with the use of a Product that results in any of the following (as defined under 21 U.S.C. § 379aa-1):
- Death
- A life-threatening experience
- Inpatient hospitalization
- A persistent or significant disability or incapacity
- A congenital anomaly or birth defect
- An event that requires medical or surgical intervention to prevent one of the outcomes listed above
Other Adverse Event
A health-related event associated with the use of a Product that does not meet the criteria for a Serious Adverse Event, including but not limited to: illness, allergic reaction, gastrointestinal distress, skin reaction, or any other reported side effect or adverse reaction.
Product Complaint
A non-health-related quality issue with a Product, including but not limited to: taste, odor, texture, appearance, packaging defects, labeling errors, foreign material, or any other deviation from expected Product quality.
3. Reporting Timelines
| Event Type | Reporting Deadline |
|---|---|
| Serious Adverse Event | Within 48 hours of Practitioner becoming aware |
| Other Adverse Event | Within 15 calendar days of Practitioner becoming aware |
| Product Complaint | Within 30 calendar days of Practitioner becoming aware |
If Practitioner is uncertain whether an event qualifies as a Serious Adverse Event, Practitioner should report it within the 48-hour timeline.
4. Report Contents
All reports must include the following information to the extent known and available:
- Product information: Product name, lot number (from Product label), and date of purchase
- Event description: Detailed description of the event, including symptoms, onset, duration, and severity
- Date of event: When the event occurred or was first observed
- Severity assessment: Whether the event is serious, non-serious, or a product complaint
- Affected individual: Age, sex, and relevant medical history (de-identified where practical — see Section 7)
- Actions taken: Any medical treatment sought, Product use discontinued, or other actions taken in response
- Product disposition: Whether the affected Product unit has been retained, returned, or discarded
5. How to Submit a Report
Submit all adverse event reports and product complaints by email to:
Include “SERIOUS ADVERSE EVENT,” “ADVERSE EVENT,” or “PRODUCT COMPLAINT” in the subject line as applicable.
For Serious Adverse Events, follow up with a phone call to confirm receipt if you do not receive an acknowledgment within 24 hours.
6. Cooperation and Preservation
- Preserve evidence. Retain the affected Product, packaging, and any related documentation. Do not discard, return, or destroy the affected Product until instructed by Company.
- Cooperate with investigation. Practitioner must cooperate fully with Company’s investigation, including providing additional information, facilitating access to relevant records, and assisting with patient follow-up as permitted by law.
- Follow-up reports. If additional information becomes available after the initial report, Practitioner must submit a follow-up report promptly.
7. Privacy and Patient Information
- De-identify patient information where practical. Do not include patient names, addresses, or other directly identifying information unless necessary for investigation and permitted by applicable law.
- Obtain any consents required by HIPAA, state privacy laws, or other applicable regulations before disclosing patient health information to Company.
- Limit disclosure to the minimum information necessary for Company to fulfill its reporting and investigation obligations.
8. Public Statements
- Practitioner must not make public statements regarding any Serious Adverse Event without Company’s prior written approval, except where required by law or reasonably necessary for immediate patient safety.
- For Other Adverse Events and Product Complaints, Practitioner should coordinate with Company before making any public statement.
- Any public communication must be factual, non-speculative, and consistent with Company’s communications on the matter.
9. Regulatory Context
Company is required under federal law (21 U.S.C. § 379aa-1) to report Serious Adverse Events associated with dietary supplements to the FDA. Practitioner’s timely reporting to Company enables Company to meet its regulatory obligations. Practitioner’s reporting obligations under this policy are in addition to, and do not replace, any independent reporting obligations Practitioner may have under applicable law.