Adverse Event Reporting

If You Are Experiencing a Medical Emergency

If you are experiencing a serious allergic reaction, difficulty breathing, or any medical emergency, call 911 or your local emergency number immediately. Do not use this page to report a medical emergency.

What This Page Is For

This page is for reporting an adverse event or unexpected health effect that you believe may be associated with a DR BARRON product (Advanced Hair Formula or Advanced Scalp Formula). Your report helps us monitor product safety and meet our reporting obligations to the U.S. Food and Drug Administration (FDA) under the Dietary Supplement and Nonprescription Drug Consumer Protection Act and the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

What Counts as an Adverse Event

An adverse event is any health-related event associated with the use of a product that is unwanted or unexpected. Examples include

• Skin irritation, rash, or redness (topical product)
• Allergic reactions (hives, swelling, difficulty breathing)
• Gastrointestinal distress (nausea, vomiting, stomach pain) after taking a supplement
• Any other unexpected health effect during or after product use

A serious adverse event is one that results in death, a life-threatening experience, inpatient hospitalization, persistent or significant disability, a congenital anomaly or birth defect, or that requires medical or surgical intervention to prevent one of these outcomes.

How to Report

Step 1. Discontinue use of the product.

Step 2. Consult your healthcare provider for any symptoms or care.

Step 3. Submit a report to us with the following information:

• Your name and email address
• The product(s) involved
• The lot number (printed on the product label or bottom of the bottle)
• A description of the adverse event or reaction
• When the event occurred- Any medical attention received
• Photos of the product, label, or affected area (if applicable)

Submit your report by:

Email: hello@drbarron.com with the subject "Adverse Event Report"

Mail: DR BARRON, hello@drbarron.com

We acknowledge reports within 2 business days. If the event meets the criteria for a serious adverse event, we are required to report it to the FDA within 15 business days.

We retain adverse event records for at least six years as required by federal law.

Reporting Directly to the FDA

You also have the right to report adverse events directly to the FDA. You do not need to contact us first.

FDA MedWatch

• Online: fda.gov/medwatch
• Phone: 1-800-FDA-1088
• Mail: MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20852

MedWatch accepts reports for both dietary supplements and cosmetic products.

What Happens After You Report

• We acknowledge receipt within [2] business days.
• We review the report and may follow up for additional information.
• If the event meets the criteria for a serious adverse event, we file a report with the FDA within 15 business days.
• We retain records of all reports for at least six years.

Product Recalls

DR BARRON has not issued any product recalls. If a recall becomes necessary, we will notify affected customers directly and post information on this page.

Questions

For general product questions not related to adverse events, visit our FAQ or Contact page.