ADVERSE EVENT REPORTING POLICY

Effective Date: December 31, 2024 | Last Updated: December 31, 2024

CRITICAL SAFETY NOTICE

Your safety is our top priority. If you experience any adverse reaction while using our herbal products, please follow the procedures outlined below. Quick reporting helps protect you and other customers.

1. WHAT IS AN ADVERSE EVENT?

Adverse Event Definition:

Any unwanted or harmful reaction that may be related to using our herbal supplements.

Examples Include:

Mild Reactions:

  • Upset stomach or nausea
  • Headache or dizziness
  • Skin rash or irritation
  • Changes in sleep patterns
  • Digestive discomfort

Moderate Reactions:

  • Persistent digestive issues
  • Skin reactions (widespread rash, hives)
  • Mood changes or anxiety
  • Blood pressure changes
  • Irregular heartbeat

Severe Reactions (Seek immediate medical attention):

  • Difficulty breathing or swallowing
  • Severe allergic reactions (anaphylaxis)
  • Chest pain or severe heart palpitations
  • Loss of consciousness or seizures
  • Severe liver symptoms (jaundice, severe fatigue)
  • Extreme mood changes or mental health crisis

2. IMMEDIATE ACTIONS IF YOU EXPERIENCE AN ADVERSE EVENT

SEVERE REACTIONS - EMERGENCY PROTOCOL:

  1. STOP taking the product immediately
  2. Call 911 or go to emergency room
  3. Bring the product bottle with you to medical facility
  4. Contact us at ethan@templeofherbs.com after receiving medical care

MILD TO MODERATE REACTIONS:

  1. STOP taking the product immediately
  2. Document the reaction (symptoms, timing, severity)
  3. Contact your healthcare provider if symptoms persist
  4. Report to us within 24 hours using methods below

DO NOT:

  • Continue taking the product "to see if it gets better"
  • Ignore symptoms hoping they'll go away
  • Take additional medications without medical consultation
  • Wait more than 24 hours to report severe reactions

3. HOW TO REPORT AN ADVERSE EVENT

IMMEDIATE REPORTING (24/7):

  • Emergency Email: ethan@templeofherbs.com
  • Phone: 213-378-4152 (business hours)
  • Emergency voicemail: Checked multiple times daily

ONLINE REPORTING FORM:

WRITTEN REPORT:

  • Email: ethan@templeofherbs.com
  • Subject: "Adverse Event Report - [Your Name]"

4. INFORMATION TO INCLUDE IN YOUR REPORT

Required Information:

Product Details:

  • Product name and batch number
  • Date purchased and date first used
  • Dosage taken and frequency
  • How long you've been taking the product

Personal Information:

  • Age and gender
  • Current medications and supplements
  • Known allergies or medical conditions
  • Pregnancy or nursing status

Reaction Details:

  • Description of symptoms
  • When symptoms started
  • How long symptoms lasted
  • Severity level (mild/moderate/severe)
  • Any medical treatment received

Additional Helpful Information:

  • Photos of skin reactions (if applicable)
  • Medical records or doctor's notes
  • Timeline of events leading to reaction
  • Other products used around the same time

5. OUR RESPONSE PROCESS

24h

Within 24 Hours:

  • Acknowledgment: Confirmation that we received your report
  • Initial assessment: Preliminary safety evaluation
  • Product hold: We may advise discontinuing specific batch
  • Medical guidance: Direction to seek medical care if needed
48-72h

Within 48-72 Hours:

  • Investigation: Detailed review of product batch and manufacturing
  • FDA notification: Required reporting for serious adverse events
  • Medical consultation: Review with our healthcare advisors
  • Customer follow-up: Check on your condition and recovery
1 Week

Within 1 Week:

  • Investigation results: Findings from our safety review
  • Corrective actions: Any changes to product or labeling
  • Compensation consideration: Refund or medical cost assistance
  • Prevention measures: Steps to prevent similar incidents

6. FDA REPORTING REQUIREMENTS

When We Must Report to FDA:

  • Serious adverse events: Death, hospitalization, disability
  • Life-threatening reactions: Emergency medical intervention required
  • Congenital anomalies: Birth defects potentially related to product use
  • Medical intervention required: To prevent serious outcome

Your Rights:

  • Direct FDA reporting: You can report directly to FDA
  • FDA Safety Reporting Portal: www.fda.gov/safety/medwatch
  • Confidentiality: Your personal information is protected
  • No retaliation: Reporting will not affect your ability to purchase products

Our Commitment:

  • Timely reporting: All serious events reported to FDA within 15 days
  • Complete information: Full disclosure of all relevant details
  • Cooperation: Full cooperation with any FDA investigations
  • Transparency: Public safety alerts if necessary

7. PRODUCT INVESTIGATION PROCESS

Immediate Actions:

  • Batch isolation: Hold all products from same production batch
  • Quality testing: Enhanced testing of reported batch
  • Manufacturing review: Investigation of production processes
  • Supplier verification: Review of raw material sources

Detailed Investigation:

  • Root cause analysis: Determine exact cause of adverse event
  • Expert consultation: Review with medical and scientific experts
  • Literature review: Check for similar reported events
  • Risk assessment: Evaluate overall product safety profile

Corrective Measures:

  • Product recall: If safety issue identified with specific batch
  • Label updates: Enhanced warnings or usage instructions
  • Process improvements: Manufacturing or quality control changes
  • Communication: Updates to customers and healthcare providers

12. CONTACT INFORMATION

24/7 Emergency Reporting:

Email: ethan@templeofherbs.com
Subject line: "URGENT - Adverse Event Report"

Business Hours Support:

Phone: 213-378-4152
Hours: Monday-Friday, 9 AM - 6 PM EST
Voicemail: Checked every 2 hours during business days

Mailing Address:

Temple of Herbs - Safety Department
1111b S Governors Ave STE 23714
Dover, Delaware 19904

Additional Resources:

  • FDA MedWatch: www.fda.gov/safety/medwatch (1-800-FDA-1088)
  • Poison Control: 1-800-222-1222 (for emergencies)
  • Your healthcare provider: Always consult for medical advice

Final Reminder

This Adverse Event Reporting Policy was last updated on December 31, 2024.

Remember: When in doubt about any reaction, seek medical attention immediately. Your safety is more important than any herbal supplement.

Report Adverse Event Now