FDA Compliance

Regulatory Compliance Statement

Herbal Fuze, LLC is committed to full compliance with all applicable FDA regulations governing herbal smoking products and tobacco alternatives.

Product Classification

Our herbal cigarettes are classified as tobacco alternatives and are subject to specific FDA oversight under the Federal Food, Drug, and Cosmetic Act. All products are manufactured in facilities that adhere to FDA Good Manufacturing Practices (GMP).

Ingredient Standards

  • All herbs are sourced from USDA Organic certified suppliers
  • No tobacco, nicotine, or synthetic additives
  • All ingredients are Generally Recognized as Safe (GRAS) for smoking applications
  • Regular third-party testing for pesticides, heavy metals, and microbials
  • Certificate of Analysis available for each batch

Manufacturing Compliance

  • FDA-registered manufacturing facility
  • Hazard Analysis and Critical Control Points (HACCP) protocols
  • Complete batch tracking and documentation
  • Environmental monitoring and contamination controls
  • Regular facility inspections and compliance audits

Labeling Requirements

All product labeling complies with FDA requirements including:

  • Complete ingredient listing
  • Appropriate health warnings
  • Manufacturing date and batch codes
  • Proper business identification
  • Age restriction notices (21+)

Health Warnings

WARNING: This product produces smoke. Smoke from any burning organic matter contains carbon monoxide and other combustion byproducts that may pose health risks. This product has not been evaluated by the FDA for safety or efficacy. Not for use by minors, pregnant or nursing women.

Adverse Event Reporting

We maintain a comprehensive adverse event reporting system and will report any serious adverse events to the FDA within required timeframes. Consumers can report adverse events to us at safety@herbalfuze.com or directly to the FDA.

Records and Documentation

We maintain detailed records for a minimum of three years including:

  • Manufacturing records and batch documentation
  • Supplier certificates and ingredient specifications
  • Quality control testing results
  • Distribution and sales records
  • Consumer complaint and adverse event logs

Updates and Changes

This compliance statement is reviewed quarterly and updated as needed to reflect current FDA regulations and guidance documents.

Last Updated: January 2024