FDA and FTC Compliance Statement

The First Medicine products are classified as dietary supplements under the Dietary Supplement Health and Education Act of 1994 (DSHEA), 21 U.S.C. § 321(ff). Dietary supplements are intended to supplement the diet and are not represented as a cure, mitigation, treatment, or prevention of disease.

All The First Medicine products comply with FDA regulations regarding dietary supplement labeling, including:

• Supplement Facts Labels: Clearly identify each ingredient and serving size with appropriate disclaimers
• Structure/Function Claims: All claims made about our products describe the role of a nutrient or dietary ingredient intended to affect normal structure or function in humans, and are substantiated
• Prohibited Claims: We do not make disease claims or unauthorized health claims about our products
• Warning Labels: Appropriate warnings and precautions are clearly displayed on all products

Our manufacturing partners comply with FDA's Current Good Manufacturing Practices for dietary supplements (21 CFR Part 111). This ensures:

• Quality control at every step of manufacturing
• Proper labeling and packaging
• Adequate testing for identity, purity, strength, and composition
• Complete batch records and traceability

Every batch of The First Medicine products is tested to verify alkaloid content using High-Performance Liquid Chromatography (HPLC) analysis.

Certificates of analysis are available upon request for batch verification.

We take consumer safety seriously. If you experience any adverse effects from our products, please report them immediately:

• Email: brickle@thefirstmedicine.com
• Include: Product name, batch number, date of incident, and detailed description
• We will investigate and, if appropriate, report to the FDA

Our products are not intended to replace professional medical advice, diagnosis, or treatment. If you have a medical condition or are taking medications, consult with a qualified healthcare provider before using our products.

The First Medicine complies with the Federal Trade Commission (FTC) Act, Section 5, which prohibits unfair or deceptive acts or practices in commerce. Our advertising practices:

• Substantiation: All claims made about our products are based on competent and reliable scientific evidence
• Transparency: We clearly disclose limitations, disclaimers, and conditions of any claims
• Expert Endorsements: Any endorsements or testimonials reflect the typical experience of consumers and are based on actual use
• No Exaggeration: We do not make claims that imply our products are more effective than they actually are

All claims made about The First Medicine products relate to:

• Structure/Function: "Supports calm," "Promotes relaxation," "Aids in hydration" - these describe normal biological functions
• Ingredient Properties: Information about the known properties of Kanna and electrolyte components
• Sourcing and Quality: Factual statements about testing, sourcing, and manufacturing practices

We do NOT claim: Our products cure, treat, prevent, or mitigate any disease or medical condition.

The First Medicine maintains scientific documentation supporting all claims made about our products, including:

• Peer-reviewed research on Kanna (Sceletium tortuosum)
• Clinical studies on electrolyte formulation and efficacy
• HPLC testing results for alkaloid content verification
• Quality assurance documentation

This documentation is available upon request for regulatory review.

• All prices are clearly displayed before purchase
• Refunds are issued as promised (30-day money-back guarantee)
• No hidden fees or surprise charges
• Subscription terms (if applicable) are clearly disclosed

We comply with FTC regulations regarding consumer privacy and data protection. See our Privacy Policy for complete details.

• Source: South African succulent plant
• Traditional Use: Used for centuries in traditional medicine for mood support
• Research Status: Subject of peer-reviewed scientific studies
• Safety Profile: Generally recognized as safe in typical use; no major drug interactions reported at recommended doses
• Not Intended For: Pregnant or nursing women, children under 18, or those with serious mental health conditions without physician consultation

• Sodium: Essential mineral for hydration and electrolyte balance
• Potassium: Critical for muscle and nerve function
• Magnesium: Supports muscle relaxation and cellular function
• No Artificial Additives: No artificial sweeteners, dyes, or preservatives

Our products are not recommended for:

• Children under 18 years of age
• Pregnant or nursing women
• Individuals with serious cardiovascular conditions (without physician approval)
• Individuals taking monoamine oxidase (MAOI) inhibitors
• Anyone with a known allergy or sensitivity to product ingredients

Always consult with a qualified healthcare provider before use if you have pre-existing medical conditions or take prescription medications.

While The First Medicine products are formulated to be well-tolerated, some individuals may experience:

• Mild GI upset (generally temporary)
• Headache (rare, may indicate dehydration)
• Sensitivity reactions in susceptible individuals

If you experience any adverse effects, discontinue use and consult a healthcare professional. Report serious adverse events to brickle@thefirstmedicine.com.

The First Medicine maintains comprehensive records demonstrating compliance with FDA and FTC regulations, including:

• Batch manufacturing records and lot traceability
• HPLC testing documentation for alkaloid verification
• Claims substantiation files
• Adverse event reports
• Quality assurance protocols

These records are maintained and available for regulatory inspection as required by law.

If you believe The First Medicine has made false or misleading claims:

• Contact Us First: Email brickle@thefirstmedicine.com with details
• FDA: Report to the FDA's MedWatch program: https://www.fda.gov/medwatch
• FTC: File a complaint: https://reportfraud.ftc.gov/

For questions about our compliance practices or to request substantiation documentation:

First Medicine LLC
1900 W Carla Vista Dr. #6805 Chandler, AZ 85246
Email: brickle@thefirstmedicine.com
Website: www.thefirstmedicine.com
Response time: Within 48 business hours

This compliance statement will be updated as regulations evolve or as our product line changes. The most current version is always available on our website.