FDA Disclaimer

Understanding This Disclaimer

This FDA disclaimer is a legally required statement that appears on all dietary supplement products and marketing materials in the United States. It serves to inform consumers about the regulatory status of dietary supplements compared to pharmaceutical drugs.

What This Means

The FDA disclaimer indicates that:

• No FDA Evaluation: The specific health claims made about our supplements have not undergone the FDA's rigorous evaluation process that is required for pharmaceutical drugs
• Not Medicine: Our supplements are dietary supplements, not prescription or over-the-counter medications
• Support, Don't Treat: Our products are designed to support normal bodily functions and overall wellness, not to treat medical conditions
• Consult Healthcare Providers: You should always consult with your healthcare provider before starting any supplement regimen

FDA Regulation of Supplements

The FDA regulates dietary supplements under the Dietary Supplement Health and Education Act (DSHEA) of 1994. This means:

• Good Manufacturing Practices (GMP): Supplement manufacturers must follow FDA GMP requirements
• Facility Registration: Manufacturing facilities must be registered with the FDA
• Adverse Event Reporting: Serious adverse events must be reported to the FDA
• Label Claims: Claims must be substantiated and may not make drug claims

Types of Supplement Claims

The FDA allows three types of claims for dietary supplements:

1. Structure/Function Claims

These describe how a supplement affects normal body functions or structure. Examples include:

• "Supports healthy joints"
• "Promotes cardiovascular health"
• "Helps maintain healthy cholesterol levels"

2. Nutrient Content Claims

These describe the level of a nutrient in the supplement, such as:

• "High in Vitamin C"
• "Good source of fiber"
• "Low sodium"

3. Health Claims

These are pre-approved by the FDA and describe a relationship between a substance and disease risk reduction. These are rare and strictly regulated.

Our Quality Standards

Even though supplements are not evaluated by the FDA like drugs, we maintain high standards:

• GMP Manufacturing: All our products are manufactured in GMP-certified facilities
• FDA Registration: Our manufacturing partner VitaLabs operates FDA-registered facilities
• Third-Party Testing: Every batch is tested by independent laboratories for purity and potency
• Quality Ingredients: We use premium, responsibly sourced raw materials
• Transparent Labeling: All ingredients and amounts are clearly listed on our labels

Before Taking Any Supplement

We strongly recommend that you:

• Consult Your Doctor: Especially if you have medical conditions, take medications, are pregnant, or nursing
• Read Labels Carefully: Follow dosage instructions and check for allergens
• Research Interactions: Some supplements can interact with medications
• Start Gradually: Begin with recommended doses and monitor your body's response
• Report Issues: Contact us and your healthcare provider if you experience any adverse effects

Reporting Adverse Events

If you experience any negative effects from our products, please:

1. Stop Use: Discontinue the product immediately
2. Contact Us: Report the issue to our customer support team
3. Consult Healthcare Provider: Seek medical attention if symptoms are serious
4. Report to FDA: Serious adverse events can be reported to the FDA through their MedWatch program

Contact Information

For questions about our products or to report any issues:

Additional Resources

For more information about dietary supplements and FDA regulations, visit:

• FDA Office of Dietary Supplements: Official FDA guidance on supplements
• National Institutes of Health (NIH): Evidence-based information on supplements
• Your Healthcare Provider: Personalized advice based on your health status