FDA & Medical Disclaimer

Last Updated: January 11, 2025

FDA Disclaimer

⚠️ IMPORTANT: These statements have not been evaluated by the Food and Drug Administration (FDA). This product is not intended to diagnose, treat, cure, or prevent any disease.

Align & Shine™ and all ZenZani products are classified as dietary supplements under the Dietary Supplement Health and Education Act of 1994 (DSHEA). As dietary supplements, our products are not subject to FDA approval before marketing, though we comply with all FDA regulations for dietary supplements including:

  • Good Manufacturing Practices (GMP) compliance
  • Accurate labeling requirements
  • Adverse event reporting
  • Substantiation of structure/function claims

Medical Disclaimer

The information provided on this website and about our products is for educational and informational purposes only and is not intended as medical advice.

Important Medical Notices:

  • Always consult with a qualified healthcare professional before starting any supplement regimen
  • This is especially important if you are pregnant, nursing, taking medications, or have a medical condition
  • Never discontinue or modify prescribed medications without consulting your healthcare provider
  • Dietary supplements are not a substitute for a varied diet and healthy lifestyle

Pregnancy & Nursing

While Align & Shine™ is formulated to be safe for breastfeeding mothers with carefully selected, postnatal-appropriate ingredients, we always recommend:

  • Consulting with your healthcare provider before use
  • Discussing any supplements with your OB-GYN or midwife
  • Monitoring how you feel and discontinuing use if you experience any adverse effects
  • Keeping all supplements out of reach of children

Note: If you are pregnant, please consult your healthcare provider before using any dietary supplements, as pregnancy has different nutritional requirements than the postpartum period.

Product Quality & Manufacturing

To ensure the highest quality and safety standards:

  • GMP Certified: Manufactured in a GMP (Good Manufacturing Practice) certified facility
  • NSF Audited: Our manufacturing facility is NSF audited for quality assurance
  • Made in USA: Proudly manufactured in the United States
  • Third-Party Tested: Products undergo rigorous quality testing
  • Allergen-Free: Free from common allergens including nuts, soy, dairy, and gluten

Individual Results May Vary

The benefits and results described on our website and in our marketing materials:

  • Are based on the experiences of individual users
  • May not be typical for all users
  • Depend on various factors including diet, exercise, and individual health conditions
  • Should not be considered guaranteed outcomes

Testimonials & Reviews

Customer testimonials and reviews on our website:

  • Reflect individual experiences and opinions
  • Are not intended as medical claims or guarantees
  • Have not been evaluated by the FDA
  • Should not replace professional medical advice

Health Claims Limitations

In accordance with FDA regulations, we do not claim that our products:

  • Diagnose, treat, cure, or prevent any disease
  • Are a replacement for prescribed medications
  • Eliminate the need for medical care
  • Are FDA approved (dietary supplements do not require FDA approval)

When to Seek Medical Attention

Stop using our products and seek immediate medical attention if you experience:

  • Allergic reactions (rash, itching, swelling, difficulty breathing)
  • Severe gastrointestinal distress
  • Unusual symptoms or side effects
  • Any concerning health changes

Interactions with Medications

Dietary supplements can interact with medications. Always inform your healthcare provider about all supplements you're taking, especially if you're on:

  • Blood thinners
  • Antidepressants
  • Hormone medications
  • Any prescription medications

Age Restrictions

Our products are formulated for adult use only (18 years and older). Keep all supplements out of reach of children. In case of accidental overdose, contact Poison Control immediately at 1-800-222-1222.

Storage & Safety

  • Store in a cool, dry place away from direct sunlight
  • Keep bottle tightly closed when not in use
  • Do not use if safety seal is broken or missing
  • Do not exceed recommended dosage
  • Check expiration date before use

Scientific References

While we strive to provide accurate information based on current scientific research:

  • Science and research are constantly evolving
  • Not all studies apply to all individuals
  • Research cited should not replace medical advice
  • We encourage you to do your own research and consult professionals

Liability Limitation

By using our products, you acknowledge that:

  • You have consulted or will consult with a healthcare provider
  • You understand the risks and benefits
  • ZenZani LLC is not liable for any adverse effects or lack of results
  • You are using the products at your own risk

Reporting Adverse Events

If you experience any adverse events while using our products:

  1. Stop using the product immediately
  2. Consult your healthcare provider
  3. Report the event to us at support@zenzani.com
  4. Consider reporting to the FDA's MedWatch program

International Customers

Regulations regarding dietary supplements vary by country. International customers are responsible for understanding and complying with their local laws and regulations.

Contact Information

For questions about our products or this disclaimer:

ZenZani LLC
9821 Godwin Drive
Manassas, VA 20110
Email: support@zenzani.com

Remember: Your health is precious. While we believe in the power of nutrition and supplementation to support wellness, nothing replaces the guidance of qualified healthcare professionals who know your individual health needs.

This disclaimer was last updated on January 11, 2025, and applies to all products sold by ZenZani LLC.