FDA Compliance & Product Safety

Medical & Regulatory Compliance

Last updated: January, 2026 

 

At Aphlora, our mission is to restore balance through the union of nature and science. Every formula is rooted in Latin American botanicals and crafted under the highest U.S. quality and regulatory standards. This page outlines our compliance commitments and your rights as a consumer under U.S. law.


1. FDA Compliance Statement

Full Moon Balance™ is classified as a dietary supplement. Dietary supplements are regulated and overseen by the 1994 Dietary Supplement Health and Education Act (DSHEA), the U.S. Food and Drug Administration (FDA), and the Federal Trade Commission (FTC).

This product is designed to support hormonal harmony and female wellness through plant-based adaptogens and antioxidants. This product is not a drug—it is not intended to diagnose, treat, cure, or prevent any disease.

Statements on this website have not been evaluated by the Food and Drug Administration (FDA). This is because, pursuant to DSHEA, the FDA does not have the authority to approve dietary supplements before they are marketed. 

Nevertheless, all Aphlora products are produced, handles, and stored, using Good Manufacturing Practices in certified U.S. facilities that adhere to all of the best practices set forth in 21 CFR Part 111.

Each batch is tested for identity, purity, strength, composition, and potency to ensure uncompromising quality.


2. Responsible Use

  • Suggested use: Take two (2) capsules daily with breakfast.
  • Recommended cadence: For best results, use consistently for three (3) months, pause for one (1) month, and then resume as desired. This cycling generally appears to allow the body to naturally recalibrate.
  • Do not exceed the recommended daily dose.
  • Not intended for use during pregnancy or breastfeeding.
  • Not recommended for individuals with high blood pressure or those taking hormone-regulating or cardiovascular medication.
  • This product is intended for generally healthy adult women (ages 18+).
  • Always consult a licensed physician before starting any new supplement, especially if you are under medical care or taking medication


Our products are designed to complement your wellness routine—not replace medical treatment or professional diagnosis.


3. Scientific Substantiation & Ethical Communication

All Aphlora claims are grounded in scientific literature, ingredient research, and traditional herbal use.
We adhere strictly to FDA and FTC regulations to ensure every statement is truthful, not misleading, and supported by reasonable, competent, and reliable evidence.
Individual results may vary. No guarantee of specific outcomes is made or implied.
The information provided on this site is for educational purposes only. It should not be interpreted as medical advice.
We encourage you to consult your physician or qualified physician for personalized guidance.


4. Ingredient Legality & Safety

All ingredients in Full Moon Balance™ are compliant with all applicable FDA and FTC regulations. This product is composed of botanicals widely recognized as safe for adult consumption.
If any future formulation includes New Dietary Ingredients (NDIs) under 21 CFR Part 190, Subpart B, Aphlora will file appropriate all applicable FDA notifications before commercialization.
Our manufacturing partners maintain full documentation of safety, batch records, and product substantiation for all lots.


5. Adverse Event & Safety Reporting

Your wellbeing is a top priority for us. If you experience any adverse or unexpected effects while using our products, please notify us immediately.
Report an Adverse Event: info@aphlora.com
Please include your name, contact details, product name, lot number (if available), date of use, and a description of your experience.
You may also report directly to the U.S. Food and Drug Administration (FDA) through the Safety Reporting Portal.


6. Transparency & Testing

Aphlora maintains rigorous quality-control standards and full traceability of every batch.
Each product undergoes third-party laboratory testing for microbial safety, heavy metals, and potency.
Certificates of Analysis (COAs) are available upon request for authorized review.

 

7. Allergen & Interaction Advisory

Our formulas are free of artificial preservatives, soy, gluten, and dairy.
However, individuals with known sensitivities or allergies should review ingredient labels carefully.
If you are taking medication or have a diagnosed condition, please consult your physician before use.


8. Legal Notices

  • Aphlora does not provide medical, diagnostic, or therapeutic advice.
  • Use of this website and purchase of Aphlora products are subject to our Terms & Conditions and Privacy Policy.
  • Aphlora’s liability is limited to the fullest extent permitted by law.
  • This page may be updated periodically to reflect changes in regulation or policy.


9. Governing Law:

This site and its contents are governed by the laws of the United States and the State of Florida, without regard to conflict-of-law principles.


10. Contact Information

  • For product, order questions, compliance or regulatory inquiries, please email us at info@aphlora.com