Product Disclaimer

1. Regulatory Classification

Femina™ products are classified as:

• United States: Dietary supplements under the Dietary Supplement Health and Education Act (DSHEA). Not evaluated or approved by the FDA as drugs.
• South Africa: Complementary Medicines under Section 14 of the Medicines and Related Substances Act, 101 of 1965, as amended. Subject to SAHPRA notification requirements.
• United Kingdom: Food supplements under the Food Supplements (England) Regulations 2003. Not licensed medicines regulated by the MHRA.
• Australia: Listed complementary medicines or food products. Not TGA-evaluated for therapeutic claims.
• European Union: Food supplements under Directive 2002/46/EC. Subject to national regulations of individual member states.

2. Health Claims Disclaimer

Any health-related statements, testimonials, or educational content on this website:

• Are based on traditional use, general nutritional science, or user experience, and not intended as therapeutic claims
• Have not been evaluated as claims under FDA 21 CFR Part 101, SAHPRA Complementary Medicines Guidelines, or equivalent regulations
• Are not a substitute for professional medical advice, diagnosis, or treatment
• Individual results may vary and are influenced by diet, lifestyle, and individual health status

3. Probiotic Strains — Specific Notice

Femina™ probiotic products contain live bacterial cultures that may support vaginal and gut microbiome balance. Probiotics are generally recognized as safe (GRAS) by the FDA for healthy adults. Claims relating to "restoring pH balance," "supporting vaginal flora," or "reducing recurrence" are based on peer-reviewed microbiome research and are made as general wellness statements, not as disease treatment claims. Efficacy is not guaranteed and has not been confirmed by clinical trials specific to Femina™ branded products.

4. Boric Acid Products — Specific Notice

Femina™ boric acid suppositories contain pharmaceutical-grade boric acid (600mg). Boric acid is classified as a poison in some jurisdictions and must be used strictly as directed. These products are for vaginal use only and must not be taken orally. Keep out of reach of children. Not for use during pregnancy. Consult a healthcare professional before use if you have a compromised immune system, are breastfeeding, or have open sores or wounds. Not a registered medicine. Not intended to replace medical treatment of infections.

5. Wellness Tools Disclaimer

The V-Check, pH Tracker, BV or Yeast Quiz, and other digital wellness tools on this platform are for general informational purposes only. They are not diagnostic tools and do not constitute medical advice. Results should not be used to self-diagnose or self-treat any medical condition. Always consult a qualified healthcare professional for medical diagnosis and treatment.

6. Safe Use

If you experience an adverse reaction to any Femina™ product, discontinue use immediately and consult a healthcare provider. Adverse events may be reported to your national pharmacovigilance authority:

• USA: FDA MedWatch — fda.gov/safety/medwatch
• South Africa: SAHPRA — sahpra.org.za
• UK: MHRA Yellow Card — yellowcard.mhra.gov.uk
• Australia: TGA — tga.gov.au/reporting-problems

7. Contact

For regulatory enquiries or to report an adverse event:
Email: femina@velobiotics.com