3. FDA Supplement Disclaimer

Applicable to all BalanceByHer products including Solstice

Required FDA Statement:

These statements have not been evaluated by the Food and Drug Administration.

This product is not intended to diagnose, treat, cure, or prevent any disease.

3.1  Regulatory Status

Solstice by BalanceByHer is a dietary supplement. Dietary supplements are regulated by the U.S. Food and Drug Administration (FDA) under the Dietary Supplement Health and Education Act of 1994 (DSHEA). Under DSHEA, dietary supplement manufacturers are responsible for ensuring their products are safe and that any claims made about those products are substantiated and truthful.

Dietary supplements are not subject to the same pre-market approval process as pharmaceutical drugs. The FDA does not evaluate dietary supplements for safety, effectiveness, or quality before they are marketed to the public.

3.2  Manufacturing Standards

Solstice is manufactured in the United States in a facility that follows Current Good Manufacturing Practices (cGMP) as defined by the FDA. Our manufacturing partner maintains rigorous quality control standards including ingredient testing, potency verification, and purity checks.

Our product is made with 100% natural ingredients and contains no synthetic hormones or prescription substances.

3.3  Not Medical Advice

Nothing on the BalanceByHer website, in our advertising, in our marketing materials, or in any communications from our team constitutes medical advice. The information we provide is for informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.

Always seek the advice of your physician or another qualified healthcare provider before starting any new supplement, especially if you:

• Are pregnant or breastfeeding

• Have or have had a hormone-sensitive condition such as breast cancer, ovarian cancer, endometriosis, or uterine fibroids

• Are currently taking prescription medications, including hormone therapy, antidepressants, blood thinners, or thyroid medications

• Have a known allergy to any of the ingredients in Solstice

• Have a pre-existing medical condition being managed by a healthcare provider

3.4  Ingredient Transparency

The complete ingredient list and supplement facts for Solstice are displayed on the product label and on our product page at balancebyher.com. We are committed to full transparency in our formulation. Solstice contains soy isoflavones — individuals with soy allergies should not use this product.

If you have questions about specific ingredients and potential interactions, please consult your healthcare provider before use.

3.5  Keep Out of Reach of Children

Solstice is formulated for adult women experiencing symptoms of perimenopause or menopause. This product is not intended for use by individuals under the age of 18. Keep out of reach of children. Store in a cool, dry place away from direct sunlight.

3.6  Do Not Exceed Recommended Dose

Take only the recommended dose of 2 capsules per day as directed on the product label. Do not exceed the recommended daily dose. Taking more than the recommended amount will not produce faster results and may increase the risk of adverse effects.

3.7  Reporting Adverse Events

If you experience an unexpected or adverse reaction to Solstice, discontinue use immediately and consult a healthcare provider. Adverse events related to dietary supplements can also be reported to the FDA's MedWatch program at fda.gov/safety/medwatch.