Supplement & Peptide Informed Consent
This Consent explains the use of nutritional supplements, peptide therapies, and similar compounded or off-label products recommended or dispensed by Lipedema Warrior Clinic ("Clinic"). Read it carefully and ask questions before signing.
1. Nature of Recommendations
Based on individualized clinical evaluation, the Clinic may recommend or prescribe: (a) dietary supplements (vitamins, minerals, amino acids, botanicals, probiotics, and similar products); (b) bioidentical or compounded hormones; (c) peptide therapies prepared by licensed compounding pharmacies; (d) injectable nutrients (such as B vitamins, glutathione, NAD+); and (e) other natural, integrative, or off-label therapies. These recommendations are part of a comprehensive plan that may also include conventional medicine, lifestyle change, and other interventions.
2. FDA Regulation and Off-Label Use
• Dietary supplements are regulated as foods, not drugs. They are not evaluated by the FDA for diagnosis, treatment, cure, or prevention of disease. Product quality varies by manufacturer; the Clinic chooses brands it believes are high-quality, but cannot guarantee any particular product.
• Many peptides are NOT FDA-approved for the indications for which they are commonly used. Some are prepared by compounding pharmacies under section 503A or 503B of the Federal Food, Drug, and Cosmetic Act. Some peptides have been placed on FDA bulks lists or have been restricted; availability and legal status can change over time.
• Off-label use of FDA-approved medications is a legal and accepted practice of medicine when supported by clinical judgment, but it means the FDA has not specifically approved the medication for that use.
• Long-term safety, efficacy, drug-drug interactions, and pregnancy/breastfeeding safety of many peptides and natural products are not fully established.
3. Potential Benefits
Potential benefits depend on the specific product, dose, and clinical indication. They may include improvement of nutritional status, support of metabolic or hormonal function, improvement of energy, sleep, body composition, recovery, inflammation, or other measures. No specific benefit is promised or guaranteed.
4. Potential Risks and Side Effects
Risks vary by product and dose. They may include, but are not limited to:
• Allergic or hypersensitivity reactions (rash, swelling, anaphylaxis).
• Injection-site pain, bruising, infection, or scarring with injectable products.
• Gastrointestinal symptoms (nausea, vomiting, diarrhea, constipation, abdominal pain).
• Headache, dizziness, fatigue, insomnia, or changes in mood.
• Changes in blood pressure, heart rate, blood sugar, electrolytes, or hormone levels.
• Liver, kidney, or other organ effects, particularly with high doses or long-term use.
• Interactions with other medications, supplements, or medical conditions.
• Unknown long-term risks for some peptides and compounded products.
• Risks specific to pregnancy, breastfeeding, fertility, or future cancers, where data are limited.
The Clinic will discuss product-specific risks before recommending or prescribing. Some peptides and hormones carry additional risks discussed in product-specific consents.
5. Alternatives
Alternatives include declining supplement or peptide therapy, lifestyle and dietary changes alone, conventional pharmacologic therapy, alternative complementary therapies, or no treatment. The Clinic will discuss alternatives appropriate to your situation.
6. Your Responsibilities
• Provide a complete, accurate list of medications, supplements, allergies, and health conditions.
• Use products only as prescribed or directed.
• Store products as instructed (refrigeration, light protection, expiration).
• Report side effects, new symptoms, or concerns to the Clinic promptly.
• Keep follow-up appointments and complete recommended monitoring (labs, blood pressure, weight, etc.).
• Do not share, sell, or transfer prescribed products to anyone else.
• Dispose of unused products safely; do not flush medications unless specifically instructed.
7. Pregnancy & Reproductive Considerations
If you are or may become pregnant, or are breastfeeding, you must inform the Clinic before starting any product. Many supplements, peptides, hormones, and compounded products are NOT recommended during pregnancy or breastfeeding because of limited safety data. Use effective contraception when advised.
8. No Guarantee
The Clinic makes no guarantee that any supplement, peptide, hormone, or other product will produce a specific clinical result. Individual response varies.
9. Financial
Most supplements, peptides, hormones, and compounded products are not covered by insurance and are billed directly to you. See the Financial Policy and Cancellation & Refund Policy for additional terms, including that compounded medications and peptides are not returnable or refundable.
10. Voluntary Consent
My participation in supplement, peptide, hormone, or compounded therapy is voluntary. I have had the opportunity to ask questions; my questions have been answered to my satisfaction. I may decline or discontinue therapy at any time.