Part A — Functional Medicine Informed Consent

This Informed Consent describes the nature of functional and integrative medicine as practiced at Optivita Health and asks you to acknowledge that you understand and consent to this approach. Please read it carefully and ask questions.

1. What Functional Medicine Is

Functional medicine is a systems-based, patient-centered approach to healthcare that seeks to identify and address the underlying biological mechanisms driving illness — including hormonal, metabolic, inflammatory, and gastrointestinal dysfunction — rather than focus solely on symptom suppression. It uses tools from conventional medicine (history, physical examination, laboratory testing, imaging, FDA-approved medications) along with tools from integrative and lifestyle medicine (advanced functional laboratory testing, nutrition, sleep, stress, environment, movement, supplements, peptides where appropriate, hormone optimization where appropriate, and targeted use of medications, including off-label use).

2. What Functional Medicine Is Not

It is not a substitute for emergency care, hospital-based care, or specialty care when those are indicated.
It is not a replacement for FDA-approved medications when those are clinically necessary.
It is not a guarantee of cure, remission, or specific outcomes.
It is not an alternative to following the recommendations of your other treating physicians.

3. Functional Laboratory Testing

Functional medicine often uses laboratory tests beyond those typically ordered in conventional care — for example, advanced micronutrient panels, comprehensive stool testing, food sensitivity testing, organic acid testing, expanded hormone panels, methylation and detoxification markers, and similar specialty tests. You should understand:

Reference ranges used in functional testing may differ from standard laboratory reference ranges.
Some of these tests have limited validation and are not generally accepted in conventional medicine.
Most functional laboratory tests are NOT covered by insurance and are billed directly to you.
A finding on a functional test is not, by itself, a diagnosis. Results are interpreted in the context of your full clinical picture.

4. Treatments and Interventions

Recommendations may include dietary changes, sleep and stress interventions, exercise and movement, supplements, peptides, hormones, prescription medications (including off-label use), IV or injectable therapies, environmental modifications, and referrals to other providers. Some of these interventions have strong evidence; others are supported primarily by mechanistic reasoning and clinical experience. Your provider will discuss the evidence base, potential benefits, potential risks, and reasonable alternatives for each significant recommendation.

5. Risks of a Functional Medicine Approach

Findings on advanced testing may lead to interventions whose benefit is not fully proven.
Costs (testing, supplements, peptides, time) can be substantial.
Lifestyle changes can be difficult to sustain and may cause frustration.
Conflicts with other providers' recommendations may arise; you are responsible for sharing information with your other treating clinicians.
Specific interventions carry their own risks, described in product- or therapy-specific consents.

6. Patient Responsibilities

Share complete, accurate health history, current medications, supplements, and prior testing.
Continue to see your primary care provider and specialists for issues outside the scope of the Clinic's care.
Notify the Clinic of significant changes, new diagnoses, hospitalizations, or new medications.
Follow-up and adhere to the plan as agreed; if you cannot, tell the Clinic so the plan can be adjusted.
Make informed decisions about which recommendations to pursue; you may decline any recommendation at any time.

7. No Guarantee

The Clinic makes no warranty, express or implied, about the results of functional medicine evaluation or treatment. Outcomes vary.

8. Financial

Functional medicine evaluations, follow-ups, advanced testing, and many recommended interventions are largely not covered by insurance and are billed directly to you. See the Financial Policy and Cancellation & Refund Policy.

Part B — 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 Optivita Health. 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.

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.
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.
Off-label use of FDA-approved medications is a legal and accepted practice of medicine when supported by clinical judgment.
Long-term safety, efficacy, drug-drug interactions, and pregnancy/breastfeeding safety of many peptides and natural products are not fully established.

3. Potential Risks and Side Effects

Risks vary by product and dose. They may include, but are not limited to: allergic or hypersensitivity reactions; injection-site pain, bruising, infection, or scarring with injectable products; gastrointestinal symptoms; 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; and unknown long-term risks for some peptides and compounded products.

4. 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.
Do not share, sell, or transfer prescribed products to anyone else.

5. 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.

6. No Guarantee

The Clinic makes no guarantee that any supplement, peptide, hormone, or other product will produce a specific clinical result. Individual response varies.

7. Voluntary Consent

Participation in supplement, peptide, hormone, or compounded therapy is voluntary. You have the opportunity to ask questions and may decline or discontinue therapy at any time.