Terms of Use and

Limitation of Liability

Website Disclaimer, Medical Risks & Terms of Use

IMPORTANT: If you are experiencing a psychiatric emergency, suicidal thoughts, or a medical emergency, call 911 immediately or text/call 988 (Suicide & Crisis Lifeline). Do not rely on this website, our app, or any AI features as your sole source of crisis support. The Service is not designed for real-time emergency monitoring or response.

  1. Acceptance of Terms

By accessing or using the New Day Therapeutics website, platform, mobile application, or any associated digital service (collectively, the “Service”), you acknowledge that you have read, understood, and agree to be bound by these Terms and Conditions (“Terms” or “Agreement”) and all applicable laws and regulations. If you disagree with any part of this Agreement, you must not use the Service.

New Day Therapeutics, Inc. (“New Day,” “we,” “us,” or “our”) may update or revise these Terms at any time in our sole discretion. Changes become effective upon posting to the Service. Your continued use of the Service after we post changes constitutes your acceptance of those changes.

  1. Eligibility and Intended Users

The Service is intended only for individuals who are 18 years of age or older and who reside in jurisdictions where New Day operates and where the Service is legally available. By using the Service, you represent and warrant that you meet these criteria. New Day’s clinical programs are designed primarily for adults with treatment-resistant post-traumatic stress disorder (PTSD), major depressive disorder, generalized anxiety disorder, or related trauma‑associated conditions, but eligibility is determined by a licensed clinician based on an individualized assessment.

  1. Relationship with New Day Therapeutics and Providers

Use of the Service for informational purposes alone does not create a physician-patient, therapist-patient, or other clinical relationship between you and New Day or any clinician. If you register for and are accepted into a New Day clinical program, you may enter a direct patient relationship with independent, licensed clinicians or medical practices that collaborate with New Day. Any such relationship is limited to the clinical services actually provided to you, and does not create a broader provider-patient relationship outside the scope of those services or as otherwise described in your clinical onboarding and informed consent documents.

New Day itself is not a medical practice and does not direct or control the independent medical judgment of any clinician. Clinicians exercise professional judgment in evaluating eligibility, prescribing or declining to prescribe medication, and determining appropriate treatment.

  1. Not Medical Advice – Informational and Supportive Use Only

The content on the Service—including articles, blog posts, program descriptions, clinical summaries, educational materials, and AI-generated responses—is provided for general informational and educational purposes only. It does not constitute, and must not be construed as, the practice of medicine, nursing, psychology, psychiatry, pharmacy, or any other licensed health care profession.

No content on the Service:

  • Creates or implies a physician-patient, therapist-patient, or other clinical relationship between you and New Day or any clinician, unless and until you have been formally enrolled into a clinical program and evaluated by a licensed provider.

  • Substitutes for a face-to-face or telehealth evaluation, diagnosis, or treatment plan by a qualified, licensed health care professional.

  • Constitutes a recommendation to begin, modify, or discontinue any medication, supplement, therapy, or treatment regimen.

Any AI‑generated or automated content may be incomplete, outdated, or inaccurate and should not be relied upon as medical advice or as a basis for emergency decision‑making. Always seek the advice of your physician or other qualified health care provider with any questions regarding a medical condition or treatment, and never disregard professional medical advice or delay seeking it because of something you have read or received through the Service.

  1. Medical Risks of Ketamine Therapy – Full Disclosure

New Day is committed to transparency about the known risks and limitations of ketamine therapy, especially in at‑home telehealth models that use compounded oral ketamine. New Day’s program uses low doses of ketamine calibrated to target a sub‑dissociative, psycholytic effect; however, individual responses vary, and some patients may still experience dissociation, perceptual changes, or other unexpected effects.

Known risks include, but are not limited to:

  • Cardiovascular Risk: Ketamine can transiently increase blood pressure and heart rate. For individuals with uncontrolled hypertension, certain cardiac conditions, or a history of aneurysm, ketamine use may be unsafe. All patients are screened for cardiovascular contraindications before enrollment, and some applicants will not be accepted.

  • Psychiatric Risk: Individuals with a history of psychosis, bipolar I disorder, or certain other severe psychiatric conditions may be at increased risk of worsening symptoms or ketamine‑associated psychosis. The New Day program is not appropriate for patients with active or high‑risk psychotic disorders.

  • Dependency and Addiction: Ketamine is a Schedule III controlled substance and has potential for misuse and addiction, particularly when used outside a supervised medical setting or at higher‑than‑prescribed doses. Patients must adhere strictly to their prescribed dose and schedule. Exceeding the prescribed dose may result in discharge from the program and could have legal consequences.

  • Long‑Term Effects: The long‑term effects of daily or near‑daily low‑dose ketamine use are not fully understood. New Day uses structured monitoring to detect potential emerging adverse effects, but this monitoring is not a guarantee of safety.

  • Bladder and Urinary Tract Issues: Long‑term and high‑dose ketamine use has been associated with bladder and urinary tract problems, including ketamine‑induced cystitis. These risks are more commonly reported with doses higher than those used in the New Day program, but patients should promptly report urinary symptoms (frequency, urgency, pain, blood in urine) to their care team.

  • Cognitive and Neurological Effects: Chronic heavy ketamine use has been associated with cognitive impairment, memory issues, and other neuropsychiatric effects. The dosing strategy in the New Day program is intended to reduce, but cannot eliminate, these risks.

  • Psychological Effects: Even at low doses, ketamine can produce perceptual changes, dissociation, anxiety, or distressing psychological experiences. Even at low doses, ketamine can produce perceptual changes, dissociation, anxiety, or distressing psychological experiences. Patients who experience distressing effects should report them through the app or directly to their care team as soon as possible.

Side Effect Profile (low‑dose oral ketamine):
Commonly reported side effects include nausea, dizziness or lightheadedness, and temporary changes in sleep. A minority of patients report these effects and they often improve within approximately 7–10 days; however, side effects can persist or newly emerge. This description is based on internal program data and clinical experience and does not represent a complete list of possible adverse effects.

Protocol and Regulatory Status:
New Day’s specific treatment protocol has not yet been evaluated in randomized controlled trials. The U.S. Food and Drug Administration (FDA) has not approved ketamine for the treatment of depression, anxiety, or PTSD; such use is “off‑label.” New Day’s compounded ketamine products are prepared by licensed compounding pharmacies and are not FDA‑approved finished drug products. The safety and effectiveness of compounded ketamine products for these indications have not been established by the FDA.

  1. Prescription Medications and Compounding

New Day facilitates access to ketamine hydrochloride (HCl) oral troches and other prescription medications as part of a structured, clinician‑supervised treatment program. Medications are dispensed only pursuant to a valid prescription issued by a licensed prescriber following an independent clinical evaluation, which may occur via telehealth consistent with applicable federal and state law.

  • Compounded ketamine troches are prepared by independent, licensed compounding pharmacies registered with applicable state boards of pharmacy. Compounded medications are not FDA‑approved drug products and have not undergone the same pre‑market review as commercially manufactured drugs.

  • Prescribing clinicians exercise independent professional judgment. New Day does not direct, control, or interfere with clinical decisions regarding whether to prescribe, continue, adjust, or discontinue any medication.

  • Medications are prescribed and dispensed only to enrolled patients who meet clinical eligibility criteria. Sharing, transferring, or reselling prescription medications is prohibited and may violate federal and state law.

  • Ketamine is a Schedule III controlled substance under the federal Controlled Substances Act. New Day and its pharmacy partners comply with applicable controlled substances regulations, including prescription requirements and Prescription Drug Monitoring Program (PDMP) reporting where required.

  • New Day and its clinicians do not guarantee any particular clinical outcome or level of improvement.

  1. AI‑Assisted Monitoring – Limitations and Disclaimers

The New Day Service uses artificial intelligence (AI) and machine learning (ML) to analyze patient‑reported data, check‑in responses, symptom trends, and adherence metrics. These tools are designed to assist clinicians and are not a substitute for professional judgment or direct clinical care.

  • The AI system does not provide continuous, real‑time monitoring and is not designed to detect or respond to emergencies. Analysis is based on data you choose to submit and may not reflect events occurring between submissions.

  • Algorithmic outputs (e.g., risk flags, pattern detection, reminders) are decision‑support tools only. Clinically significant alerts and recommendations may be reviewed by qualified clinical staff before action is taken, where reasonably practicable and subject to clinician judgment and workload constraints.

  • The AI system is not a medical device cleared or approved by the FDA and is not intended to diagnose, treat, cure, or prevent any disease.

  • The system may fail to detect or accurately characterize clinical deterioration, adverse events, or psychiatric emergencies. You must not rely solely on AI alerts or app notifications for your safety.

If you are in crisis or considering self‑harm, you must immediately contact emergency services or a crisis hotline (e.g., 911 or 988) rather than relying on the Service.

  1. Informed Consent, Patient Responsibilities, and Program Scope

Participation in any New Day clinical program requires completion of a formal informed consent process with a licensed clinician. These informed consent documents, along with any additional clinical agreements you sign, govern your medical treatment and are separate from this Agreement.

By enrolling in a clinical program, you agree that:

  • You have received, read, and understood the informed consent materials related to use of compounded ketamine and any other prescribed medications, including risks, benefits, alternatives, and limitations.

  • You are responsible for providing truthful, complete, and accurate information to New Day and your clinicians at all times, including during initial intake, daily check‑ins, and follow‑up visits; incomplete or inaccurate information may impair clinical judgment and safety monitoring.

  • Completing daily check‑ins and other required assessments is a core component of treatment and may affect clinical decision‑making and medication refill eligibility.

  • You will not drive or operate heavy machinery for at least two hours after taking a dose of ketamine, and longer if you feel impaired.

  • You will store medications securely, away from children, adolescents, and unauthorized individuals; troche containers are not child‑resistant.

  • You will not exceed the prescribed dose or frequency; doing so may lead to discharge from the program and may require additional evaluation or reporting.

The New Day program is not:

  • An emergency mental health service or crisis stabilization unit.

  • A substitute for inpatient psychiatric care, intensive outpatient programs, or other higher‑level care when clinically indicated.

  • A provider of psychotherapy, licensed counseling, or psychoanalysis, unless separately and explicitly arranged with a licensed professional.

  • A licensed pharmacy; pharmacy services are provided by independent, licensed third‑party pharmacies.

You are not considered an active medication‑management patient until you have been clinically evaluated by a licensed prescriber and, if appropriate, a prescription has been issued. Clinical evaluation alone does not guarantee that medication will be prescribed or continued.

  1. Intellectual Property and User Submissions

All content, trademarks, logos, and proprietary materials on the Service are owned by New Day or its licensors and are protected by applicable intellectual property laws. You may access and use this content solely for your personal, non‑commercial use related to the Service, and you may not copy, reproduce, modify, distribute, publicly display, or create derivative works without prior written permission, except as permitted by law.

By submitting information, content, or materials through the Service (including survey responses, text entries, and feedback), you grant New Day a non‑exclusive, worldwide, royalty‑free, sublicensable license to use, reproduce, modify, and analyze such submissions for the purpose of providing, maintaining, and improving the Service, conducting quality assurance, and supporting research and product development, subject to applicable law and our Privacy Policy.

  1. Privacy

New Day collects, uses, and protects personal information, including health information, in accordance with applicable law (such as HIPAA where it applies) and our Privacy Policy. By using the Service, you acknowledge that you have reviewed the Privacy Policy and agree that it is incorporated into these Terms by reference. The Privacy Policy is available at https://newdaythera.com/legal-privacy-terms (or a successor URL).

  1. Limitation of Liability and No Warranties

To the fullest extent permitted by law, New Day, its officers, directors, employees, clinicians, contractors, affiliates, licensors, and agents will not be liable for any indirect, incidental, consequential, special, punitive, or exemplary damages arising out of or relating to:

  • Your use of or reliance on the Service or any content, information, or features.

  • Any delay, interruption, or failure of the Service, including the AI monitoring system.

  • Any adverse clinical outcome, medication side effect, or treatment response.

  • Any unauthorized access to, use of, or alteration of your data not resulting from New Day’s gross negligence or willful misconduct.

In jurisdictions that do not allow exclusion or limitation of certain damages, liability is limited to the maximum extent permitted by law. To the extent that any liability cannot be excluded, New Day’s total aggregate liability to you for all claims arising out of or relating to the Service and these Terms will not exceed the greater of (a) one hundred dollars (US $100) or (b) the amount you paid to New Day for use of the Service during the three (3) months preceding the event giving rise to the claim.

The Service and all content, features, and functionality are provided on an “as is” and “as available” basis, without any warranties of any kind, express or implied, including but not limited to implied warranties of merchantability, fitness for a particular purpose, title, and non‑infringement. New Day does not warrant that the Service will be uninterrupted, secure, error‑free, or free of viruses or other harmful components.

  1. Indemnification

You agree to indemnify, defend, and hold harmless New Day and its officers, directors, employees, contractors, affiliates, clinicians, and agents from and against any claims, damages, losses, liabilities, costs, and expenses (including reasonable attorneys’ fees) arising out of or relating to:

  • Your use or misuse of the Service.

  • Your violation of these Terms.

  • Your violation of any rights of another person or entity.

  • Any information or content you submit through the Service.

  1. Governing Law; Binding Arbitration; Class Action and Jury Waiver

Governing Law. These Terms and any dispute, claim, or controversy arising out of or relating to the Service or this Agreement (collectively, “Disputes”) are governed by the laws of the State of Ohio, without regard to conflict‑of‑law principles, except that applicable federal and state health and controlled‑substance laws will also apply.

Agreement to Arbitrate. Except as expressly provided below, you and New Day agree that any Dispute will be resolved solely and exclusively by final and binding arbitration, not in court. The Federal Arbitration Act governs the interpretation and enforcement of this arbitration agreement. Arbitration will be administered by the American Arbitration Association (“AAA”) under its applicable rules (including, where available, consumer rules), as modified by this Section.

Unless you and New Day agree otherwise, the arbitration will be conducted by a single neutral arbitrator. To the extent permitted by the applicable rules, the arbitration may be conducted on a documents‑only basis, by telephone, or by video conference. If an in‑person hearing is required, the hearing will take place in the county where you reside or, if required by law or agreed by the parties, in Franklin County, Ohio. The arbitrator’s decision will be final and binding, and judgment on the award may be entered in any court of competent jurisdiction.

Class Action Waiver. TO THE MAXIMUM EXTENT PERMITTED BY LAW, YOU AND NEW DAY AGREE THAT EACH MAY BRING CLAIMS AGAINST THE OTHER ONLY IN YOUR OR ITS INDIVIDUAL CAPACITY, AND NOT AS A PLAINTIFF OR CLASS MEMBER IN ANY PURPORTED CLASS, COLLECTIVE, CONSOLIDATED, REPRESENTATIVE, OR MASS ACTION OR PROCEEDING. THE ARBITRATOR MAY NOT CONSOLIDATE MORE THAN ONE PERSON’S CLAIMS OR OTHERWISE PRESIDE OVER ANY FORM OF CLASS, COLLECTIVE, REPRESENTATIVE, OR MASS PROCEEDING.

Jury Trial Waiver. TO THE FULLEST EXTENT PERMITTED BY LAW, YOU AND NEW DAY KNOWINGLY AND VOLUNTARILY WAIVE ANY RIGHT TO A TRIAL BY JURY IN ANY COURT ACTION ARISING OUT OF OR RELATING TO ANY DISPUTE BETWEEN YOU AND NEW DAY.

Exceptions and Equitable Relief. Either party may bring an individual action in small claims court if the claim is within that court’s jurisdiction. Either party may also seek temporary, preliminary, or permanent injunctive or other equitable relief in any court of competent jurisdiction to protect its intellectual property rights, confidential information, or to address unauthorized access or misuse of the Service.

Time Limit. To the fullest extent permitted by law, any Dispute must be filed within one (1) year after the claim arose; otherwise, the claim is permanently barred.

  1. Notices and Electronic Communications

By using the Service, you consent to receive disclosures, notices, and other communications from New Day electronically, including by email, in‑app messaging, or posting within the Service. You agree that all electronic communications satisfy any legal requirement that such communications be in writing.

  1. Contact Information

If you have questions about these Terms or the Service, please contact:

New Day Therapeutics, Inc.
Email: admin@newdaythera.com
Website: newdaythera.com

Copyright © 2026 New Day Therapeutics, Inc. | Last Updated: April 27, 2026