This Medical, Regulatory, and FDA Compounded Drug Disclaimer applies to losingweightrx.com (the "Website"), which is owned and operated by Losing Weight RX LLC ("Company," "we," "us," or "our"). By accessing or using this Website, you acknowledge, understand, and agree to all provisions set forth below.
1. Platform Scope & Non-Medical Provider Status
Losing Weight RX LLC is a digital health publisher, educational resource, and technology-enabled performance marketing referral platform. Losing Weight RX LLC is NOT a medical practice, telemedicine group, healthcare provider, or compounding pharmacy.
We do not practice medicine, pharmacy, or nursing. We do not provide medical diagnosis, clinical evaluation, treatment plans, or prescription writing. All clinical evaluations, patient intakes, consultations, and prescriptions are conducted exclusively by independent, board-certified healthcare professionals licensed in their respective jurisdictions and affiliated with third-party telehealth networks (including Embody Health and Gala Health).
Nothing contained on this Website should be construed as medical advice, clinical diagnosis, or a recommendation for any specific medication, dosage, or therapeutic regimen. Always seek the advice of your personal physician or a qualified healthcare provider regarding any medical condition or before beginning any weight management program.
2. FDA Compounded Medication Notice (FD&C Act § 503A)
In accordance with Section 503A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 353a):
- Compounded drugs are NOT approved or evaluated by the U.S. Food and Drug Administration (FDA) for safety, effectiveness, or quality.
- Compounded pharmaceuticals do not undergo FDA premarket review, randomized double-blind clinical trials, or post-marketing adverse event surveillance equivalent to commercially manufactured, FDA-approved brand-name drugs.
- Compounded medications are prepared in state-licensed 503A pharmacies adhering to United States Pharmacopeia (USP) guidelines, including USP <797> for sterile compounding and USP <795> for non-sterile compounding.
- Losing Weight RX LLC does not compound, formulate, test, store, package, label, dispense, or ship prescription medications. All compounding and fulfillment operations are executed solely by licensed pharmacy partners.
3. Nominative Fair Use Trademark Notice
This Website contains comparative references to commercially available, FDA-approved pharmaceutical products, including:
- Ozempic® and Wegovy® (registered trademarks of Novo Nordisk A/S).
- Mounjaro® and Zepbound® (registered trademarks of Eli Lilly and Company).
Any use of these commercial brand names on losingweightrx.com is made strictly for nominative, educational, and comparative reference purposes under 15 U.S.C. § 1125(c)(3). Losing Weight RX LLC, its affiliates, and its partner clinical networks have no commercial relationship, sponsorship, licensing, or endorsement from Novo Nordisk A/S or Eli Lilly and Company. The compounded formulations referenced on this Website are distinct, customized formulations and are not manufactured by Novo Nordisk or Eli Lilly.
4. Clinical Contraindications & Black Box Warnings
GLP-1 receptor agonists (Semaglutide) and dual GLP-1/GIP receptor agonists (Tirzepatide) carry serious clinical risks, adverse side effect profiles, and statutory boxed warnings:
- Thyroid C-Cell Tumors: In rodent carcinogenicity studies, semaglutide and tirzepatide caused dose-dependent and treatment-duration-dependent thyroid C-cell tumors, including medullary thyroid carcinoma (MTC). It is unknown whether these medicines cause thyroid C-cell tumors in humans.
- Absolute Contraindications: Compounded GLP-1 and dual GLP-1/GIP therapies are strictly contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not take these medications if you have known hypersensitivity to semaglutide, tirzepatide, or any inactive ingredients.
- Pancreatitis & Gallbladder Disease: Discontinue medication immediately and seek urgent emergency medical attention if you experience severe abdominal pain radiating to your back, with or without vomiting.
- Hypoglycemia & Dehydration: Inform your doctor if you take sulfonylureas or insulin, as combination therapy increases hypoglycemia risk. Severe gastrointestinal adverse reactions can cause dehydration, which may lead to acute kidney injury.
- Pregnancy & Breastfeeding: Discontinue GLP-1 therapies at least 2 months prior to a planned pregnancy due to potential fetal harm.
5. Individual Results & No Guarantee
Weight loss outcomes described on losingweightrx.com reflect clinical study averages and individual user reports. Weight loss is not guaranteed. Actual outcomes depend on multiple individual biological variables, including starting BMI, metabolic baseline, genetic predisposition, dietary adherence, physical exercise, and medical compliance. Testimonials do not guarantee identical results.
6. Legal & Regulatory Inquiries
For inquiries regarding regulatory compliance, medical disclosures, or corporate governance, please contact Losing Weight RX LLC electronically at: [email protected].