Educational & Nutritional Disclaimer
Unitrition is formally and legally positioned as a consumer digital software utility for food composition calculations and meal building («Food Composition Calculator & Meal Builder Platform»). It operates strictly under the Descriptive Mirror Standard: the software reflects objective food chemistry metrics sourced from open scientific repositories (USDA FoodData Central, CIQUAL ANSES, Open Food Facts). Unitrition NEVER prescribes medical therapies, clinical dietary regimens, insulin dosages, or guaranteed weight-loss results.
1. Software Classification: Consumer Analytics Tool
Unitrition operates exclusively as a consumer Software-as-a-Service (SaaS) utility for personal productivity, analytical calculation of macronutrients and micronutrients, and interactive visual meal building. Subscription tiers (Unitrition Pro) unlock advanced computational software capabilities: dynamic vector visualizations, data exports in universal formats (CSV, JSON, PNG), secure client-side storage, and unrestricted concurrent queries against public open databases.
Unitrition explicitly and permanently disclaims any status, classification, or marketing claims as Medical Software or Software as a Medical Device (SaMD Class II) under US FDA Title 21 CFR 860 or EU Medical Device Regulation (EU) 2017/745 (MDR). The application does not interface with bodily biomedical sensors, infusion pumps, or electronic health records (EHR).
2. Open Scientific Repositories & Chemical Composition
All chemical values, macronutrient compositions, and micronutrient profiles presented across the platform originate directly from publicly accessible scientific datasets and governmental nutrition tables, including:
- USDA FoodData Central: United States Department of Agriculture (Agricultural Research Service).
- CIQUAL ANSES: French Agency for Food, Environmental and Occupational Health & Safety (ANSES).
- Open Food Facts: Open collaborative database of packaged food products under the Open Database License (ODbL).
Agronomic & Biological Variance Note: Nutritional values reflect representative laboratory averages. Actual agricultural food chemistry varies naturally based on crop cultivar, soil geochemistry, seasonal climate, harvest ripeness, and culinary heat preparation methods.
3. Bread Units (ХЕ / BU) & Objective Carbohydrate Counting
Unitrition includes Bread Units (Broteinheiten / Bread Units [ХЕ] / Raciones de Hidratos de Carbono) strictly as an objective mathematical conversion metric to translate available carbohydrate grams into standardized counting portions (10 grams, 12 grams, or 15 grams per unit, based on user configuration).
Unitrition strictly and invariably prohibits any insulin bolus calculations, correction doses, insulin-to-carb ratios (ICR), insulin sensitivity factors (ISF), or Fat-Protein Units (FPU / Warsaw formula). The software DOES NOT generate pharmacological dosing guidance or therapeutic infusion instructions. Individuals managing diabetes must consult their personal licensed endocrinologist or diabetologist for any clinical treatment decisions.
4. PRAL & Athletic Mineral Recovery (Non-Renal Scope)
The Potential Renal Acid Load (PRAL) calculation (based on the peer-reviewed scientific methodology of Remer & Manz) is implemented across the platform strictly for food chemistry balance modeling, electrolyte assessment (potassium, calcium, magnesium, phosphorus), and athletic mineral recovery optimization.
Unitrition’s PRAL modeling DOES NOT constitute a clinical staging, monitoring, or therapeutic treatment tool for Chronic Kidney Disease (CKD), pathological metabolic acidosis, or nephrolithiasis. In accordance with our Mineral Null-Safety standard, if mineral values are unmeasured in public datasets, Unitrition indicates uncertainty badges and never falsely treats missing values as 0.0 mg.
5. Carbohydrate Jurisdictions: EU 1169/2011 vs US FDA
Carbohydrate accounting regulations differ fundamentally across international regulatory frameworks. Unitrition programmatically accounts for this jurisdictional duality:
Carbohydrates declared on EU nutrition panels represent available/glycemic carbohydrates. Dietary fiber is declared as a separate independent line item. Subtracting fiber from EU carbohydrate values is mathematically erroneous and dangerously undercounts energy.
Total Carbohydrates declared under FDA nutrition facts include dietary fiber and sugar alcohols. To calculate net available carbohydrates, Unitrition’s engine subtracts non-digestible fiber in accordance with FDA labeling rules.
6. Relative Glycemic Kinetic Models (No CGM Emulation)
The postprandial glycemic kinetics and absorption curves displayed on the platform are theoretical mathematical projections bounded strictly within a 120-minute window (in full compliance with Unitrition’s GATE-8 safety invariants). These curves are constructed from macrochemical ratios (net carbohydrates, protein, fat, and soluble fiber) and published relative glycemic literature.
Unitrition is NOT a Continuous Glucose Monitor (CGM) and does not emulate interstitial fluid sensors or medical diagnostic hardware. Real in vivo human postprandial glucose trajectories vary widely based on individual biological factors: peripheral insulin sensitivity, gut microbiome composition, recent muscular glycogen depletion, acute stress, and circadian timing.
7. NOVA Processing Classification & Additive Data
The industrial food processing classification (NOVA 1 through NOVA 4) is displayed for taxonomic and educational purposes only, based on peer-reviewed criteria established by the University of São Paulo and recognized by the FAO. Food additive declarations (E-numbers) reflect open package registry information and do not constitute toxicological safety evaluations or allergy diagnostic screening.
8. Prohibition of Dosing & Weight-Loss Guarantees (Paddle AUP #15)
In strict compliance with Item #15 of the Paddle.com Market Limited Acceptable Use Policy (AUP) (our official Merchant of Record), Unitrition hereby declares and guarantees that:
9. Independent Professional Guidance & Healthcare Consultation
No mathematical calculation, macronutrient value, Bread Unit conversion, glycemic index score, or chart generated by Unitrition should ever be construed as a substitute for professional clinical judgment, medical diagnosis, or personalized dietary counseling from a licensed healthcare provider.
If you have a chronic medical condition (such as diabetes mellitus, kidney disease, cardiovascular disorder, or severe food allergies), are pregnant, nursing, or planning substantial nutritional modifications, always consult a licensed physician or registered dietitian (RD) before altering your dietary regimen.
10. Frequently Asked Questions & Regulatory Answers
Q:Is Unitrition a medical device or clinical diagnostic software (SaMD)?
No. Unitrition is strictly a consumer digital productivity software utility and food chemistry calculator (Food Composition Calculator & Meal Builder Platform). It does not qualify as Software as a Medical Device (SaMD Class II) under FDA 21 CFR 860 or EU MDR 2017/745.
Q:Does Unitrition calculate insulin doses, boluses, or correction units?
Under no circumstances. Unitrition strictly prohibits medical insulin dosing calculations, insulin-to-carb ratios (ICR), insulin sensitivity factors (ISF), Fat-Protein Units (FPU / Warsaw formula), or infusion advice. Bread Units (ХЕ / BU / Raciones) are computed purely as an objective arithmetic metric converter for available carbohydrate grams (10g, 12g, 15g).
Q:How does Unitrition handle carbohydrate calculation rules between EU and US datasets?
Unitrition enforces carbohydrate jurisdictional duality: under EU Regulation 1169/2011, declared carbohydrates represent available carbohydrates (dietary fiber is listed separately and must never be subtracted). For US FDA 21 CFR § 101.9 datasets, total carbohydrates include fiber, which is deducted to determine net available carbohydrates.
Q:Are glycemic curves and PRAL calculations intended to treat disease or simulate CGMs?
No. Glycemic curves are theoretical mathematical models over a 120-minute postprandial window based on macronutrient ratios and published relative glycemic literature; they do not simulate continuous glucose monitoring (CGM) hardware. PRAL models food chemistry acid-base balance and athletic mineral recovery; it does not diagnose or manage chronic kidney disease.
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