Regulatory Statements

1. United States FDA Disclaimer and DSHEA Compliance

1.1 MANDATORY FDA DISCLAIMER: These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

1.2 Product Classification: Fizzoy is formulated, manufactured, and marketed as a functional food beverage, containing live probiotic cultures and prebiotic dietary fibre, with targets under 2 grams of sugar and 30 calories per 355 ml can. Fizzoy IS NOT a dietary supplement, pharmaceutical drug, medical food, or therapeutic medicine.

1.3 Permissible Structure / Function Statements: All informational content, educational copy, and graphics on fizzoy.com represent structure/function statements describing general dietary support for intestinal health, digestive comfort, and microflora balance. Statements regarding microencapsulated live cultures refer to physiological mechanisms and do not claim to treat, mitigate, or prevent medical disorders or disease conditions. We do not make claims of disease treatment, curing gastrointestinal syndromes, or replacing medical care.

2. Medical Disclaimer and Healthcare Consultation

2.1 No Medical Advice: Content provided on fizzoy.com, including statements made by our interactive chat assistant (the mascot Fizzoy) and results generated by the Gut Happiness Score questionnaire, is provided strictly for informational and educational purposes. Nothing on this website constitutes medical advice, clinical diagnosis, or therapeutic guidance.

2.2 Medical Professional Consultation Required: Consumers should consult a qualified physician, gastroenterologist, or healthcare professional before modifying their diet or introducing functional live cultures, especially if you:

• Are pregnant, planning to become pregnant, or nursing.
• Are immunocompromised, undergoing chemotherapy, or taking immunosuppressive medication.
• Suffer from severe gastrointestinal diseases, short bowel syndrome, or central venous catheter placement.
• Are taking prescription medications that affect intestinal flora.
• Are considering administering functional beverages to young children under 12 years of age.

3. Probiotic Potency, Strain Viability, and Shelf-Life CFU

3.1 Stated CFU at End of Shelf Life: Any reference to probiotic Colony Forming Units (CFU) refers to the target quantity of viable, live probiotic cells present in each 355 ml can at the end of the product shelf life, supported by ongoing shelf-life stability validation testing.

3.2 SCO2 Microencapsulation Protection: Fizzoy utilizes proprietary Supercritical Carbon Dioxide (SCO2) microencapsulation technology patented by Velobiotics (Pty) Ltd. This physical protection layer is engineered to shield live probiotic cultures against gastric acid and bile, delivering viable cultures to the intestinal tract.

3.3 Stability and Environmental Conditions: Ambient temperature, exposure to high heat, and sunlight can affect live probiotic viability. To guarantee that consumers receive active cultures matching label specifications, our formulations are subjected to extensive real-time stability studies. Final CFU declarations on physical product labels reflect these verified counts rather than initial inoculation targets.

4. Ingredient Sourcing, Recipe Flexibility, and Allergen Notices

4.1 Recipe and Ingredient Flexibility: As Fizzoy completes pre-launch formulation validation, ingredient details, botanical extract ratios, prebiotic fibre sources, sweetener blends, and specific strain selections remain subject to refinement prior to commercial production.

4.2 Allergen Transparency: Product labels will explicitly list all ingredients, dietary fibre sources, and potential allergens in compliance with national food labeling standards. Facilities handling production adhere to Good Manufacturing Practice (GMP) protocols.

4.3 Sourcing Integrity: All botanical ingredients and dietary fibers are selected from ethical, high-quality agricultural sources. If an ingredient supplier cannot meet our purity standards, we reserve the right to substitute that ingredient with a comparable, compliant alternative to preserve taste, nutritional profiles, and digestive benefits.

5. South African Regulatory Framework Compliance

5.1 Foodstuffs, Cosmetics and Disinfectants Act 54 of 1972: In South Africa, Fizzoy is produced and commercialized in full compliance with Act 54 of 1972 and applicable food labeling regulations, including Regulations R.146 (Regulations Relating to the Labelling and Advertising of Foodstuffs) and R.429 where relevant.

5.2 SAHPRA Non-Registration Notice: FIZZOY IS NOT A SAHPRA-REGISTERED MEDICINE. It has not been evaluated or registered by the South African Health Products Regulatory Authority (SAHPRA) as a medicine or complementary medicine, because it is commercialized strictly as a non-medicinal functional food beverage.

5.3 Advertising Regulatory Board (ARB) Code Compliance: Marketing materials, claims, and public advertisements comply with the Code of Advertising Practice administered by the South African Advertising Regulatory Board (ARB). Every claim relating to nutritional performance, microencapsulation, or probiotic counts is backed by rigorous scientific verification.

5.4 Regulatory Transition and compliance: We actively monitor South African Department of Health regulatory developments. Our physical labeling and digital copy are routinely updated to comply with current mandates under Regulations R.146, and we are preparing our infrastructure to seamlessly transition to future frameworks under draft Regulation R.429 as they are formally enacted.

6. United Kingdom and European Union Regulatory Framework

6.1 Regulation (EC) No 1924/2006 on Nutrition and Health Claims: In the European Union and the United Kingdom, nutrition and health claims made on functional foods are governed by Regulation (EC) No 1924/2006.

6.2 Restriction on the Word Probiotic in the EU: Consumers and international visitors should note that the word 'probiotic' is restricted or classified as an unauthorized health claim in certain EU member states. Online marketing copy, web descriptions, and physical packaging distributed within European Union jurisdictions will be adapted to meet local statutory guidelines prior to commercial European launch. In certain European territories, the term may be replaced with descriptions such as "live cultures" or "microencapsulated bacterial strains" to maintain strict compliance with the European Food Safety Authority (EFSA).

7. Australia and New Zealand Compliance Framework

7.1 Australia New Zealand Food Standards Code: Commercialization in Australia and New Zealand adheres to the FSANZ Food Standards Code governing functional beverages, prebiotic dietary fibre claims, and general nutrition standards.

7.2 Local Adaptation: Any marketing directed toward Australia and New Zealand will be structured to comply with Standard 1.2.7 of the Food Standards Code, ensuring that nutrition content claims and health claims are backed by systemic evidence and meet regional registration criteria.

8. Claim Substantiation Statements

8.1 Substantiation Statement for 'The World's 1st 16-Strain Probiotic Soda':

Our claim that Fizzoy is 'The World's 1st 16-Strain Probiotic Soda' is based on an extensive internal market audit and comparative product evaluation conducted by Velobiotics as of October 2026. This review evaluated commercially distributed live-probiotic sodas globally. Competitor formulations and product offerings in the dynamic beverage industry may change over time.

Our audit examined more than fifty active brands in the United States, South Africa, and Europe, verifying that commercial live-probiotic sodas typically feature only one to three bacterial strains, often without gastric protection. Fizzoy is unique in its deployment of a diverse 16-strain probiotic matrix designed to foster a rich gut microbiome ecosystem.

8.2 Substantiation Statement for 'the world's first SCO2 microencapsulated synbiotic soda':

Our claim that Fizzoy is 'the world's first SCO2 microencapsulated synbiotic soda' is substantiated by Velobiotics' proprietary Supercritical Carbon Dioxide (SCO2) microencapsulation patent portfolio and global market surveys as of October 2026, confirming that no competing commercial soda incorporates SCO2 microencapsulated live probiotics combined with prebiotic dietary fibre. Our microencapsulation technology is protected under active patents held by Velobiotics (Pty) Ltd, which protect the unique method of using supercritical CO2 to coat delicate cultures in a protective lipid matrix.

9. Typical Results and Individual Variation Disclaimer

9.1 Microbiome Diversity: Individual gut microbiomes, digestive sensitivity, and responses to prebiotic fibre and live probiotic cultures vary significantly from person to person.

9.2 No Guaranteed Outcomes: Testimonials, consumer survey ratings, and scores generated by the Gut Happiness Score tool represent individual experiences and do not guarantee typical or identical results for every consumer.

9.3 Initial Dietary Adjustment: First-time consumers of high-fiber prebiotic beverages may experience temporary, mild digestive changes as their microbiome adjusts to the increased fiber and live culture intake. This is normal and typically resolves within a few days of consistent consumption. Always begin with a single can daily to assess your individual digestive tolerance.

10. Pre-Release Visuals and Product Mock-Ups

10.1 Conceptual Renders: All visuals, 3D can renders, bottle photographs, video demonstrations, and packaging mock-ups displayed on fizzoy.com are pre-release conceptual illustrations. Final commercial cans, colors, graphics, and label text may vary upon commercial launch.

11. Testimonials and Influencer Endorsement Disclosures

11.1 FTC Endorsement Guides & ARB Compliance: In compliance with the United States Federal Trade Commission (FTC) Endorsement Guides and the South African ARB Code, any testimonials, reviews, or influencer endorsements featured on our website or social channels reflect genuine opinions. Any material connection (such as free product samples or affiliate compensation) is explicitly disclosed.

12. Intellectual Property, Patents, and Brand Ownership

12.1 Patent Ownership: Proprietary SCO2 microencapsulation technology is protected under international patent registrations and patent applications held exclusively by Velobiotics (Pty) Ltd, Johannesburg, South Africa (Registration Number: 2015/306434/07, Information Officer: Dr. Chomba Chuma).

13. AI Chat Assistant ("Fizzoy" Mascot) Disclaimer

13.1 Automated Responses: The mascot Fizzoy chat assistant uses artificial intelligence algorithms to answer consumer queries. AI responses do not create a professional relationship and may contain inaccuracies. Official product information is defined exclusively by our published legal documentation.

14. Regulatory Contact Information

14.1 For regulatory inquiries, compliance questions, or technical documentation requests, please contact our regulatory affairs team:

• Regulatory Contact Email: fizzoy@velobiotics.com / fizzoy@velobiotics.com
• South Africa Office: Velobiotics (Pty) Ltd, Reg No: 2015/306434/07, Information Officer: Dr. Chomba Chuma, Phone: +27 11 392 2550, WhatsApp: +27 71 426 1495.
• United States Base: Cantobiz Inc DBA Velobiotics US (Delaware stock corporation, File No. 6130903), 1820 Avenue M #1065, Brooklyn, NY 11230, United States.