The difference between Food Supplements - PowerPoint Presentation

1. The difference between Food Supplements and Drugs

2. ContentWhat are Food Supplements?Why Food Supplements?Appearance and labelling of Food SupplementsWhat are Health Claims?Food Supplements and DrugsWhat are Food Supplements NOT?Comparison of Food Supplements and DrugsFood Supplements vs. Drugs: exampleReferences

3. The dietary ingredients in these products may include 2VitaminsMineralsHerbs or other botanicalsOther substances found in the human diet, such as enzymes, pre- and probiotics, amino acids and essentially fatty acidsConcentrates, metabolites, constituents or extracts1. What are Food Supplements?Food Supplements are concentrated sources of nutrients or other substances with a nutritional or physiological effect, whose purpose is to supplement the normal diet. 1

4. To prevent deficiencies of nutrients before they turn into diseases, we developed Denk Nutrition with food supplements for different target groups.We recognized that some target groups have higher needs, and possible deficiencies, of some elemental nutrients.Our vision is to improve living conditions and to contribute to the overall health of people.We firmly believe that by having a constantly growing portfolio, with now more than 20 food supplements, we can better serve individual needs.2. Why Food Supplements?

5. Typical dosage forms of food supplements are 1PillsTabletsCapsulesLiquids in measured dosesNecessary labeling of Food Supplements are 3, 4“Food supplement”“Not be represented for use as a conventional food or as the sole item of a meal or the diet”“Recommended intake”“Supplement facts" panelOptional labeling of food supplements are HEALTH CLAIMS3. Appearance and labelling of Food SupplementsCVC

6. Any statement about a relationship between food / food components and health in regards to: 3, 5Growth, development and functions of the bodyPsychological and behavioral functionsFor example: Health Claims immune active Denk “Vitamin C contributes to the normal function of the immune system“ 6 “Zinc contributes to the normal function of the immune system“ 6 “Selenium contributes to a normal function of the immune system” 64. What are Health Claims?

7. The scientific evidence supporting Health Claims is evaluatedby the European Food Safety Authority (EFSA). 3EFSA is a European agency funded by the European Union that operates independently of the European legislative and executive institutions (Commission, Council, Parliament) and EU Member States. 7The European Commission authorizes Health Claims (evaluated by EFSA) that are based on scientific evidence and can be easily understood by consumers. 3In Europe the Directive 2002/46/EC 1, 8harmonizes provisions regarding the addition of vitamins, minerals and certain other substances to foods and food supplements.has established rules to help ensure that food supplements are safe, highly bioavailable and properly labelled.4. What are Health Claims?

8. Food Supplements may be used to 1correct mild nutritional deficiencies or maintain an adequate intake of certain nutrients They are not drugs and therefore are not intended to treat, diagnose, mitigate, prevent or cure diseases5. Food Supplements and DrugsState of HealthHealthy orminor, moderate nutrient deficiencytemporary increased need of certain nutrientsSick / illas result of severe nutrient deficiencydue to non-nutritional causes (eg. bacterial infections)Food supplementsDrugs

9. Food Supplements are no genericsFood supplements do NOT need to contain warning messagescontraindicationsside effectsinteractionsNo bioequivalence studies have to be performed for approvalThere are no clinical studies for finished products6. What are Food Supplements NOT?GENERICS

10. 7. Comparison of Food Supplements and DrugsCharacteristicFood Supplement 1, 3Drug 9IntentionTo supplement the normal diet and correct mild nutritional deficiencies or maintain an adequate intake of certain nutrients → Health-relatedTo treat, diagnose, mitigate, prevent or cure diseases→ Disease-relatedUserCustomers of every age group in different phases of life cyclePatients with severe diseasesSubstances contained in preparationsConcentrated sources of nutrients or other substances with a nutritional or physiological effectChemically specified substances, minerals, vitamins, herbal preparationsDeclarationFood SupplementDrug

11. 8. Food Supplements vs. Drugs: example Food SupplementDrug 500 mg Calcium (highest authorized amount in Europe)For the maintenance of normal bones and normal teethContributes to normal muscle functionHas a role in the process of cell division and specialization 1000 mg Calcium 22 µg cholecalciferolAs an adjunct to specific osteoporosis therapy in patients with proven or at high risk of developing simultaneous calcium and vitamin D deficiencyIngredientsTarget group/ indication

12. 9. References1 EFSA: Food supplements. https://www.efsa.europa.eu/en/topics/topic/food-supplements2 EAS (2007): The use of substances with nutritional or physiological effect other than vitamins and minerals in food supplements. https://ec.europa.eu/food/sites/food/files/safety/docs/labelling_nutrition-supplements-2007_a540169_study_other_substances_en.pdf3 European Commission (2018): Health Claims. http://ec.europa.eu/food/safety/labelling_nutrition/claims/health_claims_en4 European Comission (2018): Food Supplements. https://ec.europa.eu/food/safety/labelling_nutrition/supplements_en5 Canadian Food Inspection Agency (2017): Function Claims. http://www.inspection.gc.ca/food/labelling/food-labelling-for-industry/health-claims/eng/1392834838383/1392834887794?chap=76 European Commission (2012): Commission regulation (EU) No 432/2012. http://eur-lex.europa.eu/legal-content/DE/TXT/?uri=CELEX:32012R0432&qid=14326284914557 EFSA: About EFSA. http://www.efsa.europa.eu/en/aboutefsa8 Directive 2002/46/EC https://www.fsai.ie/uploadedFiles/Dir%202002.46%20EC(2).pdf9 U.S. FDA: Drug definition. https://www.registrarcorp.com/fda-drugs/definitions/

13. Our contributions to keeping you healthy: affordable pharmaceuticals for your therapy German high premium quality for tablets, sachets, packaging, studies, consultation, availability, support, etc… raise awareness by conducting Check Up Days (blood glucose, blood pressure, cholesterol and triglyceride) constantly enhancing the product portfolioJoin Denk Pharma

14. HEALTHCARE MADE IN GERMANYsince 1948

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