The difference between Food Supplements and Drugs

1. The difference between Food Supplementsand Drugs

2. Content • What are Food Supplements? • Why Food Supplements? • Appearance and labelling of Food Supplements • What are Health Claims? • Food Supplements and Drugs • What are Food Supplements NOT? • Comparison of Food Supplements and Drugs • Food Supplements vs. Drugs: example • References

3. 1. What are Food Supplements? The dietary ingredients in these products may include 2 • Vitamins • Minerals • Herbs or other botanicals • Other substances found in the human diet, such as enzymes, pre- and probiotics, amino acids and essentially fatty acids • Concentrates, metabolites, constituents or extracts 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. 2. WhyFood Supplements? • 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.

5. 3. Appearance and labelling of Food Supplements • Typical dosage forms of food supplements are 1 • Pills • Tablets • Capsules • Liquids in measured doses • Necessary 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" panel • Optional labeling of food supplements are HEALTH CLAIMS CVC

6. 4. WhatareHealth Claims? Any statement about a relationship between food / food components and health in regards to: 3, 5 • Growth, development and functions of the body • Psychological and behavioral functions For 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” 6

7. 4. WhatareHealth Claims? • The scientific evidence supporting Health Claims is evaluatedby the European Food Safety Authority (EFSA). 3 • EFSA 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. 7 • The European Commission authorizes Health Claims (evaluated by EFSA) that are based on scientific evidence and can be easily understood by consumers.3 • In Europe the Directive 2002/46/EC 1, 8 • harmonizes 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.

8. 5. Food Supplements and Drugs • Food Supplements may be used to 1 • correct 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 diseases State of Health • Healthyor • minor, moderate nutrient deficiency • temporary increased need of certain nutrients Food supplements • Sick / ill • as result of severe nutrient deficiency • due to non-nutritional causes (eg. bacterial infections) Drugs

9. 6. Whatare Food Supplements NOT? • Food Supplements are no generics • Food supplements do NOT need to contain • warning messages • contraindications • side effects • interactions • No bioequivalence studies have to be performed for approval • There are no clinical studies for finished products GENERICS

10. 7. Comparison of Food Supplements and Drugs

11. 8. Food Supplements vs. Drugs: example • 500 mg Calcium (highest authorized amount in Europe) • For the maintenance of normal bones and normal teeth • Contributes to normal muscle function • Has a role in the process of cell division and specialization • 1000 mg Calcium • 22 µg cholecalciferol • As an adjunct to specific osteoporosis therapy in patients with proven or at high risk of developing simultaneous calcium and vitamin D deficiency Ingredients Target group/ indication Food Supplement Drug

12. 9. References 1EFSA: Food supplements. https://www.efsa.europa.eu/en/topics/topic/food-supplements 2 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.pdf 3 European Commission (2018): Health Claims. http://ec.europa.eu/food/safety/labelling_nutrition/claims/health_claims_en 4 European Comission (2018): Food Supplements. https://ec.europa.eu/food/safety/labelling_nutrition/supplements_en 5 Canadian Food Inspection Agency (2017): Function Claims. http://www.inspection.gc.ca/food/labelling/food-labelling-for-industry/health-claims/eng/1392834838383/1392834887794?chap=7 6 European Commission (2012): Commission regulation (EU) No 432/2012. http://eur-lex.europa.eu/legal-content/DE/TXT/?uri=CELEX:32012R0432&qid=1432628491455 7 EFSA: About EFSA. http://www.efsa.europa.eu/en/aboutefsa 8 Directive 2002/46/EC https://www.fsai.ie/uploadedFiles/Dir%202002.46%20EC(2).pdf 9 U.S. FDA: Drug definition. https://www.registrarcorp.com/fda-drugs/definitions/

13. Join DenkPharma 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 portfolio

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