Food supplements A webinar presented by: Dr Andy Bowles Attendee Notes 12/06/2018 Food Supplements Dr Andy Bowles 1 This webinar will consider What are food supplements? Legal framework Permitted ingredients Labelling of food supplements Common non-compliances This webinar will consider What are food supplements? Legal framework Permitted ingredients Labelling of food supplements Common non-compliances 1 Page1 12/06/2018 What are food supplements? Vitamin tablets Protein powders Mineral capsules Body building mixes 4 What are food supplements? Defined as - Any food the purpose of which is to supplement the normal diet and which – a) Is a concentrated source of a vitamin or mineral or other substance with a nutritional or physiological effect, alone or in combination; AND b) Is sold in dose form 5 What are food supplements? “Dose Form” A form such as capsules, pastilles, tablets, pills, and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids or powders designed to be taken in measured small unit quantities. “Nutritional or Physiological Effect” Not defined 6 2 Page2 12/06/2018 What are food supplements? Food Supplements must be sold prepacked Prepacked – Ready for sale to the ultimate consumer or a catering establishment, AND It is put into packaging before being offered for sale in such a way that the food supplement cannot be altered without opening or changing the packaging. 7 Medicinal products Any substance or combination of substances presented as having properties of preventing or treating disease in human beings that may be used by or administered to human beings with a view to restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action, or making a medical diagnosis 8 Medicinal products Medicines and Healthcare products Regulatory Agency (MHRA) Further information https://www.gov.uk/guidance/decide-if-your- product-is-a-medicine-or-a-medical-device What is a Medicinal Product Guidance (https://www.gov.uk/government/uploads/system/uploads/attachment_dat a/file/398998/A_guide_to_what_is_a_medicinal_product.pdf) 9 3 Page3 12/06/2018 Borderline medicinal products Agnus castus Phenibut Amygdalin Picamilon Benzocaine Pygeum Africanum Black cohosh DMAA Rhubarb root GABA Synephrine Hoodia Yohimbine Hydroxycitric Acid Lidocaine Melatonin 10 This webinar will consider What are food supplements? Legal framework Permitted ingredients Labelling of food supplements Common non-compliances Legal framework Directive 2002/46/EC Food Supplements (E, W, S & NI) Regulations 2003 As amended 12 4 Page4 12/06/2018 Food Supplements (E) Regulation 2003 Regulation 5 Regulation 6 Regulation 2 Prohibition on sale Regulation 8 Labelling Definitions relating to Enforcement requirements composition Schedule 1 Regulation 3 Regulation 7 Regulation 9 Permitted vitamins & Scope Manner of marking Offences minerals Schedule 2 Regulation 4 Form of vitamins & Restriction on sale minerals Guidance Non-statutory guidance produced by DoH Summary information on legislation relating to the sale of food supplements Label advisory statements and suggested reformulations Summary information on the labelling of food supplements Guidance notes on legislation implementing Directive 2002/46/EC on food supplements List of Vitamins and Minerals which may be used in the manufacture of food supplements in the EU 14 15 5 Page5 12/06/2018 16 This webinar will consider What are food supplements? Legal framework Permitted ingredients Labelling of food supplements Common non-compliances Permitted vitamins and minerals Permitted List Schedule 1 Food Supplements Regs Annex 1 of Directive 2002/46/EC Form of vitamins and minerals to be used Schedule 2 Food Supplements Regs Annex 2 of directive 2002/46/EC 18 6 Page6 12/06/2018 Permitted list 19 Permitted form 20 EFSA Register of questions http://registerofquestions.efsa.europa.eu/roqFrontend/login?0 21 7 Page7 12/06/2018 This webinar will consider What are food supplements? Legal framework Permitted ingredients Labelling of food supplements Common non-compliances Labelling of food supplements Labelling requirements set out: Regulation (EU)1169/2011 Mandatory requirements Food Supplements Regulations Additional requirements Regulation (EC) 1924/2006 Nutrition and health claims 23 Regulation 1169/2011 Art 9 Mandatory Food Information Information must be: Easily visible and Clearly Legible Exempt from nutritional labelling requirement Minimum font size applies to mandatory requirements only 24 8 Page8 12/06/2018 Labelling Requirements Regulation 6 Must be marked with: Name “Food Supplement” Name of the category of any Vitamin, Mineral or Other Substance with a nutritional or physiological effect which characterises the product or an indication of the nature of the vitamin or mineral or other substance. 25 Labelling Requirements Regulation 6 The portion of product recommended for daily consumption. Statement to the effect that food supplements should not be used as a substitute for a varied diet. 26 Labelling Requirements Regulation 6 Statement to the effect that the product should be stored out of the reach of young children. 27 9 Page9 12/06/2018 Labelling Requirements Regulation 6 Amount of Vitamin, Mineral or Other Substance providing nutritional or physiological effect In numerical form with relevant unit of measurement Average amount based on analysis Vitamins and Minerals listed in Annex 1 also state percentage of RDA 28 Source: Guidance Note No. 21: Food Supplements Regulations and Notifications (Revision 2) FSAI 29 This webinar will consider What are food supplements? Legal framework Permitted ingredients Labelling of food supplements Common non-compliances 10 Page10 12/06/2018 Common non-compliances Nutrition claims Health claims Claims generally not substantiated Novel ingredients General labelling issues Non-permitted additives Failure to include food supplement label info. 31 This webinar will consider What are food supplements? Legal framework Permitted ingredients Labelling of food supplements Common non-compliances Dr Andy Bowles Specialist Food Law Solicitor [email protected] www.abcfoodlaw.co.uk @abcfoodlaw 01603 274486 11 Page11 Page12 Page13 Page14 Source: Guidance Note No. 21: Food Supplements Regulations and Notifications (Revision 2) FSAI Page15 02002L0046 — EN — 26.07.2017 — 007.001 — 8 ▼M3 ANNEX I Vitamins and minerals which may be used in the manufacture of food supplements 1. Vitamins Vitamin A (μg RE) Vitamin D (μg) Vitamin E (mg a-TE) Vitamin K (μg) Vitamin B1 (mg) Vitamin B2 (mg) Niacin (mg NE) Pantothenic acid (mg) Vitamin B6 (mg) Folic acid (μg) (1 ) Vitamin B12 (μg) Biotin (μg) Vitamin C (mg) 2. Minerals Calcium (mg) Magnesium (mg) Iron (mg) Copper (μg) Iodine (μg) Zinc (mg) Manganese (mg) Sodium (mg) Potassium (mg) Selenium (μg) Chromium (μg) Molybdenum (μg) Fluoride (mg) Chloride (mg) Phosphorus (mg) Boron (mg) Silicon (mg) (1 ) Folic acid is the term included in Annex I of Commission Directive 2008/100/EC of 28 October 2008 amending Council Directive 90/496/EEC on nutrition labelling for foodstuffs as regards recommended daily allowances, energy conversion factors and definitions for nutrition labelling purposes and covers all forms of folates. Page16 02002L0046 — EN — 26.07.2017 — 007.001 — 9 ▼M3 ANNEX II Vitamin and mineral substances which may be used in the manufacture of food supplements A. Vitamins 1. VITAMIN A (a) retinol (b) retinyl acetate (c) retinyl palmitate (d) beta-carotene 2. VITAMIN D (a) cholecalciferol (b) ergocalciferol 3. VITAMIN E (a) D-alpha-tocopherol (b) DL-alpha-tocopherol (c) D-alpha-tocopheryl acetate (d) DL-alpha-tocopheryl acetate (e) D-alpha-tocopheryl acid succinate (f) mixed tocopherols (1 ) (g) tocotrienol tocopherol (2 ) 4. VITAMIN K (a) phylloquinone (phytomenadione) (b) menaquinone (3 ) 5. VITAMIN B1 (a) thiamin hydrochloride (b) thiamin mononitrate (c) thiamine monophosphate chloride (d) thiamine pyrophosphate chloride 6. VITAMIN B2 (a) riboflavin (b) riboflavin 5′-phosphate, sodium 7. NIACIN (a) nicotinic acid (b) nicotinamide (c) inositol hexanicotinate (inositol hexaniacinate) (1 ) alpha-tocopherol < 20 %, beta-tocopherol < 10 %, gamma-tocopherol 50-70 % and delta- tocopherol 10-30 % (2 ) Typical levels of individual tocopherols and tocotrienols: — 115 mg/g alpha-tocopherol (101 mg/g minimum), — 5 mg/g beta-tocopherol (< 1 mg/g minimum), — 45 mg/g gamma-tocopherol (25 mg/g minimum), — 12 mg/g delta-tocopherol (3 mg/g minimum), — 67 mg/g alpha-tocotrienol (30 mg/g minimum), — < 1 mg/g beta-tocotrienol (< 1 mg/g minimum), — 82 mg/g gamma-tocotrienol (45 mg/g minimum), — 5 mg/g delta-tocotrienol (< 1 mg/g minimum), (3 ) Menaquinone occurring principally as menaquinone-7 and, to a minor extent, mena­ quinone-6. Page17 02002L0046 — EN — 26.07.2017 — 007.001 — 10 ▼M3 8. PANTOTHENIC ACID (a) D-pantothenate, calcium (b) D-pantothenate, sodium (c) dexpanthenol (d) pantethine 9. VITAMIN B6 (a) pyridoxine hydrochloride (b) pyridoxine 5′-phosphate (c) pyridoxal 5′-phosphate 10. FOLATE (a) pteroylmonoglutamic acid (b) calcium-L-methylfolate ▼M6 (c) (6S)-5-methyltetrahydrofolic acid, glucosamine salt ▼M3 11. VITAMIN B12 (a) cyanocobalamin (b) hydroxocobalamin (c) 5′-deoxyadenosylcobalamin (d) methylcobalamin 12. BIOTIN (a) D-biotin 13. VITAMIN C (a) L-ascorbic acid (b) sodium-L-ascorbate (c) calcium-L-ascorbate (1 ) (d) potassium-L-ascorbate