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FSAI Seminar

Health claims on foods and food supplements in Ireland

Radisson Hotel, Golden Lane, Dublin 8

J. Michael Morris, Senior Scientific Advisor, IMB

Food Supplements or Medicines

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Overview

• Definition of a medicine• Definition of a food• Legislative issues• Herbal substances used in food and

medicines• IMB Classification service• Experiences to date• Conclusions

What is a Medicine I

• Definition given in Article 1.2 of Directive 2001/83/EC

• Revision in Directive 2004/27/EC• IMB guide to definition of a medicinal

product for human use based on• Composition• Claim• Presentation• Function

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What is a Medicine II

Article I of Directive 2001/83/EC, as amended by Directive 2004/27/EC makes changes to the definition of a Medicinal Product. The new definition states that a medicinal product is:

(i) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or

(ii) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.

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Requirements of Medicinal Products

• Marketing is controlled by valid authorisation or registration

• Protection of consumers• Medicines should be of good quality• Risk of using the product should be

reasonable and acceptable in the light of the expected benefit

• Demonstrable therapeutic benefit should be anticipated

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IMB Guideline “Definition of a Human Medicine”

• Non-legally binding advice – definition is in the Directive

• Borderline between MP’s and foods, cosmetics, Medical Devices etc.

• Adjudication by IMB Classification Committee

• Application form and fee• Guideline revised February 2008

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What is a food? 1

• Collins “n. What one eats; solid nourishment; ”• Animal or vegetable origin?• Covers liquid preparations as well as solid

materials?• Fresh, dried, frozen, preserved or otherwise

processed foods• Sale of Foods & Drugs Acts 1875 – 1936• Health Acts 1947 – 1953• The vast majority of foods and drinks are clearly

recognisable as such• However a relatively few products may be

confused with medicines or vice-versa

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What is a food? 2

• Food additives – large range• Food contaminants• Food standards• Baby foods• Waters• Legislation administered by DoHC and

other bodies including FSAI

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Food legislation

• Food for particular nutritional uses [PARNUTS]

• Novel foods• Health claims on foods• Plant substances found in foods• Food supplement legislation

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PARNUTS Legislation

• Directive 89/398/EC• European Communities (Foodstuffs for Particular Nutritional Uses)

Regulations 2006• Foodstuffs which, owing to their special composition or

manufacturing process are clearly distinguishable from normal foodstuffs

• Must fulfill the particular nutritional requirement of persons whose digestive processes or metabolism are disturbed or persons who are in a special physiological condition and will benefit from such substances or infants or young children in good health

• Special categories - infant formulae and FOF- dietary foods FSMP- foods in energy restricted diet- intense muscular effect- carbohydrate metabolic disorder

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PARNUTS Legislation Cont.

• FSAI notification required for new foodstuffs• Additive – must be safe

– vitamins, minerals, amino acids etc.• FSMP Directive 1999/21/EC as amended• E.C. (Dietary Foods for Special Medical

Purposes) Regulations 2001, SI 64 of 2001 amended by SI 241 of 2007

• Composition and labelling requirements

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Food supplements

• Directive 2002/46/EC amended by 2006/37/EC• European Communities (Food Supplement)

Regulations 2007, S.I 506 of 2007• Foodstuffs which supplement the normal diet and

which are concentrated sources of nutrients in the form of oral solid dose, powders or liquids

• Vitamins and minerals as listed in the annexes• Medicinal products excluded• Labelling, presentation and advertising provisions

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Vitamins restricted by medicines legislation 2

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Vitamin Chemical name(s) RDA POM Notes

A Retinol (all trans) 750 µg 2.250 µg 1 IU = 0.3 µg Retinol(2500 IU (7,500 IU) 5000 IU previously

RE1 as threshold- Betacarotene Suggest 8 mg _ 1 mg ≡ 170 mcg retinolE α Tocopherol 10 mg (15 IU) - 1 mg = 1.48IUD Ergocalciferol 10 microgram 75 µg1 1µg = 40 IU

(400 IU) 3000 IU Antirachitic activityVit D

D Cholecalciferol 10 microgram 75 microgram “B1 Thiamine 2 mg -B2 Riboflavin 2 mg -B3 Niacin 20 mg -B5 Pantothenic acid 6mg (?) -B6 Pyridoxine 2.0 mg 50 mg- Folic acid 300 µg 500 µg

B12 Cyanocobalamin 4 microgramHydroxycobalamin 25 microgramMethylcobalamin -

K1 Phytomenadione No limit

1/ R.E = Retinol Equivalent2/ Medicinal Products (Prescr iption and Control of Supply) Regulations 2003 – 2008

Health and nutrition claims for food

• Regulation 1924/2006/EC• Claims shall be true, balanced and not imply

medicinal action• Claims scientifically substantiated – EFSA• Article 13 health claims well established and

scientifically based notified to EC by January 2008

• List adopted by EC 31/1/2010• New claims to be substantiated in advance

by EFSA – Articles 15 - 19

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Classification Process 1

• Application form on IMB websitewww.imb.ie

• Complete application form in full• Enclose all labels, leaflets, promotional

material• Pay attention to websites used to promote

products• Application fee €250 (€200 for supplements)• Submit to Classification Committee • Response usually within 28 days

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IMB Classification Committee

• Multidisciplinary scientific in-house committee• Consists of representatives from Human

Medicines, Medical Devices, Compliance Departments

• Expertise in medicine, pharmacy, herbal medicine, toxicology, market surveillance and pharmacovigilance , medical devices, cosmetics.

• Meets once monthly• Typically 100 applications p.a• Provides a formal response in writing• Decisions can be appealed to ACHM (final)

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Classification Process 2

• Open to dialogue – removing a claim or even changing language may alter status

• Consultation with other interested parties –e.g. FSAI for food supplements

• Two way process – FSAI makes referrals to IMB also

• Same active may be present in medicines and foods – e.g, garlic, ginger

• Some herbs may be present exclusively in foods i.e. not medicines provided no claims made

Plant substances used in medicines and foods

• “Herbal” medicines• Chambers –”a plant used in medicine; an aromatic

plant used in cookery”• “Botanical” substances used in foods as designated

by European Food Safety Authority (EFSA)• Herbal drugs and Herbal Drug Preparations (Ph.

Eur)• Herbal drugs are mainly whole, fragmented, or cut

plants, parts of plants, algae, fungi or lichen, in an unprocessed state, usually dried but sometimes fresh

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Herbal medicines

• Growing demand for herbal “natural” substances for health benefits and medicinal uses

• Effective regulation of herbal medicines is necessary to protect public health

• Ensure continued availability of herbal medicinal products of good quality in pharmacies and health stores

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Herbal Medicine Regulation

There are two routes available to approve herbal medicinal products for marketing in Ireland

• A Marketing Authorisation (MA). Products in this case must be able to demonstrate appropriate standards of quality, safety and efficacy and be accompanied by the necessary information of safe use. For more detail on product in this category please see the Human Medicines Licensing section of the IMB website www.imb.ie

• A Certificate of Traditional-use Registration (as per article 16a of Directive 2001/83/EC as amended). Products in this category are registered under the Traditional Herbal Medicinal Products Registration Scheme and are known as traditional herbal medicines

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Traditional Herbal Medicines

• Despite long tradition of use a large number of herbal products do not fulfill requirements for obtaining a MA

• Legal framework introduced by Directive 2004/24/EC for THMP’s

• Implemented in Ireland in July 2007 (SI 540 of 2007)

A traditional herbal medicinal product is a product that fulfills the following criteria (according to Directive 2004/24EC):

• intended and designed for use without the intervention of a medical practitioner for diagnosis, prescription or monitoring of treatment

• taken orally, for external use or inhalation• administered exclusively at a specified strength and dose

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Directive on Traditional Herbal Medicinal Products [THMPs]

• Directive 2004/24/EC amending Directive2001/83/EC

• Products must meet pre-defined standards:

- Quality

- Safety

- Traditional Use

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Quality

• All traditional medicinal products must conform to agreed quality standards as for any other medicinal product

• Herbal Medicinal Product Guidelines –HMPWP

⇒ 2001/83/EC - where appropriate⇒ New legislation 2004/24/EC⇒ EMA guidelines

• European Pharmacopoeia monographs

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Efficacy

• Full product authorisation application=> clinical trial data

• Well-established use’=> bibliographic applications

• 2004/24/EC -30 years on market, at least 15 in EU for THMP registration

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Manufacturing considerations

• Good Agricultural Practice [GAP]

• Good Manufacturing Practice [GMP]

⇒ Manufacturer’s Authorisation

• Good Distribution Practice [GDP]

⇒ Manufacturer’s/Wholesaler’s Authorisation

Third country importation = manufacture

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EU/Irish initiatives

• European Scientific Co-Operative on Phytotherapy [ESCOP]

• Pharmaceutical Committee of the European Union

• Herbal Medicinal Products Working Committee [HMPC]/OtherWorking Parties of the European Medicines Agency

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• IMB Herbal Medicines Project 2000 – 2002• IMB Herbal Medicines Group

herbalmedicines@imb.ie

Herbal Medicines post 2011

• Since July 27th 2007 no new THMP can come on the market without PRIOR IMB approval

• Existing herbal medicines can remain on the market up to 30/4/2011

• Applications should be received by IMB for by end April 2010 (THMP or WEU)

• Products with PA’s can of course continue to be marketed

• Few applications received• Problem not restricted to Ireland – same

across EU generally25/05/2010 Slide 27

Herbal Medicines post 2011 (2)

• Few registrations• Herbal medicines masquerading as foods• “Health claims” vs. medicinal claims• Illegal products• Marketplace availability of herbal

products?

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Herbal Medicines post 2011 (3)

• What can IMB do?• All products need to be registered

- as herbal medicines- as food supplements

• Registration with IMB or FSAI as appropriate

• Documented proof of legal status• No documentation - expect products to be

seized

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Herbal Medicines Registration

• Registration process is feasible and user friendly

• IMB is now the primary authority for determining method of sale and supply

• No longer bound by the restrictions of prescription legislation

• For example Ginkgo biloba could be accepted for THM registration provided suitable indication

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Herbal Medicines Registration (2)

• IMB aiming constantly to improve clarity of the registration process

• Developing lists of herbal substances which can only be considered as medicines

• Examples G. bilobaA. belladonnaH. perforatum

• Some of these might be acceptable OTC once registered as THM’s

e.g. GinkgoValerian

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Herbal Medicine Registration (3)

• IMB also developing a list of herbal substances acceptable for marketing as foods provided no medicinal claims made

• Developing policy in conjunction with- IMB expert Herbal sub-Committee- FSAI- DOHC- Industry

• Draft list has approximately 150 entries• Looking forward to further discussion

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Classification Committee (CC) outcome

• CC has been in existence for 10 years• 1600 products on CC Database to date• Many types of products at the interface

- Medicine/Food- Medicine/Medical Device- Medicine/Cosmetic- Medicine/Biocide- Medical Device/Cosmetic

• A large number of queries relate to oral products –medicinal product/food borderline

• Products go into one or other “box”• Cosmetics cannot be taken by mouth

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Classification examples

• Botanical substances – food or medicine?• Slimming preparations• Stimulants - “head shops”

- “sex shops”• Hair loss products for oral administration• Claims are critical

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Slimming products

• In general IMB considers these products as foods under the remit of FSAI

• May be low calorie products, bulk formers etc.• Products with or claiming pharmacological or metabolic

effects are medicinal products- Stimulate metabolism (“fat burners”)- Reduce metabolic activity e.g. enzyme suppressors – Orlistat

- Appetite suppressant – amphetamine like products

• Oral “anti-cellulite” products also regarded as medicinal products

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Classification examples cont/d

• Traditional ethnic medicines remain a problem (language etc.)

• Ph. Eur set up a TCM working party to supplement the work of its 3 groups of experts – 13A, 13B, 13H.

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Summary and Conclusions

• Products taken by mouth are foods or medicines• Products containing pharmacologically active substances

are medicines• Products making medicinal claims are medicines• Foods can make health claims• Herbal substances for oral use could be foods or

medicines depending upon the nature of the plant, method of preparation and claims

• All herbal Products in Ireland must be registered with FSAI (foods) or IMB (medicines) by 30/4/2011 at the latest

• If in doubt contact IMB Classification Committee www.imb.ie25/05/2010 Slide 37

Conclusion

• Need to be aware of the distinction between medicines and foods

• IMB Classification process is there to assist • Herbal and homeopathic medicines require

registration or authorisation by April 2011• Herbal medicines registration scheme up and running• “Positive” and “negative” lists being developed to help

improve clarity• 30/4/2011 is only 1 year away

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Questions

Thank you for your attention

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