Health Claims For Dietary Supplements2


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Short Introduction to Health Claims for SMVs

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  • Health Claims For Dietary Supplements2

    1. 1. Health claims for dietary supplements<br />Helle Buchardt Boyd<br />Senior Toxicologist, M.Sc. (food science), Environment and Toxicology<br />, 4516 9097<br />June 15, 2011<br />
    2. 2. Outline<br /><ul><li>Whatarehealthclaims?
    3. 3. The legal basis
    4. 4. Procedure for approval
    5. 5. Criteria for approval of healthclaims
    6. 6. Experience from the assessment of submittedhealthclaims
    7. 7. Takehomemessage</li></li></ul><li>What are health claims?<br />Dietary supplements are foods (legally speaking) supplied in dosage form<br />Dietary supplements must have some kind of function: nutritional and/or health-wise<br />
    8. 8. Definition of healthclaims<br />‘health claim’ means any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health<br />‘claim’ means any message or representation, which is not mandatory …., including pictorial, graphic or symbolic representation, in any form, which states, suggests or implies that a food has particular characteristics<br />
    9. 9. Examples of health claims submitted for approval<br />Increased insulin sensitivity<br />Improved blood glucose control<br />Change in body shape<br />Reduction of waist circumference<br />Good for maintenance of joints<br />Reduced risk of osteoarthritis<br />Protection of skin from UV-induced damage<br />Maintenance of skin function<br />Antioxidant<br />Antioxidant defence<br />Protection of cells from premature aging<br />Contributes to a normal homocysteine metabolism<br />Maintenance of normal blood pressure<br />
    10. 10. The legal basis<br />In EU: regulation 1924/2006 on nutrition and healthclaims made on foods<br />Article 13 claims: the role of a nutrient or other substance in:<br /><ul><li>growth, development and the functions of the body, or
    11. 11. psychological and behavioural functions; or
    12. 12. slimming or weight-control or a reduction in the sense of hunger or an increase in the sense of satiety or to the reduction of the available energy from the diet</li></ul>Article 14 claims: <br /><ul><li>reduction of disease risk claims; and
    13. 13. claims referring to children's development and health</li></li></ul><li>Procedure for approval (1)<br />Article 13.1 claimssubmitted via <br />memberstates to Commission<br /> by 31 Jan 2008<br />EFSA has <br />postponed all the 13.1 claims for herbaldietary supplements <br />EFSA assesseswhetherclaims<br />arebased on generally <br />acceptedscientificevidence<br />The commission is delayed in issuing the list<br />Commission to issue a list of <br />acceptable claims with conditions<br />
    14. 14. Procedure for approval (2)<br />Article 13.5 claims submitted<br /> to the Commission via a<br /> Member State at any time<br />EFSA issues opinion on the<br />newly developed and/or proprietary<br /> evidence within 5 months<br />Applicant is protected from subsequentapplicantsusing his data for 5 years<br />The commission decides the <br />Permission within two months and <br />after consultation of Member States<br />
    15. 15. Procedure for approval (3)<br />Article 14 claims submitted<br /> to the Commission via a<br /> Member State at any time<br />EFSA issues opinion on <br />Scientific evidence and <br />wording within 5 months<br />The commission decides the <br />Permission within two months and <br />after consultation of Member States<br />
    16. 16. Main criteria for approval of claims<br />The health claim must be substantiated by generally accepted scientific evidence<br />The claimed effect must be beneficial<br />The average consumer can be expected to understand the beneficial effects as expressed in the claim<br />The substance must be available in sufficient quantity and form to exert the claimed effect<br />
    17. 17. Experience so far<br />Generally acceptedevidence = human intervention studies of goodquality; meta analyses; maybesupported by animal data and other data.<br />Characterisation of substance is veryimportant<br />Antioxidant claims: theseeffectsremains to beproved as beneficial for humans, and theyneed to be more specific<br />Avoidpitfalls in measurements of oxidativedamage to lipids, DNA or proteins in the body<br />Youare not excluded from usingstudy populations whichare not entirelyhealthy, such as hypercholesteremic persons<br />…….and much more<br />
    18. 18. What can we learn from this?<br />