Regulatory Compliance of Health Claims on Omega-3 Fatty Acid Food Supplements

Unlike the mandatory information that must be provided on a food supplement label, health claims are voluntary. This study assesses the regulatory compliance of omega-3 fatty acid (ω-3-FA) supplement label claims. Of the 97 supplements, 76 (78.4%) carried verbal claims referring to active substance,...

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Main Authors: Jelena Banović Fuentes, Ivana Beara, Ljilja Torović
Format: Article
Language:English
Published: MDPI AG 2024-12-01
Series:Foods
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Online Access:https://www.mdpi.com/2304-8158/14/1/67
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author Jelena Banović Fuentes
Ivana Beara
Ljilja Torović
author_facet Jelena Banović Fuentes
Ivana Beara
Ljilja Torović
author_sort Jelena Banović Fuentes
collection DOAJ
description Unlike the mandatory information that must be provided on a food supplement label, health claims are voluntary. This study assesses the regulatory compliance of omega-3 fatty acid (ω-3-FA) supplement label claims. Of the 97 supplements, 76 (78.4%) carried verbal claims referring to active substance, of which 68 (89.5%) were claims specific to ω-3-FA. According to the European Union Health Claims Registry, 107 claims listed on 59 supplements were authorized, as opposed to nine unauthorized claims on nine supplements. The degree to which claims aligned with regulatory standards, expressed in terms of scores scaled from 0 to 1, was the highest for supplements intended for pregnant women (1), while, in the case of adults, the mean score was 0.76 ± 0.35, and, in case of children, was 0.85 ± 0.27. Statistical analysis revealed a minor tendency for higher health claim scores to be associated with lower product prices. Furthermore, differences in compliance levels across groups of supplements formed according to the country of origin/sources of ω-3-FA/target populations were explored. The main differences were associated with products from Sweden and Italy/fish oil/supplements for pregnant women. A comparison of the daily intake of ω-3-FA provided by the supplement (based on labeled information) with the intake requirements for supplements with claims referring to ω-3-FA, supported 91 claims, five were unsubstantiated, and 11 were missing required data. Supplements also contained mineral- (19 approved) and vitamin-related claims (73, of which 9 were unauthorized). This study’s findings reveal the extent of misuse of labelled information in markets that require pre-market supplement registration. Importantly, the non-compliance of health claims can significantly undermine consumer trust.
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spelling doaj-art-a7b71d94d487493791dbe4dc29280f972025-01-10T13:17:41ZengMDPI AGFoods2304-81582024-12-011416710.3390/foods14010067Regulatory Compliance of Health Claims on Omega-3 Fatty Acid Food SupplementsJelena Banović Fuentes0Ivana Beara1Ljilja Torović2Department of Pharmacy, Faculty of Medicine, University of Novi Sad, 21000 Novi Sad, SerbiaDepartment of Chemistry, Biochemistry and Environmental Protection, Faculty of Science, University of Novi Sad, 21000 Novi Sad, SerbiaDepartment of Pharmacy, Faculty of Medicine, University of Novi Sad, 21000 Novi Sad, SerbiaUnlike the mandatory information that must be provided on a food supplement label, health claims are voluntary. This study assesses the regulatory compliance of omega-3 fatty acid (ω-3-FA) supplement label claims. Of the 97 supplements, 76 (78.4%) carried verbal claims referring to active substance, of which 68 (89.5%) were claims specific to ω-3-FA. According to the European Union Health Claims Registry, 107 claims listed on 59 supplements were authorized, as opposed to nine unauthorized claims on nine supplements. The degree to which claims aligned with regulatory standards, expressed in terms of scores scaled from 0 to 1, was the highest for supplements intended for pregnant women (1), while, in the case of adults, the mean score was 0.76 ± 0.35, and, in case of children, was 0.85 ± 0.27. Statistical analysis revealed a minor tendency for higher health claim scores to be associated with lower product prices. Furthermore, differences in compliance levels across groups of supplements formed according to the country of origin/sources of ω-3-FA/target populations were explored. The main differences were associated with products from Sweden and Italy/fish oil/supplements for pregnant women. A comparison of the daily intake of ω-3-FA provided by the supplement (based on labeled information) with the intake requirements for supplements with claims referring to ω-3-FA, supported 91 claims, five were unsubstantiated, and 11 were missing required data. Supplements also contained mineral- (19 approved) and vitamin-related claims (73, of which 9 were unauthorized). This study’s findings reveal the extent of misuse of labelled information in markets that require pre-market supplement registration. Importantly, the non-compliance of health claims can significantly undermine consumer trust.https://www.mdpi.com/2304-8158/14/1/67consumer informationfood labellingpublic healthsupplementation
spellingShingle Jelena Banović Fuentes
Ivana Beara
Ljilja Torović
Regulatory Compliance of Health Claims on Omega-3 Fatty Acid Food Supplements
Foods
consumer information
food labelling
public health
supplementation
title Regulatory Compliance of Health Claims on Omega-3 Fatty Acid Food Supplements
title_full Regulatory Compliance of Health Claims on Omega-3 Fatty Acid Food Supplements
title_fullStr Regulatory Compliance of Health Claims on Omega-3 Fatty Acid Food Supplements
title_full_unstemmed Regulatory Compliance of Health Claims on Omega-3 Fatty Acid Food Supplements
title_short Regulatory Compliance of Health Claims on Omega-3 Fatty Acid Food Supplements
title_sort regulatory compliance of health claims on omega 3 fatty acid food supplements
topic consumer information
food labelling
public health
supplementation
url https://www.mdpi.com/2304-8158/14/1/67
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