Dietary Supplement Fraud as a Global Issue: Post-COVID-19 Increase and Regulatory Framework

Yıl 2025, Cilt: 2025 Sayı: 23, 1 - 23, 24.12.2025

Levent Şen , İlknur Koçak Şen

Öz

The global dietary supplement market has been expanding rapidly, accompanied by increasing risks of fraud and adulteration. This study examines the main types of fraud in dietary supplements, the use of prohibited substances, and their adverse health impacts. The regulatory frameworks of the United States and the European Union are comparatively analyzed, highlighting similarities and differences in approaches. According to the FDA Health Fraud Database results, the number of non-compliant products increased sharply between 2017 and 2021, with a surge in unapproved and misbranded products, particularly during the COVID-19 pandemic. In the European Union, RASFF notifications showed a similar rising trend, with sexual performance enhancers and weight-loss supplements being among the most frequently reported. In Türkiye, new regulations have been introduced since 2013, establishing significant standards for production and labeling; however, online sales and misleading advertisements persist as persistent challenges. Overall, this study highlights that fraud in dietary supplements poses significant risks to consumer health, underscoring the need for more harmonized and effective global regulations.

Anahtar Kelimeler

Dietary supplements , RASFF , fraud , consumer health , regulations

Etik Beyan

The authors have no conflict of interest with any institution or organization.

Destekleyen Kurum

The study was not supported by any institution or organization.

Proje Numarası

Çalışma herhangi bir kurum ya da kuruluş tarafından desteklenmemiştir

Küresel Bir Sorun Olarak TEG Sahteciliği: COVID-19 Sonrası Artış ve Yasal Çerçeve

Öz

Takviye edici gıda (TEG) pazarı dünya genelinde hızla büyümekte olup, bu artış sahtecilik ve tağşiş girişimlerini de beraberinde getirmiştir. Bu çalışmada, TEGlarda görülen hile türleri, kullanılan yasaklı maddeler ve bunların sağlık üzerindeki olumsuz etkileri incelenmiştir. Amerika Birleşik Devletleri ve Avrupa Birliği mevzuatları karşılaştırmalı olarak ele alınmış, düzenleyici yaklaşımlar arasındaki benzerlikler ve farklılıklar ortaya konmuştur. FDA Sağlık Sahtekârlığı Veri Tabanı sonuçlarına göre 2017–2021 yılları arasında uygunsuz ürün sayısı hızla artmış, özellikle COVID-19 pandemisi ile birlikte yeni ve onaylanmamış ürünler piyasada çoğalmıştır. Avrupa Birliği’nde de RASFF bildirimleri benzer bir artış eğilimi göstermiş, ayrıca uygunsuz ürünlerde cinsel performans artırıcı ve kilo verdirici takviyelerin öne çıktığı tespit edilmiştir. Türkiye’de 2013 yılından itibaren yürürlüğe giren düzenlemeler üretim ve etiketleme süreçlerinde önemli standartlar getirmiş olsa da, internet üzerinden satış ve yanıltıcı reklamlar hâlen ciddi bir sorun olarak devam etmektedir. Çalışma, TEGlarda yapılan sahteciliğin tüketici sağlığı açısından ciddi riskler içerdiğini ve bu alanda küresel ölçekte daha uyumlu ve etkili düzenlemelere ihtiyaç duyulduğunu ortaya koymaktadır.

Anahtar Kelimeler

Takviye edici gıda , RASFF , sahtecilik , tüketici sağlığı , yasal düzenlemeler

Etik Beyan

Yazarların herhangi bir kurum ya da kuruluşla çıkar çatışması yoktur

Destekleyen Kurum

Çalışma herhangi bir kurum ya da kuruluş tarafından desteklenmemiştir

Proje Numarası

Çalışma herhangi bir kurum ya da kuruluş tarafından desteklenmemiştir

Kaynakça

• European Commission, “Directive 2002/46/EC of the European Parliament and of the Council of 10th June 2002 on the approximation of the laws of member states relating to food supplements.,” Med. Etika Bioet., 2002, [Online]. Available: http://data.europa.eu/eli/dir/2002/46/2025-03-16
• FDA, “Dietary Supplement Health and Education Act of 1994.” Accessed: Jun. 09, 2022. [Online]. Available: https://www.govinfo.gov/content/pkg/STATUTE-108/pdf/STATUTE-108-Pg4325.pdf
• K. Barnes, L. Ball, B. Desbrow, N. Alsharairi, and F. Ahmed, “Consumption and reasons for use of dietary supplements in an Australian university population,” Nutrition, vol. 32, no. 5, pp. 524–530, 2016, doi: 10.1016/j.nut.2015.10.022.
• J. Hamulka, M. Jeruszka-Bielak, M. Górnicka, M. E. Drywié, and M. A. Zielinska-Pukos, “Dietary Supplements during COVID-19 Outbreak. Results of Google Trends Analysis Supported by PLifeCOVID-19 Online Studies,” Nutrients, vol. 13, no. 1, p. 54, 2020, doi: 10.3390/nu13010054.
• Pharmalinea, “Food supplement industry data in 2020.,” p. 21, 2020, [Online]. Available: Chrome extension://efaidnbmnnnibpcajpcglclefindmkaj/https://pharmalinea.com/wp-content/uploads/2020/01/2020-food-supplement-industry-data.pdf
• T. Rocha, J. S. Amaral, and M. B. P. P. Oliveira, “Adulteration of Dietary Supplements by the Illegal Addition of Synthetic Drugs: A Review,” Compr. Rev. Food Sci. Food Saf., vol. 15, no. 1, pp. 43–62, Jan. 2016, doi: 10.1111/1541-4337.12173.
• FAO, “Food fraud-Intention, detection and management. Food safety technical toolkit for Asia and the Pacific No. 5. Bangkok,” pp. 1–44, 2021.
• N. Artık, “Gıdalarda Tağşiş, Taklit Haksız Kazanç ve Gıda Güvenliği Riskleri Oluşturur,” Akademik Akıl. Accessed: Oct. 25, 2024. [Online]. Available: https://www.akademikakil.com/gidalarda-tagsis-taklit-haksiz-kazanc-ve-gida-guvenligi-riskleri-olusturur/nevzatartik/
• Resmi Gazete, VETERİNER HİZMETLERİ, BİTKİ SAĞLIĞI, GIDA VE YEM KANUNU. 2010. [Online]. Available: https://www.resmigazete.gov.tr/eskiler/2015/02/20150217-1.htm
• Food and Agriculture Organisation of the United Nations and World Health Organisation, “Discussion paper on food integrity and food authenticity.,” Codex Aliment. Comm. Codex Comm. Food Import Export Insp. Certif. Syst., no. August, pp. 1–7, 2018, [Online]. Available: http://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FMeetings%252FCX-733-24%252FWorking%2BDocuments%252Ffc24_07e.pdf
• European Commission, “Knowledge Centre for Food Fraud and Quality,” Knowledge for Policy. Accessed: Jun. 08, 2022. [Online]. Available: https://knowledge4policy.ec.europa.eu/food-fraud-quality/topic/food-quality_en
• N. A. S. Abdul Aziz and N. H. Kamarulzaman, “Factors Influencing Consumers’ Behaviour Towards Fraudulent Dietary Supplements,” Malaysian J. Agric. Econ., vol. 29, no. 1, pp. 1–21, 2020, doi: 10.36877/mjae.a0000161.
• I. B. G. Bernstein, J. PharmD, and J. Karin L. Bolte, “AMA Journal of Ethics 2019,” AMA J. Ethics, vol. 24, no. 5, pp. 590–595, 2022.
• V. M. Wheatley and J. Spink, “Defining the Public Health Threat of Dietary Supplement Fraud,” Compr. Rev. Food Sci. Food Saf., vol. 12, no. 6, pp. 599–613, Nov. 2013, doi: 10.1111/1541-4337.12033.
• FDA, “Health Fraud Product Database,” US Food and Drug Administration. Accessed: Jun. 25, 2024. [Online]. Available: https://www.fda.gov/consumers/health-fraud-scams/health-fraud-product-database
• European Commission, “RASSF Results.” Accessed: Apr. 18, 2025. [Online]. Available: https://webgate.ec.europa.eu/rasff-window/portal/?event=searchResultList
• FDA, “Current Food Manufactoring Practice in Manufacturing, Packaging, Labelling or Holding Operations for Dietary Supplements.” Accessed: Aug. 20, 2025. [Online]. Available: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/small-entity-compliance-guide-current-good-manufacturing-practice-manufacturing-packaging-labeling
• European Commission, “REGULATION (EC) No 1924/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 December 2006 on nutrition and health claims made on foods,” Off. J. Eur. Union, vol. 9, no. 4, 2007, [Online]. Available: https://eur-lex.europa.eu/eli/reg/2006/1924/oj
• European Comission, “setting maximum levels for certain contaminants in foodstuffs (Text with EEA relevance),” Off. J. Eur. Union, vol. No 1881, 2006, Accessed: Apr. 04, 2020. [Online]. Available: http://www.efsa.europa.eu/etc/medialib/efsa/
• European Parliament and the Council of the European Union, “Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 etc.,” Off. J. Eur. Union, vol. 327, no. 258, pp. 1–22, 2015.
• S. Thakkar et al., “Regulatory landscape of dietary supplements and herbal medicines from a global perspective,” Regul. Toxicol. Pharmacol., vol. 114, no. January, 2020, doi: 10.1016/j.yrtph.2020.104647.
• M. Avigan, R. Mozersky, and L. Seeff, “Scientific and Regulatory Perspectives in Herbal and Dietary Supplement Associated Hepatotoxicity in the United States,” Int. J. Mol. Sci., vol. 17, no. 3, p. 331, Mar. 2016, doi: 10.3390/ijms17030331.
• WHO, “WHO technical consultation: Nutrition-related health products and the World Health Organization Model List of Essential Medicines – practical considerations and feasibility,” Geneva, Switzerland, 2019. doi: 10.3109/13506129508999011.
• T. Rocha, J. S. Amaral, M. Beatriz, and P. P. Oliveira, “Adulteration of Dietary Supplements by the Illegal Addition of Synthetic Drugs: A Review”, doi: 10.1111/1541-4337.12173.
• L. Manning, M. Bieniek, A. Kowalska, and R. Ward, “Dietary supplements, harm associated with synthetic adulterants and potential governance solutions,” Crime, Law Soc. Chang., no. 0123456789, 2021, doi: 10.1007/s10611-021-09992-9.
• R. L. Bailey, “Current regulatory guidelines and resources to support research of dietary supplements in the United States,” Crit. Rev. Food Sci. Nutr., vol. 60, no. 2, pp. 298–309, 2020, doi: 10.1080/10408398.2018.1524364. [27] J. D. Morrow, “Why the United States still needs improved dietary supplement regulation and oversight,” Clin. Pharmacol. Ther., vol. 83, no. 3, pp. 391–393, 2008, doi: 10.1038/sj.clpt.6100500.
• FDA, “Draft Guidance for Industry: Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notification.” Accessed: Jun. 17, 2025. [Online]. Available: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-policy-regarding-certain-new-dietary-ingredients-and-dietary-supplements
• FDA, “Understanding dietary supplements,” 2022. [Online]. Available: https://www.fda.gov/media/158337/download (Giriş Tarihi: 07.09.2025).
• FDA, “Dietary Supplement and Nonprescription Drug Consumer Protection Act.,” Public Law 109-462, 2006.
• T. Y. Low, K. O. Wong, A. L. L. Yap, L. H. J. De Haan, and I. M. C. M. Rietjens, “The Regulatory Framework Across International Jurisdictions for Risks Associated with Consumption of Botanical Food Supplements,” Compr. Rev. Food Sci. Food Saf., vol. 16, no. 5, pp. 821–834, 2017, doi: 10.1111/1541-4337.12289.
• FDA, “Dietary Supplement Labeling Guide: Chapter I. General Dietary Supplement Labeling.” Accessed: Jun. 23, 2022. [Online]. Available: https://www.fda.gov/food/dietary-supplements-guidance-documents-regulatory-information/dietary-supplement-labeling-guide-chapter-i-general-dietary-supplement-labeling
• FDA, “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Final Rule.” https://www.fda.gov/food/dietary-supplements-guidance-documents-regulatory-information/backgrounder-final-rule-current-good-manufacturing-practices-cgmps-dietary-supplements (Giriş tarihi: 10.07.2025)
• M. A. LeDoux et al., “A quality dietary supplement: Before you start and after it’s marketed—a conference report,” Eur. J. Nutr., vol. 54, no. 1, pp. 1–8, 2015, doi: 10.1007/s00394-014-0827-4.
• FDA, “Questions and Answers on Dietary Supplements.” Accessed: Oct. 09, 2022. [Online]. Available: https://www.fda.gov/food/information-consumers-using-dietary-supplements/questions-and-answers-dietary-supplements
• J. Tucker, T. Fischer, L. Upjohn, D. Mazzera, and M. Kumar, “Unapproved Pharmaceutical Ingredients Included in Dietary Supplements Associated With US Food and Drug Administration Warnings,” JAMA Netw. open, vol. 1, no. 6, p. e183337, 2018, doi: 10.1001/jamanetworkopen.2018.3337.
• R. Lordan, “Dietary supplements and nutraceuticals market growth during the coronavirus pandemic – Implications for consumers and regulatory oversight,” PharmaNutrition, vol. 18, p. 100282, 2021, doi: 10.1016/j.phanu.2021.100282.
• The Council of Responsinle Nutrition(CRN), “Dietary Supplement Usage Up Dramatically During Pandemic, New Ipsos-CRN Survey Shows.” Accessed: Jun. 27, 2024. [Online]. Available: https://www.crnusa.org/newsroom/dietary-supplement-usage-dramatically-during-pandemic-new-ipsos-crn-survey-shows
• L. G. Saldanha, J. T. Dwyer, and R. A. Bailen, “Modernization of the National Institutes of Health Dietary Supplement Label Database,” J. Food Compos. Anal., vol. 102, no. April, p. 104058, 2021, doi: 10.1016/j.jfca.2021.104058.
• US National Institutes of Health. (NIH), “US National Institutes of Health, Office of Dietary Supplements Dietary Supplement Label Database (DSLD).” Accessed: Jun. 25, 2025. [Online]. Available: https://ods.od.nih.gov/Research/Dietary_Supplement_Label_Database.aspx
• V. Silano, P. Coppens, A. Larrañaga-Guetaria, P. Minghetti, and R. Roth-Ehrang, “Regulations applicable to plant food supplements and related products in the European Union,” Food Funct., vol. 2, no. 12, p. 710, 2011, doi: 10.1039/c1fo10105f.
• European Parliament and Council, Regulation (EC) No 178/2002 of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, vol. L31. 2002, pp. 1–24. [Online]. Available: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2002:031:0001:0024:EN:PDF
• European Commission, REGULATION (EC) No 852/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 April 2004 on the hygiene of foodstuffs. 2004.
• European Commission, “REGULATION (EU) No 1169/2011 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament,” p. L 304/18-L 304/63, 2011, [Online]. Available: https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=celex%3A32011R1169
• European Commission, “REGULATION (EC) No 1925/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods,” 2006.
• I. Pravst, “Dietary supplement labelling and health claims,” in Dietary Supplements, K. Berginc and S. Kreft, Eds., Elsevier, 2015, ch. 1, pp. 3–24. doi: 10.1533/9781782420811.1.3.
• A. Kušar and I. Pravst, “Exploitation of the traditional evidence for botanical health claims on foodstuffs in Europe,” J. Funct. Foods, vol. 89, no. August 2021, 2022, doi: 10.1016/j.jff.2022.104936.
• European Commission, Commission Regulation (EU) No 432/2012 establishing a list of permitted health claims made on foods other than those referring to the reduction of disease risk and to children’s development and heal, vol. 56, no. 1924. 2013, pp. 43–45.
• European Commission, “Evaluation of the Regulation (EC) No 1924/2006 on nutrition and health claims made on foods with regard to nutrient profiles and health claims made on plants and their preparations and of the general regulatory framework for their use in foods,” European Comission. Accessed: Jul. 22, 2022. [Online]. Available: https://ec.europa.eu/food/document/download/298ba7f2-3502-43d6-a384-d77265f0ae40_en
• European Commission, “Questions and Answers: Rapid Alert System for Food and Feed (RASFF),” 2017. Accessed: Sep. 25, 2024. [Online]. Available: https://ec.europa.eu/commission/presscorner/detail/en/MEMO_17_2461
• European Commission, “ACN Notifications.” Accessed: Oct. 25, 2025. [Online]. Available: https://food.ec.europa.eu/food-safety/acn/acn-notifications_en
• European Commission, “RASFF Annual Reports Home Page.” Accessed: Sep. 07, 2025. [Online]. Available: https://food.ec.europa.eu/safety/rasff-food-and-feed-safety-alerts/reports-and-publications_en
• D.-G. for H. and C. European Commission, The Rapid Alert System for Food and Feed (RASFF) Annual Report, no. December. 2010. doi: 10.2772/59932.
• European Comission, RASFF Annual Report. 2018. [Online]. Available: https://ec.europa.eu/food/sites/food/files/safety/docs/rasff_annual_report_2018.pdf
• Food and Veterinary Office, “Overview report Controls on food supplements in Member States,” 2015. doi: 10.2772/5906.
• DG Health and Food Safety, “Overview report Official Controls on Internet Sales of Food in EU Member States,” 2019. doi: 10.2772/57153.
• European Commission, “2020 Annual Report The EU Agri-Food Fraud Network and the Administrative Assistance and Cooperation System,” pp. 1–21, 2021.
• EUROPEAN COMMISION, “RASFF Annual Reports from 2002 to 2022,” RASFF Annual Reports from 2002 to 2022. Accessed: Aug. 20, 2024. [Online]. Available: https://food.ec.europa.eu/safety/acn/reports-and-publications_en#rapid-alert-system-for-food-and-feed-rasff