Dietary supplements: International legal framework and adulteration profiles, and characteristics of products on the Brazilian clandestine market

Regulatory Toxicology and Pharmacology

Volumn 73, Issue 1, 2015, Pages 93-104

  Justa Neves, Diana Brito da ^a   Caldas, Eloisa Dutra ^b  

^a National Institute of Criminalistics   (Brazil)

^b UNIVERSITY OF BRASILIA   (Brazil)

Author keywords

Adulteration; Brazil; Dietary supplements; European union; Fat burners; Hormones; Irregular products; Legislation; United states

Indexed keywords

ANABOLIC AGENT; ANOREXIGENIC AGENT;

ADULTERATION; ARTICLE; BODY BUILDING; BRAZIL; CHEMICAL ANALYSIS; CHEMICAL COMPOSITION; CHEMICAL PROCEDURES; CLINICAL EFFECTIVENESS; DIET SUPPLEMENTATION; EUROPEAN UNION; FOOD AND DRUG ADMINISTRATION; FOOD CONTAMINATION; FOOD SAFETY; HEALTH EDUCATION; HEALTH HAZARD; HUMAN; LAW; PRIORITY JOURNAL; SEXUAL FUNCTION; UNITED STATES; WEIGHT REDUCTION; DIETARY SUPPLEMENT; DRUG CONTAMINATION; LEGISLATION AND JURISPRUDENCE; PRODUCT SAFETY; STANDARDS;

BRAZIL; CONSUMER PRODUCT SAFETY; DIETARY SUPPLEMENTS; DRUG CONTAMINATION; EUROPEAN UNION; HUMANS; LEGISLATION, FOOD; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84936858440     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2015.06.013     Document Type: Article

References (93)

1. Almeida A.E., Ribeiro M.L., Polese L. Determination of Amfepramone Hydrochloride, Fenproporex, and Diazepam in so-called "Natural" Capsules used in the Treatment of Obesity 2000, vol. 23:1109-1118. Rel. Tech, (Accessed 29.09.14.).
2. ANVISA (Brazilian Sanitary Surveillance Agency) Resolução - RDC n° 16, de 30 de abril de 1999 - Aprova o Regulamento Técnico de procedimentos para registro de alimentos e ou novos ingredientes, constante do anexo desta Portaria 1999.
3. ANVISA (Brazilian Sanitary Surveillance Agency) Resolução - RDC n° 18, de 30 de abril de 1999 - Aprova o Regulamento Técnico que estabelece as diretrizes básicas para análise e comprovação de propriedades funcionais e ou de saúde alegadas em rotulagem de alimentos 1999.
4. ANVISA (Brazilian Sanitary Surveillance Agency) Resolução - RDC n° 259, de 20 de setembro de 2002 - Aprova o Regulamento sobre rotulagem de alimentos embalados 2002.
5. ANVISA (Brazilian Sanitary Surveillance Agency) Resolução - RDC n° 81, de 05 de novembro de 2008 - Dispõe sobre o Regulamento Técnico de Bens e Produtos Importados para fins de Vigilância Sanitária 2008.
6. ANVISA (Brazilian Sanitary Surveillance Agency) Resolução - RDC n° 18, de 27 de abril de 2010 - Dispõe sobre alimentos para atletas 2010.
7. ANVISA (Brazilian Sanitary Surveillance Agency) Resolução - RDC n° 27, de 06 de agosto de 2010 - Dispõe sobre as categorias de alimentos e embalagens isentos e com obrigatoriedade de registro sanitário 2010.
8. ANVISA (Brazilian Sanitary Surveillance Agency) Informe Técnico n° 45, de 28 de dezembro de 2010 - Esclarecimentos sobre a regulamentação de chás 2010.
9. ANVISA (Brazilian Sanitary Surveillance Agency) Gerência Geral de Medicamentos 2011, Nota Técnica n° 4, de 07 de janeiro de 2011.
10. ANVISA (Brazilian Sanitary Surveillance Agency) Resolução - RDC n° 28, de 28 de junho de 2011 - Altera dispositivos da Resolução de Diretoria Colegiada - RDC n° 81, de 5 de novembro de 2008, que aprovou o Regulamento Técnico de Bens e Produtos Importados para fins de Vigilância Sanitária 2011.
11. ANVISA (Brazilian Sanitary Surveillance Agency) Resolução - RDC n° 37, de 02 de julho de 2012-Dispõe sobre a atualização do Anexo I, Listas de Substâncias Entorpecentes, Psicotrópicas, Precursoras e Outras sob Controle Especial, da Portaria SVS/MS n° 344, de 12 de maio de 1998 e dá outras providências 2012.
12. ANVISA (Brazilian Sanitary Surveillance Agency) Resolução - RDC n° 26, de 13 de maio de 2014 - Dispõe sobre o registro de medicamentos fitoterápicos e o registro e a notificação de produtos tradicionais fitoterápicos 2014.
13. ANVISA (Brazilian Sanitary Surveillance Agency) Alimentos/Assuntos de Interesse/Informes Técnicos 2014, Updated on October 2, 2014, (Accessed 30.06.15). http://portal.anvisa.gov.br/wps/content/Anvisa+Portal/Anvisa/Inicio/Alimentos/Assuntos+de+Interesse/Informes+Tecnicos.
14. ANVISA (Brazilian Sanitary Surveillance Agency) NOTIVISA - Sistema de Notificações em Vigilância Sanitária 2014, Updated on May 26, 2014, (Accessed 30.06.15). http://www.anvisa.gov.br/hotsite/notivisa/relatorios/index.htm.
15. ANVISA (Brazilian Sanitary Surveillance Agency) Resolução - RE n° 572, de 14 de fevereiro de 2014 2014.
16. Baume N., Mahler N., Kamber M., Mangin P., Saugy M. Research of stimulants and anabolic steroids in dietary supplements. Scand. J. Med. Sci. Sports 2006, 16:41-48.
17. Bove A.A. Dietary supplements in athletes. ACC Curr. J. Rev. 2002, 11:18-20.
18. BRAZIL Decreto-Lei n. 986, de 21 de outubro de 1969. Institui normas básicas sobre alimentos 1969, 8935. Diário Oficial da União, retificação em 11 de novembro de 1969, p. 9737.
19. BRAZIL Lei n. 5.991, de 17 de dezembro de 1973. Dispõe sobre o controle sanitário do comércio de drogas, medicamentos, insumos farmacêuticos e correlatos, e dá outras providências 1973, 13049. Diário Oficial da União, retificação em 21 de dezembro de 1973, p. 13182.
20. BRAZIL Lei n. 6.360, de 23 de setembro de 1976. Dispõe sobre a Vigilância Sanitária a que ficam sujeitos os medicamentos, as drogas, os insumos farmacêuticos e correlatos, cosméticos, saneantes e outros produtos, e dá outras providências 1976, 12647. Diário Oficial da União.
21. BRAZIL Lei n. 9.677, de 02 de julho de 1998. Altera dispositivos do Capítulo III do Título VIII do Código Penal, incluindo na classificação dos delitos considerados hediondos crimes contra a saúde pública, e dá outras providências 1998, vol. 1:1. Diário Oficial da União, Seção, (03/07/1998).
22. BRAZIL Lei n. 10.742, de 06 de outubro de 2003. Define normas de regulação para o setor farmacêutico, cria a Câmara de Regulação do Mercado de Medicamentos - CMED e altera a Lei n° 6.360, de 23 de setembro de 1976, e dá outras providências 2003, vol. 1:1. Diário Oficial da União, Seção, (07/10/2003).
23. Brownie S. The development of the US and Australian dietary supplement regulations - what are the implications for product quality?. Comp. Ther. Med. 2005, 13:191-198.
24. Carvalho L.M., Correia D., Garcia S.C., Bairros A.V., Nascimento P.C., Bohrer D. Anew method for the simultaneous determination of 1,4-benzodiazepines and amfepramone as adulterants in phytotherapeutic formulations by voltammetry. For. Sci. Int. 2010, 202:75-81.
25. Carvalho-Silva L.B., Braga G.G., Lollo P.C.B. Utilização de suplemento alimentar e anabolizante por praticantes de musculação nas academias de Goiânia-GO. Rev. Bras. Nutr. Clin. 2012, 27:158-163.
26. Cohen P.A. DMAA as a dietary supplement ingredient. Arch. Int. Med. 2012, 9(172):1038-1039.
27. Coppens P., Delmulle L., Gulati O., Richardson D., Ruthsatz M., Sievers H., Sidani S. Use of botanicals in food supplements. Ann. Nutr. Met. 2006, 50:538-554.
28. Coppens P., Silva M.F., Pettman S. European regulations on nutraceuticals, dietary supplements and functional foods: a framework based on safety. Toxicology 2006, 221:59-74.
29. Corby-Edwards A.K. Regulation of Dietary Supplements 2013, R43062. Congressional Research Service, (Accessed 30.06.15). http://www.law.umaryland.edu/marshall/crsreports/crsdocuments/R43062_11132012.pdf.
30. CE (Council of Europe) Homeostasis, a Model to Distinguish between Foods (Including Food Supplements) and Medicinal Products. Partial Agreement in the Social and Public Health Field 2008, Council of Europe, Strasbourg, France.
31. Damiano F., Silva C., Gregori A., Vacondio F., Mor M., Menozzi M., Di Giorgio D. Analysis of illicit dietary supplements sold in the Italian market: identification of a sildenafil thioderivative as adulterant using UPLC-TOF/MS and GC/MS. Sci. Justice 2014, 54:228-237.
32. De Rose E.H., Feder M.G., Pedroso P.R., Guimarães A.Z. Referred use of medication and dietary supplements in athletes selected for doping control in the South-American games. Rev. Bras. Med. Esporte 2006, 12:239-242.
33. Diehl K., Thiel A., Zipfel S., Mayer J., Schnell A., Schneider S. Elite adolescent athletes' use of dietary supplements: characteristics, opinions, and sources of supply and information. Int. J. Sport Nutr. Exerc. Met. 2012, 22:165-174.
34. Doménech-Carbó A., Martini M., Carvalho L.M., Viana C., Doménech-Carbó M.T., Silva M. Screening of pharmacologic adulterant classes in herbal formulations using voltammetry of microparticles. J.Pharm. Biomed. Anal. 2013, 74:194-204.
35. Eliason M.J., Eichner A., Cancio A., Bestervelt L., Adams B.D., Deuster P.A. Case reports: death of active duty soldiers following ingestion of dietary supplements containing 1,3-dimethylamylamine (DMAA). Mil. Med. 2012, 177:1455-1459.
36. Ernst E. Harmless herbs? A review of the recent literature. Am. J. Med. 1998, 104:170-178.
37. Eudy A.E., Gordon L.L., Hockaday B.C., Lee D.A., Lee V., Luu D., Martinez C.A., Ambrose P.J. Efficacy and safety of ingredients found in preworkout supplements. Am. J. Health Sys. Pharm. 2013, 70:577-588.
38. European Commission Rapid Alert System for Food and Feed (RASFF) Portal 2014, (Access on December 30, 2014). https://webgate.ec.europa.eu/rasffwindow/portal/?event=SearchForm%26cleanSearch=1.
39. EEC (European Economic Community) Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products. Off. J. 1965, 022:369-373.
40. EC (European Parliament and European Council) Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the member states relating to the labelling, presentation and advertising of foodstuffs. Off. J. Eur. Comm. 2000, L109:29-42.
41. EC (European Parliament and European Council) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the community code relating to medicinal products for human use. Off. J. Eur. Comm. 2001, L311:67-128.
42. EC (European Parliament and European Council) Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the member states relating to food supplements. Off. J. Eur. Comm. 2002, L183:51-57.
43. EC (European Parliament and European Council) Regulation 178/2002 of the European Parliament and of the Council 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. Off. J. Eur. Comm. 2002, L31:1-24.
44. EC (European Parliament and European Council) Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the community code relating to medicinal products for human use. Off. J. Eur. Comm. 2004, L136:34-57.
45. EC (European Parliament and European Council) Regulation 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. Comm. 2006, L404:9-25.
46. EC (European Parliament and European Council) Regulation 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. Off. J. Eur. Comm. 2006, L404:26-38.
47. Eussen S.R.B.M., Verhagen H., Klungel O.H., Garssen J., van Loveren H., van Kranen H.J., Rompelberg C.J.M. Functional foods and dietary supplements: products at the interface between pharma and nutrition. Eur. J. Pharm. 2011, 668:S2-S9.
48. Fayh A.P.T., Silva C.V., Jesus F.R.D., Costa G.K. Consumption of nutritional supplements among individuals in Porto Alegre's fitness centers. Rev. Bras. Cien. Esporte 2013, 35:27-37.
49. Finley J.W., Finley J.W., Ellwood K., Hoadley J. Launching a new food product or dietary supplement in the United States: industrial, regulatory, and nutritional considerations. Ann. Rev. Nutr. 2014, 34:421-447.
50. Gee P., Tallon C., Long N., Moore G., Boet R., Jackson S. Use of recreational drug 1,3-dimethylethylamine (DMAA) associated with cerebreal hemorrhage. Ann. Emerg. Med. 2012, 60:431-444.
51. Geyer H., Braun H., Burke L.M., Stear S.J., Castell L.M. A-Z of nutritional supplements: dietary supplements, sports nutrition foods and ergogenic aids for health and performance-part 22. Br. J. Sports Med. 2011, 45:752-754.
52. Geyer H., Parr M.K., Mareck U., Reinhart U., Schrader Y., Schänzer W. Analysis of non-hormonal nutritional supplements for anabolic-androgenic steroids - results of an international study. Int. J. Sports Med. 2004, 25:124-129.
53. Geyer H., Parr M.K., Koehler K., Mareck U., Schänzer W., Thevis M. Nutritional supplements cross-contaminated and faked with doping substances. J.Mass Spectr. 2008, 43:892-902.
54. Goston J.L., Correia M.I.T.D. Intake of nutritional supplements among people exercising in gyms and influencing factors. Nutrition 2010, 26:604-611.
55. Gratz S.R., Flurer C.L., Wolnik K.A. Analysis of undeclared synthetic phosphodiesterase-5 inhibitors in dietary supplements and herbal matrices by LC-ESI-MS and LC-UV. J.Pharm. Biomed. Anal. 2004, 36:525-533.
56. Health Canada, Health Products and Food Branch Classification of 1,3 Dimethylamylamine (DMAA) 2011, http://pt.scribd.com/doc/82744576/DMAA-Health-Canada-2011.
57. Jacobson I.G., Horton J.L., Smith B., Wells T.S., Bouko E.J., Lieberman H.R., Ryan M.A.K., Smith T.C. Bodybuilding, energy, and weight-loss supplements are associated with deployment and physical activity in U.S. military personnel. Ann. Epidem. 2012, 22(5):318-330.
58. Kicman A.T. Pharmacology of anabolic steroids. Br. J. Pharmacol. 2008, 154:502-521.
59. Kristiansen M., Levy-Milne R., Barr S., Flint A. Dietary supplement use by varsity athletes at a Canadian university. Int. J. Sport Nutr. Exerc. Met. 2005, 15:195-210.
60. Lachenmeier D.W., Steffen C., El-Atma O., Maixner S., Löbell-Behrends S., Kohl-Himmelseher M. What is a food and what is a medicinal product in the European Union? Use of the benchmark dose (BMD) methodology to define a threshold for "pharmacological action". Regul. Toxicol. Pharmacol. 2012, 64:286-295.
61. Lachenmeier D.W., Löbell-Behrends S., Böse W., Marx G. Does European Union food policy privilege the internet market? Suggestions for a specialized regulatory framework. Food Control 2013, 30:705-713.
62. Li Y., Zhang H., Hu J., Xue F., Li Y., Sun C. AGC-EI-MS-MS method for simultaneous determination of seven adulterants in slimming functional foods. J.Chromatogr. Sci. 2012, 50:928-933.
63. Marcheti R.G.A. Evaluation of medicine counterfeiting in Brazil from forensic reports issued by the Brazilian Federal Police Department from 2006 to 2012 2014, (Master dissertation), Universidade de Brasília, Brasília.
64. McCann M. Dietary supplement labeling: cognitive biases, market manipulation & consumer choice. Am. J. Law Med. 2005, 31:215-268.
65. Navarro V.J., Seeff L.B. Liver injury induced by herbal complementary and alternative medicine. Clin. Liver Dis. 2013, 17:715-735.
66. Nogueira F.R.S., Souza A.A., Brito A.F. Prevalence of the use and ergogenic resources effects by body builders in Brazilian academies: a systematic review. Rev. Bras. Ativ. Fís. Saúde 2013, 18:16-30.
67. Oliver A.S., León M.T.M., Guerra-Hernández E. Prevalence of protein supplement use at gyms. Nutr. Hosp. 2011, 26:1168-1174.
68. Petroczi A., Taylor G., Naughton D.P. Mission impossible? Regulatory and enforcement issues to ensure safety of dietary supplements. Food Chem. Toxicol. 2011, 49:393-402.
69. Rebiere H., Guinot P., Civade C., Bonnet P.-A., Nicolas A. Detection of hazardous weight-loss substances in adulterated slimming formulations using ultra-high-pressure liquid chromatography with diode-array detection. Food Addit. Cont. 2012, 29:161-171.
70. Saeedi P., Nasir M.T.M., Hazizi A.S., Vafa M.R., Foroushani A.R. Nutritional supplement use among fitness club participants in Tehran, Iran. Apetite 2013, 60:20-26.
71. SVS (Brazilian Secretary of Health Surveillance) Portaria n° 32, de 13 de janeiro de 1998. - Aprova o regulamento técnico para suplementos vitamínicos e ou de minerais 1998.
72. SVS (Brazilian Secretary of Health Surveillance) Portaria n° 344, de 12 de maio de 1998 - Aprova o Regulamento Técnico sobre substâncias e medicamentos sujeitos a controle especial 1998.
73. Sepkowitz K.A. Energy drinks and caffeine-related adverse effects. J.Am. Med. Assoc. 2013, 309:243-244.
74. Shahidi N.T. Areview of the chemistry, biological action, and clinical applications of anabolic-androgenic steroids. Clin. Ther. 2001, 23:1355-1390.
75. Silva A.A., Marins J.C.B. Consumption and level of knowledge about nutritional ergogenic resources in athletes. Biosci. J. 2013, 29:1038-1048.
76. Song F., Monroe D., El-Demerdash A., Palmer C. Screening for multiple weight loss and related drugs in dietary supplement materials by flow injection tandem mass spectrometry and their confirmation by liquid chromatography tandem mass spectrometry. J.Pharm. Biomed. Anal. 2014, 88:136-143.
77. Tang M.H.Y., Chen S.P.L., Ng S.W., Chan A.Y.W., Mak T.W.L. Case series on a diversity of illicit weight-reducing agents: from the well known to the unexpected. Br. J. Clin. Pharmacol. 2011, 71:250-253.
78. Timcheh-Hariri A., Balali-Mood M., Aruan E., Sadeghi M., Riahi-Zanjani B. Toxic hepatitis in a group of 20 male body-builders taking dietary supplements. Food Chem. Toxicol. 2012, 50:3826-3832.
79. USA (United States of America) Federal food, drug, and cosmetic act. Public Law 1938, 75-717:52. Stat. 1040 - 1059; June 25 1938, (last updated in December 5, 2011). http://www.fda.gov/regulatoryinformation/legislation/FederalFoodDrugandCosmeticActFDCAct/default.htm.
80. USA (United States of America) Dietary supplement health and education act of 1994. Public Law 1994, 103-417:108. Stat. 4325 - 4335; October 25 1994.
81. USA (United States of America) FDA food safety modernization act. Public Law 2011, 111-353:124. Stat. 3885 - 3973; January 4 2011.
82. USFDA (U.S.Food and Drug Administration) Food and drug administration modernization act. Public Law 1997, 105-115. Section 303.
83. USFDA (U.S.Food and Drug Administration) Guidance for Industry: Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements 2003, http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm053832.htm.
84. USFDA (U.S.Food and Drug Administration) Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Final Rule, 72 Federal Register 34752-34958, June 25, 2007 2007.
85. USFDA (U.S.Food and Drug Administration) Guidance for Industry: Evidence Based Review System for the Scientific Evaluation of Health Claims - Final 2009, (Accessed 30.06.15). http://www.fda.gov/food/guidanceregulation/ucm073332.htm.
86. USFDA (U.S.Food and Drug Administration) Beware of Fraudulent Dietary Supplements 2011, (Accessed 30.06.15). http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm246744.htm.
87. USFDA (U.S.Food and Drug Administration) Questions and Answers on Tainted Products Marketed as Dietary Supplements 2011, Updated on March 23, 2011, (Accessed 30.06.15). http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm247094.htm.
88. USFDA (U.S.Food and Drug Administration) OxyElite Pro Supplements Recalled 2013, (Accessed 30.06.15). http://www.fda.gov/forconsumers/consumerupdates/ucm374742.htm.
89. USFDA (U.S.Food and Drug Administration) FDA Uses New Authorities to Get OxyElite Pro off the Market 2013, (Accessed 30.06.15). http://blogs.fda.gov/fdavoice/index.php/2013/11/fda-uses-new-authorities-to-get-oxyelite-pro-off-the-market/.
90. USFDA (U.S.Food and Drug Administration) MedWatch Safety Alerts for Human Medical Products 2014, (Accessed 30.12.14.). http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/default.htm.
91. USFDA (U.S.Food and Drug Administration) Tainted Supplements CDER 2014, (Accessed 30.06.15). http://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?sd=tainted_supplements_cder.
92. Van Poucke C., Detavernier C., Van Cauwenberghe R., Van Peteghem C. Determination of anabolic steroids in dietary supplements by liquid chromatography-tandem mass spectrometry. Anal. Chim. Acta 2007, 586:35-42.
93. 1H-NMR. Food Addit. Cont. 2010, 27:903-916.