IADSA Annual mee,ng, April 2013, Jakarta, Indonesia La#n America: Regulatory trends across the region Ta#ana Pires, Ph.D. President, ALANUR La,n America Alliance for Responsible Nutri,on Director of ABIAD - Brazilian Industry Associa,on on Special Products and coordinator of the Dietary Supplements Working Group ALANUR, the La#n American Alliance for Responsible Nutri#on, is the first regional associa9on of food supplements in La9n America. Founded in Nov 2011 with the aim of helping create an op9mal policy and regulatory framework for food supplements and food ingredients in La9n America. 1
Alanur working plan Support regulators in the development of na9onal and regional regula9ons Informa9on program: workshops, conferences, mee9ngs Scien9fic & Technical Program: Developing and transla9ng Publica9ons Build a Regional Scien9fic Board ALANUR Publica,ons: transla,on of the IADSA Global Guide to Good Manufacturing Prac,ce for Supplements to Spanish (April 2013) 2
Regulatory Scenario in La9n America MEXICO: 1. Adver5sing control 2. Revision of botanicals 3. Scien5fic evalua5on of risks to establish maximum Levels. ECUADOR: DraS Regula5on 1. Food Supplements DraS Regula5on COLOMBIA: Revision 1. Dietary Supplements Decree 2. Health claims for dietary supplements Decree Central America Mercosur: Nutri5onal Claims VENEZUELA: DraS regula5on Defini5on, Maximum levels, Botanicals, BRAZIL: Revision Specific Regula5on: a) Classifica5on b) Defini5on c) Maximum Levels d) Botanicals CHILE: Revision 1. Aminoacids 2. Botanicals PARAGUAY: New Regula5on Defini5on, Maximum Levels, Botanicals, Claims ARGENTINA: Revision 1. Revision of Defini5on 2. Botanical s List 3. Claims URUGUAY: DraS Regula5on DraS Regula5on: Defini5on, Maximum Levels, Botanicals, Claims September 26 th, 2012 ALANUR/IADSA technical workshop in Bogotá, Colombia Par9cipants: The Na9onal Ins9tute of Food and Drugs Surveillance (INVIMA), and the Review Commission. Presenta9ons: Professor David Richardson: - Importance of supplements and ingredients. - Condi9ons of usage of nutri9onal claims and requirements to scien9fically jus9fy the usage of health claims in dietary supplements in different parts of the world and Codex. Dr. Andrew Shao: focused his presenta9on on the role and safety of bioac9ve ingredients and on botanicals. Ac5vi5es in 2013 Follow up mee9ng with authori9es (INVIMA) in Colombia: proposal to run in Bogotá a Dietary Supplements Workshop in Sept 2013 is acepted. 3
September 25th, 2012 ALANUR/IADSA mee5ng with authori5es in Quito, Ecuador Par9cipants: Public Health Ministry and the Na9onal Ins9tute of Hygiene. Presenta9ons: Dr. Andrew Shao: importance of suplements and trends in their regula9on and in scien9fic- technical ma\ers at interna9onal level. Dr. Ta5ana Pires: Alanur and developments in La9n America: trends in the region. Ac5vi5es in 2013 In March 2013, MOH request to Alanur technical and scien9fic informa9on to support the new DS regula9on in Ecuador; In April 2013: Dr. Hector Cori presenta9on via conference call to the MOH November 22nd, 2012 ALANUR/IADSA workshop in Caracas, Venezuela Follow up ac5vi5es in 2012 Par9cipants: Omega 3 regulatory status and The Na9onal Ins9tute of Nutri9on, the Ministry of Health, claims document was sent to the and the Na9onal Ins9tute of Hygiene "Rafael Rangel" (INHRR). Venezuelan authori5es as a result of the workshop in November Presenta9ons: Dr. Ta5ana Pires: trends in regula9on of food supplements in La9n America and worldwide, focusing a considerable part of the presenta9on on the classifica9on and defini9on of supplements. Dr. Luis Mejía: focused on the importance of supplements and their ingredients, and the use of nutri9onal and health claims. Dr. Hector Cori: focused on scien9fic risk assessment for the establishment of nutrient maximum levels in replacement of the RDI (recommended daily intake). 4
Addi#onal plans for 2013 Support ABIAD in the 3rd Technical Workshop on Dietary Supplements to ANVISA, the Brazilian Regulatory Agency of Health Surveillance Brasilia, Oct 2013 ABIAD Brazilian Industry Associa,on on Special Products Dietary Supplements Working Group 5
Regulatory Status of Dietary Supplements in Brazil Food Drug Supplements: Vitamins and Minerals (Portaria 32/98) Novel Foods/ Ingredients Specific medicine (RDC 24/11) Func5onal Foods Foods for athletes Bioac5ve substances and probio5cs with func5onal claims Vitamins and Minerals medicine (Portaria 40/98) Phytomedicine Main topics for the New Dietary Supplements regula#on proposed by Abiad to Anvisa: Proposal of a new Dietary Supplements regula9on including all different (current) categories (i.e. vitamins and minerals; novel foods, etc); Review max levels of vitamins and minerals based on safety (not as RDA) Permit the use of other substances together with vitamins and minerals NOT CONSIDERED AS NOVEL FOODS (reducing the level of requirements for registra9on proposals) Focus on no9fica9on instead of registra9on. 6
Ac#vi#es and Plans in 2013 March 2013 Anvisa published PORTARIA Nº 562, DE 22 DE MARÇO DE 2013 Working Group on Dietary Supplements. April 2013 Mee9ng with the President of Anvisa Dr. Dirceu Barbano and the General Manager on Special Foods Antonia Maria Aquino Plans for 2013: Develop the study: the economic impact of Dietary Supplements in reducing public health costs (TBC). In 2007: 72% of total death = Non- transmissible chronic diseases (NTCD) Potencial economic loss: US$ 4,18 billion (2006 2015) Thank you! 7