IADSA Newsflash April 2014

The IADSA Annual Week, Verona 2014

Words from Ric Hobby, New IADSA Global Leadership elected Chaiman Recap of the week’s event Awards

The 2014 IADSA Annual Meeting held in Dear Members the beautiful Italian city of Verona 2014 once again provided an opportunity for HongMin Xu, Heads of the the members to address the major I am delighted to have been entrusted Healthcare Association’s Information strategic issues facing the sector with the Chairman's role at this Exchange Committee and is Director worldwide and meet with other exciting time in IADSA's development. of Regulatory Policies for Amway members and with leading regulators China, for his exceptional work from across the world. Regulators or Having been involved in IADSA since over many years in leading work to leading scientific advisers to the founding meeting in 1998, I have build a regulatory system to support government attended from ASEAN, constantly been impressed with the the development of the Chinese China, the EU, , Korea, Mexico way the Alliance works so effectively market in food supplements. and Russia. In addition to the Annual together on so many diverse and complex issues, and achieves such Meeting, IADSA organised the first ever impressive results. global Regulator Roundtable on Peter Berry Ottaway, key technical botanical supplements and hosted advisor to IADSA since its creation, To maintain this path requires us to meetings of its Scientific Council, who has represented IADSA in many continue to work closely together, Technical Group and the Board. Codex Alimentarius committees whether from associations, small, for his world-leading experience medium or large companies or the After two terms as IADSA Chair Pete and analysis of the technical regulatory scientific community. Zambetti stepped down as Chair and issues impacting the sector RIc Hobby nominated by CRN UK, Our unique style of working with Bernd Haber, nominated by BLL 2013 government is clearly appreciated by Germany, and Michelle Stout Zubaidah Mahmud, Chair of the decision makers. We need to continue nominated by CRN US, took on their ASEAN Traditional Medicines and to provide value to them and share our two-year terms as Chair, VIce Chair Health Supplements Scientific ideas on the direction for policy and and Treasurer respectively. Committee (ATSC), for her work to regulation in our sector. help create what is the most Two Global Leadership Awards were comprehensive regional regulatory I welcome and invite your participation presented to two long-standing and model for supplements in the world. as we all work together over the next extremely dynamic experts in the sector, HongMin Xu and Peter Berry two years. Ottaway. Both had shown exceptional Dr. John Hathcock, U.S. Council leadership over many areas. for Responsible Nutrition (CRN), Ric Hobby for his exceptional contribution IADSA Chair It was agreed that the next Annual to the science that underpins Meeting would be held in Singapore in dietary supplement regulation. 2015 in view of the approaching John has worked for more than 20 deadline for the completion of the years as a leading voice in the ASEAN Economic Community which will world on the science to underpin the International Alliance of Dietary/Food create, in population terms, the regulation and use of supplements. Supplement Associations world's largest single trading market. He is the author of numerous International Non-Profit Organisation This meeting will be hosted by HSIAS, publications that have helped 50 Rue de l’Association, B-1000 Brussels – Belgium the Singapore association. shape the way regulatory bodies Tel: +32 2 209 11 55 Website: www.iadsa.org view food supplements.

Regulatory news

Japan reduction of chemical induced liver damages, hepatitis related liver damages, liver fibrosis, and

Consumer survey reveals that fatty liver. For more

40% of Japanese take information:

supplements everyday http://goo.gl/NBbpCz

The Consumer Affairs Agency

releasds early April the results of its consumer survey on 3,000 people, both males and females, from 15-69 years old. This survey was launched ASEAN in the context of the reflection on the development of the new TMHS PWG Working towards functional claims system based around he US model for finalisation of harmonized ASEAN Regulation dietary/food supplements (D/F supplements). New Zealand

The Scientific Committee, Framework Results of this survey show: Task Force and GMP Task force of Natural Health & the ASEAN Consultative Committee Supplementary Products Bill Ratio of intake D/F supplement for Standards & Quality (ACCSQ) − expected later this year past 1 year ca.44 % Traditional Medicines − Frequency of intake: About 40% and Health Supplements Product take supplements everyday The Bill is foreseen later this Working Group (TMHS PWG) met in Feeling of safety for D/F year, potentially prior to an Kuala Lumpur Malaysia from 3 - 7 − supplement: 20 - 40% believe October/November election and March 2014. Though the scientific that supplements are safer than may likely enter into force 1 – 2 committee did not manage to drugs months after its enactment. complete pending technical − Impression for active requirements such as safety data ingredients of natural sources: The Natural Health & requirements and limits of microbial more than 50% feel that these Supplementary Products Bill contaminants, significant progress ingredients are safe seeks to regulate low-risk had been made. The finalisation of Reasons for taking D/F natural health products in New these technical requirements can be − supplement No.1 Health Zealand. Part 1 of the bill expected in the next 2 meetings. The Promotion ca.40% - No.2 defines a natural health product next meeting for the scientific Balance of Nutrients: Ca.38%- according to how the product is committee, Framework Task Force No.3 Recovery of fatigue consumed, its ingredients, and and GMP Task force, will be held Ca.23% the type of claim of health from 23- 27 June 2014, back to back Impression for structure/ benefit made. It also proposes with the 22nd ACCSQ TMHS PWG − function claims in US: More the establishment of a meeting, at Siem Reap . than 70% think the can make regulatory authority within the

their right choice themselves Ministry of Health, which would

− Scientific Evidence for recognise decisions made by India functional claims of D/F other authorities, create an supplement: More than 60% advisory committee to advise Calls for data for more than 1x believe that human studies for the authority, and maintain an RDA all foods would be required. online database of natural This percentage increases to health products. The Chair of the Sub-group on the 80% for both tablet/capsule Part 2 sets out the regulatory draft Nutraceuticals Regulations has forms. scheme. It proposes that before recently called for published data on products can be marketed, they the Indian population to support Tawain more than one RDA in view of revising would have to be notified on an the Draft Food/Heath supplement/ online database. Part 2 would nutraceutical Regulation. The issue Taiwan FDA to revise health establish penalties, a code of will be referred to the Indian Council food efficacy evaluation manufacturing practice, and of Medical Research (ICMR), the body methods for claims on liver mechanisms for appeal and the responsible of the RDA for the Indian protection recall of products. It would also population. require product notifiers to Taiwan FDA on 4 March issued inform the authority about any A 2006 law currently restricts the use revised draft "Efficacy Evaluation serious adverse reactions to of minerals or vitamins in amounts Methods for Claims on Liver products, and any ingredients exceeding the RDA for Indians. Protection" for public consultation which were not previously until 18 March 2014. The draft also notified.

includes requirements on claims, advertisements, and product labelling. Approved claims are related to the prevention and risk

http://eur- safety concern at the proposed lex.europa.eu/LexUriServ/LexUriSer uses. v.do?uri=OJ:L:2014:050:0011:0016:E N:PDF Polyvinylpyrrolidone-vinyl acetate copolymer (E1208) has now been added to the list of Illegal presence of meso- food additives approved for use zeaxanthin in eye- health in solid form supplements at a supplements level of 100,000 mg/kg.

Strong suspicion were put on eye- Polyvinylpyrrolidone-vinyl health supplements containing acetate copolymer is a binding / lutein and zeaxanthin, following the Europe coating agent known to improve occurrence of adverse events film toughness, increase coating reported under the French Adverse application rates and promotes Favourable EFSA opinion on Report System ‘Nutrivigilance’. The better film adhesion. vitamin D and contribution to investigation of the French normal bones and teeth Authorities DGCCRF concluded that EFSA evaluates the Qualified development ‘50% of products were Presumption of Safety contaminated by meso-zeaxanthin, approach for botanicals EFSA has published a favourable an unrated isomer of zeaxanthin. The ingredient present in this scientific opinion on the The EFSA opinion relating to the substantiation of a health claim molecule was the result of a manufacturing process not use of the Qualified Presumption related to vitamin D and contribution of Safety (QPS) approach to to normal bone and tooth authorized at European level that could cause adverse effects”. botanicals is now available. development pursuant to Article 14 http://www.efsa.europa.eu/en/ of the Claims regualtion. The same efsajournal/pub/3593.htm Maximum level for citrinin set Article 13(1) health claim has already been authorised for the general for supplements The QPS approach was originally population, whereas this opinion is developed for the safety targeted at the population of infants Following concerns raised on the assessment of micro-organisms. and young children. safety of citrinin, the European However, the context of Commission published Regulation botanicals is much more (EC) No 212/2014 setting a complex. According to EFSA, the MEPs reject the new definition of maximum level for this contaminant QPS approach offers only limited nanomaterials at 2000 µg/kg for food supplements advantages over the existing based on rice fermented with red methodologies and may not be The European Parliament has yeast Monascus purpureus. This cost-effective in the short term. rejected the European Commission’s level is to be reviewed before 1 EFSA recommends its use as an proposal to exempt from labelling January 2016 in the light of extension of the 2009 EFSA engineered additives already in use information on exposure to citrinin guidance for the safety at the nano size. MEPs have now from other foodstuffs and updated assessment of botanicals and called on the Commission to submit a information on the toxicity of botanical preparations intended new act. citrinin, in particular as regards to be used in food supplements carcinogenicity and genotoxicity. http://eur- EFSA publishes scientific opinions on DRVs for biotin and lex.europa.eu/LexUriServ/LexUriSer v.do?uri=OJ:L:2014:067:0003:0004:E pantothenic acid N:PDF ANVISA bans food for athletes with irregular substances The EFSA Panel on Dietetic Products, 2 novel ingredients authorized Nutrition and Allergies (NDA) has now ANVISA has banned four products published their scientific opinions on for use for supplements present as food for athletes in Dietary Reference Values for biotin the Brazilian market for non- and Pantothenic acid. For more − 6S)-5-methyltetrahydro-folic acid, glucosamine salt as a compliance with regulations. information: The causes of prohibition were http://www.efsa.europa.eu/en/efsaj source of folate in food supplements. the presence of vitamins in ournal/pub/3580.htmhttp://www.efs excess of the maximum limits − Coriander seed oil in food a.europa.eu/en/efsajournal/pub/358 permitted levels, the use of 1.htm supplements with a maximum dose of 600 mg per day. substances whose safety has not been evaluated by the authority, Commission publishes Regulation such as glutamine and ornithine, with non-authorised Art. 13(5) Polyvinylpyrrolidone-vinyl and the inclusion of substances health claims acetate copolymer now in formulas considered unsafe authorise for use in foods, such as The European Commission has Following a request from the conjugated linoleic acid (CLA). recently published Regulation (EU) No European Commission, the European 155/2014, refusing to authorise Food Safety Authority (EFSA) Another cause of prohibition was twelve Article 13(5) health claim. evaluated the safety of the food that some products containing Full details are available at: additive in food supplements and branched-chain amino acids concluded in 2010 that this which if presented to consumers compound was unlikely to be of as food for athletes also violates

Brazilian regulations (RDC 18/2010). The products were recalled and can GCC (Gulf Cooperation Council) no longer be sold in Brazil.

Ecuador GSO draft standard on food additives notified to the WTO

New notification process for food The GCC Standardisation advertising Organisation (GSO) has notified the draft standard on additives United States Following the regulation of the permitted for use in foodstuffs (GSO Communications Law in Ecuador users 5/DS.....:2013) to the WTO. Many FDA about to revise its who wish to advertise their products additives (e.g E160a carotenes beta for food and health no longer will vegetables, E900 labeling regulations need to request permits but must polydimethylsiloxane, E952 notify the advertising or promotion to cyclamates, E962 aspartame The Food and Drug the National Agency for Regulation, acesulfame salt used in food Administration (FDA) is proposing Control and Health Surveillance supplements are missing. to amend its labeling regulations (ARCSA). Two other standards, the GSO for conventional foods and 23/1998 “Colouring matters dietary supplements to provide Under Article 62 of the General permitted in foodstuffs” and updated nutrition information on Regulation of the Communications GSO5/FDS..../2013 "Sweeteners the label to assist consumers in Law "advertisers or agencies Permitted for Use in Food Products" maintaining healthy dietary representing them in the media, have also been notified. Warning practices. This would include an should notify the Ministry of Public statement will be required for update of the list of nutrients Health on advertising for food or Sunset Yellow E 110 and Allura Red that are required or permitted health at national level, notification E129. to be declared; revision of Daily will serve as authorization. " https://members.wto.org/crnattac Reference Values and Reference hments/2014/sps/SAU/14_1282_00_ Daily Intake values ; amendment In this context, users who want to e.pdf of requirements for foods advertise their products shall first represented or purported to be submit a notification to ARCSA in specifically for children under order to be able to start broadcasting the age of 4 years and pregnant their advertising. and lactating women and Morocco harmonises labeling establishment of nutrient Mexico rules with EU reference values specifically for these population subgroups, and

The Moroccan Food Safety Office finally the revision of the format New bill on GMO labelling and appearance of the Nutrition (ONSSA) introduced a draft decree number 2-12-389 on food labelling Facts label. Last March 13 a decree proposal about GMOs was published in the based on the EU labellling regulation. This decree laid down Parliamentary Gazette of Mexico. The FDA issues draft guidance for bill seeks to add to the Federal restrictions on minimum font size, and imposes mandatory country of honey labeling (FDA) Consumer Protection Act an article where it is established that origin labelling for primary This draft guidance summarizes genetically modified food must ingredients). Its implementation is FDA's legal authority over honey indicate its content of GMOs on its expected in May 2014. and honey products and provides labels or containers. a commonly used definition of

honey. FDA also provides draft Given the scope of the Federal Africa regional groups guidance on labeling issues like Consumer Protection Act, the the floral source of honey, initiative would impact food East African Community (EAC) blends of honey and other supplements containing GMOs and a Discusses harmonized draft sweeteners and blends of honey change in the labelling of the standard for supplements and other ingredients, such as products that are currently marketed flavors. It also describes some of in the country will be needed. Regulators are currently working on the measures FDA takes to guard

a harmonised draft standard and against honey adulterated with The bill, proposed by Senator guidelines on fortified foods and cane sugar, corn syrup, or Fernando Herrera Avila from the food supplements. The draft East residues of chloramphenicol or National Action Party (PAN), was African Community Standard on fluoroquinolones. presented to the Senate plenary on vitamins and mineral food March 13 and given to committees of supplements requirements specifies Commerce, Industrial Development FDA extends comment period the terms and definitions, the and Legislative Studies where the on proposed rule on general requirements, composition analysis will be conducted and an intentional requirements, the labelling and opinion will be delivered. adulteration packaging requirements for food

supplements. The EAC countries are FDA has announced the still working on setting maximum extension of the comment period levels and establishing to 30 June on “Focused recommended nutrient intakes.

Mitigation Strategies to Protect Food introducing sanctions for breaching Ukraine Against Intentional the Russian legislation related to Adulteration,” and the associated genetic engineering. Ukraine allows a number of Draft Qualitative Risk Assessment, which was published in December. The bill is aimed at strengthening food additives in supplements The subject of this proposed rule is to government regulation of genetic protect food from intentional engineering by means of: The State Sanitary and adulteration when the intent is to Epidemiological Service of cause large-scale public harm. − Introducing controls over Ukraine has recently approved Each food facility would be required cross-border movements of the use of food additives sorbitol to identify and implement focused genetically engineered and E420, cellulose E460, salts of mitigation strategies to minimize or genetically modified fatty acids E470, magnesium prevent significant vulnerabilities in organisms; oxide E530 in the composition of its food production process. FDA is dietary supplements. proposing these requirements as part − Setting up a monitoring In accordance with the of the implementation of the FDA system for GMOs intended for recommendations of the Food Safety Modernization Act release into the environment, National Commission of the (FSMA). and for products Codex Alimentarius, No manufactured with or maximum limits will be set for Import Alert on Dietary Ingredient containing such organisms; those ingredients. Amounts of Kratom use will be left to the discretion of companies in accordance with − Introducing a mandatory the production technology. FDA has published an import alert requirement for labelling notifying its field personnel that they GMO products (the bill does may detain certain products not establish a threshold of Codex Events 2014 & 2015 containing kratom, without the need 0.9% for knowingly processing for a physical inspection. ingredients); Kratom is a new dietary ingredient − Granting the Russian that does not appear to have a government the right to Codex Alimentarius Commission history of safe use. Its Consumption restrict or ban the use of (CAC37) could ‘lead to a number of health GMOs in the manufacture of Geneva, Switzerland impacts, including respiratory individual products, including From: 14/07/14 To: 18/07/14 the use of GMO at individual depression, nervousness, agitation, Codex Committee on Food processing stages. aggression, sleeplessness, Labelling (CCFL42) hallucinations, delusions, tremors, Place: To be confirmed loss of libido, constipation, skin The key impact of the bill is the From: 21/10/14 To:24/10/14 hyperpigmentation, nausea, possibility of the Russian Codex Committee on Food vomiting, and severe withdrawal government restricting the use of Hygiene (CCFH46) signs and symptoms’ said FDA. GMO in the manufacture of individual products, including at Place: To be confirmed FDA has seen an increase in the From: 17/11/14 To: 21/11/14 number of shipments of dietary individual processing stages. The supplements and bulk dietary authors of the bill insist that this Codex Committee on Nutrition ingredients containing this provision fully meets international and Foods for Special Dietary ingredient. These shipments of practice. The bill also imposes Uses (CCNFSDU36) kratom have come in a variety of sanctions for violations of the Bali, Indonesia From: 24/11/14 To: 28/11/14 forms, including whole leaves, Russian legislation related to processed leaves, leaf resins, leaf Codex Committee on Fats and genetic engineering; owing to this extracts, powdered leaves, and bulk Oils (CCFO24) fact, the bill proposes introducing liquids made of leaf extracts. Malaysia corresponding amendments to the From: 09/02/15 To: 13/02/15 Russian Code of Administrative Codex Committee on Offences. At the same time, the Contaminants in Foods (CCCF9) Russian consumer rights watchdog Rospotrebnadzor has prepared a Netherlands From: 16/03/15 To: 16/03/15 draft federal law on amending the Russian Code of Administrative Codex Committee on Food Offences to toughen sanctions for Additives (CCFA47) failure to observe the food labeling China requirements. From: 23/03/15 To: 27/03/15

Russia Codex Alimentarius Commission Russian ministries seek to pose The bill applies to manufacturers (CAC38) more restrictions on GMO foods and sellers of food products. It Geneva, Switzerland imposes more severe penalties for From: 06/07/15 To: 11/07/15 failure to omit from the label of a In accordance with the Russian food product information about its Codex Committee on Food president's instruction, the Russian having been manufactured with the Hygiene (CCFH47) Education Ministry has prepared a use of genetically modified or United States of America draft federal law on improving From: 09/11/15 To: 13/11/15 genetically engineered organisms or government regulation with regard to containing such organisms. Proposed genetic engineering, the oversight of Codex Committee on Nutrition measures will fully apply to food the circulation of genetically and Foods for Special Dietary supplements. engineered and genetically modified Uses (CCNFSDU37) organisms and products manufactured Germany with the use of such organisms or From: 23/11/15 To: 27/11/15 containing such organisms, and on

Focus on harmonisation in the world

IADSA's initial work in 1998 focussed on global harmonisation Latin America. Progress is much slower in much of the Latin in Codex Alimentarius, the international food standards American region than either ASEAN or the EU but recently a setting body that was working on a global Guideline on trade accord which removes tariffs on 92% of trade has been Vitamin and Mineral Supplements. It was however recognised signed by the regional trade block "Pacific Alliance" that in a number of regions governments were inevitably composed of Chile, Colombia, Mexico and going to be working to build frameworks for supplementation Peru. This agreement will have a direct impact on (or at least discuss frameworks) which would draw on this supplements. In order to make free trade more efficient the Codex work but apply much more detail. Pacific Alliance established the need to develop Guidelines for the Approximation of Regulations on a number of priority The EU led the way with its Food Supplement Directive of sectors, cosmetics, medicines and processed foods. In this 2002 which now creates legislation for 28 Member regard, Pacific Alliance member governments have requested States. This has been followed by extensive work in ASEAN their National Industries Chambers to develop and provide a which is now coming to the end of the first critical phase, to proposal for Guidelines for the Approximation of Food the Customs Union which is just beginning, to a number of Supplements Regulations. initiatives in Africa and in Latin America, where the new Pacific Alliance has just started work to build a new framework. Customs Union in Eastern Europe. Bzielorussia, Kazakhstan and Russia initiated a new Customs Union in 2010 which will European Union. The European Union is currently the be a region with shared borders, customs and harmonised most developed Single Market in the world, with a track technical standards. Once a product is approved for sale in record of work stretching back more than 40 years. any member country it will be accepted in all others. The Supplements are currently covered by a core piece of Customs Union initiative is a part of a bigger entity created legislation, the Food Supplement Directive, plus a range of eleven years ago called EurAsEC (Eurasian Economic other legislative texts on manufacturing, additives, Community) which brings together Russia, Belorussia, contaminants, etc that apply across more categories than Kazakhstan, Uzbekistan, Tajikistan and Kyrgyzstan as full supplements. All legislation is supported by the principle of members and Ukraine, Moldova and Armenia as observers. mutual recognition of goods, which means that a product legally marketed in one country of the EU can be sold in all others.

Overview of harmoninisation of food/health supplement regulation

Focus on ASEAN Harmonisation

A model for governments THE ASEAN COMMUNITY

ASEAN: 10 Countries who plan to harmonise by 2015 The ASEAN Community comprises three their regulations on Health Supplements and Traditional pillars each of which has its own Blueprint. These, together with the Initiative for ASEAN Medicines (TMHS). By joining ASEAN each member country has agreed that it will Integration (IAI) Strategic Framework and IAI Work Plan Phase II (2009-2015), form the change its existing legislation and introduce new legislation. Roadmap for an ASEAN Community by 2015.

POLITICAL-SECURITY COMMUNITY (APSC)

ECONOMIC COMMUNITY (AEC)

SOCIO-CULTURAL COMMUNITY (ASCC)

The establishment of the ASEAN Economic Community by 2015 is crucial for the ASEAN health supplement sector because of the opportunities it will create to increase trade between ASEAN Member States and build opportunities to market products internationally.

Overview of the ASEAN harmonization of regulations for TMHS

Currently 10 areas for harmonisation have completed their respective guidelines. Some areas are in more advanced stages as compared to the others while work on one area (products at interface) has yet to commence.

Key discussions include harmonisation initiatives on terminologies, common technical requirements on product placements, Post- marketing alert (PMA) systems, Good Manufacturing Practices (GMP), labelling requirements, mapping and building the capacities of member countries. An ASEAN Scientific Committee (ATSC) was established in July 2007 to provide risk assessments and the appropriate scientific recommendations on key areas of the emerging regulatory framework.

IADSA and its regional partner AAHSA has long supported this ASEAN vision and work continues to provide the scientific, technical and regulatory expertise as required by the governments in this process. Achieving this goal of one legal framework across the priority integration sectors will create greater incentives for international companies to invest in the region and a stronger framework from which ASEAN companies can export to the world’s major markets. AAHSA-IADSA have recently completed the first scorecard on this process for governments and the section providing an overview of the timing is as below:

1 55 Website: www.iadsa.org