IASC Member Update

January 30, 2009 –As the international organization representing the interests of the finest suppliers, manufacturers, distributors and growers of Aloe vera and its related products, the IASC is dedicated to maintaining a focus on the issues that may be of concern to your business, including dietary supplement and other similar regulations around the world. Below you will find information, broken down by country, pertaining to the dietary supplement and related industries and compiled from various sources provided to IADSA, the International Association of Dietary Supplement Associations.

For questions or comments about this information, please feel free to contact me.

Devon Powell
Executive Director
International Aloe Science Council
301.588.2420
dpowell@iasc.org

AFRICA

Early results from a business survey commissioned by the South African Health Products Association (HPA) indicate an almost 100% increase in financial growth of the Complementary and Alternative Medicine (CAM) industry in the years 2003 – 2008. Companies participating in the survey also showed an increase of 27% in 2007 over the previous year.

The objectives of the survey, whose full results have yet to be analysed, were to establish:

Source: HPA

ASIA

JAPAN

Japan’s Ministry of Health, Labour and Welfare (MHLW) has recently published the results of its ‘Investigation of National Health and Nutrition, 2008’.

The Report estimates the number of adults (defined as people over 20 years old) being treated for diabetes or having a high possibility suffering from diabetes, as judged by a hemoglobin A1c (HeA1c) value more than 6.1%, to be about 8.9 million. Adults who may be at risk of diabetes, having an HeA1c value of between 5.6% and 6.1%, number about 13.2 million.

This total, about 22.1 million, means that one out of 4.7 Japanese adults either already suffers from diabetes or is at risk of developing the disease, and l compares with figures of 13.7 million and 16.2 million in 1997 and 2002 respectively. The report notes that few of the 40% at high risk of developing diabetes have ever received any treatment.

Source: JIHFS

A recent market research report estimates the size of the Japanese health food market in 2008 to be about US$ 11.5 billion. This figure does not include FOSHU (Food for Special Health Use) and shows a decline of about 4% compared with 2007. At its peak in 2005 the market was about US$ 12.85 billion, but it has been in decline for last three years. The market size for FOSHU in 2008 was about US$ 7.1 billion, almost the same level with 2007.

Industry groups see 2009 as very important for market recovery and are taking action to ensure the quality, safety and efficacy of the products and also to promote activity designed to achieve one comprehensive law for food supplements.

Source: JIHFS

EUROPE

The long-overdue European Commission (EC) Report on the extension of the Food Supplements Directive to cover the use of substances other than vitamins and minerals in food supplements has recently been adopted and sent to the European Parliament.

As anticipated, the Report does not advocate further harmonisation of other substances at this stage as the EC considers that the current regulatory framework (including the General Food Safety legislation, Novel Food Regulation and the Regulation on the Addition of Vitamins and Minerals on Foods) provides sufficient rules to ensure that supplements containing other substances are adequately regulated, in particular as regards any potential safety issues.

The EC notes the helpful role that mutual recognition legislation can play in the marketing of food supplement containing ‘other substances’, particularly in respect of barriers to entry in individual member states, who must now justify such barriers in accordance with European Court of Justice case law and the new regulation on mutual recognition.

In relation to botanicals, the Report highlights the work of the European Food Safety Authority (EFSA) European Scientific Cooperation (ESCO) Group on the development of methodology for the safety assessment of botanicals as a step towards a common EU approach on this issue. As to the borderline between medicines and foods, the Report particularly points to the relevant ECJ rulings and stresses that the interpretation of the definition of a medicinal product as ‘medicinal by function’ must be interpreted restrictively – a point recently highlighted in the ECJ decision on the ‘Red Rice’ case (see the report at the end of this section).

To read the full report, see: http://ec.europa.eu/food/food/labellingnutrition/supplements/index_en.htm

Source: EHPM

The European Food Safety Authority (EFSA) has now issued opinions on 43 non-generic Article 14 and Article 13.5 claims (disease risk reduction/children’s and 'new scientific evidence' claims). EFSA has until now issued favourable or partly favourable opinions on 8-9 opinions, while the outcome for the majority of other applications has not been favourable. For further details see: http://www.efsa.europa.eu/EFSA/KeyTopics/efsa_locale-1178620753812_NutritionAndHealthClaims.htm

The EHPM has recently had a meeting with the European Commission’s DG SANCO Deputy Director Mrs Testori-Coggi, to discuss health claims issues. The following key points were addressed:

The Commission was reassuring and seemed confident that appropriate management measure will be found in the assessment of Article 13.1 claims. However, whether this will result in the adoption of the majority of claims on the industry list will depend on EFSA’s approach to claims assessment for Art. 13.1 claims. At present EFSA had indicated this would seem to remain the same as that used for Art.13.5 and 14 claims.

EHPM will therefore meet with EFSA in February to further convey its concerns on these issues and to seek clarification on the process of claim evaluation. In the meantime, all EHPM member associations are being encouraged, as a matter of urgency, to discuss these issues with their national authorities.

Since the EHPM/DG SANCO meeting, EFSA has published on its website the list of functional Article 13.1 ‘generic’ health claims that it has received from the European Commission and which it is scheduled to assess by January 2010. You can find the database of claims at: http://www.efsa.europa.eu/cs/Satellite?c=Page&childpagename=EFSA%2FPage%2Fntp_A&cid=1211902055970&pagename=efsa.

EFSA’s timeline for its assessment work are as follows:

Source: EHPM

Officials, regulators, academics, and industry representatives from Belgium, France, Italy, the UK, Germany, Hungary, Poland, Czech Republic, Turkey, EFSA and the European Commission were amongst the delegates at the European Botanical Forum's 4th Annual Workshop, held in December 2008 in Brussels.

The purpose of this highly successful event was to discuss the application of current regulation to botanicals and whether it was appropriate for their particular nature. Agenda items included health claims, quality and safety issues, the borderline between food and medicine products, and the impact of the new regulation on Mutual Recognition which comes into force in May of this year.

The Workshop also saw the launch of the first issue of the European Botanical Forum Fact File – a series of fact sheets on topics such as the history, usage, legal basis, benefits and claims for botanicals. Further fact sheets are planned to appear during the year. For more details, contact info@botanical-forum.be

Source: EHPM

A new project entitled Food Allergy Specific ImmunoTherapy (FAST), aimed at developing treatments for allergy sufferers is commencing work.

The EU-wide project, which has funding for seven years, differs from previous projects on the treatment of food allergies which mainly focused on on exposure to allergen extracts, which in themselves had the potential for causing anaphylaxis. Instead, the aim is to develop modified hypo-allergenic versions of allergic proteins as potential treatments.

Source: ERNA

The European Food Safety Authority (EFSA) has issued draft guidance on transparency in the scientific aspects of risk assessment (its previous guidance in this area dealt with procedural issues).
The document sets out general principles – data sources, inclusion/exclusion criteria for data, confidentiality and dealing with uncertainties and assumptions. Core points include:

Source: EHPM

The European Union published its new Food Improvement Agent Package (FIAP) on 31 December 2008. It comprises four new regulations providing a common authorisation procedure for food additives, food enzymes and food flavourings, and individual regulations on enzymes, additives and flavourings. The various regulations come into force this month and most measures apply from January 2010.

The Regulations can be accessed at: http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2008:354:SOM:EN:HTML

Source: EHPM

The European Parliament's (EP) Environment, Public Health and Food Safety Committee recently released its draft report on the European Commission's proposal for a new food labelling regulation.

The EP Committee has deleted the proposed 3mm minimum font size requirement for all mandatory information on food labels because it considers that font size alone does not guarantee legibility – what is important is legibility by a "normally-sighted consumer’. The requirement to include mandatory nutrition declaration on the front of the package has also been amended so that only the energy content (calories kcal kJ) would be required to be given in the bottom right hand corner on the front of the package, surrounded by a rectangular border. The amount of energy and nutrients must be given per 100g or 100ml and may be expressed per portion provided the number of portions contained in the package is stated and that the portion sizes are realistic, and the EP has recommended that the European Commission should develop guidance on this point.

Details on nutrients and ingredients providing the energy content should be given in the following order: energy, protein, fat (with specific reference to saturates), carbohydrates (with specific reference to sugars and starch), sodium from salt and presented in table format.

Source: EHPM

An 8 page article entitled “Food supplements: a load of hogwash! And a risk for health”, was recently published in the French monthly magazine Que Choisir. In the article, the journalist’s comments that food supplements are inefficient, not to say harmful, were supported by Irène Margaritis, an expert from AFSSA (the French Food Safety Agency) and the European Food Safety Authority (EFSA).

The French supplement association Synadiet immediately wrote to the Director General of AFSSA, pointing out that food supplements are subject to a strict regulatory framework and that they satisfy rigorous quality standards. Supplement manufacturers/distributors were therefore both shocked and surprised that such negative comments were supported by an expert from the National Agency.

As a result of this letter, Synadiet is to meet the Director General and four other important members of AFSSA. Synadiet welcomes the opportunities offered by this meeting where, apart from discussion of AFFSA’s position on food supplements in general and the media in particular, it hopes to address:

Source: Synadiet

The publication of the Royal Decree (RD) 1275/2003 in October 2008 which regulates food supplements was long-awaited as an important first step toward appropriate regulation for food supplements. Until then, the market existed in a situation of legal uncertainty, and there was a growing demand for clear regulation.

However RD 1275/2003, which is still in force, is not as positive anticipated because it does not fully implement the EC Food Supplements Directive – with the result that Spanish law in this area is incomplete and not in line with European legislation.

In November 2008, AESAN, the Spanish food authority, asked the supplement association AFINUR for its opinion on a new draft RD on food supplements, which if approved would abolish RD 1275/2003. AFINUR’s opinion is positive because the text is in line with European regulations issued in accordance with EU Directive 2002/46/EC on food supplements, and the draft transposes it faithfully on the same grounds, thereby adapting Spanish law to the common criteria of the European Community.

While it is not yet formalised, the new draft RD represents an important change in the policy of AESAN, which AFINUR believes has been made possible through its administrative complaint to the European Community. AFINUR is cautiously optimistic that it may represent an encouraging response to years of struggle to defend and preserve the interests of the food supplements market.

Source: AFINUR

The Food Standards Agency (FSA) is encouraging food manufacturers to let them know if they want their company or brands to be included on a list of those free from certain colours.

The colours in question are Sunset Yellow FCF (E110), Quinolene Yellow (E104), Carmiosine (E122), Allura Red (E129), Tartrazine (E102), and Ponceau 4R (E124). The list will be published on the Agency’s website, and, while it will not specify individual products, it will provide '..general information that will help consumers identify quickly whether a product they use is likely to contain these colours'.

Source: HFMA

A Workshop, organised by the UK Committee on Toxicology of Chemicals in Food, Consumer Products and the Environment (COT) is to look at the emerging tools for refining toxicology safety assessment.

Specifically, it will discuss a recent report form the US National Academy, Toxicity Testing in the 21st Century: A Vision and a Strategy, which calls for the faster development and adoption of tests on human cells – conducted in the laboratory or simulated on computer – as a way to predict hazards.

Such methods would not only avoid animal testing, but, by speeding up the time spent on experiments, would facilitate further testing, particularly on combinations of compounds, where information about safety is currently incomplete.

For further details see http://cot.food.gov.uk

Source: CRN

A recently published Ipsos MORI report commissioned by the United Kingdom Medicines and Healthcare Regulatory Agency (MHRA) found that of 2305 adults samples, 35% have used a herbal medicine. Although 88% consider them to be generally safe, 77% support regulation as a means of ensuring the safety of the product.

Historically, many herbal medicines in the UK have been marketed as unlicensed products. Now, according to European medicines legislation, to stay on the market after 2011 such products must achieve Traditional Herbal Medicinal Products Registrations (THRs), which means that products must meet assured standards of safety, quality and patient information.

To date 53 registration applications have been received in the UK and 25 registrations have been granted.

Source: HFMA

NORTH AMERICA

Following the recent announcement from the Canadian Government that legislation amending the Food and Drugs Act would be re-introduced in the current parliamentary session, the Canadian Health Food Association (CHFA), representing the $3.5 billion Canadian natural health product (NHP) and organics industry, has been meeting Canadian Members of Parliament to discuss the importance of fair and effective food and drug legislation.

CHFA President and CEO Penelope Marrett is quoted as saying that ‘75% of Canadians have used NHPs and want uninterrupted access and choice’ and that the NHP industry is ‘totally committed to the safety of Canadians because unsafe products not only hurt consumers, they also hurt the perception of the industry as a whole.’

CHFA’s aim is that the proposed new legislation should reflect the safer nature of NHPs as compared with drugs, and that industry must be fully consulted before any legislative changes are made.

Source: CHFA

In December 2008 Health Canada released its decision on the labelling of cough and cold products, including natural health products, for children.

Preliminary analysis of available information led to a recommendation in 2007 that over-the-counter (OTC) cough and cold medicines, including natural health products, should not be used in children under the age of 2, unless directed by a health-care practitioner. Now, following completion of its analysis and further input from a Scientific Advisory Panel, Health Canada has decided that certain over the counter (OTC) cough and cold medicines should not be labelled for use in children under 6 and that the necessary label changes should be in place by Autumn 2009. Products for children ages from 6 – 12 will also require enhanced labelling, child resistant packaging, and the inclusion of dosing devices for all liquid formulations.

For more information, visit http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2008/2008_184-eng.php

SOURCE: CHFA

The Food and Drug Administration (FDA) has now published its final guidance on claim substantiation entitled ‘Substantiation for Dietary Supplement Claims made under Section 403(r)(6) of the Federal Food Drug and Cosmetic Act’.

One of the non-binding recommendations published in the draft guidance is that ‘manufacturers possess adequate substantiation for each reasonable interpretation of the claims'. FDA also advises that it intends to apply a standard consistent with the Federal Trade Commission standard of ‘competent and reliable scientific evidence’, to substantiate a claim.

Source: NPA / AHPA

The Food and Drug Administration (FDA) has announced the availability of a draft guidance for industry entitled, ‘Good Importer Practices’.

The guidance provides general recommendations to importers on possible practices and procedures they may follow to increase the likelihood the product they import are in compliance with applicable US safety and security requirements.

Source: NPA

The US Food and Drug Administration (FDA) is revising its requirements for cochineal extract and carmine.

Following reports of severe allergic reactions to foods and cosmetics containing these colour additives, products must now declare their presence by name, on the product labels.

Source: CRN US

The Food and Drug Administration (FDA) has published a further draft of its guidance with regard to labeling requirements of the ‘Dietary Supplement and Nonprescription Drug Consumer Protection Act [the Adverse Event Reporting (AER) Bill] and has extending the compliance deadline to January 2010 ‘..because the agency is still in the process of finalising the guidance(s)’.

The guidance requires manufacturers to provide a ‘..clear, prominent statement information consumers that the domestic address or phone number is for reporting serious adverse events associated with this product’, in contrast to the stated intent of the US Congress, that the legislation ‘does not require the label to make any statement other than providing the address or phone number’.

The supplement industry continues to maintain that the label changes that the FDA guidance seeks go beyond what the legislation requires, and would also mean an unnecessary and heavy cost-burden in terms of label changes.

Source: CRN US

The Food and Drug Administration (FDA) has recently issued a letter to food manufacturers and distributors to inform them about current regulatory schemes and requirements with regard to nutrition claims in the light of the expanding use of front-of-pack symbols on food products.

The purpose of the letter is to advise that such symbols may constitute nutrient content claims which are subject to Federal labelling regulations, and, depending on the claim, may require disclosure statements.

Source: NPA

Two sweeteners made from the leaf of the stevia plant, at 95% purity or above, have been granted Generally Accepted as Safe (GRAS) status by the Food and Drug Administration, (FDA) for use as a general purpose sweetener in food and drink and in food supplements.

The FDA approval only applies to a highly purified form of stevia known as rebaudioside A.

Source: NPA

Following on from the release by the Food and Drug Administration (FDA) of an analysis of 324 multivitamin/mineral products for women and children, 56 dietary supplement marketers have been named by the California Attorney General as defendants in Proposition 65 complaint alleging failure to warn of the presence of lead in their products.

The American Herbal Products Association (AHPA) has recently released to its members a newly-revised document, ‘Background on California Proposition 65: Issues related to heavy metals and herbal products’ which deals with the regulatory and liability implications of Proposition 65 on heavy metals that may be present in herbal products sold in the state of California.

Source: AHPA

In the face of criticism of sluggish response to food scares, the Food and Drug Administration (FDA) has abandoned the use of random inspections to ensure food safety in favour of inspections targeted at high-risk sites.

Under this new approach, the Agency will focus its attention on importers with lower quality standards and other at-risk food suppliers.

Source: CRN US

Following the recent publication of the results of a survey, carried out in 2006, on levels of colours in foods which showed usage well below maximum permitted levels, Food Standards Australia New Zealand (FSANZ) has stated that the survey provides ‘.. significant reassurance that there is no public health and safety risk from the consumption of foods containing added colours as part of a balanced diet’.

Unlike the European situation, where food additive regulation includes a warning label for products containing colours linked to hyperactivity and the general view is that the main role of food colours is cosmetic, FSANZ’s view is that colours provide ‘…a visual cue for quality, to induce the perception of flavour and to meet consumer expectations’.

Source: CHC

The Complaints Resolution Panel (CRP) of the Australian Therapeutic Goods Authority (TGA) has recently issued a notice regarding the term ‘clinically proven’.

Concerned by the increasing use of the term in advertisements, the CRP have published extracts from recent determinations:'The Panel also noted the use of the words “clinically proven” in relation to the product. Given the strength of this claim and the clear potential for it to mislead and deceive consumers, the Panel considers that its use in advertising should not even be contemplated unless unequivocally supported by robustly designed, published, peer-reviewed clinical trials which have been conducted upon the actual product being advertised or an identical formulation (as a minimum). Even where such evidence is available, the claim must also reflect the weight of all available evidence and not just the specific research being relied upon'.

Further, the Panel also refer to “undue emphasis on the weight of scientific evidence in relation to products”. They advise advertisers to make sure that if they '...make representations regarding the efficacy of those therapeutic goods, they must ensure that the strength of the evidence is reflected in the strength of the representations..", and further advise that to do otherwise risks misleading the public and is a breach of the Therapeutic Goods Advertising

Code.

Source: CHC