Download UNITED STATES: FDA says Pyridoxamine is not a dietary

IADSA NEWSFLASH
FEBRUARY 2009
CONTENTS
INTERNATIONAL DEVELOPMENTS
Additives committee meeting
Resolution on traditional medicine
ASIA
CODEX:
WHO:
INDIA:
Food supplements or Ayurvedic medicines?
EUROPE
EUROPEAN UNION:
IRELAND:
UNITED KINGDOM:
Maximum levels update
Update on annex II of the EU food supplement directive
Health claims update
ESCO working groups report
Opinions on supplement ingredients
Clarification on status of POM vitamins
Ireland and maximum Levels
Survey calls for more research on metals
New register of practitioners launched
NORTH AMERICA
UNITED STATES:
FDA says Pyridoxamine is not a dietary supplement
CISPI rejects trans fat advice
INDEX OF ASSOCIATION CONTRIBUTORS
KEY EVENTS
IADSA
The International Alliance of Dietary /Food Supplements Associations was founded in 1998
to address the globalization of dietary supplement markets and increasing regulatory
challenges. IADSA brings together 55 dietary supplement associations with the aim of
building a sound legislative and political environment for the development of the dietary
supplement market worldwide.
IADSA serves its worldwide network of associations and companies by:
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Providing a fast flow of regulatory and policy information on dietary supplements,
ensuring that there is an awareness and understanding of new developments.
Coordinating strategy and action on global regulatory issues, particularly in relation to
Codex Alimentarius initiatives.
Widening and deepening the network of associations around the world by helping the
establishment of new dietary supplement associations and supporting existing national
associations.
Organizing global and regional events to promote dialogue on the scientific and
regulatory issues underpinning the dietary supplement market.
February 2009
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INTERNATIONAL DEVELOPMENTS

CODEX
ADDITIVES COMMITTEE MEETING
The Codex Committee on Food Additives will be considering next month the levels of use
of a number of key food additives in food supplements.
An electronic working group (eWG) has reviewed the use in food supplements of
aspartame-acelsufame salt and 3 bulking agents; sorbates, phosphates and
sucroglycerides. While the eWG is recommending a lower level of use of 200 mg/kg for
aspartame-acesulfame salt, it is requesting more information to address the level for
phosphates and has not suggested yet a level for sucroglycerides when in Codex a fixed
level has to be set. The eWG’s recommendations will be considered by the Committee
next month.
In addition, the Committee will consider the adoption of a number of aluminium containing
additives and of key colours. These additive provisions were either not considered by the
Committee last year or not resolved. The eWG has not reviewed them, although the
Committee would welcome any additional information that it is provided. In fact, if more
information is not provided these additives run the risk of being removed from the Codex
list.
Although IADSA has provided over the past few years to the Additives Committee
information to justify the use of these key colours, it is requested to members provide any
further technological information to justify the use of these colours in food supplements. An
IADSA delegation will be participating at the next Committee meeting in Shanghai.
For more information, please contact the Secretariat: [email protected].

WHO
RESOLUTION ON TRADITIONAL MEDICINE
The Executive Board of the World Health Organisation (WHO) has recently adopted a draft
Resolution on Traditional Medicine which will be submitted to the World Health Assembly
in May of this year.
Based on the ‘Beijing Declaration’, prepared by 12 countries at last year’s WHO Congress
on Traditional Medicines, the Resolution calls on Governments to integrate traditional
medicines into their national health systems, and to promote further research and
innovation in line with the resolution adopted at the 2008 WHO Assembly on ‘Global
strategy and plan of action on public health, innovation and intellectual property’.
For more information, please contact the Secretariat: [email protected].
ASIA
February 2009
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
INDIA
FOOD SUPPLEMENTS OR AYURVEDIC MEDICINES?
An Indian herbal manufacturing company has recently challenged a sectoral tribunal ruling
which held that its products, which are registered as ayurvedic proprietary medicines, did
not cure any disease, and were thus liable to pay higher excise duty.
The Indian Supreme Court will now decide whether the products in fact have “preventative
and curative properties” and therefore, as medicines, qualify for lower excise duty.
Source:
HADSA
EUROPE

EUROPEAN UNION
MAXIMUM LEVELS UPDATE
The European Commission (EC) is currently working with a small group of Member States
(Denmark, France, German, Ireland, Portugal, United Kingdom, Norway) to test the model
provided by EHPM/ERNA for food supplements and Professor Albert Flynn's model on
fortification, provided by the food industry. The results of this exercise are currently
awaited.
In parallel the food industry is still working to agree acceptable levels of use because the
theoretical levels presented by Prof. Flynn on the basis of his model are unlikely to be
acceptable to Member States. Some Member States have also raised the issue of intake
for children, in particular in relation to fortified foods.
So far, the EC has been supportive of the application of the EHPM/ERNA model for food
supplements, and continues to request that no level be set for nutrients where there is no
safety concern. It also remains keen to avoid an arbitrary division of levels between
fortified foods and supplements.
At a recent hearing of the European Parliament Petition Committee, the EC reiterated its
wish to establish levels based on safety risk assessment conducted by the European
Food Safety Authority (EFSA), and stated that the Directive does not intend to restrict the
choice of consumers but rather to allow them access to safe products across Europe.
The EC indicated it still hopes to be able to come forward with a proposal for maximum
levels of vitamins and minerals in food supplements by March of this year.
Source:
EHPM, ERNA
UPDATE ON ANNEX II OF THE EU FOOD SUPPLEMENT DIRECTIVE
The European Commission presented a proposal for discussion and vote at this month’s
Standing Committee meeting of Member States for a Regulation to update the sources
listed in Annex II of the Food Supplement Directive (Directive 2002/46/EC) on the basis of
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the first EFSA favourable opinions, as well as Annexes of various other pieces of
legislation regarding PARNUTS and fortified foods (Directives 2001/15/EC, 2006/125/EC
and Regulation (EC) 1925/2006)
It is important to point out that the Commission's proposal did not yet take into account the
most recent EFSA positive nutrient source opinions, as for example, the opinion regarding
zinc mono-L-methionine sulphate. Moreover, not all EFSA nutrient source evaluations
have yet been completed.
EFSA has indicated in its 2009 Management Plan that it intends to evaluate 147 nutrient
substance dossier applications in 2009 (with 5 still ongoing at the end of 2009). This
means, that the European Commission will most likely table further amendments to the
Annexes later this year/beginning next year, to include potential additional positive EFSA
nutrient substance evaluations of 2009. An additional draft Commission Regulation to
include these opinions as a follow-up is therefore likely to be issued during course of 2009.
It is to be noted that EFSA has recently also released a number of opinions indicating the
impossibility to assess the safety of the proposed nutrient sources due to lack of data in
the provided dossiers. These concerned in particular dossiers on: Selenium amino acid
chelate, and chromium and copper ethanolamine phosphate.
EFSA also released an opinion on calcium L-methionate and magnesium L-methionate as
sources for calcium and magnesium expressing a very precautionary approach.The EFSA
opinion concludes that there could be a safety concern if these were used at tolerable
upper intake levels.
The content of the above mentioned proposal has not raised particular questions from
members states although the legal form of the text is still under discussion with the legal
services. The issue of whether selenium yeast was to be considered as another substance
or a mineral was raised by one member stated and it was agreed that it was a mineral
source.
In addition, the EC indicated that once a choice is made on the legal form of this text,
currently proposed as a Regulation covering the amendment of several acts including the
Annex II of the Food Supplement Directive, the proposal will be presented again to
member states with a view of its adoption, possibly at the Standing Committee at the end
of April or June.
Furthermore, EFSA has delivered further opinions on the dossiers it has received on:
-
Monomethylsilanetriol added for nutritional purposes to food supplements - safety
cannot be established
-
Ferrous phosphate added for nutritional purposes to food supplement - safe
-
Inositol hexanicotinate (inositol hexaniacinate) as a source of niacin (vitamin B3)
added for nutritional purposes in food supplements - safe but concerns on proposed
levels
-
Iron (II) taurate, magnesium taurate and magnesium acetyl taurate as sources of iron
or magnesium added for nutritional purposes in food supplements - safe
-
Choline-stabilised orthosilicic acid added for nutritional purposes to food supplements
- no safety concern provided that the upper level for choline is not exceeded.
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More details on the above EFSA nutrient source opinions can be found on the following
web page:
http://www.efsa.europa.eu/EFSA/ScientificPanels/ANS/efsa_locale1178620753812_OpinionsANS.htm
Source:
EHPM
HEALTH CLAIMS UPDATE
The consolidated list of proposed Article 13 claims was published on the EFSA website in
mid January – see:
http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_article13.htm
It contains over 4185 health claims. The database details comments from EFSA’s
screening process and the agreed deadline for the opinion.
EFSA’s criteria for returning health claims to the Commission for further clarification on the
scope or for information to be added, is:
•
•
•
•
•
•
where clarification on scope is needed (e.g. claims referring to risk
reduction or referring to children’s development and health, or medicinal
claims)
General 'well-being' claims where the health relationship is not clear, e.g.
“Compound X supplementation sustains vitality while aging”
Claims that are too vague (claim effect not specified/measurable), e.g.
Compound X is “necessary to maintain energy and general vitality”
Foods which are not sufficiently characterised or conditions of use are not
sufficiently specified
Combination constituents that are not sufficiently defined
Claims in other languages than English (to be returned for translation).
.
Currently about 1000 claims have a deadline for review of 31st July 09, and a further 470
have a deadline of 30 November 09. That leaves about 2700 claims, including about 1000
for botancials currently without a deadline for review.
EFSA has now delivered 47 opinions on Article 14 and 13.5 claims. These include 34
children’s claims, 8 disease risk reduction claims, and 5 Article 13.5 claims (on 'new
scientific evidence'). 7 of the 47 scientific opinions are favourable and further 3 were
concluded to show cause and effect, but because intakes of the substances (animal
protein and omega-6 fatty acids) are not inadequate in European diets, it remains to be
seen whether these claims will be given final approval.
The European Commission issued its revised draft proposals for the adoption/rejection of
a first list of Article 14 and 13.5 claims. It is to be noted that, whereas previously the
proposals were for a Regulation and a Decision, both texts have now been issued in the
form of Regulations. Both texts have been adopted by the Member States at this month’s
Standing Committee meeting.
The texts had been slightly changed based upon comments received and further changes
have been included during the meeting.
The proposals will now go to the European Parliament for scrutiny.
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Source:
EHPM
ESCO WORKING GROUPS REPORT
The Plenary meeting of the European Food Safety Authority (EFSA) Scientific Committee
recently reported on the activities of its Scientific Cooperation (ESCO) Working Groups:
Botanicals: in an interim report the Group said that in 2008 EFSA had published a draft
guidance document which proposed a two-level approach for the safety assessment of
botanicals. This approach was now being tested by the ESCO Group with a selected
number of examples. The Group was also working on enlarging the information in its
compendium of botanicals reported to contain toxic, addictive, psychotropic or other
substances of concern. Good progress was being made, and the Group expected to
deliver its final report to EFSA’s Executive Director by May of this year.
Emerging Risks: the ESCO Working Group has identified 11 indicators of possible
emerging risks in the areas of chemical microbial and nutritional hazards, as well as key
resources of information and best practices for data collection and exchange. Its final
report will be available soon.
Folic acid: the ESCO Group working on ‘Analysis of Risks and benefits of Fortification of
Food with Folic Acid’ presented a compilation of the situation regarding folic acid in
different European countries, together with statistics on neural tube defects, and data on
food supplementation, whether voluntary or mandatory.
Harmonisation of Risk Assessment approaches in Member States: a comprehensive
questionnaire was developed which asked Member States to describe possible
discrepancies in their risk assessment approaches from existing EFSA guidance
documents. One particular outcome was the recommendation to address the further
harmonisation of risk assessment approaches within specific scientific areas. The Group’s
final report will now be submitted to EFSA’ s Executive Director.
Source:
ERNA
OPINIONS ON SUPPLEMENT INGREDIENTS
To date 49 nutrient source ingredients have been given a positive opinion by EFSA and a
further 127 positive opinions are possible from those yet to be assessed which would
result in a maximum of 176 possible additions to Annex II. The remaining 241 ingredients
listed on the Commission website and granted derogation until 31st December 2009 will
not be allowed to be used in food supplements from January 2010.
Most recently, EFSA has published positive opinions on:
•
•
•
•
•
Sodium monofluorophosphate as a source of fluoride in food supplements
Calcium fluoride as a source of fluoride in food supplements
Copper aspartate as a source of copper in food supplements
Zinc aspartate as a source of zinc in food supplements
Zinc mono-methionine as a source of zinc in food supplements
There was insufficient evidence to prove safety of:
• Silver hydrosol as a source of silver in food supplements (considered to be
nanotechnology)
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•
•
•
•
•
•
Calcium aspartate
Magnesium aspartate
Potassium aspartate
Chromium (poly)nicotinate
Calcium methionate
Magnesium methionate
Source:

EHPM
IRELAND
CLARIFICATION ON THE STATUS OF POM VITAMINS
The Irish Medicines Board (IMB) has recently published a clarification on the medicinal
status of certain products containing vitamins which are subject to their Prescription and
Controls of Supply (POM) regulations.
The notification reiterates the current practice that while in general any substance
restricted by the prescription regulatons is considered automatically to be a prescriptiononly medicine, products in oral form containing the following vitamin substances, which do
not make medicinal claims, and are subject to the maximum daily doses stated below,
may be presented as food supplements and marketed in accordance with the European
Community Food Suppplements Directive:
•
•
•
•
•
•
Folic acid 500 microgram
Vitamin A 7,500 IU (2.25mg)
Vitamin D (ergocalciferol; cholecalciferol) 300 IU (75 microgram)
Vitamin B6 50mg
Vitamin B12 25 microgram
Phytomeniadione (Vitamin K1) any dose.
However, while the IMB reserves the right to review the status of any product and
determine the approriate prescription status, the notification goes on to say that following
advice received from the Irish Department of Health and Children, the IMB understands
that products containing vitamins exceeding the dosage levels above may also be
marketed as food supplements, providing no medicinal claim is made.
Source:
IHTA
IRELAND AND MAXIMUM LEVELS
A recent meeting of the Irish Food Standards Authority (FSAI) Consultative Council was
devoted to the subject of food supplements, and particularly on maximum levels for
vitamins and minerals.
Speakers included Dr Mary Flynn, who represents Ireland in maximum levels discussions
in the European Union Expert Group meetings, Dr Alan Ruth, Chief Executive of the Irish
Health Trade Association (IHTA) and Basil Mathioudakis of the European Commission.
.
In response to a reminder from Dr Flynn that the current FSAI policy was that Food
Supplements should not contain more than 1 x RDA, Dr Ruth pointed out that this did not
accord with European Court of Justice (ECJ) case law. This was supported by Mr
Mathioudakis, who explained that nutritional need was not the basis for setting maximum
February 2009
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levels and that the EC did not intend to limit levels to multiples of RDA. Instead, the EC
approach follows the criteria laid out in the Food Supplement Directive, adopted by the
European Parliament and the Member States, and is based on evaluating the risk, taking
into particular account the European Food Safety Authority (EFSA) opinions on Upper
Safe Levels.
Mr Mathioudakis confirmed that for those nutrients where no Upper Levels were set
because there were no identified risk at high intakes, the EC’s view was that no levels
were necessary. He also re-affirmed that it was the EC’s intention that the levels to be
proposed should allow a wide choice of safe supplements for consumers across Europe.
Source:

IHTA
UNITED KINGDOM
SURVEY CALLS FOR MORE RESEARCH ON METALS
A recently released study carried out by the Food Standards Agency (FSA) Committee on
Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) has
indicated that while levels of most metals in foods are falling, more information on the
bioavailability of barium and manganese was desirable, as was clarification of the reasons
for the large variations of aluminium found in foods.
The aim of the project was to estimate dietary exposures of the elements for UK
consumers. 24 elements - including metals - were studied, from samples of 20 different
food groups bought in 24 randomly selected towns in the UK.
Source:
HFMA
NEW REGISTER OF PRACTITIONERS LAUNCHED
A new Register has recently been launched, aimed at providing the public with
reassurance as to the status of complementary practioners/businesses.
The Complementary and Natural Healthcare Council (CHNC) will not judge whether clinics
or therapies are effective, but will only accept onto their Register those practitioners and/or
businesses which can demonstrate that they operate in a professional and safe manner.
Source:
HFMA
NORTH AMERICA

UNITED STATES
February 2009
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FDA SAYS PYRIDOXAMINE IS NOT A DIETARY SUPPLEMENT
Following an on-going debate between the manufacturer, the US Council for Responsible
Nutrition (CRN) and the US Food and Drug Administration (FDA), the FDA has finally ruled
that pyridoxamine dihydrochloride, a B6 compound, cannot be used in dietary
supplements.
The basis for FDA’s decision is that the ingredient was authorised for investigation as a
new drug before it was marketed as a food supplement. This is despite the fact that the
supplement industry and CRN had produced evidence to show that the product had been
on the market as a food supplement prior to the enactment of the 1994 Dietary
Supplement and Health Education Act – and that its continued marketing as a food
supplement was therefore covered by a ‘grandfathering’ clause.
There is industry concern that FDA’s decision might set a precedent for other supplement
ingredients, and CRN has warned its members to ensure that they keep records of when
products were first placed on the market.
Source:
CRN US
CISPI REJECTS TRANS FAT ADVICE
The US Centre for Science in the Public Interest (CISPI) has recently challenged the
advice of the Trans Fat Task Force in Pennsylvania that a mandatory ban could, from a
health perspective, do more harm than good.
The conclusions of the Task Force, set up to find ways to reduce trans fat consumption in
Pennsylvania, were that a public education programme plus industry encouragement to
make the switch, was preferable to a total ban.
CISPI has countered this view by pointing out that acceptable alternatives to trans fats are
much more readily available than they were, say, ten years ago, and hence an outright ban
was a far better solution.
Source:
UNPA
INDEX OF ASSOCIATION CONTRIBUTORS
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CRN (US) (Council for Responsible Nutrition): [email protected]
EHPM (European Federation of Associations of Health Product
Manufacturers): [email protected]
ERNA (European Responsible Nutrition Alliance): [email protected]
HADSA (India) (Health & Dietary Supplements Association): [email protected]
HFMA (UK) (Health Food Manufacturers’ Association): [email protected]
IHTA (Irish Health Trade Association): [email protected]
UNPA (US) (United Natural Products Alliance): [email protected]
KEY EVENTS:
February 2009
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Date
Conference
Place
March 04 - 05
Nutracon
www.nutraconference.com/nutracon09/public/ent
er.aspx
Anaheim, CA, United
States
March 05 - 08
Natural Products Expo West/ Supplyexpo
http://expowest.com/ew09/public/enter.aspx
Anaheim, CA, United
States
March 16 - 20
Codex Committee on Food Additives
www.codexalimentarius.net
Beijing, China
March 23 - 27
Codex Committee on Contaminants in Foods
www.codexalimentarius.net
Rotterdam, The
Netherlands
March 25 - 27
WorldFood Uzbekistan
www.worldfood.uz/en/2009/
Tashkent, Uzbekistan
March 30 April 04
Codex Committee on General Principles
www.codexalimentarius.net
Paris, France
April 02 - 05
CHFA Expo West 2009
www.chfa.ca
Vancouver, Canada
April 02 - 06
Cosmoprof/Cosmopack
www.cosmoprof.com/en/index.asp
Bologna, Italy
April 27 - 29
SupplySide East
www.supplysideshow.com/east/2009/
Secaucus, NJ, United
States
May 04 - 08
Codex Committee on Food Labelling
www.codexalimentarius.net
Calgary, Canada
May 05 - 07
Vitafoods International
www.vitafoods.eu.com
Geneva, Switzerland
Date
Conference
Place
February 2009
10
May 08 -10
Cosmofarma 2009
www.cosmofarma.com/
Bologna, Italy
May 12 - 13
IADSA Annual General Meeting (AGM)
www.iadsa.org
Cancun, Mexico
June 15 - 16
Health Ingredients South America Summit 2009
www.hi-events.com.br/ingles.html
São Paulo, Brazil
June 23 - 25
Food Ingredients Asia-China/Health Ingredients
China/Natural Ingredients China 2009
http://asiachina2008.fievents.com/content/default.aspx
Shanghai, Chin
June 23 - 26
Executive Committee of the Codex Alimentarius
www.codexalimentarius.net
Rome, Italy
June 29 - July
04
Codex Alimentarius Commission
www.codexalimentarius.net
Rome, Italy
Prepared by the
INTERNATIONAL ALLIANCE
OF DIETARY/FOOD SUPPLEMENT ASSOCIATIONS
rue de l’ Association 50
B-1000 Brussels
Tel: (00) (32) (2) 209 11 55; Fax: (00) (32) (2) 223 30 64,
E-mail: [email protected] - Website: www.iadsa.org
IADSA endeavours to check the veracity of information covered in the Newsflash, but
cannot be held responsible for any inaccuracies in the articles published. Where available,
IADSA provides links to other World Wide Web sites as a convenience to users, but cannot
be held responsible for the content or availability of these sites
February 2009
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