09 by nuhman10


									                              IADSA NEWSFLASH
                                MAY/JUNE 2009

CODEX:                 Key supplement issues adopted
SOUTH AFRICA:           New self-regulation objectives for industry

JAPAN:                  New consumer office for health foods
EUROPEAN UNION:         EFSA to review its science
                        Health claims update: 2010 deadline won’t be met
                        Outcome of standing committee on claims
                        Regulation on materials in contact with food
                        EFSA working group on soy isoflavones
                        EFSA advice on carbohydrate reference intake
                        Scientific Committee adopts recommendations on transparency
                        New mutual recognition regulation in force
                        EFSA consults on enzyme guidelines
                        European Parliament elections
                        ESCO Report on Botanicals
                        PARNUTS, food supplement ingredients and boron
BELGIUM:                CoQ10 at 200 mg authorised
                        Belgian and French associations join forces on health claims
FRANCE:                 Improvement in relations between industry and regulators?
                        SDCA seeks consultation on ‘Nutrivigilance’
                        Association acts on negative publications about supplements
UNITED KINGDOM:         COT statement on glucosamine
                        Agency warns on arsenic in rice
                        Advertising complaints
                          NORTH AMERICA
UNITED STATES:          New guidance on calcium and vitamin D
                        New FDA head sets out priorities
                        Sports supplements destroyed
                        FDA warning on Hydroxycut products
                        Industry coalition on swine flu products
                        Prior notice rule relaxed for small companies
                        Warning on cholesterol claims for ‘functional food’
                        Association responds to sports supplement article
                        SOUTH WEST PACIFIC

AUSTRALIA:              Research shows high supplement consumption
                        Association warns on Ginkgo quality

May/June 2009                                                                      1
                                KEY EVENTS

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 54 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:

   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
   Organizing global and regional events to promote dialogue on the scientific and
    regulatory issues underpinning the dietary supplement market.

                        INTERNATIONAL DEVELOPMENTS

      CODEX

                          KEY SUPPLEMENT ISSUES ADOPTED

The Codex Alimentarius Commission (CAC), the decision-making body in Codex, has
adopted five key issues for the food supplement industry this month.

-      The Recommendations on the Scientific Substantiation of Health Claims, as
       supported by IADSA. This text takes into account the totality of the available
       relevant scientific data and weighing of the evidence to substantiate a health claim.

-      The Nutritional Risk Analysis Principles, as supported by IADSA. This text shares
       the principles and recommendations of the 2006 FAO/WHO nutrient risk
       assessment report and is a solid framework for the potential future application of the
       risk assessment method by Codex for the use of vitamins, minerals and other
       substances in food supplements.

-      The Provisions on Gum Arabic as a carrier at the proposed level of 10 mg/kg
       supported by IADSA.

-      The Use of the following eight Food Colours in food supplements: Allura Red AC,
May/June 2009                                                                                  2
      Caramel Colour-Class IV, Carotenoids, Chlorophylls-Copper Complexes, Fast
      Green FCF, Grape Skin Extracts, Indigotine and Iron Oxides.

      However, all the provisions related to Erythrosine for all food categories including
      food supplements were returned to Step 6 for further discussion by the Codex
      Committee on Food Additives. In addition, the Joint FAO/WHO Expert Committee
      on Food Additives (JECFA) was requested to re-evaluate this colour, do another
      exposure assessment and update the exposure level using data to be provided by
      Codex member governments.

-     The definition and table of conditions of dietary fibre, which take into account that
      three main categories of carbohydrate polymers are distinguished, refer to
      monomeric units and leave the decision to include carbohydrates with monomeric
      units from 3 to 9 to national authorities.

For further information, contact the IADSA Secretariat: secretariat@iadsa.be.




The South African Health Products Association (HPA) continues to negotiate with the
Department of Health (DoH) to implement acceptable and appropriate regulations for the
broader category under which food supplements fall under but is also pushing ahead with
plans to set up a self-regulatory structure that will both assist the DoH and protect the
industry from unethical practices and unscrupulous marketers.

The self-regulatory initiative is felt to be particularly important as, to quote HPA Chairman
Dr. Alan Tomlinson, “until appropriate regulations are put in place, there is currently
‘regulatory limbo’ with ‘certain operators …taking chances with the safety, quality and
efficacy of products being placed in the market’, creating a ‘…totally unacceptable’

A series of further meetings are planned to work out the structure, legal basis and
objectives of such a scheme, and practical issues such as costs, premises, staffing, etc.

Source:       HPA


May/June 2009                                                                                   3
      JAPAN


The Japanese government has decided to establish the new office named the ‘Office of
Consumers’, under the control of the Cabinet Office. The new Office will deal with the
regulation of health foods.

The Japanese parliament (both the House of Representatives and the House of
Councillors) has now adopted several laws relating the establishment of the Office of
Consumers. The new Office will accept the application of FOSHU and Foods for Special
Dietary Uses and deal with all issues relating to label description, including health claims.
However, safety issues will continue to be dealt with by the Ministry of Health, Labour and

Source:       JIHFS



                              EFSA TO REVIEW ITS SCIENCE

As part of a quality assurance process based on an internal and an external review, the
European Food Standards Agency (EFSA) has put out a call for scientific experts to take
part in a working group to review the quality of EFSA’s science.

The external review will cover an evaluation of a sample of already adopted and published
scientific opinions from EFSA. The aim will be to evaluate whether:
       best assessment practices were followed in the development of the output
       conclusions and recommendations were supported by an adequate description of
        the reasoning underlying the interpretation of the scientific data
       the terms of reference were adequately address in the conclusions

Source:       ERNA


An ‘Access’ database of Article 13 (generic) health claims representing the consolidation of
circa 42,000 claims down to around 4,185 substance/health relationships is published on
their website, as is a list of Questions relating to these health claims – see:

The Article 13 claims have been screened by EFSA and placed in three categories:
    1024 with a deadline for review by 31st July 2009
    468 with a deadline for review of 30th November 2009
    2693 with no deadline set as yet.

EFSA is due to complete the review of all claims submitted by the end of the year, and the

May/June 2009                                                                                   4
publication of the list of Article 13 claims is scheduled for the end January 2010. However,
the European Commission has now acknowledged that this deadline is most unlikely to be
met, and no further deadline has been set as yet.

The majority of claims submitted under Article 13.5 and Article 14 (for products for children
and disease risk reduction claims) have been rejected by EFSA because the
substantiating evidence was not considered to be adequate and EFSA has now published
a draft ‘Frequently asked Questions’ (FAQ) document which addresses the key issues for
assessing the evidence for these claims.

The FAQ was discussed at the EFSA ‘Technical meeting’ to which key industry members
were invited, and which EFSA hoped would assist industry understand what their scientific
assessors expect in terms of substantiating data.

Technical experts from both ERNA and EHPM attended the meeting which, it was hoped,
would also offer the opportunity to discuss the methodology for the review of Article 13
claims. Currently, despite the fact that the Regulation says that the assessment and
authorisation process should be different from that for Article 13.5 and 14 claims, EFSA
continues to maintain that the same level of assessment will be applied.

As foreseen, EFSA did not want to address the article 13.1 claims during the meeting and
provided no opportunity to discuss it, and indicated that it is up to the Commission and the
Member States to organise such meeting.

Although the participants were able to put forward a number of technical questions, there
was no real and practical new information, apart from a new procedure for a dialogue with
applicants. EFSA referred very often to the need for a case by case evaluation and to the
impossibility to provide general guidance.

Regarding how EFSA complied with the requirement to weigh the evidence, EFSA
indicated that it had decided not to use grading of evidence, but it does underline the
degree of quality of the evidence underlying the claim and that it would not change their
approach as to if a cause and effect is established (a YES/NO approach).

Source:      EHPM / ERNA


During the June’s meeting of the Standing Committee, between the Commission and the
EU Member States, a number of key issues related to the EU Claims Regulation were
discussed and approved.

a) The European Commission tabled for discussion a proposal to amend the Annex on
nutrition claims to introduce only five new nutrition claims:

     - Source of Omega-3 fatty acids;
     - High Omega-3 fatty acids;
     - High mono unsaturated fat;
     - High poly unsaturated fat;
     - High unsaturated fat.

Member States asked for more amendments to be introduced before the end of the
transition period (19 January 2010). For example, it was proposed to have a discussion on
the possibility to allow some nutrition claims for nutrient reductions that would be smaller

May/June 2009                                                                               5
than the 30% reduction currently required for a "reduced" claim.

However, the Commission indicated it would be willing to discuss the inclusion of other
additional claims in the Annex only at a later stage (no timeline proposed). For the
moment, the Commission is only prepared to discuss the five claims in the current
proposal as there was an agreement to work on these before the adoption of the
Regulation and because any potential discussion on additional nutrition claims would delay
- beyond the end of the transition period - the adoption of the current five.

It was reminded that as of 20 January 2010 all nutrition claims that were allowed at
national level prior 1 January 2006 to and that are not mentioned in Annex would be
prohibited across the EU according to the Regulation provisions.

b) Two texts rejecting Article 13.5 and Article 14 claims were approved:

-    Rejected Article 13.5 claim: Algatrium promotes your antioxidant response: a singular
     nutritional substance that has scientifically demonstrated in humans a stimulation of
     the own cells antioxidant defences.

-    Rejected Article 14 claims:
     -    The regular consumption of Melgaço mineral water reduces body
          hyperglycaemic levels.
     -    Regular consumption of 2 servings per day of an Ocean Spray product each
          containing typically 80mg cranberry proanthocyanidins helps reduce the risk of
          urinary tract infection in women by inhibiting the adhesion of certain bacteria in
          the urinary tract.
     -    Kinder Chocolate, the chocolate that helps to grow.
     -    [a specific follow-on formula] Aids minor intestinal ailments (as colic,
          constipation, digestive symptoms).

d) The proposed Regulation clarifying that Member States must verify the validity of
applications for the authorisation of health claims under article 14 or 13.5 and confirming
that applications cannot be withdrawn anymore after EFSA has adopted its opinion was

Source:      EHPM


A new EU regulation on active and intelligent food contact materials has recently been
published, introducing an authorisation scheme for substances used in food packing. To
gain authorisation, packaging manufacturers must submit technical dossiers for each
substance for scrutiny by the European Food Safety Authority (EFSA).

Active substances include oxygen absorbers or releasers of preservative or flavourings,
while intelligent materials provide information to food companies and consumers, warning,
for instance, of microbial contamination. Manufacturers are also obliged to label
containers in order to ensure information is passed down the supply chains.

Source:      EHPM


The German Federal Institute for Risk Assessment (BfR) has formally requested the

May/June 2009                                                                                  6
European Food Safety Authority to deliver a scientific opinion on the use of isolated
isoflavones in food supplements.

An ESCO working Group on isoflavones will be created to collect all the relevant scientific
information. The Group will undertake a review of the literature and of the data via a
structured search strategy, with the aim of completing the report by the end of the year.

Source:       EHPM


The European Food Safety Authority (EFSA) has adopted a set of recommendations on
transparency in risk assessment for its Scientific Committee, and Panels and other
scientific outputs it produces.

The recommendations on transparency in the scientific aspects of risk assessment are:
     General aspects: risk assessments must be understandable and reproducible
     Scope and objectives must be documented and clarified with the requestor, if
     Data and data sources must be described and referenced, evaluated for quality and
     Inclusion and exclusion criteria must be explained and the rationale given
     Assumptions should be documented and explained
     Assessment process: the reasoning, calculation or mathematical modelling applied
      should be explained
     Conclusions of a scientific opinion must address the terms of reference
     Opinions issued by bodies other than EFSA should be considered.

The conclusions on transparency in the procedural aspects of risk assessment
Include the involvement of stakeholders prior to and during the risk assessment.

Source:       EHPM


Regulation EC 764/2008 on Mutual Recognition came into force on May 13, 2009, in all 27
EU member states. This Regulation applies to food supplements in areas of legislation that
are not yet harmonised (i.e. that are subject to national rules) such as the regulation of
other substances than vitamins and minerals, the maximum levels for vitamins and
minerals (harmonisation pending as long as no EU proposal is adopted) or the use of
health claims (harmonisation pending the final EU list being adopted).

The Regulation defines the rights and obligations of national authorities and operators
intending to sell in a Member State products lawfully marketed in another Member States
when the national authorities intend to take restrictive measures about the product on the
basis of national technical rules. In particular, the Regulation clearly states that the burden
of proof is on member states and sets out detailed procedural requirements for denying
mutual recognition. It also establishes a list of national contact points that are expected to
provide appropriate information on national technical rules that are applicable to food
supplements. For a list of national contact points, see:

Source:       EHPM

May/June 2009                                                                                 7

The European Food Safety Authority (EFSA) has launched a public consultation on draft
guidelines for the safety evaluation of food enzymes. The guidelines will specify the type
of information that industry should provide to enable EFSA to carry out the safety
assessment of enzymes – including description of chemical composition, properties and
toxicological tests.

On the basis of this information, EFSA will address the safety of the source materials from
which the food enzyme is produced (including the presence of possible impurities), the
manufacturing process and dietary exposure.

As an initial phase, EFSA is requested to evaluate food enzymes presently on the market
in the European Union (EU). Once completed, an EU list of authorised substances will
be established by the European Commission. New enzymes will require safety
assessment by EFSA before use.

Source:      EHPM

                         EUROPEAN PARLIAMENT ELECTIONS

The results of the recent European Parliament elections in which members were elected
for a new 5 year term, were a victor for centre-right parties. The European People’s Party
(EPP), which is generally receptive to industry’s views, will remain the largest group in the
new Parliament. However, the EPP lacks an overall majority and will need to cooperate
with other parties.

The first plenary session of the new Parliament takes place in mid-July. Many issues of
major importance to the supplement industry will be on the agenda for the new Parliament,
particularly those relating to Novel Foods, Food Information, Maximum Levels, and Health

Source:             EHPM

                            ESCO REPORT ON BOTANICALS

The ESCO working group on Botanicals and Botanical Preparations is due to finalise its
report on the EFSA guidance document on the safety of botanicals and botanical
preparations used in food supplements and the Compendium of botanicals reported to
contain toxic, addictive psychotropic or other substances of concern. The final outcome
will first be presented to the Steering Group on Cooperation and the Scientific Committee,
and then to the Advisory Forum in June.

A workshop to present the work done by the EFSA Scientific Committee and the ESCO
working group is to be considered for the second half of 2009.

Source:      EHPM


Dossiers for 66 nutrient source ingredients for assessment by EFSA have already been
given a positive opinion, and a further 78 positive opinions on applications have yet to be

May/June 2009                                                                                   8
Both Boric acid and Sodium borate have been accepted as nutrient source ingredients in
Products for Particular Nutritional Uses (PARNUTS), but although the Commission
continues to be pressed to accept Boron as a nutrient source for food supplements, this
has not yet been agreed. Other ingredients adopted for PARNUTS products include
mineral bisglycinates (chelates), Vitamin K2, and L-carnitine-L-tartrate.

Source:      EHPM


                             CoQ10 AT 200 mg AUTHORISED

A national decree has recently authorised that supplements containing 200mg CoQ10 can
be marketed in Belgium.

Now that the new Mutual Recognition Regulations have come into force, it is anticipated
that its procedures may be used to facilitate the marketing of CoQ10 in other Member

Source:      NAREDI


The French supplement association SDCA recently attended a meeting with their
authorities where it was agreed that evidence of ‘tradition of use’ could be used in
substantiation for some botanical claims – something that EFSA is so far refusing to

SDCA also alerted them to the absence of transparency and absence of guidance for the
assessment of article 13.1 (generic) claims, and the need for a different process from that
for Article 13.5 and 14 claims. In addition, with the help of detailed and comprehensive
written argument prepared by the Belgian supplement association NAREDI, the French
government expert was persuaded to liaise with his Belgian counterpart with a view to
table the question at an EEC meeting.

Source:      NAREDI / SDCA

     FRANCE


The French food supplement industry has been waiting for more than two years for the
publication of its national order on other substances and botanicals. The text will contain
the list of ingredients (other than vitamins and minerals) that were authorised through
article 16 of decree 2006-352 establishing mutual recognition of standards for food
supplements. Apparently, the delay is attributable either to one of the three relevant
Ministries (Agriculture, Economy and Finance, and Health) or to AFSSA (the French Food
Safety Agency).

The supplement trade association SYNADIET has recently met the officials responsible for
the case at the Health Ministry. The Ministry expressed its support for cooperation
May/June 2009                                                                                 9
between the Authorities and professionals - a big step forward in relations between French
industry and the regulatory authorities.

The SYNADIET botanicals working group has already made comments about a draft text
submitted by the Ministry. This first practical and detailed exchange demonstrates the way
to progress this text, which has until now been the subject of an unjustified block, leading
to legal insecurity for industry.

Source:       SYNADIET


The French supplement association SDCA recently met members of French Parliament
and alerted the offices of the ministers of Consumption and Agriculture so as to block a
regulatory proposal intended to create a ‘Nutrivigilance’ system for supplements, Parnuts
and enriched foods.

SDCA is not against a system of nutrivigilance but is asking for a consultation before the
regulation is finalised, to ensure its conformity with European Food Law (Reg. /2002/EEC)
and to ensure the correct application and separation of the principles of Risk assessment
and Risk management.

Source:    SDCA


SDCA recently had a meeting with officials from the office of the Minister of Health and the
General Manager of the French Food Safety Agency (AFSSA) to ask them to stop attacks
against food supplements.

This was because some leaflets were launched by Ministry of Health in cooperation with
 AFSSA on " Cancer & Nutrition", "Doping" , and "The Elderly and Nutrition" . In each
leaflet the same key message was included: "Food supplements are not necessary and
in some case can be dangerous" "Eat a balanced diet, eat fruits and vegetables but
not food supplements which can encourage consumption of junk foods". The result of the
meeting was that the Ministry of Health agreed to withdraw the leaflet on ‘Doping’, revise
the leaflet on "Cancer and feeding" and to consult SDCA for further discussion in the

Source:       SDCA


                           COT STATEMENT ON GLUCOSAMINE

Following a review of current evidence, the UK Food Standards Agency (FSA) Committee
on Toxicology (COT) has concluded that glucosamine is unlikely to cause hepatitis.

The review was brought about as a result of a small number of studies which suggested a
link between the supplement and inflammation of the liver. However, COT’s view was that
although it could not rule out a causal link in relation to these studies, the risk, if there was
one, was ‘very low’.

May/June 2009                                                                                 10
Source:      HFMA

                         AGENCY WARNS ON ARSENIC IN RICE

The UK Food Standards Agency has recently published results from a study of arsenic
levels in rice drinks. In a study of 60 samples of rice drinks, the study found levels of total
arsenic ranging from 0.0010 – 0.0034 milligram/kilogram, but also levels of inorganic, more
harmful arsenic ranging from 0.0005 -0.020 milligram/kilogram.

None of these levels were over the current legal limit, but the results have led the Agency
to warn that toddlers and young children between 1 and 4.5 years should not have rice
drinks as a replacement for cow’s milk, breast milk, or infant formula. This is because they
would drink a relatively large amount of arsenic, greater than that for older children and
adults, because of their bodyweight.

Source:      HFMA

                               ADVERTISING COMPLAINTS

The UK Advertising Standards Agency (ASA) has told a Guernsey-based supplier of food
supplements to cease claiming that it is the number one supplier for food supplements in
the UK.

The ASA’s view was that the figures provided by the company were not sufficient to
substantiate the claim that ‘..more people buy their vitamins from …….than any other
supplier in the UK’ and that the claim was therefore misleading.

Other recent ASA judgements include one for misleading advertising for a hoodia gordonia
product which claimed that it could reduce calorie intake, lose weight, boost mood and act
as an aphrodisiac, and a claim for a health juice which showed a hangman’s noose,
together with the claim, ‘Cheat death. The antioxidant power of …juice’. ASA did not
consider that the evidence submitted showed any direct relation between consuming the
juice and length of life’.

Source:      HFMA

                                   NORTH AMERICA



The US Food and Drug Administration (FDA) has issued new industry guidance on its
recently published final rule which amends the health claims associating calcium with
osteoporosis and therefore claims associating calcium and vitamin D with osteoporosis.

The new guidance, presented in the form of a Q & A, explains the specific requirements
that must be on the label, the necessary characteristics of the food/food supplement, and
gives some examples of the type of wording that may now be used:
     a claim for calcium and osteoporosis could read: ‘adequate calcium throughout
       life, as part of a well-balanced diet/physical activity, may reduce the risk of
       osteoporosis in later life’’
May/June 2009                                                                               11
       a claim for calcium, vitamin D and osteoporosis could read: ‘adequate calcium and
        vitamin D throughout life, along with a well-balanced diet/physical activity may
        reduce the risk of osteoporosis in later life’.

Source:       AHPA

                         NEW FDA HEAD SETS OUT PRIORITIES

Following a spate of foodborne illness outbreaks, and the recent publication of a report
showing Food and Drug Administration (FDA) failures to meet goals for food safety
inspections, the newly appointed Commissioner of the FDA, Dr Margaret Hamburg, has
pledged to focus on food safety.

She is also supporting a contentious proposal aimed at lessening FDA’s funding shortfall,
whereby food manufacturers would be required to pay $1,000 per facility to fund FDA
safety inspections. Such inspections, it is proposed, would take place at least once every
4 years, and every 18 months for high-risk facilities.

Dr Hamburg has also declared her intention to further scrutinise the area of health claims,
saying that ‘A laissez-faire approach to nutritional claims can lead to more confusion than

Source:       UNPA

                          SPORTS SUPPLEMENTS DESTROYED

At the request of the US Food and Drug Administration (FDA), U.S. Marshals have seized
more than 23,300 bottles of three dietary supplement products marketed for use by body
builders and distributed on the internet and in retail stores under the names Methyl 1-D,
Methyl 1-D XL, and Formadrol Extreme XL.

Based on laboratory tests, the FDA determined that the products contained one or more
unapproved food additives and/or new dietary ingredients for which there is inadequate
information to assure that the ingredients do not present a significant or unreasonable risk
of illness or injury, and included substances that are steroids that inhibit the activity of the
enzyme aromatase, which were being used in dietary supplements promoted to boost
testosterone levels.

Source:       NPA


The Food and Drug Administration have warned consumers to immediately stop using
certain Hydroxycut products because of association with a number of serious liver injuries.

This action was taken following information to FDA of 23 adverse event reports of liver-,
associated damage, and is an example of the agency’s expanded authority under the
‘Dietary supplement and Non-Prescription Drug Consumer Protection Act’.

Source:       AHPA


Whilst acknowledging that dietary supplements have much to offer in terms of enhancing

May/June 2009                                                                                 12
general immune function, in relation to the current swine flu outbreak, IADSA member
associations, the American Herbal Products Association, (AHPA), the Council for
Responsible Nutrition (CRN USA) and the Natural Products Association (NPA) were
amongst those endorsing the following unified advice for marketers, retailers and
consumers of dietary supplements:

   Marketers and retailers of dietary supplements are urged to refuse to stock or sell any
    supplements that are presented as treating or curing swine flu

   Marketers and retailers should refrain from promoting any dietary supplement as a cure
    or treatment for swine flu

   Anyone who believes they may have swine flu or may have come in contact with the
    virus should contact a healthcare professional.

Source:       AHPA / CRN USA / NPA


The Department of Health and Human Services (DHHS) of the Food and Drug
Administration (FDA) has published new guidance on the Prior Notice rule for small
companies involved in the import and export of food products in the USA.

The rule requires all companies dealing with food/food ingredients entering the US to give
prior notice of their arrival so as to help intercept contaminated products, and organise
inspections. However, the DHHS are now quoted as saying that ‘FDA examined the
implication of this final rule….and determined that it would have a significant economic
impact on a substantial number of companies’

Now, the FDA is allowing more time for importers to inform it of food product imports – up
from 5 to 15 or 30 days, depending on the mode of notification. Provided certain
conditions are met, information requirements are also simplified, allowing a carrier tracking
number to be used instead of anticipated arrival information, bill of lading, etc.

The guidance is available at http:// www.cfsan.fda.gov/guidance.html

Source:       NPA


A major manufacturer has been reprimanded by the Food and Drug Administration (FDA)
for making illegal claims on a popular brand of cereal, to the effect that the cereal ‘…is
clinically proven to lower cholesterol’ and ‘you can lower your cholesterol 4% in 6 weeks’.

FDA regards such claims are appropriate for a drug, not a food, and products using them
should be authorised as such. However, it was also said that the cereal ‘is not generally
recognised as safe and effective for use in preventing or treating hypercholesterolemia or
coronary heart disease.

The FDA is still reviewing is position on the future regulation of functional foods.

Source:       UNPA


May/June 2009                                                                              13
The US Council for Responsible Nutrition has recently put out a statement strongly refuting
the implications of a recent article in a Sports magazine entitled ‘What You Don’t Know
Might Kill You’.

The article focused on a variety of adverse health event reports received by the Food and
Drug Administration from consumers who had used a variety of supplements. Whilst the
FDA itself stated that it was usually difficult or impossible to tell whether a supplement had
been the cause of an adverse reaction, the magazine implied that such reactions were due
to poorly manufactured, and/or unregulated products.

In refuting these allegations, CRN USA have drawn attention to the comprehensive
regulatory structures surrounding dietary supplements, and the new Good Manufacturing
Practice rules that relate specifically to dietary supplements.

Source:      CRN USA

                                SOUTH WEST PACIFIC



The Complementary Health Council of Australia (CHC) has welcomed new research which
shows that Australian consumption of natural supplements to be high, with the majority of
consumers believing them to be effective in maintaining or restoring health.

The study found that of the 867 people aged 14+ that were surveyed:
    75% had taken a supplement in the last l2 months
    75% rated the effect as fairly to very effective
    Supplement consumption had risen considerably compared with figures of 27% in
      2004 and 42% in 2008

Source:      CHC


The Complementary Health Council of Australia (CHC) has advised its members to
beware of ginkgo products adulterated with other herbs being passed off as pure gingko.

The Australian Therapeutic Goods Administration (TGA) is aware of the problem but is
currently unable to take effective action because such products did not formally reference
any ginkgo pharmacopoeial standard, and the products could not, therefore, be considered
as non-compliant, nor were they hazardous to public health.

However, to remedy the situation, the TGA is now proposing that as an additional condition
of listing a product on the Australian Register of Therapeutic goods, there should be a
more comprehensive analysis of flavonol glycosides for products that contain ginkgo as an
active ingredient.

Source:      CHC

May/June 2009                                                                              14
      AHPA (US) (American Herbal Products Association): ahpa@ahpa.org
      CHC (Complementary Healthcare Council of Australia): chc@chc.org.au
      CRN (US) (Council for Responsible Nutrition): webmaster@crnusa.org
      EHPM (European Federation of Associations of Health Product
       Manufacturers): secretariat@ehpm.be
      ERNA (European Responsible Nutrition Alliance): secretariat@erna.be
      HFMA (UK) (Health Food Manufacturers’ Association): hfma@hfma.co.uk
      HPA (Health Product Association of Southern Africa): bruce@vhf.co.za
      JIHFS (The Japanese Institute for Health Food Standards): info@jihfs.com
      NAREDI (Belgium) (Federation of the Industry and Trade of Natural and
       Dietetic Products): info@naredi.be
      NPA (US) (Natural Products Association): natural@naturalproductsassoc.org
      SDCA (France) (Syndicat de la Diététique et des Compléments Alimentaires) :
      SYNADIET (France) (Syndicat des Fabricants de Produits Naturels,
       Diététiques et Compléments Alimentaires): f.cheymol@synadiet.org
      UNPA (US) (United Natural Products Alliance): loren@unpa.com

                          KEY EVENTS: JULY – DECEMBER 2009

       Date                          Conference                               Place

  July 09 - 11               Natural MarketPlace 2009                    Las Vegas, NV,
                   www.naturalmarketplaceshow.com/nm09/public/e           United States

  July 19 - 21             Cosmoprof North America 2009                  Las Vegas, NV,
                          www.cosmoprofnorthamerica.com/                  United States

 August 27 - 29              Natural Products Expo Asia                 Hong Kong, China

 September 09 -                  Food Ingredients Asia                  Bangkok, Thailand
      11           http://asia2008.fi-events.com/content/default.aspx

 September 10 -                      SANA 2009                            Bolgona, Italy
      13                             www.sana.it

May/June 2009                                                                               15
 September 23 -             Natural Products Expo East              Boston, MA, United
      26          http://www.expoeast.com/expoeast09/public/enter         States

  October 14 -        Health Ingredients Japan 2009/ Safety &          Tokyo, Japan
      16                      Technology Japan 2009

  October 23 -                Food Ingredients India                  Mumbai, India
      24                        http://india2008.fi-

  October 27 -                Worldfood Ukraine 2009                  Kyev, Ukraine
      30                 http://www.worldfood.com.ua/en/

 November 02 -      Codex Committee on Nutrition and Foods for      City TBC, Germany
     06                      Special Dietary Uses

 November 11 -                   Supply Side West                     Las Vegas, NV,
     13                                                                United States

 November 11 -                  Cosmoprof Asia 2009                    Hong Kong
     13                   http://www.cosmoprof-asia.com/

 November 17 -      Food Ingredients Europe/Natural Ingredients     Frankfurt, Germany
     19                                  2009

 December 08 -    Executive Committee of the Codex Alimentarius        Rome, Italy
      11                    www.codexalimentarius.net

May/June 2009                                                                            16
                                       Prepared by the
                                INTERNATIONAL ALLIANCE
                                    rue de l’ Association 50
                                       B-1000 Brussels
                 Tel: (00) (32) (2) 209 11 55; Fax: (00) (32) (2) 223 30 64,
                  E-mail: secretariat@iadsa.be - 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

May/June 2009                                                                           17

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