IADSA NEWSFLASH JULY/AUGUST 2007 CONTENTS: INTERNATIONAL DEVELOPMENTS
Philippines association joins the al iance
Food additive levels and risk analysis principles
New committee looks at health food safety
Demands for supplement heavy metal details
Novel food ingredient application for CLA
European parliament seeks tougher additive
New procedures for supplements and claims
Associations’ quality guide for supplements
Association’s concerns about plant safety
Discussion on supplement levels continues
NETHERLANDS: UNITED KINGDOM:
Study shows consumers confused by claims
UK data confirms non-novel status of Goji berries
Opinions sought on glucosamine, kiwi concentrate,
Organic certification for herbal medicines?
NORTH A MERICA
Government invests in natural health products
DSEA report shows huge healthcare savings
FDA’s food safety and label ing priorities
New programme to protect against bio-terrorism
Risk-based assessment for imported foods
Label warnings for black cohosh & green tea?
Organic ingredient rule nears finalisation
Supplement products fail to meet label claim
Chinese ingredient test programme launched
Ginseng label ing act introduced in congress
SOUTH WEST PACIFIC AUSTRALIA & NEW ZEALAND: INDEX OF ASSOCIATION CONTRIBUTORS KEY EVENTS
The International Al iance of Dietary /Food Supplements Associations was
founded in 1998 to address the globalization of dietary supplement markets
and increasing regulatory chal enges. IADSA brings together 59 dietary
supplement associations with the aim of building a sound legislative and
political environment for the development of the dietary supplement market
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
• 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
PHILIPPINES ASSOCIATION JOINS THE ALLIANCE
The Health and Dietary Supplement Association of the Philippines Inc.
(HADSAP), has recently been welcomed into IADSA membership.
Created in March this year, HADSAP brings together over 12 member
companies, 60% of which are engaged in the manufacture/marketing of
dietary supplements. IADSA now has 59 member associations throughout the
For further information on HADSAP please contact its President, Mr
Dominador B. Bonquin, email: email@example.com .
FOOD ADDITIVE LEVELS AND RISK ANALYSIS PRINCIPLES ADOPTED
As had been hoped, fol owing intensive lobbying by IADSA and considerable
input from IADSA member associations and companies, the Codex
Alimentarius Commission, the decision-making body in Codex, have final y
adopted the food additive provisions for Castor oil, Polysorbates, Polyvinyl
alcohol, Acesulfame potassium, Aspartame, Cyclamates, Neotame, Saccharin
and Sucralose of the General Standard for Food Additives (GFSA) at the
This means that they become the official provisions within the GSFA, thereby
avoiding any potential barriers to trade.
At the same meeting, the Codex Commission adopted the Working Principles
for Risk Analysis for Application by Governments - another extremely
important achievement because it has resulted in a set of Codex working
principles for risk analysis which do not contain any mention of the
precautionary principle. CRN USA has been particularly active in achieving
For further information, contact the IADSA Secretariat at
The Codex Alimentarius Commission has held further intense discussions on
the development of a Standard for Ginseng Products. The issue was whether
to endorse the current draft standard as developed so far by the Codex
Coordinating Committee for Asia (CCASIA) at Step 5 of the 8-step Codex
decision-making procedure, and whether this draft standard should be
finalised as a regional or international standard.
Eventual y, the Codex Commission agreed the adoption of the draft standard
at Step 5 and the proposal that it should be finalised by CCASIA as a regional
standard, with the proviso that once the regional standard was final y adopted
at Step 8, the Commission would have to decide whether to convert it or not
IADSA’s particular interest is that the regional standard should only cover
Panax ginseng, the main species in Asia. To quote David Pineda, IADSA
manager of regulatory affairs, ‘…as the regional standard wil apply to the Asian members of Codex only, it is logical that it should cover only this
For further information, contact the IADSA Secretariat at
On July 2nd, 2007, The European Food Safety Authority (EFSA) and the US
Food and Drug Administration signed the first US/European agreement in the
This is the first formal international cooperation agreement that EFSA has
signed and the first formal step in cooperation between the two bodies, and is
designed to facilitate the sharing of confidential scientific and other
information, such as methodologies to ensure food is safe. The formal
agreement ensures appropriate protection of such confidential information
under the applicable legal frameworks in the United States and the European
For further information, contact the IADSA Secretariat at
NEW COMMITTEE LOOKS AT HEALTH FOOD SAFETY
A new advisory committee of the Japanese Ministry of Health, Labour and
Welfare (MHLW) has recently been formed, with the task of examining the
The Committee wil discuss measures to ensure the safety of health foods
and any revisions to current practice that may be necessary, including the
current Good Manufacturing Practice framework and safety inspection
guidelines. It wil also consider the setting up of an adverse effect reporting
system, a registration system for health food products, and the best ways to
The committee has 16 members, including representatives from three industry
groups, the Japan Medical Association, the Pharmaceutical
Association, the National Institute of Health and Nutrition, the National
Institute of Health Sciences and Tokyo Metropolitan Government and three
consumer groups. Four university professors of medicine, nutrition and
law, and a scientific writer are also included in the committee, which must
submit its proposals to MHLW by March 2008.
A fermented soybean extract imported from the United States for use in food
supplements was recently found to have been gamma irradiated. Under the
terms of the Japanese Food Sanitation Law, this has led to the recal of al
food supplements on the market which contained the ingredient.
The first FOSHU product with a disease risk reduction health claim has
recently been approved. It is a skimmed milk product with the claim ‘Calcium reduces the risk of osteoporosis’. EUROPEAN UNION
European Commission Regulation 1924/2006 on nutrition and health claims
for foods came into force from July 1st. While in terms of timescale for
compliance there are a number of different transitional periods, the coming
into force of the Regulation essential y means that any food product claiming
to have a nutritional, health or disease-risk related benefit must now have
prior approval based on evidence that substantiates the claim wording.
Nutrition claims must accord with the Regulation’s Annex of nutrition claims,
health claims must be represented on the yet to be developed European Food
Safety Authority (EFSA) central list of approved ‘generic’ claims, and for
disease risk reduction claims must achieve EFSA approval of the individual
Fol owing public consultation, EFSA has now published its final guidance to
applicants on disease risk reduction claims and claims for children, and is now
ready to receive such applications which its Scientific Panel on Dietetic
products, Nutrition and Al ergies (NDA) wil assess within 5 months.
Further information on EFSA’s preliminary discussion document on new
nutrition claims, particularly relating to claims for Omega 3 and unsaturated fat
Separately, the food and the food supplement industry have been preparing a
centralized European industry list of ‘generic’ claims. The list, which contains
over 700 claims, has been put together from submissions from the national
member associations of EHPM, ERNA and the Confederation of Food and
Drink Industries of the EEC (CIAA). A grading of evidence system was used
to judge the validity of the scientific evidence submitted in support of the
claims. The completed list has now been returned to the national associations
for submission to their national food authorities, who wil then pass the
submissions on to EFSA for assessment for the central list.
EFSA have two years to assess claims for the central list. However,
considerable uncertainty remains as to the fate of the claims on the industry
list because EFSA has not yet issued any guidelines as to the volume of type
of scientific evidence they wil require, or how the ‘average consumer’ (who
must be able to understand the claim) is defined. In addition, for botanicals,
the European Botanical Forum is concerned by EFSA’s apparent reluctance
to accept evidence of traditional use as a foodstuff.
DEMANDS FOR SUPPLEMENT HEAVY METAL DETAILS
Fol owing a recent meeting with the European Commission on their proposals
for heavy metal maximum limits in supplements, the EHPM has advised its
members that the fol owing information is urgently required, and that unless it
is forthcoming, the levels proposed by the Commission, which could have
significant commercial consequences for many companies, are likely to be
• Batch by batch results of lead, cadmium and mercury assays on
botanical extracts for as many batches of the raw materials as
possible, together with details of the type of extract or extract ratios.
• Assay results for lead, cadmium or mercury results on as many
batches of kelp as possible together with details of the origin of the kelp
(North Atlantic, South Pacific) and the species of the kelp (laminaria,
• Information on heavy metals (Pb, Cd, Hg) in products containing
botanicals or their extracts, algal sources or high inputs of mineral salt,
giving the actual input of the active components in mg/tablet or capsule
as wel as the total weight of the tablet or capsule.
While the proposals to revise the Novel Food Regulations (applicable to food
ingredients not used to a significant degree in foods legal y sold in the
European Union before May l997) are under discussion, the European
Commission is intending to publish an informal ‘Novel foods catalogue’ that
was discussed at a recent meeting of the Standing Committee composed by
the European Commission and the Member States of the European Union.
The catalogue was described as ‘…a non-exhaustive list of products of plant
or animal origin as wel as of other substances which have been considered
only in relation to their status within the meaning of the Novel Food
Regulations’. The Commission intends to publish the catalogue by the end of
The European associations, EHPM and ERNA have had sight of a current
version of the draft catalogue and a meeting with the Commission is being
sought to discuss issues of concern. In the meantime, a clear message has
• There has been no consultation with industry on the content of the
catalogue (it contains many plants currently included in the positive
lists of a number of Member States, including Belgium, the Czech
• If it is published, it wil have significant commercial implications
• There is no indication of the criteria used to establish the document
NOVEL FOOD INGREDIENT APPLICATION FOR CLA
The European Commission has advised Member States of a submission to
the Spanish Food Safety and Nutrition Agency (AESAN), for the authorization
of Conjugated Linoleic Acid (CLA) as a novel food ingredient when added to
This submission is a further il ustration that proof of an ingredient’s use in food
supplements before May 1997 is not sufficient to support its non-novel food
status if used in other food applications.
EUROPEAN PARLIAMENT SEEKS TOUGHER ADDITIVE REGULATION
Fol owing a first reading, the European Parliament (EP) has voted through
four regulations relating to food ingredients: on authorisation procedures,
additives, enzymes and flavourings – al of them amendments aimed at
strengthening and streamlining existing regulation in this area.
More transparency on decisions on authorisation procedures is sought, and
the environmental aspects of chemicals is to be taken into account, together
with enhanced protection for consumers with food intolerances, and the
flagging of additives whose production has involved genetical y modified
organisms. Flavourings are only to be used if there is technological need,
enzymes only if they do not mislead as to the quality of the product. One
welcome amendment for industry is the proposed protection for 5 years of
scientific data submitted to gain approval.
The second reading on these amendments is expected to take place in
The European Food Safety Authority (EFSA) Working Group is now close to
finalising its draft guidance document for the safety assessment of botanicals
and botanical preparations, together with two compendia listing botanicals
reported to contain toxic substances or reported to have food supplement and
It is understood that these documents wil be submitted to EFSA’s Scientific
Committee in September. Additional y, fol owing the identification of this
activity by the Steering Committee on Cooperation as a possible ‘front-runner’
project, a new mandate wil be prepared for enhancing cooperation on
botanical issues between European Member States.
Further to the report in last month’s Newsflash, the future access of fish oil to
the European market remains under threat though a European regulation
which comes into force in November 2007. It brings fish oil manufacture
within its scope, but places inappropriately high standards of manufacture on
EHPM and ERNA have had a number of meetings with the European
Commission, with technical experts and member companies to try to resolve
the issue. At present, while the Commission seems to be open to the idea of
a permanent derogation for fish oils, some Member States are not, favouring
one year extension of the time period for enforcement of the Regulation.
It is hoped that industry action wil encourage the Commission to open up the
debate in favour of a long-term solution which wil not be detrimental to the
The Standing Committee composed by the European Commission and the
Member States of the European Union met recently to discuss comments
received from Member States on its consultation paper on the feasibility and
advisability of establishing fees for European Food Safety Authority (EFSA).
It was noted that most Member States were not in principle opposed to a fee
system, but had concerns about its feasibility. The man concerns were the
need to safeguard EFSA’s independence, the difficulties of identifying
beneficiaries and the creation of an additional administrative and financial
burden for smal and medium enterprises. It was also considered unfair to
The need for further reflection on this complex issue was recognized, and an
impact assessment to al ow identification of additional costs and
administrative burdens for industry may be carried out.
As required by the terms of the Directive, two years’ after its coming into force
the European Commission has issued a draft Report on the practical working
of the Traditional Herbal Medicinal Products Directive, which is out for public
The draft Report notes that as 31st March, only 79 applications had been
introduced in only 12 Member States; that the distribution of applications was
uneven with most Member States having few or no applications. Only 8
registration applications had been granted, and some Member States had yet
Other issues noted in the draft Report as important for the proper working of
Directive were the need to develop monographs speedily – but lack of
resources were cited as delaying that process. Similarly, in part because of
the requirement for genotoxicity data, often not available for herbals, the
central Community list of monographs which can be used by registration
applicants, thereby reducing the amount of data that must be provided, is very
The draft Report also includes a lengthy discussion about the extension of
Traditional Use Registration to categories of ingredient other than herbal,
which could facilitate the registration of Ayurvedic and Traditional Chinese
products, but no timescale or concrete plans for action are proposed.
NEW PROCEDURES FOR SUPPLEMENTS AND CLAIMS
The Czech Ministry of Health has advised that from 1 July the licensing
system for food supplements containing ingredients not listed in national
Decree No.446/2004 (implemented from Directive 2002/46/EC plus a minor
positive list) only applies to those vitamins and minerals not listed in national
Decree No.446/2004 (vitamins and minerals from Directive 2002/46/EC). Al
other ingredients, including botanicals, wil be subject to notification only, with
the requirement to send the product label to the Ministry of Health, (copied to
the Ministry of Agriculture), prior to placing the product in the market. This
requirement also applies to fortified foods – and in future letters confirming the
fulfil ment of obligation to notify wil no longer be issued.
Also, as from 1 July, the Ministry of Health wil take over responsibility from
the Ministry of Agriculture for the Nutrition and Health Claims regulation, and
has advised a deadline of 15 October for the receipt of health claim
Fol owing a meeting with the French industry association SDCA, the French
food authorities have now agreed to receive health claim applications for
Article 13 of the Regulation on Nutrition and Health Claims. Providing they
meet the conditions of the Regulation, the claims wil be submitted to the
European Commission without pre-assessment.
Additional y, providing they conform the general conditions of the regulation,
the French authorities have agreed to accept applications based on tradition
of use – a particularly point for botanicals.
ASSOCIATIONS’ QUALITY GUIDE FOR SUPPLEMENTS
With the aim of assisting stakeholders to ensure that the products they place
on the market ful y conform to new regulatory requirements, two French
supplement associations, Synadiet and SDCA, have been working together to
prepare a Quality Charter for Food Supplements.
An interactive document on Cdrom, has now been prepared, covering al the
relevant regulation, and it has now been sent out for comment to other
associations, consumer groups, and the French food authorities.
For further details, contact firstname.lastname@example.org
As reported in the June Newsflash, the French food supplement association
SYNADIET recently received a letter from the Food agency (DGCCRF)
advising that the French Medicines Agency (AFSSAPS) is considering the re-
classification of 3 plants currently listed for food supplement use. Their
reason is that they consider them to be medicinal by function.
Since then, Synadiet has held meetings with the regulatory authorities and
with government Ministers, and has particularly concentrated on the fol owing
• The criteria on which the proposed reclassifications are based, and the
list of plants which have been examined.
• The creation of a joint food/medicine working group with the aim, within
an agreed timescale, of agreeing those plants whose food
supplement/medicine status is contentious.
• The early publication of the decree which wil al ow the public sale of
147 plants included in the pharmacopoeia.
It is understood that the Health Ministry (DGS) has accepted in principle that it
wil not, as a general rule, oppose the use in food supplements of plants listed
in the pharmacopoeia and authorized by the DGCCRF under the Article 16
procedure – unless it considers that they pose a risk to public health.
ASSOCIATION’S CONCERNS ABOUT PLANT SAFETY
Discussions at the fourth Consumer Protection Forum have resulted in the
German Federal Institute for Risk Assessment (BfR) advising that plant
ingredients used in foods and food supplements should be properly assessed.
Examples of extracts discussed included coumarin, found in some types of
cinnamon, which may in high dose cause liver damage, the potential side-
effects from isoflavones in isolated, enriched or high dose form, and the
sunburn-like effects of the furocoumarin content of celery on sensitive
Additional y, in its information letter Nr. 012/2007, BfR is advising consumers
to avoid consumption of jojoba seeds, Simmondsia chinensis samen, because
of a potential risk suggested by animal tests.
According to BfR jojoba seeds are not used in foods or food supplements in
Germany and are not sold in any retail outlets and would have first to undergo
an evaluation of novel/non-novel food status before being placed on the
market. However, consumers can currently purchase such products via
DISCUSSION ON SUPPLEMENT LEVELS CONTINUES
Fol owing last month’s report on industry concerns at the proposal from the
Food Safety Authority of Ireland (FSAI) for a 1 x RDA maximum level for
vitamins and minerals, further discussions between EHPM Scientific Advisor
Dr. Derek Shrimpton, the Irish Health Trade Association (IHTA) and the Irish
authorities have been held. Several amendments to sections of the FSAI’s
response were suggested, and the importance of the role of risk assessment
While it is understood that FSAI, who had previously said that they would be
‘guided by science’, are unlikely to amend their submitted position paper at
this stage, it is hoped that they may yet consider adjustments to their position
as discussions on maximum levels reach their final stage.
Complementing industry action, the Irish Association of Health Stores has
launched a campaign aimed at protecting the rights of Irish consumers to buy
The Dutch Ministry of Health has posted to its website a procedure for
submissions to the national health claims list required by the EU Regulation
on Nutrition and Health Claims on Foods.
Submissions, which can only come from companies with trade in the
Netherlands, must be posted by 31 October 2007. The Ministry wil not carry
out any pre-assessment of the content of the submissions, only of their
format. For further details, see www.row.minvms.nl
STUDY SHOWS CONSUMERS CONFUSED BY CLAIMS
The UK Food Standards Agency has recently published a study on consumer
• consumers are sceptical about claims on food labels, seeing them as
attempts at marketing – but equal y, consumers are influenced by such
• claims are more likely to be interpreted accurately if the consumer is
familiar with the nutrient referred to. Simple, brief claims are likely to
• There is considerable contradiction in the research as to which claims
are most accurately understood. Words such as ‘may’ are sometimes
• Health claims cause consumers the most confusion in terms of
• Disclaimers are not popular, often confusing consumers as they appear
to contradict the claim rather than qualify it.
• Brands and brand attributes such as colours and logos are crucial to
consumer understanding, trust and acceptance of health claims.
• Consumers do not categorise claims into nutrient, health or disease
risk reduction claims, and do not always understand the difference.
UK DATA CONFIRMS NON-NOVEL STATUS OF GOJI BERRIES
Further to the report in last month’s Newsflash, the UK Food Standards
Agency (FSA) has now confirmed that Goji berries are not to be classified as
Evidence col ated by the Health Food Manufacturers Association (HFMA)
including the sale of the berries in Chinese food stores, their use in soft and
alcoholic drinks, published recipes including the berries, plus a Belgian decree
and a German decision classifying the berries as foods was deemed sufficient
by the FSA to confirm their non-novel food status.
OPINIONS SOUGHT ON GLUCOSAMINE, KIWI CONCENTRATE AND
Glucosamine Hydrochloride: in a previous ruling the Food Standards Agency
(FSA) had ruled that a vegetarian glucosamine hydrochloride (HCI), derived
from A. niger, was substantial y equivalent to glucosamine derived from
shel fish. However, it has now delayed issuing its opinion on whether to al ow
HCI as a novel food ingredient for use in beverages and yogurts for joint
health because of a lack of information on its effect on diabetics.
Kiwiberry Concentrate: The FSA is seeking comment on an application to
approve kiwiberry concentrate as a novel food ingredient in a range of food
products, including drinks and cereal products.
Algal extract: The Advisory Committee on Novel Foods and Processes has
been asked to approve an algal extract from Haematococcus pluvialis algal
meal, previously approved for marketing by another company. The
carotenoid Astaxanthin is found in H.pluvialis, and the raw material supply
company for the previous approval now wants to market their extract
themselves as an ingredient for food supplements manufacturers to use in
capsules and tablets The same starting material and extraction process is
used, and the company is seeking approval on the grounds that it is
‘substantial y equivalent’ to the previously authorised material.
ORGANIC CERTIFICATION FOR HERBAL MEDICINES?
The UK Herbal Forum and the Soil Association are currently discussing with
the UK Medicines and Healthcare products Regulatory Agency the
development of organic standards appropriate to the production of herbal
medicinal products, and how products meeting those standards can be
identified in terms of wording on labels and advertisements.
It is hoped that an appropriate scheme, analogous to that for food products,
can be finalised by the end of the year.
GOVERNMENT INVESTS IN NATURAL HEALTH PRODUCTS
The Canadian Government has announced a $721,000 investment in the
Nutri-Net Canada project to help expand market opportunities for the
Canadian functional food and natural health products industry.
Via a nationwide industry networking website, case studies and national and
regional workshops and conferences, Nutri-net Canada aims to bring together
public and private stakeholders to develop a national strategy and an action
plan to lay a firm foundation for a sustainable national network and to
The project is administered by the Canadian Health Food Association (CHFA)
on behalf of the coalition of functional food and natural health product
organisations, and wil receive further funding of over $900,000 from these
Health Canada is currently considering the growing body of evidence on the
role of vitamin D in relation to health, but has advised that a comprehensive
review encompassing benefits and safety should be undertaken before
making any recommendation to revise the current adult Tolerable Upper
Intake Level if 2000IU/day from al sources, including supplements.
For this reason, Health Canada is to take part in a Conference to be held by
the US National Institute of Health in September, which wil evaluate the
efficacy and safety of vitamin D across al age groups. For further details,
Fol owing the recommendations of a task force report proposing a trans fat
limit of 2% total fat in vegetable oils and margarines, and 5% in al other
foods, the Canadian Health Minister, Tony Clement has given the food
industry two years to voluntarily remove trans fats from their products.
This time period is considered adequate to al ow the industry to reformulate
appropriately. However, in announcing the voluntary initiative, the Minister
added that, ‘If significant progress has not been made over the next two
years, we wil regulate to ensure the levels are met.’
The US Food and Drug Administration (FDA) has now published its long
awaited final rule, Current Good Manufacturing Practice in Manufacturing, label ing or Holding Operations for Dietary Supplements (CGMPs) – see
www.fda.gov/OHRMS/DOCKETS/98fr/cf0441.pdf. The document establishes
the minimum CGMPs necessary for activities related to manufacturing,
packaging, label ing, or holding dietary supplements to ensure the quality of
• The rule is relevant only to dietary supplements, not raw material
suppliers or retailer. It is relevant to al supplements sold or offered for
sale in the United States, so its standards also apply to foreign
• The rule requires the testing of every incoming dietary ingredient,
although companies may petition the FDA for exemption if they have
the data to support a system that offers the same assurance as that
• The rule focuses more on process control than finished product testing,
requiring the establishment and use of many written procedures and
• It is the responsibility of the manufacturer to confirm ingredient
identity/quality, which can be via certificate of analysis if an adequate
• There is no requirement for an expiry date, but if such data is used,
• Companies with less than 20 employees have a 3 year compliance
period, those with less than 500 employees have 2 years, and larger
• FDA wil exercise ‘discretion’ with regard to products made by
practitioners ‘adequately trained in their profession’, using them in one
The Standardised Information on Dietary Ingredient (SIDI) protocol wil be the
subject of a top-level panel discussion at a forthcoming annual Expo in
Developed jointly by the Natural Products Association (NPA), the American
Herbal Products Association (AHPA), the Consumer Health Products
Association and the Council for Responsible Nutrition, the SIDI protocol aims
to standardise ingredient information exchange so as to increase productivity
and assist in understanding analysing, control ing and documenting the
manufacturing process throughout the supply chain.
DSEA REPORT SHOWS HUGE HEALTHCARE SAVINGS
The final report of a study commissioned by the Dietary Supplement
Education Al iance (DSEA) shows that over the next 5 years, appropriate use
of certain dietary supplements could both improve the health of key
populations, and save more than $24 bil ion in healthcare costs.
Amongst the key findings of the study, which updated research carried out by
the Lewin Group in 2004/5, were that over 5 years:
• Calcium with vitamin D could save $16.1 bil ion by avoiding hospital
• Folic acid could save $1.4 bil ion by preventing neural tube defects.
• Omega 3 fatty acids could save over $3.2 bil ion by reducing the
occurrence of coronary heart disease in the over 65s.
• Lutein with zeaxanthin could save £3.6 bil ion by helping people with
age-related macular degeneration avoid dependency on community or
FDA’S FOOD SAFETY AND LABELLING PRIORITIES
In its recently published FY 2007 Report to Stakeholders, the Food and Drug
Administration (FDA)’s Centre for Food Safety and Applied Nutrition (CFSAN)
has identified it priorities for food safety and label ing.
Priorities relevant to the supplement/health products industry include:
• Advisory label ing for food al ergens
• The development of analytical methods for low levels of trans fatty
• The publication of Guidance on an evidence-based scientific review system for health claims (recently published in draft)
• Seeking comment on updating daily values on nutrition label ing
• A rule to revise existing regulation requiring irradiated food to be
A recently published study by the US Food and Drug Administration (FDA)
has revealed that many consumers have serious problems understanding
food labels to help them avoid ingredients to which they may be al ergic.
General problems highlighted were lengthy ingredient lists which made it
difficult to locate a particular ingredient, and the use of hard to understand
‘technical’ language. Additional y, over 40% of participants in the study
• Ingredients lists which give a general name to the ingredient, without
specifying the source – such as spices and flavours
• Different words used to describe an al ergen on different food products
• Labels which do not actively alert consumers to a new ingredient in the
food (despite it being included on the ingredient list)
NEW PROGRAMME TO PROTECT AGAINST BIO-TERRORISM
The US Food and Drug Administration (FDA) has released details of a new
software programme, the CARVER + Shock Software Tool, to help the food
industry determine the vulnerability of individual food facilities to biological,
As a science-based prevention strategy to safeguard the food supply, the tool
is an example of the type of approach currently being developed as part of
FDA’s broader food protection strategy.
It is understood that the Food and Drug Administration (FDA) is considering
taking legal advice on how the new adverse event reporting law may apply to
supplements and over the counter (OTC) drugs, and whether there should be
an amendment in law to clarify their slightly different reporting requirements.
FDA would prefer to issue two separate industry guidance documents, rather
than the one currently mandated. Apparently anticipating a heavy influx of
adverse events, FDA are also concerned about how they would notify
manufacturers if they received prior knowledge of an adverse event, how they
should col aborate with poison control centres in relation to the reporting of
such events, and whether a ful postal address would be the best way to help
The dietary supplement industry is now concerned that the FDA’s ongoing
concerns may lead to delay in the publication of their guidance, which would
adversely impact on industry’s ability to meet the anticipated compliance date
RISK-BASED ASSESSMENT FOR IMPORTED FOODS
Fol owing a recommendation in its 2002 Import Strategic Plan, the Food and
Drug Administration is now actively considering the imminent implementation
of risk-based inspections for imported foods.
The proposed new procedures are likely to require importers and
manufacturers to provide more information to inspectors who currently have
little advance information on imports. It is hoped that the new system would
help to enable inspectors to concentrate on shipments that pose a risk to food
safety, whilst reducing shipment time overal .
LABEL WARNINGS FOR BLACK COHOSH AND GREEN TEA?
The US Pharmacopoeia (USP) is proposing warning statements on the labels
of dietary supplements that claim to contain USP-grade black cohosh or
Caution: In rare cases black cohosh has been reported to affect the liver. Discontinue use and consult a healthcare practitioner if you have a liver disorder or develop symptoms of liver trouble, such as abdominal pain, dark urine, or jaundice. Caution: Must take with a meal. In rare cases extracts from green tea have been reported to adversely affect the liver. Discontinue use and consult a healthcare practitioner if you have a liver disorder or develop symptoms of liver trouble, such as abdominal pain, dark urine, or Fol owing a 60 day comment period, the black cohosh proposal is due to be
published in September. No date has yet been set for the publication of the
ORGANIC INGREDIENT RULE NEARS FINALISATION
The US Department of Agriculture (USDA) is seeking comment from organic
food producers on the proposed addition to the list of ingredients permitted for
use in organic products of 38 non-organic ingredients, including colours,
Colours from a number of plant sources, including blueberry, elderberry and
pumpkin juices are included in the proposal. Other examples include omega
3 for baked goods and beverages, kelp as a thickener in supplements,
oligofructose enriched inulin, and unbleached lecithin.
SUPPLEMENT PRODUCTS FAIL TO MEET LABEL CLAIM
Recent tests by Consumerlab.com of nine milk thistle supplements have
revealed that only two contained the claimed amount of silymarin compound.
Similarly, of 11 Chondroitin products recently tested, Consumerlab.com found
The US Council for Responsible Nutrition (CRN USA) has announced plans to
launch a multi-year, multi-mil ion dol ar public relations campaign,
‘Life….supplemented’, focused on the more than 150 mil ion Americans who
Year one wil see the launch of a microsite to provide consumers with
information on the pil ars of a healthy lifestyle, offering a unique tool to help
them with their personal wel ness regime. The programme wil also focus on
lifestyle research projects that wil be shared with the public via the website,
and other publicity. The second and third years wil build on and develop the
CHINESE INGREDIENT TEST PROGRAMME LAUNCHED
The Natural Products Association (NPA) has recently launched a new
programme to test Chinese raw materials for purity and composition.
Under the new programme, raw materials commonly used in dietary
supplements wil be tested in the laboratory of the United States
Pharmacopoeia in Shanghai, China. NPA wil provide test results to member
companies and build a database on raw material suppliers which wil be made
available to manufacturers to inform supply-chain decisions.
GINSENG LABELLING ACT INTRODUCED IN CONGRESS
Legislation was introduced last week in both the US Senate and House of
Representatives that would require that ginseng (Panax spp.), when sold in its
whole form, is label ed to identify its country of harvest.
Senate Bil 1953, the Ginseng Harvest Labeling Act of 2007, has long-
standing support from ginseng farmers and the Ginseng Board of Wisconsin
as wel as the support of the American Herbal Products Association (AHPA)
and the United Natural Products Al iance (UNPA).
“This bil wil ensure that buyers of whole ginseng root are given truthful
information as to its source, without creating unnecessary label ing
requirements for other herbal ingredients or for finished herbal products,”
Michael McGuffin, AHPA’s President said.
SOUTH WEST PACIFIC AUSTRALIA & NEW ZEALAND
Because it currently has insufficient parliamentary support, the Government of
New Zealand has decided not to proceed with legislation aimed at
establishing a joint agency with Australia to regulate therapeutic products.
However the NZ State Services Minister, Annette King, emphasised the
Government’s continued support for a joint trans-Tasman therapeutics
authority, and said that the Therapeutic Products and Medicines Bil would
remain on the Order Paper to be revisited when sufficient votes can be
Changes to food regulations in Australia aim to significantly improve the
assessment and consultation procedures for new and amended food
Until now, Food Standards Australia New Zealand (FSANZ) has had a single
model for assessing applications to amend food standards, regardless of the
scope of the proposed change. The new regulations al ow three different
streams for applications, based on the level of complexity. In addition,
applications must be completed within a given time-scale: major changes
can take up to 12 months but minor changes must be processed within three
INDEX OF ASSOCIATION CONTRIBUTORS • AHPA (American Herbal Products Association): email@example.com
• BLL (German Federation for Food Law and Food Science): firstname.lastname@example.org
• CASP (Ceská Asociace Pro Speciální Protaviny): email@example.com
• CHC (Complementary Healthcare Council of Australia): firstname.lastname@example.org
• CHFA (Canadian Health Food Association): email@example.com
• CRN (UK) (Council for Responsible Nutrition): firstname.lastname@example.org
• CRN (USA) (Council for Responsible Nutrition): email@example.com
• EHPM (European Health Product Manufacturers Association): firstname.lastname@example.org
• ERNA (European Responsible Nutrition Alliance): email@example.com
• HFMA (UK) (Health Food Manufacturers’ Association): firstname.lastname@example.org
• IHTA (Irish Health Trade Association): email@example.com
• JIHFS (The Japanese Institute for Health Food Standards): firstname.lastname@example.org
• JHNFA (Japan Health Food & Nutrition Food Association): email@example.com
• NNFA-J (JAPAN) (National Nutritional Foods Association): firstname.lastname@example.org
• NPN (Natuur- & GezondheidsProducten Nederland): email@example.com
• NPA (US) (Natural Products Association): natural@NaturalProductsAssoc.org
• SDCA (France) (Syndicat de la Diététique et des Compléments Alimentaires): firstname.lastname@example.org
• SYNADIET (France): email@example.com
• UNPA (United Natural Products Alliance): firstname.lastname@example.org KEY EVENTS: SEPTEMBER – DECEMBER 2007 Conference
SANA 2007: International Exhibition of Natural
Products - Nutrition, Health, Environment
Natural Ingredients - Exhibition & Conference
Supply Side West - International Trade Show
Codex Committee on Nutrition and Foods for
Cosmoprof Asia - Where beauty meets trends
Executive Committee of the Codex Alimentarius
Tel: (00) (32) (2) 209 11 55; Fax: (00) (32) (2) 223 30 64,
E-mail: email@example.com - Website: www.iadsa.org
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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
Annex to the fan operating and maintenance instructions Contents 1 General Maintenance . 1 1 General Maintenance When starting the maintenance, the motor must be disconnected and it must be ensured that it is not possible to connect it during the maintenance. In addition, check that there is no voltage in any part connected to the power supply. If the motor is disconnected from the