INTERNATIONAL
DEVELOPMENTS
|
|
CODEX:
New
entries on claims & GMO labelling under discussion
SOUTH
AFRICA : Association
aims to speed up CAM dossier assessment
JAPAN: Supplements
for evacuees from the Tohoku disaster
OTC status granted for Red Grape Leaf product
EUROPEAN
UNION:
Health
Claims Update
Proposed safety measures for 'other substances'
and botanicals
Impact assessment for EFSA fee options
EFSA assesses the safety of food irradiation
Novel food negotiations collapse
Call for data on arsenic
Amendments to the Pesticide Regulations
'Health at a Glance: Europe 2010'
DENMARK:
Random
checks for misleading products
Warning about Internet sports supplements
FRANCE:
A step nearer national
lists of other substances/plants?
IRELAND: FSAI
to list supplement notifications on the web
Association prompts questions to the Commission
ITALY:
Draft law on botanicals re-submitted
NORWAY:
Association launches new consumer website
SPAIN:
The
SENIFOOD project
UNITED
KINGDOM:
Warning on herbal product containing an antihistamine
Algal oil seeks novel food approval
CANADA: Survey
shows decline in confidence in health claims
UNITED
STATES: FDA
warning on products to treat radiation
US District Court upholds supplement GMPs
Recent product recalls
FDA votes against label warnings for food colours
FDA
warning on vitamin levels in dietary supplement
FDA launches improved search engine for consumers
FDA proposes research into consumer understanding
Joint FDA/University research project on botanicals
FDA meetings of New Food Safety Law
NIH launches web resource on CAM
AUSTRALIA
&
CHC warns consumers about online purchases
NEW
ZEALAND : Hemp
foods to be authorised?
Bioinformatics
and Traditional Chinese Medicine
INTERNATIONAL
DEVELOPMENTS
u
CODEX
NEW
ENTRIES ON CLAIMS & GMO LABELLING UNDER DISCUSSION
The
Codex Committee on Food Labelling (CCFL) will meet next month in
Quebec City, Canada, and will consider the establishment of claims
for sugars, sodium/salt and trans fatty acids, as agreed at its
last year's meeting.
In
particular, this work will address the inclusion in the Table of
Conditions for Nutrient Contents of the Guidelines for the Use of
Nutrition and Health Claims of new entries for the non addition
of sugars and sodium/salt and that additional condition of use be
established for comparative claims for sugar and sodium/salt content.
This work will also cover trans fatty acids.
In
addition, the CCFL will continue the discussion on developing Guidelines
on the Labelling of Genetically Modified Organisms (GMO) for which
there is a clear division in the Committee between those countries
that are proposing process-based GMO labelling and those that agree
that GMOs should be declared on the label only when they are present
in the final product. It remains to be seen whether the CCFL will
make any progress on this issue.
IADSA
will be monitoring the discussions on these two issues and report
on their outcome.
For
further information, please contact the Secretariat at: secretariat@iadsa.be
AFRICA
u
SOUTH
AFRICA
ASSOCIATION
AIMS TO SPEED UP CAM DOSSIER ASSESSMENT
In
order to try to speed up the assessment process for dossiers for
complementary medicine products (CAMs), the Health Product Association
of Africa (HPA) is continuing its dialogue with the South African
Department of Health (DoH) in respect of the procedural methodology
used.
The
DoH has explained that many delays have been caused by applicants
misunderstanding the procedural process - and some dossiers are
poorly and inaccurately completed. However, in
the opinion of the HPA, the process is still too slow, and the delays
are likely to cause long-term negative effects for the industry.
Therefore, they are seeking an urgent meeting with the Director-General
of Health, Mrs Precious Motoso, to try to resolve the matter.
Source:
HPA
ASIA
u
JAPAN
SUPPLEMENTS
FOR EVACUEES FROM THE TOHOKU DISASTER
Japan's
Miyagi prefecture has started to give out nutritional supplements
to some 7,200 people to compensate for the lack of nutrients in
their food. Although food supplies have now improved, most food
aid consists of meals high in carbohydrates such as rice-balls or
bread, lacking vitamins or protein.
As
a consequence and because of the prolonged period of evacuation,
the nutritional status of evacuees is getting worse, with many complaining
of oral ulcers because of lack of vitamins.
The
vitamin and mineral supplements distributed in Miyagi are contributed
by the trade organizations which represent health food manufacturers
and marketers. The supplements are delivered
to the healthcare centres in the areas where there are still many
evacuees - with priority given to children, the elderly and the
sick.
Source:
AIFN
OTC
STATUS GRANTED FOR RED GRAPE LEAF PRODUCT
A
medicine containing a mixture of Red Grape Leaf Extracts (Resveratrol,
etc.) as a main active substance has been evaluated and approved
as a direct over the counter (OTC) medicine by the Investigation
Committee of Japan's Ministry of Health, Labour and Welfare (MHLW).
The product is permitted to claim that it improves swelling of the
feet, calves, ankles etc. and also tired feet with swelling and
pain caused by mildly impaired venous circulation.
Already
approved as an OTC medicine in over 20 other countries, previously,
this active substance was only approved as a prescription drug in
Japan. MHLW's decision on the status of the product
is causing some concern in the Japanese supplement industry as to
whether it is a precedent for the future legal status of herbal
supplements or supplements containing phytochemical substances.
Source:
AIFN
EUROPE
u
EUROPEAN
UNION
HEALTH
CLAIMS UPDATE
The
European Food Safety Authority (EFSA) has now released their fourth
batch of opinions on health claims, and assessment of 442 Article
13 general function claims in areas such as protection against oxidative
damage to body cells, contribution to either cognitive or bowel
function; and maintenance of normal blood cholesterol levels.
For further details, see: http://www.efsa.europa.eu/cs/Satellite
Claim
failures, according to EFSA, mainly relate to poor information:
an "inability to identify the specific substance on which the
claim is based; the lack of evidence that the claimed effect is
indeed beneficial to the maintenance or improvement of body functions;
or the lack of precision regarding the health claim being made".
EFSA
now intends to hold stakeholder consultations on:
- Bone,
joint and oral health;
- Oxidative damage
and cardiovascular health;
- Satiety, weight
management and blood glucose concentrations.
The
last 600 or so general function claims are due for assessment by
June 2011, after which EFSA will consider botanical claims - there
is currently a moratorium on the assessment of botanical claims,
while EFSA considers how they should best be dealt with. (All botanical
claims assessed to date have failed.)
Following
the publication of the latest batch of claims, European industry
associations, the European Botanical Forum (EBF), the European Federation
of Health Product Associations (EHPM) and the European Responsible
Nutrition Association (ERNA) put out a strongly worded joint press
release urging the
European Commission to undertake a discussion of the specificities
and limitations of nutritional research and reappraise the claims
evaluation process before rejecting claims based on EFSA opinions,
because their continued reliance in the assessment
process on criteria which are unfeasible and inappropriate for the
majority of claims, is contributing to the high number of negative
EFSA opinions.
Source:
EBF, EHPM, ERNA
PROPOSED
SAFETY MEASURES FOR 'OTHER SUBSTANCES' AND BOTANICALS
The
European Commission (EC) has recently published a working paper
on the draft implementing regulation establishing rules for the
application of Article 8 of Regulation EC No 1925/2006 on the Addition
of Nutrients to Foods. The EC is now seeking
comments from stakeholders on how the proposals in the draft will
work in practice.
The
importance of the document for the supplement industry is that Article
8 of the Regulation provides a procedure to prohibit, restrict or
place under Community scrutiny substances other than vitamins or
minerals, or ingredients containing substances other than vitamins
or minerals that are added to foods or used in their manufacture.
Key
concerns for the supplement industry are:
· The
proposed exclusion of fortified foods and supplements from
consideration as part of the "normal" dietary intake that will be
considered in the assessment of whether a substance greatly exceeds
the normal intake and can thus should be subject to scrutiny. The
proposed exclusion would allow any substance used in supplements
but not in the normal diet to be subject to Community scrutiny -
for instance, glucosamine.
· The
definition of "greatly exceeding" average intake by reference to
three times the average intake as demonstrated by data in at least
one Member State. This proposal greatly oversimplifies the complexity
of the European diet where there are many wide variations of
intake of particular substances, making it well-nigh impossible
to determine a true average intake.
· The
requirement that submissions from companies to establish the safety
of botanical substances under Community scrutiny be based on
the European Food Safety Authority (EFSA) Guidance on Botanical
Safety and its accompanying Compendium. The EFSA
Guidance recommends the submission of data (toxicological and other)
that is not currently available for the majority of botanicals and
ignores the fact that many of the safety concerns can be addressed
through relevant quality control and preparation measures which
negate the need to undertake further studies.
Source:
EBF, EHPM, ERNA
IMPACT
ASSESSMENT FOR EFSA FEE OPTIONS
Proposals
from the European Commission that the European Food Safety Authority
(EFSA) should charge fees for its work has already attracted considerable
comment from stakeholders. Now, an Impact Assessment
(IA) is proposed in order to gain a wider range of views on the
plan partly because, as the roadmap for the proposal acknowledges,
of the "complexity of the Food Sector".
The
roadmap details some of the arguments for charging fees together
with some of the obstacles, which will be addressed as the IA is
prepared. The Commission sets out four policy options, together
with their perceived advantages and disadvantages, which will be
the basis for the IA. These are:
· Option
A: Maintaining
the existing system without fees.
· Option
B: Establishing
a flat-rate fee for all applicants for authorisation.
· Option
C: Establishing
graduated fees for applications for authorisation.
· Option
D: Establishing
graduated fees for applicants who are authorisation holders.
An
IA Steering Group will be formed in the first quarter of 2011 and
work on the IA itself will start at the same time. The
IA will be conducted internally by DG SANCO's "Science and Stakeholder
Relations" Unit and other Commission Departments such as DG Environment
and Enterprise will be invited to sit on the group, and advice and
further studies/data from an external contractor may also be commission.
The exercise is expected to be completed by 2012.
Source:
EHPM
EFSA
ASSESSES THE SAFETY OF FOOD IRRADIATION
The
European Food Safety Authority's (EFSA's) scientific experts have
updated scientific advice on the safety of irradiation of food/food
ingredients. In its comprehensive advice to European
Union policy makers, different EFSA panels looked at the efficacy
and microbiological safety of the process, and at possible risks
arising from the formation of several chemical substances as a result
of food irradiation.
The
Panels recommend that decisions on foods which can be irradiated
and on the doses used should not be based only on predefined food
categories, as is currently the case, but also on factors such as:
the bacteria concerned, the level of bacterial reduction required,
whether the food is fresh, frozen, dried, or on the food's fat or
protein content. They also say that decisions on the type of food
which can be irradiated should also take into account the diversity
of food products nowadays available to consumers.
Source:
EHPM
NOVEL
FOOD NEGOTIATIONS COLLAPSE
After 3 years of discussion, negotiations on the revision of the Novel
Food Regulation have collapsed because the European Parliament
and the Council failed to reach a compromise agreement on the issue
of animal cloning during a final attempt of conciliation. Thus the
existing Novel Food Regulation (EC) No 258/97 from May 1997 remains
in force.
However, it is understood that the European Commission (EC) intends
to draft and publish a new proposal as soon as possible for
potential publication within a month. The proposal would then have
to be adopted through co-decision with the Council and the European
Parliament (EP) - a process that can take up to 2 years.
The EC wants to integrate into the new proposal the elements agreed
during the previous negotiations with the EP and Council: a definition
for 'nano'; the ban on cloned animals; the notification system for traditional
products from third countries; the centralised approval system
for novel foods etc. In parallel, the current EC and Member State
discussions on the guideline on the interpretation of "significant
degree of consumption" remain on the agenda.
Source:
EHPM
CALL
FOR DATA ON ARSENIC
The European Commission (EC) is currently considering the possibility
of introducing limits for arsenic into the EU contaminants
legislation. These limits would also apply to supplements.
While
data on total arsenic content is available, the EC is now considering
differentiating the data on organic and inorganic arsenic and has
asked the Federation of European Health Product Associations (EHPM)
to provide further detail by the end of April.
For
further information, contact secretariat@ehpm.be
Source:
EHPM
AMENDMENTS
TO THE PESTICIDE REGULATION
Commission
Regulation (EC) No 310/2011 has recently been published, amending
Annexes II and III to Regulation (EC) No 396/2005 regarding
maximum residue levels for pesticides.
This
new regulation relates to residues of aldicarb, bromopropylate,
chlorfenvinphos, endosulfan, EPTC, ethion, fenthion, fomesafen,
methabenzthiazuron, methidathion, simazine, tetradifon and triforine
in or on certain products, including a number of ingredients often
used in food supplements, such as herbs, spices and other botanicals.
Source:
EHPM
'HEALTH
AT A GLANCE: EUROPE 2010'
The
'Health at a Glance' report is the result of collaboration between
the Organisation for Economic Co-operation and Development (OECD),
and the European Commission. Health data from 31 countries are included
in the report, namely the 27 member states of the European Union
(EU) along with Iceland, Norway, Switzerland and Turkey.
The
report finds that life expectancy has increased to an average of
78 years (but with considerable differences between Member States)
- but the additional years are not necessarily years of good health.
While risk factors such as smoking and alcohol are in decline
overall, obesity rates have risen very considerably.
Health expenditures have risen in all European countries,
with 'sick care' - curative and rehabilitative care - accounting
for over 60%, compared with 2.9% allocated to public health campaigns
and preventative measures.
For
further details of this publication, see: http://ec.europa.eu/health/reports/european/health_glance_2010_en.htm
Source:
EHPM
u
DENMARK
RANDOM
CHECKS FOR MISLEADING PRODUCTS
A
campaign by the Danish Food Administration is seeking to curb misleading
marketing of dietary supplements in retail stores, with random inspections
and fines for the worst offenders.
Inspectors
are primarily checking for dietary supplement products which make
medicinal claims - illegal both under national legislation and the
EU health claims regulation. In addition, inspectors
have been checking for misleading product displays - the positioning
of products of medicines and supplements on store shelves - as they
may mislead consumers into believing, for instance, that the supplement
has the same properties as the medicine.
Source:
DI
WARNING
ABOUT INTERNET SPORTS SUPPLEMENTS
The
Danish Food Administration has issued a warning on a range of sports
and nutritional supplements sold on Swedish- and Gibraltar-registered
website.
The
products have been found to contain Tribulus terrestris L, which
can affect the liver, Huperzin A, which can cause muscle tremors
and incontinence, or the combination of caffeine and synefrin, which
can affect the central nervous system,cause
cardiovascular disease and osteoporosis.
The
public has been warned of the dangers of buying products over the
Internet because they may not be subject to the appropriate controls.
Denmark does have a registration scheme for dietary supplements
sold in the country and has a website listing registered supplements
(see www.altomkost.dk/Kosttilskud/forside.htm).
However,
the registration is simply a notification procedure and does not
imply that any form of pre-market approval has been given - although
registered supplements are subject to random checks by the authorities.
Source:
DI
u
FRANCE
A
STEP NEARER NATIONAL LISTS?
After
much procrastination, thanks to continued industry pressure the
French supplement industry is hopeful that a realistic step has
now been taken towards the publication of the national lists of
other substances and plants permitted for use in food supplements.
From
now on, procedures have been simplified and only the Direction Générale
de la Concurrance, de la Consommation et de la Répression des Fraudes
(DGCRF) will sign the Orders connected with the Decree 2006 - 352.
Industry hopes, this will facilitate the publication of these
long awaited lists.
Source:
SYNADIET
u
IRELAND
FSAI
TO LIST SUPPLEMENT NOTIFICATIONS ON THE WEB
The
Food Safety Authority of Ireland (FSAI) has recently advised the
Irish Health Trade Association (IHTA) that in response to its request
to make such a list available to industry, it plans to post on its
website a list of products
that have been notified.
The
list will be updated with new notifications on a regular basis and
the weblink will be advised shortly.
Source:
IHTA
·
ITALY
DRAFT
LAW ON BOTANICALS RE-SUBMITTED
The
February edition of the Newsflash carried a report that the Italian
Ministry of Health had notified the European Commission (EC) of
a revised draft law on the use of botanical substances and
preparations in food supplements which was open for comment by the
Commission and Member States until early May.
Now,the
Ministry of Health, at the request of the EC, has re-notified the
Commission of the draft ministerial decree regulating the use of
substances in food supplements and herbal preparations, under Regulation
1925/2006 and Directive 2000/13/EC.
The text, which proposes a positive list of over 1,000 plants that
should be acceptable for use in food supplements, remains unchanged,
but the date for comment has now been extended until the end of
June 2011.
Source:
AIIPA
u
NORWAY
ASSOCIATION
LAUNCHES NEW CONSUMER WEBSITE
In
preparation for the new European Union health claims regulation,
the Norwegian supplement association Bransjerådet for Naturmidler
(BRN) has launched an information website for consumers.
The
website provides consumers with objective and product-neutral information
about substances and how they can be used in regards to prevention
of disease and selfcare. There is also a database of interactions
and possible side effects of herbals.
For
further details, see: www.helsekostopplysningen.no (The
page is in Norwegian but a google translator will give some idea
of the page content.)
Source:
BRN
u
SPAIN
THE
SENIFOOD PROJECT
SENIFOOD
is an initiative aimed at designing specific foods for older people,
(currently 17% of the Spanish population, a figure expected to rise
still further) in order to maintain balanced nutrition. The developed
ingredients and diets are intended to ameliorate the metabolic syndrome,
and to improve bone, muscle, gastrointestinal and visual health,
in addition to cognitive function and neurodegenerative disorders.
The
project is funded by the Spanish Ministry of Science and Innovation
with a budget of over € 26 million and is scheduled for completion
in 2012. It brings together four manufactures of functional ingredients,
seven food manufacturers, a manager of nursing homes and a network
of 25 technological centres and universities.
The
aim of the SENIFOOD project is to advance the understanding of the
mechanisms of action of the functional food ingredients in the designed
foods in relation to the most common metabolic diseases in the elderly,
in order to be able to produce suitable simple and enjoyable products
for consumption.
Source:
AFINUR
u
UNITED
KINGDOM
WARNING
ON HERBAL PRODUCT CONTAINING AN ANTIHISTAMINE
The
UK Medicines and Healthcare Products Regulatory Agency (MHRA) has
recently warned UK consumers not to purchase an unlicensed herbal
product because it contains an undeclared medicinal ingredient,
Chlorpheniramine, which is an antihistamine and can cause serious
side effects, particularly in those hypersensitive to antihistamines.
The product is promoted as a herbal food supplement and is marketed
with illegal claims for the relief of pain and other symptoms related
to arthritis.
After
the end of April 2011, all herbal medicinal products on the UK market
will be required to hold Traditional Herbal Medicinal Product Registrations
or other medicinal market authorizations. Unlicensed herbal medicinal
products will become illegal. Herbal food supplements
may still be marketed, but must comply with all the relevant regulations
for food products, and must not make medicinal claims.
Source:
HFMA
ALGAL
OIL SEEKS NOVEL FOOD APPROVAL
A
US company has applied to the UK Food Standards Agency (FSA) for
approval to market an algal oil produced from Schizochytrium microalgae,
as a Novel Food ingredient. A novel food is a food or food ingredient
that does not have a significant history of consumption in the European
Union before May 15th, 1997.
The
oil, which is rich in both DHA and EPA is known as DHA-O.
After the comment period ends in late April, it will be assessed
for safety by the Advisory Committee for Novel Foods and Processes,
an independent committee of scientists appointed by the FSA.
Source:
HFMA
NORTH
AMERICA
u
CANADA
SURVEY
SHOWS DECLINE IN CONFIDENCE IN HEALTH CLAIMS
A
recently released survey commissioned by Health Canada finds that
scepticism about health claims made by the manufacturers of vitamins,
herbal supplements and non-prescription drugs has increased in the
last five years, with about half of Canadians (49%) now saying the
claims are unproven. In 2005 the figure was 46%.
Similarly,
the public's level of confidence in the safety of natural health
products due to their natural origins has declined from 52% in 2005
to 42% in 2010.
"The
strongest benefits associated with natural health products continue
to be that (they) can be used to maintain and promote health and
that they can be used to treat illness. However, these positive
perceptions of natural health products have declined significantly
compared to 2005" the
survey found.
Source:
IADSA
u
UNITED
STATES
FDA
WARNING ABOUT PRODUCTS TO TREAT RADIATION
The
US Food and Drug Administration (FDA) has warned consumers
"
... to be wary of Internet sites and other retail outlets promoting
products making false claims to prevent or treat effects of radiation
or products that are not FDA-approved. These fraudulent products
come in all varieties and could include dietary supplements, food
items, or products purporting to be drugs, devices or vaccines."
The
warning comes at a time when some consumers are considering taking
dietary supplements during the reported shortage of potassium iodide,
the FDA-approved drug to help prevent radiation-induced thyroid
cancer.
Source:
CRN US
US
DISTRICT COURT UPHOLDS SUPPLEMENT GMPs
A
recent lawsuit which challenged several regulations adopted by the
Food and Drug Administration (FDA) to establish current good manufacturing
practices for dietary supplements has been denied by the US District
Court of Columbia.
The
plaintiffs argued that FDA were in breach of the Due Process Clause
of the Fifth Amendment requirement against vague laws, and asked
for areas of the rule to be rewritten so that dietary supplement
manufacturers could understand when they are in breach of the law.
However, the judge's decision was that: "The Court concludes
that the challenged sections of the GMP Final Rule did not exceed
the FDA's statutory authority, are not impermissibly vague under
the due process clause, and are not arbitrary and capricious under
the (Administrative Procedure Act). Accordingly, summary judgment
is granted for the defendants and denied for the plaintiff".
Steven
Mister, president and CEO at the Council for Responsible Nutrition
(CRN) is quoted as saying that he found the result 'unsurprising'
- and he emphasised the importance of Good Manufacturing Practices
to give the consumer confidence in the quality of the products they
buy.
Source:
CRN US
RECENT
PRODUCT RECALLS
-
Possible contamination:
following three recent voluntary recalls by manufacturers of whey
protein, the Food and Drug Administration (FDA) has identified a
further supplier to recall around one million pounds of whey protein
because of possible contamination with Salmonella.
Four
recalls of organic peppermint leaf products have also been announced
and additional recalls for ginger and chilli powder, again for possible
Salmonella contamination.
-
Undeclared ingredients:
additional recalls have been made for several supplement products
which have been found to contain undeclared soy.
-
Inaccurate usage information: a
voluntary recall of an Arnica Flower and Stem Arnica product has
been instituted, due to inaccurate usage information on the product
label. The current label states 'Use to enhance the flavor of
your favorite dish.' The label should have stated: 'Recommended
for external use only.'
-
'Spiked' products: recalls
for 'spiked' products continue. Several recalls
for products for male erectile dysfunction have been instituted
because they contain undeclared analogues of Sildenafil, an FDA-approved
drug.
Such
analogues can interact with prescription drugs to lower blood pressure
to dangerous levels and their inclusion in these supplements makes
the products themselves unapproved new drugs.
Source:
GOED
FDA
VOTES AGAINST LABEL WARNINGS FOR FOOD COLOURS
A
Food and Drug Administration (FDA) Food Advisory Committee has recently
met to discuss whether available relevant data demonstrate a link
between children's consumption of synthetic colour additives in
food and adverse effects on behaviour.
The
outcome of the meeting was that, unlike in the European Union, the
FDA Advisory Committee did not find sufficient linkage between food
colouring and hyperactivity in children, and therefore narrowly
voted against introducing warning labels for US products.
Source:
UNPA
FDA
WARNING ON VITAMIN LEVELS IN DIETARY SUPPLEMENT
TheFood
and Drug Administration
(FDA)
has warned consumers to stop using a Spanish-labelled vitamin solution
because the product may contain dangerously high levels of vitamins
A and D.
FDA
notes that it has received seven reports of serious adverse effects
associated with the product, and states that the product cannot
be marketed legally in the U.S. due to drug claims in its labelling:
claims to treat "hypo
and avitaminosis, rickets, growth, dentition, lactation, fractures,
infection, convalescence, protection and regeneration of certain
epithelium (bronchial, glandular, ocular, cutaneous), corticotherapy,
aging and pregnancy."
FDA
does not state the levels of vitamins A and D in the product, but
it is understood that a 5 ml vial contains 120,000 IU of vitamin
A, 600,000 IU of vitamin D, and 5.0 mg of vitamin E.
Source:
AHPA
FDA
LAUNCHES IMPROVED SEARCH ENGINE FOR CONSUMERS
US
consumers can now search for food and other product recalls more
easily and quickly on the Food and Drug Administration's (FDA) recently-launched
improved
website. For greater ease of use, the search
results provide data from news releases and other recall announcements
in a table that organizes information from news releases on recalls
since 2009 by date, product brand name, product description, reason
for the recall and the recalling firm.
Under
the Food Safety Modernization Act (FSMA), recently signed into law
by President Obama, FDA was required to provide a consumer-friendly
recall search engine within 90 days after the law went into effect.
Further, for recalls conducted under FSMA, it requires FDA to indicate
whether the recall is ongoing or completed. Prior to the passage
into law of FSMA, FDA did not have mandatory recall authority for
food and feed products other than infant formula.
Source:
UNPA
FDA
PROPOSES RESEARCH INTO CONSUMER UNDERSTANDING
The
Food and Drug Administration (FDA) is seeking comment from industry
on a research project to evaluate how consumers respond to multiple
nutrition labelling on food packaging. The
proposed study would be a controlled randomised experiment based
on a 15-minute web-based survey of 4,000 English-speaking US adults.
Following
criticism of previously permitted nutrition labelling schemes, and
the fact that consumers are already faced with multiple labelling
statements, the FDA's aim is to develop standardised, science-based
criteria on which to base front of pack nutrition labeling.
The intention is that the "...results of the study will
be used primarily to enrich the Agency's understanding of how multiple
claims and other labeling statements on food packages may affect
how consumers perceive a product or a label, which may in turn affect
their dietary choices."
Source:
CRN US
JOINT
FDA/UNIVERSITY RESEARCH PROJECT ON BOTANICALS
The
Food and Drug Administration (FDA) has announced the availability
of grant funds for the support of a cooperative agreement with the
University of Mississippi's National Centre for Natural Products
Research (UM-NCNPR). The goal of the agreement is to promote the
efficient development and dissemination of natural products research
and science. The estimated amount of support in 2011 will be for
up to $2.1 million, with the possibility of four additional years
of support for up to $2.5 million per year, subject to the availability
of funds.
The
cooperative agreement will provide continued support so that UM-NCNPR
can:
· Assist
in the identification and development of a list of Botanical Dietary
Supplements (BDS) and botanical ingredients, based on safety concerns,
trends, and knowledge of botanicals being marketed in the United
States, to prioritize for further research.
· Acquire,
validate, and characterize authenticated reference materials, including
raw and processed plant materials and purified natural products
of relevance to FDA, for evaluation of their safety.
· Exchange
technical and scientific information, analytical methods, and reference
material with FDA scientists and other stakeholders.
· Collaborate
with FDA scientists in research areas of mutual interest.
· Coordinate
scientific workshops and conferences on BDS-related topics of public
health relevance to address high priority science and research needs.
Source:
AHPA
FDA
MEETINGS OF NEW FOOD SAFETY LAW
The
Food and Drug Administration (FDA) held public meetings on March
29-31 on how FDA should implement the Food Safety Modernization
Act (FSMA) on improving the safety of imported food.
The
meetings provided an opportunity to discuss among others, FSMA Section
on Foreign Supplier Verification Program, which, as of January 2013,
will require all food importers to verify that the foods they import
are manufactured in compliance with U.S. laws and are not adulterated;
and accreditation of 3rd-party auditors, which will require accredited
auditors to notify FDA of conditions that could cause or contribute
to a serious risk to public health. During both regulatory and consultative
audits FDA representatives welcomed further comments and suggestions
to clarify the exact scope of this section of the law, and accepted
written comments until April 29, 2011.
Throughout
the meetings, the agency stressed that it would respect all US trade
obligations to treat foreign producers and importers on an equitable
level with domestic producers. It also communicated its understanding
of the potential impact of new costs on small businesses and stated
its intention to minimize these while still meeting its goals. FDA
also promised that any new importer requirements would be clearly
announced well in advance of compliance dates.
Furthermore,
on April 20 the FDA continued its series of educational meetings
to discuss components of the Food Safety Modernization Act (FSMA)
on Preventative Controls.
Preventative
Controls are used by facilities to identify and address hazards
associated with specific foods and food processes. Two main themes
recurred through the meeting: risk assessment for individual products
and how facilities can learn about and apply preventative controls
in their own manufacturing business.
FDA
offered to prepare particular documents immediately after inquiries
were received on guidance documents to better explain the terminology
in the law and intentions of the regulation. Also mentioned were
possible educational guidance documents showing general examples
of how preventative controls and Hazard Analysis Critical Control
Point (HACCP) requirements apply in actual situations. FDA stated
that it would consider guidance documents from international bodies
such as Codex Alimentarius during development of new regulations.
FDA
is accepting general written comments through June 30, 2011, and
AHPA's Government Relations Committee continues to review the process
in the interim.
Source:
AHPA
NIH
LAUNCHES WEB RESOURCE ON CAM
The
National Center for Complementary and Alternative Medicine (NCCAM)
of the National Institutes of Health (NIH) launched a new online
resource designed to give health care providers easy access to evidence-based
information on Complementary and Alternative Medicine (CAM).
With
this new resource, providers will have the tools necessary to learn
about the various CAM practices and products and be better able
to discuss the safety and effectiveness of complementary and alternative
medicine with their patients.
The
portal on the NCCAM Web site at www.nccam.nih.gov
is meant to fit the needs of health care providers including physicians,
nurses and nurse practitioners, physician assistants, and CAM providers.
It includes information on the safety and efficacy of a range of
common health practices that lie outside of mainstream medicine-natural
products, such as dietary supplements, herbs, and probiotics, as
well as mind-body practices such as meditation, chiropractic, acupuncture,
and massage.
Source:
AHPA
SOUTH
WEST PACIFIC
·
AUSTRALIA
& NEW ZEALAND
CHC
WARNS CONSUMERS ABOUT ONLINE PURCHASES
Following
recent media coverage on the dangers associated with purchasing
complementary medicines online from overseas retailers, the Australian
Complementary Healthcare Council (CHC) has put out a strong warning
on this issue, coupled with reassurance for consumers that the Australian
Complementary Medicines industry is tightly regulated.
Products
sold legally in Australia must be entered on the Australian Register
of Therapeutic Goods (ARTG) before they enter the market. This means
they have been subject to assessments and requirements which ensure
their quality and safety. Products available
for purchase from overseas may not have been subjected to the same
level of regulation.
In
addition, the Therapeutic Goods Administration (TGA) website recommends
to consumers that they "do not order medicines, including dietary
supplements and herbal preparations, over the Internet unless they
know exactly what is in the preparation and have checked the legal
requirements for importation and use in Australia."
Source:
CHC
HEMP
FOODS TO BE AUTHORISED?
Responding
to an application to permit Cannabis sativa extracts in the
food supply that were low in the psychoactive constituent, delta
9-tetrahydrocannabinol (THC) - Food Standards Australia New Zealand
(FSANZ) noted its use in other parts of the world: "Hemp
is cultivated worldwide, including in Australia and New Zealand,
and is used as a source of many products, ranging from foods, to
cosmetic products, to clothing and building products."
The
agency went on to say: "Hemp foods are widely available in many
overseas markets, including Europe, Canada and the United States
of America. Hempseed oil is permitted to be sold as a food in New
Zealand. However, the use of hemp as a food in Australia, and for
foods other than hempseed oil in New Zealand, is still prohibited."
"FSANZ
has conducted a safety assessment to determine whether there are
any risks associated with the consumption of hemp foods".
A
final decision on this issue is awaited.
Source:
CHC
BIOINFORMATICS
AND TRADITIONAL CHINESE MEDICINE
Researchers
at the University of Sydney are using computer science to investigate
the efficacy of herbal treatments widely used in China to treat
common ailments. The long-term goal is to build a database that
health-care providers could use to help them decide if such treatments
would benefit their patients.
Central
to the program is bioinformatics, the application of computer science
to molecular biology. The researchers use algorithms to try to discover
what herbs and combinations of herbs are most effective in treating
various ailments. Data from a Chinese hospital that uses traditional
medicine are being supplied to the researchers by the China Academy
of Chinese Medical Sciences, a Beijing-based research organization
of the Chinese government.
Source:
CHC
INDEX
OF ASSOCIATION CONTRIBUTORS
KEY
EVENTS: MAY - DECEMBER 2011
|
Date
|
Conference
|
Place
|
|
May
02 -04
|
SupplySide
East
http://www.supplysideshow.com/2010/east/
|
Secaucus,
NJ, United States
|
|
May
09 - 13
|
Codex
Committee on Food Labelling
www.codexalimentarius.net
|
Quebec
City, Canada
|
|
May
10 - 12
|
Vitafoods
International
www.vitafoods.eu.com
|
Geneva,
Switzerland
|
|
May
13 - 15
|
Cosmofarma
2011
www.cosmofarma.com/
|
Bologna,
Italy
|
|
June
14 - 16
|
Rio
Sports Show
http://www.riosportshow.com.br/
|
Rio
de Janeiro, Brazil
|
|
June
21 - 23
|
Natural
Ingredients/Health Ingredients China 2011
http://fiasiachina.ingredientsnetwork.com/home
|
Shanghai,
China
|
|
June
23 -25
|
Natural
MarketPlace 2011
http://www.naturalmarketplaceshow.com/nm10/public/enter.aspx
|
Las
Vegas, NV, United States
|
|
June
28 - July 1
|
Executive
Committee of the Codex Alimentarius
www.codexalimentarius.net
|
Geneva,
Switzerland
|
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:
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
|
