NEWS - May 2010:
International
Update
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NEWS - May 2010: International
Update |
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International Update International Update
To: IASC Members From: Devon Powell, IASC
Please find below
a list of current international and US items which may be of relevance
or interest to your business. As the international organization representing
the interests of suppliers, manufacturers, distributors and growers of
Aloe vera and its related products, we are dedicated to maintaining a
focus on the issues that may be of concern to your business, including
dietary supplement and other similar regulations.
Best regards,
INTERNATIONAL DEVELOPMENTS
CODEX
AMENDMENTS TO NUTRITION LABELLING GUIDELINES
The Codex Committee on Food Labelling (CCFL) will be meeting next month in Quebec City and will be addressing proposals to amend the Codex Guidelines on Nutrition Labelling in relation to three main areas:
- The expansion of the list of nutrients to be declared: At present the following four nutrients/elements have to be declared in a voluntary basis or when a nutrition claim is used - energy, available carbohydrates, protein and fat. While the CCFL decided last year to add saturated fat to the list, it will consider this year whether to add to the list trans fatty acids, sodium/salt, total sugar/added sugars and dietary fibre.
- The potential application of mandatory nutrition labelling (instead of the current voluntary system): IADSA provided comments to the CCFL proposing that in case mandatory nutrition labelling would be agreed, an exemption should be considered for food supplements and that products placed on the market before the end of the transition period should be allowed to continue to be sold until the end of their shelf-life.
- The development of criteria and principles for legibility of nutrition labeling: IADSA provided comments to the CCFL highlighting the concern of a minimum font size.
In addition, a proposal has recently been submitted by the International Association of the Development of Natural Gums (AIDGUM) to include in the Guidelines conditions for use of the word "natural" for foods, food ingredients and food additives that do not undergo any chemical treatment so that these foods may be labelled as "natural".
While this initiative may be interpreted as potentially presenting some opportunities, there could be some risk to leave it to Codex to work on what is natural as it is uncertain what the outcome could be.
For further information, contact the IADSA Secretariat at secretariat@iadsa.be.
WHO
DRAFT GUIDELINES ON QUALITY OF STARTING MATERIALS
The World Health Organisation (WHO) has recently published draft guidance which sets out its recommendations on ways to ensure the quality of starting materials so as to ensure product quality in the most cost-effective manner.
In the face of concerns about over-regulation, the document aims to offer a global approach to defining quality without overburdening manufacturers with regulations. It recognises the critical need for certain defined levels of quality control, such as methods to detect impurities which may impact on the final product. However, rather than applying a uniform, across-the-board approach to good manufacturing practice, the guidance recommends that manufacturers decide the appropriate level of quality for their products, based on the guidance, or, if felt necessary, on risk assessment.
The guidance is open for comment until the beginning of May 2010.
For further information, contact the IADSA Secretariat at: secretariat@iadsa.be
AFRICA
SOUTH AFRICA WEIGHT LOSS PRODUCTS Following an increase in hospital emergency admissions of people who had used a particular slimming product, the South African regulatory authorities have been clamping down on weight loss products that are presented as Complementary and Alternative Medicines (CAMs). While the active ingredient of the product in question (which was imported from China), was listed as being bitter orange, on analysis some of the samples were instead found to contain Sibutramine, which in South Africa is a schedule 5 medicine that requires registration. It was present at more than twice the prescribed dose. The product has since been taken off the market and the authorities have tested more unregistered “CAM” weight loss products that were subjected to the same process. At least two others were found to contain Sibutramine. The South African Health Products Association (HPA), is in close liaison with the authorities to proactively monitor the availability of these products on the market. Source: HPA
ASIA
JAPAN
REDUCTION IN THE FOSHU MARKET
Following a survey of 182 companies marketing 883 Foods for Specified Health Use (FOSHU), the market size for FOSHU products in 2009 was estimated to be US$ 5.84 billion, a reduction about 20% on the 2007 figure of US$ 6.80 billion.
This market survey has been carried out biennially since 1997 by the Japan Health Food and Nutrition Food Association (JHNFA), and the 2009 figure is the first time that any shrinkage of the market has been noted. The main reasons for this are considered to be the recession of 2009, coupled with the suspension of the sale of probably the most successful FOSHU product, a cooking oil, because of concerns about carcinogenicity.
Source: JHNFA, JIHFS CONSUMER RESEARCH AND THE USE OF FOSHU PRODUCTS According to recent consumer research, 72% of Japanese consumers have used Foods for Specified Health Use (FOSHU) products. 37.5% say they consume them more than once a week, 17.0% say two to three times a month and 19.2% say once every month or so. Although the numbers of users for dietary/food supplements is greater than for FOSHU products, the research shows that almost 40% of consumers use FOSHU products more than once a week. The most-used FOSHU product is cooking oil, the second is yogurt products and the third is lactic acid drinks. However, only 10% of users said they found benefit from FOSHU products with 42.7% saying they found no benefit. Source: AIFN 10% OF JAPANESE CHILDREN TAKE FOOD SUPPLEMENTS Recent research carried out by the Medical Pharmacy Department of a Japanese university hospital shows that 10% of Japanese children take either dietary/food supplement or health food products. The research was conducted by interviewing the parents of 1,198 children between 0-16 years-old who visited the paediatrics department of the hospital from 2006 to 2008. The most commonly-used supplements were vitamin C and folic acid, followed by minerals such as calcium, zinc and iron. The next most popular category was botanical sourced products such as green juice. The main reasons given for the children’s use of supplements were “It is good for health”, followed by “For nutritional support” and “Essential for growth”. Source: AIFN
EUROPE
EUROPEAN UNION
HEALTH CLAIMS UPDATE
Standing Committee meeting: The Standing Committee, which is composed by the European Commission and the Member States, and has the task of risk-managing EFSA’s opinions on health claims before they go forward to European Parliament for adoption and eventual publication as a Regulation and inclusion in the Community Register of claims, met on 26 April. The agenda for the meeting included discussion on the first batch of EFSA opinions delivered in October of last year, and the inclusion of rejected claims in the Community Register (these claims will then have a 6 month transition period after which they can no longer be used).
There was however no vote on the article 13, and this is now postponed for the next Standing Committee meeting, which will be held on 12 July. In the meantime, this issue will be back to the Member States Working Group meeting on 21 May. The industry associations EHPM and ERNA and their individual member associations have consistently lobbied against this piecemeal approach because of the serious commercial consequences for the food supplement industry.
MEP Workshop: As part of the process of informing MEPs of the critical impact on industry of the way the Nutrition and Health Claims Regulation is being implemented, the EHPM held this month a Workshop for Members of the European Parliament (MEPs) with the following title ‘Regulation of Generic Health Claims: 4 years on...’ to obtain support from MEPs to put additional pressure onto the European Commission to hold the adoption of the first batch of claims.
The Workshop set out the status quo and the current industry concerns and covered as well:
· A legal perspective on the process being followed in the implementation of the Regulation and the issues arising · A national view, from the Italian Ministry of Health, on the importance of traditional claims for botanical products to inform Italian consumers · The impact of the legislation and the effect on small and medium enterprises in France from the French Directorate General for competitiveness of industry and services.
Stakeholder meeting: The European Food Safety Authority (EFSA) is to host a meeting with stakeholders on recent developments regarding health claims. It will be held in Parma, Italy in early June. The purpose of the meeting is to “provide an update on EFSA’s health claims evaluations “and bring together for an exchange of views “experts from food industry/applicants, Member States, European Commission, NDA Panel members and EFSA staff.” Topics to be discussed include general conditions for claim substantiation, the scientific criteria for claim substantiation and the beneficial physiological effects of foods that claims are related to. Representatives of ERNA, EHPM and The European Botanical Forum will attend the meeting.
Source: EHPM, ERNA
NEW INDUSTRY ALLIANCE JOINS HEALTH CLAIMS BATTLE Instead of publishing the Community list of approved and rejected health claims all at the same time, in January 2010, the European Food Safety Authority (EFSA) has chosen to publish its opinions on the circa 4500 claims in batches. The first batch of opinions on 523 claims appeared in October 2009, and the second batch of 416 claims in February 2010. A third batch of 600 or more claims is expected in July of this year, and as yet there is no indication from EFSA as to when and how the remainder will be published. Now, over 350 companies have signed a letter to the President of the European Commission (EC) in a mass appeal to halt this piecemeal approach to the adoption of the list of functional health claims (‘generic’) claims under Article 13.1 of the EC Nutrition and Health Claims on Foods Regulation. The strongly-worded letter, which seeks the personal intervention of EC President José Manuel Barroso, was co-ordinated by the European Health Claims Alliance (EHCA), an alliance of companies from many different sectors of the food and nutrition industry who have come together in pursuit of the same aim. The shared concern of these companies is that the intention to adopt the health claims in batches distorts competition in the market; creates unnecessary and disproportionate costs for manufacturers due to successive label changes; and creates confusion in the market as non-harmonised claims co-exist with harmonised claims with unequal conditions of access to markets across the EU. The EHCA letter also makes reference to a recently commissioned pan-European Regulatory Impact Assessment, aimed at demonstrating in concrete terms the huge financial impact that the Regulation and its implementation will have on the food industry. Further signatures to the letter are still being accepted, and interested companies can find further details at: www.healthclaimsletter.org Source: EHPM, ERNA EFSA SETS DRVs FOR NUTRIENT INTAKES
The European Food Safety Authority (EFSA) has now published new dietary reference values (DRVs) for carbohydrates, sugar, fibre, fats and water: Intake of total carbohydrates
should range from 45 – 60% of the total energy intake for adults
and children. Source: EHPM
EFSA LAUNCHES NEW SCIENTIFIC JOURNAL
The European Food Safety Authority (EFSA) has recently launched ‘The EFSA Journal’, a dedicated web area that serves as an electronic, open-access scientific journal.
It contains the vast body of work being carried out by EFSA and its Scientific Committee and Panels, spanning the entire food chain, from food and feed safety, nutrition, animal health and welfare, to plant health and plant protection. It will also facilitate referencing of the Authority’s scientific work in scientific literature.
For further detail see: http://www.efsa.europa.eu/en/efsajournal.htm
Source: EHPM
SCIENTIFIC DEVELOPMENTS ON FOLIC ACID: EFSA UPDATE
In 2008 the European Food Standards Agency (EFSA) established a Scientific Cooperation Working Group (ESCO) on the ‘Analysis of risks and benefits of fortification of food with folic acid’, which focussed on: A review of current
practice in Member States on the level of voluntary fortification of foods
and categories of foods to which the addition of folic acid is permitted
In January 2009 EFSA and the Swedish National Food Administration organised a meeting on ‘Folic Acid: an update on Scientific Developments’, attended by experts from the European Union, USA and Canada, which considered evidence related to folic acid and risk of cancer. Now, EFSA has published an update on scientific developments on folic acid which compiles the content and outcomes of these events - but does not consider papers published since these events. It can be accessed at: http://www.efsa.europa.eu/en/home/publication/efsafolicacid.pdf Source: EHPM REVISED IMPORT CONTROLS FOR GUAR GUM FROM INDIA The European Commission has issued revised import control measures for guar gum imported from India. This follows an incident in summer 2007 in which dioxin contamination was discovered in Indian guar gum, a thickening agent used in a wide range of processed foods. There was no immediate risk to health, but large numbers of food products, including yoghurts and fruit drinks, were withdrawn from sale all over Europe. Although there has been no further contamination, in order to allow time for the implementation of improved quality control measures, and to prevent a repeat of the 2007 incident, the Commission has decided that all consignments of guar gum imported into Europe from India (which produces almost 90% of the world’s guar gum) should be subject to continued import controls. Source: EHPM LYCOPENE LEVELS
The colour lycopene E160D is permitted for use in the European Union in various foodstuffs.
Now, following a risk assessment by the European Food Safety Authority (EFSA) the European Commission (EC) proposes to amend the current maximum levels, to include reducing the level in liquid food supplements from 100mg/l to 30mg/kg (there seems to be an error in the unit given by the EC) and in solid food supplements from 300mg/kg to 30 mg/kg.
For further information, contact the EHPM secretariat: secretariat@ehpm.be
Source: EHPM
THE SAFETY OF STEVIOL GLYCOSIDES
The ANS panel, the European Food Safety Authority scientific panel on additives, has assessed the safety of steviol glycosides, (sweeteners extracted from the leaves of Stevia rebaudiana Bertoni). The assessment has been sent to the European Commission to consider whether to authorise the substances in the European Union for use in sugar-free or energy reduced foods.
Toxicological testing showed that the substances were neither genotoxic nor carcinogenic, or linked to other adverse effect on the reproductive human system or the developing child. The panel therefore set an Acceptable Daily Intake (ADI) of 4 mg per kg body weight per day.
Source: EHPM
NOVEL FOODS UPDATE
· A single centralised authorisation procedure at EU level. · An accelerated authorisation procedure for traditional food from third countries (i.e. food derived from primary production which has been part of the customary diet for at least 25 years in a large part of the population of a third country). · Clarification of the definition of novel food and the scope of the regulation which now includes food containing or consisting of engineered nano-materials. · The opportunity for applicants to request the protection of scientific data on newly- developed innovative foods for a period of five years.
Key issues of the draft regulation in relation to supplements include:
Reiteration of the
interpretation that proven non-novel use as food supplements would not
allow extension of use to other foods. Also, indications that the European
Commission will offer guidance on the criteria for "significant use”.
Source: EHPM DIOXINS, PCBs & DIOXIN-LIKE PCBs
The European Commission and Member States are currently discussing new maximum levels for dioxins, PCBs and dioxin-like PCBs. The proposals, which include issues of particular concern to fish oils, include: New limits on dioxins
and dioxin-like PCBs to be set on the basis of the 2005 WHO-TEFs which,
when applied to existing data, reduces calculated TEQs by an average of
about 15%. The Commission is now discussing the practicalities of reducing
the total sum of dioxins and dioxin-like PCBs in fish oils from 10 pg/g
fat to a new target of 5 pg/g fat. For further information, contact the EHPM Secretariat at: secretariat@EHPM.be
Source: EHPM
PROPOSAL TO DOUBLE VITAMIN D INTAKE FOR THE ELDERLY
Finland’s National Nutritional Council has recently published recommendations that the vitamin intake for people over 60 years old should be doubled, to 20 micrograms per day.
Sunlight is one of the main sources of vitamin D, and is relatively lacking in Finland. While fatty fish, egg yolks and fish liver oils are also good sources and fortification of milk and margarine products with vitamin D is already mandatory in Finland, there is concern that the elderly do not eat enough of these foods to compensate for any deficiency.
Now, by advocating daily supplementation with vitamin D for the over 60s, the Finnish authorities hope to boost their vitamin D intake and also to target those most at risk of one of the main adverse effects of D deficiency, osteoporosis.
Source: LTL
FRANCE
NATIONAL DECREE ON ‘OTHER SUBSTANCES’ REMAINS IN LIMBO
In 2006 the French government published a decree which transposed the EC Food Supplements Directive into the French legal system. According to the Decree, it was planned to publish application Orders listing the "other substances" (including botanicals) which would be allowed for food supplement use.
However, the three Ministries involved could not reach a common position on these lists, with the result that the Ministry of Health, and, it is now understood, the Ministry of Agriculture and Food, have decided to pull out from the regulatory process.
The remaining Ministry (Industry), specifically the General Directorate for Competition Policy, Consumer Affairs and Fraud Control (DGCCRF) now plans to handle the situation alone. Therefore, in order to have the application Orders published, the DGCCRF has no other choice but to have the Decree amended by removing the signatures of the two other Ministries. This can only be done with the approval by the Conseil d'Etat (the highest public/administrative jurisdiction in France) and is not yet known if or when this approval will be granted.
Source: SYNADIET
GERMANY
45% OF GERMANS LOW ON VITAMIN D?
In a paper recently published in a food research journal, a professor at a German university estimates that up to 45% of the German population may have insufficient levels of vitamin D, and a further 15 – 30% are actually deficient in the vitamin, and as a result, a large section of the population are at risk of health problems. In addition, he warns that current intake recommendations are insufficient, and should be doubled to at least 25 micrograms a day. (Current recommendations range from 5 – 10 micrograms per day).
Source: BLL
IRELAND
FSAI PUBLISHES HEALTH CLAIMS LISTS
The Food Safety Authority of Ireland (FSAI) have recently updated their website to advise food business operators of Health Claims which have been published in the Official Journal of the European Union. FSAI have devised three tables to help simplify the labelling rules and conditions applying to the use of permitted health claims because, in their view, it can be difficult to identify all the labelling requirements applicable to the use of these claims, and, in the case of rejected health claims, the Register does not clearly specify the date by which products bearing these claims must be removed from the market. The FSAI tables can be accessed by choosing from the claim categories on the FSAI web site: http://www.fsai.ie/science_and_health/nutrition_and_health_claims.html
Source: IHTA
FSAI TO HOLD HEALTH CLAIMS SEMINAR
In May of this year the Food Safety Authority of Ireland (FSAI) is to hold a Seminar for stakeholders on Health Claims. The issues discussed will include the scientific assessment of health claims and the classification of products on the food/medicines borderline.
It is understood that FSAI will also give industry stakeholders some indications of how enforcement of the regulation will work, especially in relation to unapproved claims and their removal from the market place. The focus is likely to be on medicinal claims and those considered to be potentially harmful.
Source: IHTA
UNITED KINGDOM
NEW NANOTECHNOLGY DATABASE
The UK oHouHHouse of Lords Scientific Committee has recommended the setting up of a confidential database of food industry research into nanotechnology, and also a publicly accessible list of foods and food packaging products containing nanomaterials approved by the European Food Safety Authority.
Accepting the recommendations, Andrew Wadge, chief scientist at the UK Food Standards Agency is quoted as saying, ‘The way that we respond in terms of nanotechnology is a test case for the way we, as a regulator, respond to emerging and new technologies”.
Source: HFMA
FSA & SACN RECOMMEND FOLIC ACID LIMIT
In response to the 2009 Scientific Advisory Committee on Nutrition (SACN) report on ‘Folic acid and colorectal cancer risk: review of recommendations for mandatory folic acid fortification, the UK Food Standards Agency (FSA) has written to UK food supplement trade associations with the following request: 'The Food Standards Agency in agreement with the Department of Health kindly requests, with immediate effect, that your members do not introduce any products to the market containing above 200 microgram folic acid that may be taken by people aged over 50 years or with a previous history of colorectal adenomas. We would also encourage reformulation of existing products that may be taken by these groups to less than or equal to 200 micrograms. This action will help decrease the current risk of exposure to high doses of folic acid within these groups as well as address future concerns if a decision is made to introduce mandatory fortification.’
The FSA’s letter goes on to make it clear that SACN continues ‘to endorse the Government's previous recommendation that all women who could become pregnant and those with a history of a previous neural tube defect-affected pregnancy should supplement their diet with 400 microgram and 5 milligram per day of folic acid respectively prior to conception and until the twelfth week of pregnancy ‘
Source: HFMA
WARNING ON HERBAL SUPPLEMENTS
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has recently warned that more than 900 bottles of a Chinese herbal product containing the banned herb Aristolochia remained on the UK market, despite a product recall issued by the UK distributor.
Extracts of Aristolochia have been linked with kidney failure, urinary tract and other cancers, and have been banned in the UK since 1999.
Source: HFMA
NORTH AMERICA
UNITED STATES
FDA-APPROVED CLAIMS AND THE HEALTH CARE REFORM BILL
U.S. President Barack Obama’s health care reform bill, “The Patient Protection and Affordable Care Act”, includes several provisions that address complementary and alternative medicine (CAM), primarily by better incorporating alternative practitioners into the U.S. health care system.
One provision also included in the final law which has a direct effect on those dietary supplements for which there are health claims approved by the US Food and Drug Administration (FDA), concerns the setting up of a pilot program for "wellness plans", which can now include those few supplements with "health claims approved by the Secretary." Currently approved health claims include claims for calcium and osteoporosis; soluble fiber and coronary heart disease; folic acid and neural tube birth defects. The full list can be found on the (FDA) Web site.
According to the American Herbal Products Association (AHPA), the new health care law is a starting point for a broader inclusion of CAM within the U.S. healthcare system. If managed properly, greater inclusion of alternative practitioners in health care should open a pathway for increased acceptance of the dietary supplement products they provide.
Source: AHPA
SENATOR PUSHES FOR NDI GUIDANCE
Following his decision to drop his proposed new bill, “The Dietary Supplement Safety Act of 2010”, which attracted wide criticism from industry, Senator John McCain, together with Senator Orrin Hatch, a long-time supporter of dietary supplements, has agreed on four areas where they want action:
The rapid publication
by the Food and Drugs Administration (FDA) of New Dietary Ingredient (NDI)
guidelines Source: UNPA
HEAVY FINE FOR DECEPTIVE ADVERTISING A national pharmacy chain has agreed to pay nearly $6 million to settle Federal Trade Commission (FTC) charges that it deceptively advertised a line of dietary supplements using baseless claims that the supplements could prevent colds, fight germs, and boost the immune system. In a separate case, the manufacturers of the products sold by the pharmacy chain have agreed to a fine of over $500,000.
Source: AHPA
PRODUCT WARNINGS AND RECALLS
Product seizure: At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals recently seized a range of bee-derived products, including creams, capsules, tablets, gum, throat spray, and shampoos, on the grounds that the products are misbranded and unapproved new drugs in violation of the Federal Food, Drug, and Cosmetic Act.
Via links on its Web site and in labeling and promotional material, the company concerned claimed that some of the products could be used to diagnose, cure, and prevent diseases such as asthma, dermatitis and ulcers. Additional claims indicated that the products could aid in the treatment or prevention of cancer, liver or kidney disease, insomnia, bone fractures, and skin disorders.
Voluntary recall: Two manufacturers have issued nationwide voluntary recalls of capsules marketed as dietary supplements because they contain undeclared amounts of Sildanfil or Aildenafil, (similar to Sildanfil), and also the drug Phentolamine, an alpha-adrenergic blocker. Sildanfil is the active ingredient in an FDA-approved drug to treat erectile dysfunction – and the concern is that these products may cause severe adverse effects to consumers with diabetes, high blood pressure or heart problems. FTC sues over bogus ‘cure’: the Federal Trade Commission (FTC) is suing a company offering a cure for alcoholism, on the grounds that it tricked problem drinkers into paying hundreds or even thousands of dollars for a service prescribing ineffective natural supplements, and then threatened to reveal the drinkers’ alcohol problems if they canceled their memberships. The supplements included Vitamin C, Calcium and St.John’s wort. Using several Web sites, the defendants advertised that their program “cures alcoholism while allowing alcoholics to drink socially” and “is scientifically proven to cure alcoholism.” Internet company warned about unauthorized Swine flu remedies: following review of the company’s website, the US Food and Drug Administration (FDA) recently sent a Warning letter to a company based in the Nicobar and Andeman islands. The grounds for the Warning were that the website offered products for sale that had not been authorized by the FDA but which were intended to diagnose, mitigate, prevent, treat or cure the H1N1 Flu Virus in people – in contravention of the Federal Food, Drug and Cosmetic Act. Specifically, the Warning letter said that under the subheading "Swine Flu Remedies", "BUY NOW” links appear for holy basil supplements, ginger supplements, and Tinospora supplements. These links take the user to order pages for the Tulasi (Holy Basil) capsules, Sunthi (Ginger) Capsules, and Guduchi Salva (Tinospora Cordifolia) Capsules, respectively. Near each of the "BUY NOW” links is a "Read more" link for the product that opens a separate, product-specific webpage with information on the uses of the product. These product-specific pages also bear claims about treatment of the H1N1 Flu Virus. Source: AHPA
CALL TO ACTION AGAINST THE FTC AMENDMENT
The Natural Products Association (NPA) and 40 other national trade associations sent this month a letter urging the US Senate to keep proposals for expansion of the Federal Trade Commission (FTC) powers out of its current debate over financial regulatory reform. The expansions being discussed could have a dire impact on the dietary supplement business.
NPA calls trade associations to take action on this important issue by contacting the senators, and urging them to oppose the FTC amendment. NPA declares that at a time when businesses are struggling to both survive and create new jobs, adding burdensome new regulations and ceding more authority over the business to the FTC is just what the economy does not need. The Senate may take action on the "Restoring American Financial Stability Act" as early as next week.
Should these additional powers be granted to the FTC, the following might be expected to happen:
· The FTC will have authority to create advertising guidelines that are inconsistent with what is allowed under DSHEA and the FDA. · The FTC acting as a legislative body, creating "rules" for industries in areas in which it has no expertise. · The FTC levying fines against businesses for practices it deems illegal without allowing the business to change its policies. · The FTC levying fines against companies for "aiding and abetting" wrongdoing even when the companies did not know a violation was occurring. · The FTC making, approving, and policing rules with virtually no oversight.
For further information, please contact: jgay@npainfo.org
Source: NPA
SOUTH WEST PACIFIC
AUSTRALIA & NEW ZEALAND
CHANGES TO AUSTRALIAN GMP REQUIREMENTS
Together with the Australian Self Medication Industry (ASMI), the Complementary Healthcare Council of Australia (CHC) has recently written to its member to make them aware of imminent changes to the requirements for Good Manufacturing Practice (GMP) and the implications for the responsibilities of manufacturers.
The three most important consequences of the changes, which come into force in July of this year, are that: Product manufactures
will be audited according to the revised Manufacturing principle from
that date. The new GMP Guide encompasses change to many GMP requirements, including Product Quality Reviews, Stability testing, Quality risk management systems, Complaints and product recall, and Release for supply.
The Australian Therapeutic Goods Association is now preparing a Technical Guidance on the implementation of the new GMP Guidance, which will shortly be posted to their website on the following link: http://www.tga.gov.au/manuf/twg.htm#cmguides
Source: CHC CHANGES TO THE DIETARY REGULATION Further to the public consultation on the Supplemented Food Standard, the proposed changes to the Dietary Supplements Regulations 1985 (DSR) have now been approved and have been placed into effect from 31 March 2010. The changes provide for:
- Food-type supplements to be removed from the DSR, leaving therapeutic-type supplements/ products to be administered under the DSR. The DSR will exclude products that most people would recognise as foods from coverage under the regulations. The administration of the DSR will be provided by the Ministry of Health rather than NZFSA. (This is viewed as an interim measure until a new regulatory system for the manufacture and supply of natural health products in NZ can be put into place).
- Increase in the permitted maximum level of Folic Acid in dietary supplements from 300mcg to 500mcg for products made in accordance with the New Zealand Code of Good Manufacturing Practice.
In addition, the NZ Ministry of Health has released a high level consultation paper for the proposal for regulation of natural health products in New Zealand.
The consultation paper sets out high-level proposals, developed under the Memorandum of Understanding between the National and Green parties, for a natural health products scheme that would regulate products on the New Zealand market.
The Development of a Natural Health Products Bill: Consultation Paper is available at http://www.moh.govt.nz/moh.nsf/indexmh/consult-development-natural-health-products-bill-mar10. Submissions close on 17 May 2010.
Source: NPNZ
Prepared by the 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.
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