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To: IAHF LIST
Subject: IADSA Report and Commentary on IADSA from IAHF: Your Help Urgently Needed to Get Videos To the EU!
From: "International Advocates for Health Freedom" jham@iahf.com
Date: Sun, 15 Oct 2000 07:47:51 -0400

IAHF List: There is a lot to take in when you look at this report from the International Alliance of Dietary Supplement Associations (IADSA). I'd like to make some key observations from it:

First: Note the commentary on Holland. Note that in the EU now, a country can't even enact its own laws without the approval of the EU Commission which must "review" and "approve" them... this is ominous. Please go to the recommended reading section on the IAHF site http://www.iahf.com/ and get some of the books listed there, especially the last one on the list: MASS CONTROL: Engineering Human Consciousness by Jim Keith. The Codex vitamin issue is just the tip of the iceberg... http://www.amazon.com/exec/obidos/tg/stores/detail/-/books/1881532208/customer-reviews/ref=pm_dp_ln_b_7/104-9422464-4422354

Note the section on Germany. Germany is drafting legislation for vitamins that will be in sync with the EU Vitamin Directive that will be rammed down the throats of the populace by sometime in January unless there is massive grass roots opposition. IAHF will be sending some videotapes to key health freedom fighters in Europe in PAL VHS format. The video we're sending to Europe helped us pass DSHEA here in the states in 1994.

The sickening thing about IADSA is that it is doing nothing to even ATTEMPT to rally the grass roots, because this umbrella group of vitamin trade associations is dominated by pharmaceutical interests. If we can't stop the EU Vitamin Directive, we'll have a much harder time stopping Codex in the future because through the EU, the Cartel intends to force all 15 EU countries to march in lockstep with Germany.

Your donations will help me send as many videos as possible in PAL VHS format to true blue health freedom fighters in key positions in Europe. We don't have to take this lying down, and we WON'T! As the TRUTH about the healing properties of vitamins continues to circle the globe, it will be harder and harder for this viperous den of Cartel thieves to pull off this attempted baloney slicing heist of our vitamins. We need to identify the people on the EU Parliament who are our allies, and those who require "reeducation" and we'll roll up our sleeves and wade into this battle armed with the truth.

Please alert more people to visit the IAHF website at http://www.iahf.com/ so that they'll join the distribution list, and please send your donation to IAHF PO Box 625 Floyd VA 24091 USA to help IAHF send copies of "Let Truth Be the Bias", the award winning documentary by Kevin Miller (c.APMA) that helped us pass DSHEA in the states, and together, we'll STOP this MADNESS!

IADSA NEWSFLASH

OCTOBER 2000

INTERNATIONAL DEVELOPMENTS

IADSA NEWS

EXECUTIVE COMMITTEE MEETING

The IADSA Executive Committee met on 16 September in Bologna, Italy. One of the key conclusions of the meeting was that the VMS strategy leading up to the next Codex Nutrition Committee meeting in October 2001 should continue to be the main focus of IADSA.

It was also agreed that the following would be Executive Committee members for 2001:

Shuhei Yoshida - NFTS Japan
Bill Lee - KHFSNA Korea
Anthony Bush - EHPM
Luc Claessens - ERNA
Maurice Hanssen - EHPM
David Seckmann - NNFA United States
Michael McGuffin - AHPA United States
Loren Israelsen - UNPA United States
Bruce Dennison - HPA South Africa

Following consultation with the South Pacific associations, it is envisaged that a representative from this region will be asked to join the Executive.

AGM AND MEMBER'S WORKSHOP TO BE HELD IN CAPE TOWN, 30-31 MARCH 2001

The Health Products Association (HPA) of South Africa, which is celebrating its 25th anniversary in 2001, has kindly proposed to host both the IADSA and EHPM (European Federation of Associations of Health Products Manufacturers) annual general meetings.

The IADSA Annual General Meeting (AGM) 2001 will be held in Cape Town, South Africa, on Friday 30 March.

The AGM will be followed by an international regulatory workshop, which will be held on Friday afternoon 30 March and Saturday 31 March. This IADSA members' workshop will focus on the future regulation of the dietary supplement business. Issues that will be covered are the following:

- Food/Dietary Supplements Frameworks
- Risk Assessment / Risk Management
- Health / Benefit Claims
- Innovation
- Quality
- Herbals

Information on flights, accommodation and the programme will be sent to all members as soon as possible.

CODEX ALIMENTARIUS

CODEX COORDINATING COMMITTEE FOR EUROPE DISCUSSES PRECAUTIONARY PRINCIPLE

The Codex Coordinating Committee for Europe met from 3-6 October in Madrid. One of the main issues on the agenda was the work on risk analysis including the precautionary principle and other legitimate factors.

Sweden and Spain prepared a report on this issue, particularly regarding the precautionary principle in the European Union, as applied to internal and external trade.

The Committee expressed its support for the precautionary principle in the area of food safety and considered that:

The precautionary principle, as regards food safety, should continue to be debated in the Codex Committee for General Principles (CCGP);

It might be helpful to consider specific illustrative cases in order to develop more detailed guidance on the implementation of the precautionary principle;

Further development of the precautionary principle could be of particular value when considering specific cases in the framework of risk analysis.

The next Committee meeting for Europe will be coordinated by Slovakia and will be held in September 2002.

WORLD TRADE ORGANISATION (WTO)

TRADE DISPUTE ON LABELLING GM PRODUCTS

Europe and the United States are in conflict over the labelling of genetically modified products. The US considers a formal complaint to WTO on the grounds that labelling GM products is unfair discrimination against US products.

The US Food and Drug Administration (FDA) insists only nutritional information should appear on the label, while the European Commission believes in consumer choice, therefore requiring GM foods to be labelled.

So far, no formal complaint from the US side had been made to WTO.

Website: http://www.wto.org/

TRANSATLANTIC BUSINESS DIALOGUE (TABD)

NEXT TABD CONFERENCE TO TAKE PLACE FROM 16-18 NOVEMBER IN CINCINNATI

The Transatlantic Business Dialogue (TABD) is a business-driven process launched in 1995 by the transatlantic business community, the US government and the European Commission. The aim of the TABD is to boost transatlantic trade and investment opportunities by removing costly inefficiencies caused by excessive regulation, duplication and differences in the US and EU regulatory systems and procedures.

TABD Conferences are held on an annual basis and bring together Chief Executive Officers (CEOs) and senior-level government representatives. The next TABD conference will take place from 16-18 November in Cincinnati, United States.

Following the Berlin conference in November 1999, the dietary supplement sector has worked to develop transatlantic understanding on four key issues: definition, safety, claims and GMP. The communique also encouraged greater cooperation between EU and US scientific bodies.

Website: http://www.tabd.org/

INTERNATIONAL LIFE SCIENCES INSTITUTE (ILSI)

ILSI REPORT ON NUTRITION AND IMMUNITY PUBLISHED

The International Life Sciences Institute has published a report, titled 'Nutrition and Immunity in Man' about the immune system and its many interactions with nutrition and in particular, supplementation.

The report focuses on vitamins, minerals, probiotics and fatty acids and the positive correlation with the immune system. Although the report warns for the potential health risks of supplementation at high concentrations, it concludes by saying that 'preliminary research suggests that altering the immune response by dietary means may be of value in the reduction of risk and/or the treatment of a wide variety of disorders'.

Website: http://www.ilsi.org/

ASIA

JAPAN

INDUSTRY PETITION ON DRUG/FOOD CLASSIFICATION

The Japanese Health Food and Nutrition Food Association (JHNFA) has presented a petition to the Vice-Minister of Health and Welfare, Mr. Shingo Haketa, concerning the drug/food classification and the regulatory system in general.

The JHNFA commented that the current food regulation is drug-oriented and that the labelling system is too strict and unfair to the food industry. More specifically, the petition called for:

* The promotion of a strong food/health policy
* The establishment of basic policy for food/drug administration
* Clarification of food/drug classification and flexibility in using health claims
* Establishment of food/health expert training program

Other Japanese associations and industry representatives such as NNFA, NFTS, all Japanese Health and Natural Foods Associations, the Health and Food Society, the Health Food Group of Pharmaceutical Manufacturers and CRN have sent similar comments to the Ministry.

The response by the Ministry is expected by the end of the fiscal year.

Contact: Yannick Yuichi O'Hara, Japan Health Food & Nutrition Food Association
Tel: +81 3 3268 31 34, Fax: +81 3
THAILAND

EXPERT MEETING HELD ON DIETARY SUPPLEMENTS NOTIFICATION

On 13 September, the Thai FDA conducted an expert meeting to discuss the draft Notification on Dietary Supplements, produced by the Ministry of Health. The Thai Health Food SuppIements Association (HFSA) was also involved in the discussions.

A final meeting will be held at a later date in October. The Thai HFSA will report back on the final conclusions.

Contact: Mr Pisuth Lertvilai, Health Food Supplements Association (HFSA), Thailand
Tel: 662-3327120-29 ext 300, Fax:662-3327135,
Email : pisuth.lertvilai@roche.com

EUROPE

EU

EUROPEAN FOOD SUPPLEMENT DIRECTIVE MOVES FORWARD IN EUROPEAN PARLIAMENT

The European proposal for a Directive on food supplements is moving forward in the European Parliament and in the special working group established for negotiation among the EU´s fifteen Member States.

Following the first Council meeting of Member States in early July, the second Council meeting took place mid-September. The discussions mainly focused on two issues: the scope in the Directive and the safety principle.

The first meeting had been strongly in favour of a more ambitious scope to the Directive. However, when the second meeting in September considered the difficulties related to including other ingredients, the support for expansion lessened among some of the Member States. Support for expanding the definition in order to take account of combination products is growing.

Member States also address the safety basis of the proposals and it became clear that there are still divergent views amongst the member states.

As to timing in the European Parliament, although this may yet change, the Industry Committee and the Environment Committee are due to vote on the Directive in early November and early December respectively, with the vote in the Plenary session due in January 2001.

Contact: European Federation of Health Product Manufacturers (EHPM)
Tel: +32 2 209 11 45, Fax: +32 2 223 30 64,
Email: ehpm@eas.be

SCF OPINION ON CREATINE SUPPLEMENTATION

The EU Scientific Committee for Food (SCF) discussed the safety of creatine in view of the European Commission's intention to draft EU legislation on sports foods.

The SCF reported that little information exists on the short-term or long-term safety of creatine. Although no important adverse effects have been reported, there is insufficient evidence about the safety of high doses, in particular in relation to kidney function.

Therefore the SCF concluded that high creatine doses in supplementation should be avoided, but indicated that a lower dose of 2 g daily is unlikely to pose any risks. Before making any final conclusions the SCF would however need further studies evaluating short- and long-term effects of oral creatine on renal and hepatic systems and organs where creatine plays a metabolic role in not highly trained people.

Contact: European Federation of Health Product Manufacturers (EHPM)
Tel: +32 2 209 11 45, Fax: +32 2 223 30 64,
Email: ehpm@eas.be

SCF REPORT ON BETA CAROTENE TAKES NEGATIVE APPROACH

The conclusions of a report on beta carotene only concern its use as a food additive. Upper levels in relation to food supplements, which the European Commission will take into account for the draft EU food supplement Directive, are to be published by the SCF later.

The general reflections of the report are not very positive:

'However, the general assumption that individuals who eat more fruits and vegetables , rich in caretonoids, and/or have high levels of serum b-carotene have a lower risk for cancer or cardiovascular disease cannot be extended to synthetic pure b-carotene or to specific formulations containing b-carotene, because the role of other caretonoids or other compounds from vegetables and fruits, and associated dietary or lifestyle patterns, has not been adequately explored in the epidemiological studies.'

The SCF had previously set the Group ADI (Acceptable Daily Intake) for carotenoids at 0-5mg/kg b.w. day, but the Committee has now decided to withdraw this figure because of a lack of human data and following the adverse effects reported in relation to smokers. There are no reports of 1-2mg/day being consumed as food additives are dangerous. The Committee therefore concludes that for the time being these levels of intake are acceptable from a health point of view. There is not sufficient data to set an ADI.

The report can be found on:
http://europa.eu.int/comm/food/fs/sc/scf/out71_en.pdf

Contact: European Responsible Nutrition Alliance (ERNA)
Tel: +32 2 209 11 50, Fax: +32 2 223 30 64,
Email: erna@eas.be

EUROPEAN PARLIAMENT WARNS FOR MISUSE OF PRECAUTIONARY PRINCIPLE

The European Parliament held a second debate on the European Commission communication on the precautionary principle. Major conclusions were that the precautionary principle could be a good tool and extremely valuable in risk management, but it should not be used to stifle innovation, or for political gains.

The draft report of the European Parliament says that the precautionary principle should be properly implemented and that any measures taken should be regularly reviewed in the light of scientific developments. The European Parliament will vote on the issue in the Plenary session in November.

DRAFT DOCUMENT ON GENERAL FOOD LAW PRINCIPLES UNDER CONSIDERATION IN EUROPEAN COMMISSION

The European Commission has released a draft General Food Law regulation. This regulation lays down the general definitions and principles governing food and feed in general, and food and feed safety in particular, in the European Community.

The draft is currently under discussion within the European Commission and will be combined with the regulation on the European Food Authority. The idea is that the General Food Law would underpin the creation of the European Food Authority.

It is expected that both will be adopted by the 10th of November. They will then be sent to the European Parliament and the European Council. According to the European White Paper on Food Safety the final adoption will be in December 2001.

BELGIUM

LEVELS UNDER DISCUSSION IN BELGIAN WORKING GROUP ON HERBS

The Advice Commission on health preparations of the Belgian Ministry of Health has mandated a specific working group to work out a list of limits which will be the distinction between herbal preparations sold under food law and those which will be medicines.

NAREDI, which has two seats in the above mentioned Commission, has executed a specific task force in order to prepare the scientific arguments of our industry for the official working group.

The working group will start work with the 20 most commercially important herbs, including laxatics, hypericum and ginseng. This work is due to be presented to the Belgian Minister at the end of this year and it will eventually be added to the current Belgian law on herbs.

Contact: Michel Horn, NAREDI, Belgium
Tel: +32 2 218 6760, Fax: +32 2 218 6679,
Email: jan@naredi.uunethost.be

GERMANY

GERMAN LEGISLATION ON SUPPLEMENTS DRAFTED IN PARALLEL TO EU LEGISLATION

The German Ministry of Health is in the process of drafting national legislation on food supplements. The legislation will be developed in parallel to the EU Directive on food supplements, covering all the points of the EU Directive.

In addition, other ingredient categories not covered by the EU Directive will also be included to reflect the total German food supplement market. Germany would like to see the categories of amino acids, herbal products and fibres to be included in the EU draft Directive at this stage.

IRELAND

PROPOSALS FOR A REGULATORY FRAMEWORK FOR HERBAL MEDICINE

The Irish Medicines Board has appointed a herbal project manager to develop proposals for a regulatory framework for herbal medicine.

In addition the Board has requested proposals from industry and other interested groups and placed advertisements in the national press asking for proposals from the public on the subject.

Contact: Martin Murray, Irish Health Trade Association (IHTA)
Tel: +353 61 33 44 55, Fax: +353 61 33 15 15,
Email: mjm9@indigo.ie
ITALY

ITALY REVIEWS FORMER POSITION ON CHITOSAN

The Italian Ministry of Health has officially approved the use of chitosan, a fat-absorbing crustacean fibre, in food supplements.

Due to the numerous positive results of scientific studies on chitosan over the last years the Ministry re-evaluated its former position on chitosan. When the Ministry prohibited the use of chitosan in 1997, several products had to be withdrawn from the Italian market.

NETHERLANDS

DUTCH DRAFT LAW ON HERBAL PREPARATIONS ENTERS EUROPEAN PROCEDURES

Last month, the Dutch Board of Ministers adopted a draft Dutch law on herbal preparations. The draft law is based on the principle of safety and relates to herbal preparations sold under food law, containing herbs and herbal extracts. The rules do not apply to herbal spices, flavourings, cosmetics and herbal medicines.

In accordance with the EU notification procedure, the draft law was sent to the European Commission. The notification procedure will last 3 months if neither the Commission nor Member States raise any concern. If concerns are raised it will last 6 months and if the Commission decides to propose legislation on this matter the procedure will last for 12 months.

According to the European Commission, Member States should not have any major concerns as the law will not have a direct effect on already harmonised European legislation nor on inter-Member State trade.

If there are no concerns, the European Commission will send its comments to the Dutch Ministry before 15 December.

EUROPEAN COMMISSION TAKES THE NETHERLANDS TO THE EUROPEAN COURT OF JUSTICE OVER FORTIFIED FOODS REGULATION

The European Commission announced it will take the Netherlands to the European Court of Justice for its regulations on adding nutrients to food. The Dutch regulation restricts the use of vitamins A and D, folic acid, selenium, copper and zinc to the restoration and substitution of these substances in foods. This means that these substances may not be added to foodstuffs for any other purpose (e.g. the enrichment of foods to produce functional foods).

The Commission says that these requirements are incompatible with the principles of European food law and believes that they constitute a barrier to the free movement of goods.

NORWAY

NEW LEGISLATION ON CLAIMS TO BE EXPECTED IN SPRING

In February 1998, the Norwegian Medicines Control Authority (SLK) published guidelines on claims they consider to be medicinal claims. These guidelines were extremely strict.

Since then, the Norwegian Bransjeradet for Naturmidler (BRN) has strongly protested against the guidelines on claims. BRN managed to have questions raised in the Parliament. Consequently, the Minister of Health asked the Department of Health to reconsider the legislation.

In January 2000, the law on Pharmacies was accepted by the Parliament. It states that the government had to evaluate the medicinal law, in order to accommodate the views of the Health and Social Committee on the above subject. This Committee had spoken to BRN and concluded that there was a definite need for changes in the medicinal laws.

The Department of Health is expected to present their conclusions to the Parliament in the Spring.

Contact: Turid Backer, Bransjerådet for Naturmidler, Norway
Tel: +47 23 37 64 50, Fax: +47 22 72 39 40,
Email: turidlbacker@brn.no

MEASURES ON ST. JOHN'S WORT

St. John's Wort is a natural medicine in Norway, and has to have approval by the Norwegian Medicines Control Authority (SLK) before it can be marketed. Natural medicines can, as defined by law, be sold through all approved channels, e.g. pharmacies, health food stores and groceries.

In February 2000, the SLK issued a rapid alert on St. John's Wort. All products had to be withdrawn from the market in order to get a warning printed on labels and attachments. The warning was primarily on interactions, and that a physician should be asked for advice before self-medication.

In July, SLK wrote a letter to the companies marketing St. John's Wort, informing them that due to the seriousness of the interactions with medicines, they would be evaluating the market approval of the product unless the companies restricted their sales to pharmacies only.

By law, the SLK does not have the mandate to do this. The Norwegian Bransjeradet for Naturmidler (BRN) considers the letter to be nothing but a clear threat as it means that if the sales of St. John's Wort are not limited to pharmacies, the SLK will make it a medicinal drug.

Contact: Turid Backer, Bransjerådet for Naturmidler, Norway
Tel: +47 23 37 64 50, Fax: +47 22 72 39 40,
Email: turidlbacker@brn.no

UNITED KINGDOM

FINAL MCS GUIDANCE NOTE ON BORDERLINE PRODUCTS PUBLISHED

Following the June draft document, the Medicines Control Agency (MCA) has released its final Guidance Note on borderline products. The MCA developed these notes to explain its policy for the classification of borderline products as foods or medicines.

This Guidance Note is meant to provide input for the development of a potential EU Directive for traditional herbal medicines. The introduction of a simplified pharmaceutical registration procedure (only requesting data on quality and safety and proof of traditional use) for traditional medicines is a significant step forward towards the establishment of the legal status for herbal products in the EU.

A copy of the Guidance Note can be obtained from the IADSA Secretariat.

Contact: Penny Viner, HFMA, United Kingdom
Tel: +44 181 398 98 88, Fax: +44 181 398 69 06,
E-mail: hfma@hfma.co.uk

BBC RUNS SERIES ABOUT VITAMINS

In August, the BBC ran a series of radio programmes entitled the 'ABC of Vitamins'. These programmes featured vitamins A, B, C, D and E.

CRN was given as a contact address for enquiries from listeners and to date 133 letters have received replies.

For further information, please contact Carl Rawlings of the CRN.

Carl Rawlings, Council for Responsible Nutrition (CRN)
Tel: +44 191 232 31 00, Fax: +44 191 232 25 00,

NORTH AMERICA

CANADA

REPORT ON VIEWS ON NATURAL HEALTH PRODUCTS IN CANADA

Health Canada has carried out research after the views on natural health products (NHP) in Canada and has published a report based on this research. Main findings of the report are that Canadian consumers believe that most doctors do not feel that NHPs are plausible treatments or preventatives.

Another finding was that most respondents were not satisfied with the amount of information supplied with NHPs, and said the government should have a role in regulating the industry.

USA

Contact: Michael McGuffin, American Herbal Products Association
(AHPA), US
Tel: +1 301 588 1171, Fax: +1 301 588 1174,
Email: mmcguffin@ahpa.org

David Seckman, National Nutritional Foods Association
(NNFA), US
Tel: +1 949 622 6272, Fax: +1 949 622 6266,
Email: Dseckman@nnfa.org

Loren Israelsen, Utah Natural Products Alliance (UNPA), US
Tel: +1 801 474 25 72, Fax: +1 801 474 25 71,
Email: ldi@ldigroup.com

FDA RESPONDS TO QUESTIONS ON DIETARY SUPPLEMENT CLAIMS

The Food and Drug Administration (FDA) published responses on September 29 to comments filed by several trade associations regarding the implementation of new rules for dietary supplement claims.

These new rules were published by the FDA on January 6, 2000. On the one hand, the agency agreed in its September 29 response to allow certain products that were not yet in the market to be considered eligible for the full compliance period for conforming to the rules. The result of this response is that products for which labels had been printed on January 6, 2000 but were not yet marketed will have until January 7, 2001 (or until July 7, 2001 for “small” companies with less than 500 employees) to conform to the final rule. FDA also stated that the marketer of such products will be required to identify all such eligible products in writing.

On the other hand, FDA was not receptive to the industry´s request to allow certain products to be sold after the compliance dates so long as they were labelled prior to those dates. The result of this response is that manufacturers should be focused on moving fully compliant product labelling into the marketplace sooner rather than later.

FDA TAKES INTERIM MEASURES ON DIETARY SUPPLEMENT HEALTH CLAIMS

The US Food and Drug Administration (FDA) has issued interim provisions for health claim labelling, following decisions in the Pearson v. Shalala case. This judgement said that the 'free speech' provisions of the First Amendment to the American constitution prohibited the FDA from denying claims on dietary supplement labels.

With the 'interim enforcement strategy' for dietary supplement health claims, the FDA no longer intends to deny outright all dietary supplement health claim petitions that do not meet the significant scientific agreement standard. Considerations for approving petitions include:

* The claim must provide supporting evidence as a health claim;
* The scientific evidence supporting the claim must outweigh the scientific evidence against the claim;
* Consumer health and safety are not threatened;
* And the claim meets general requirements to be a health claim.

FDA intends to respond to each petition in writing and outline the agency's rationale for determination that the evidence does not meet the significant scientific agreement standard. It would then state the conditions, such as the use of a disclaimer, under which the FDA would ordinarily expect to allow use of the claim in the marketplace.

The FDA will use these interim measures until a rule is developed, incorporating all parts of the Pearson v. Shalala decision.

CHOLESTIN CASE SETS STANDARDS FOR MARKETING DIETARY SUPPLEMENTS THAT ARE ALREADY APPROVED AS DRUGS

In a case on cholestin, a key provision of the Dietary Supplement Health and Education Act (DSHEA) was interpreted for the first time. The case sets the standards for when a dietary supplement may not be marketed because a drug with the same active ingredient was on the market first.

The provision at issue in DSHEA states that: The term 'dietary supplement…' does… not include… an article that is approved as a new drug… which was not before such approval,… marketed as a dietary supplement or a food…

In the cholestin case, the Food and Drug Administration (FDA) detained the importation of red yeast rice, which was to be made into Cholestin capsules, claiming it was a drug. FDA argued that another product with the same active ingredient was approved as a drug before Cholestin was sold as a dietary supplement and therefore Cholestin would also be a drug.

The Court of Appeals agreed with the FDA decision that if the principal substance in a dietary supplement is the same as the active ingredient in an approved drug, if the drug came first, the product cannot be sold as a dietary supplement.

USP DRAFT PROPOSAL FOR QUALITY DEMONSTRATION PROGRAM FOR DIETARY SUPPLEMENTS

The United States Pharmacopoeia (USP) has issued a draft proposal for a quality demonstration program for dietary supplements. The USP proposal includes the development of a certification program of specific standards and can be divided in four components:
* Science/technical: product standards, conformity testing, and manufacturing standards
* Procedural and legal: certification mark, compliance issues and indemnity
* Resources: enrollment and licensing fees and collateral participation
* Implementation of the program

The USP intends to begin certifying single ingredient products and would then work towards certifying combination ingredient products. Comments are now being sought before the USP will progress its work.

FDA RELEASES GUIDANCE ON BOTANICAL DRUGS

The Food and Drug Administration (FDA) issued on 11 August its 'Draft Guidance for the Industry: Botanical Drug Products', in which the agency presented its 'current thinking', rather than a proposed regulation on the issue.

This guidance identifies the steps that would be necessary to bring a botanical product to the market. It also explains when a botanical drug may be marketed under an over-the-counter (OTC) drug monograph and when FDA approval of a new drug application (NDA) is required for marketing.

In addition, this document provides guidance to sponsors on submitting investigational new drug applications (INDs) for botanical drug products, including those botanical products (or botanicals) currently lawfully marketed as foods and dietary supplements in the United States.

This long-awaited document will now be widely discussed in the United States and the rest of the world.

Website: http://www.fda.gov/cder/guidance/1221dft.htm

CFSAN EXPECTED TO PRESENT PROGRAM PRIORITIES 2001 SOON

The comment period for submitting input to FDA´s Center for Food Safety and Applied Nutrition (CFSAN) for their "Program Priorities 2001" closed on August 25, 2000.

Several trade groups provided suggestions to this process. FDA has stated its intention to publish their Program Priorities sometime in October. CFSAN's 2001 plan is expected to look similar to last year's, which identified health claims and labelling, pre-market review of food ingredients, and dietary supplements as a few of the program areas that need emphasis.

REVIEW PROCESS OF DIETARY SUPPLEMENTS CONTAINING EPHEDRA STILL UNDER CONSIDERATION

Earlier this year the Food and Drug Administration (FDA) announced to withdraw the proposed serving and duration limits on dietary supplements containing ephedra (See IADSA Newsflash April 2000).

Following the decision to review all available data, ephedra continues to be a focus for the Food and Drug Administration (FDA) and the industry. A meeting was held at the Department of Health and Human Services on August 8-9, 2000 to discuss the safety of dietary supplements containing ephedrine alkaloids.

Although FDA has hosted such meetings on two other occasions since 1995, this is the first time that the agenda allowed full scientific presentations from experts other than those who are under contract to FDA. As a result, a much broader range of analysis was made available, and an opportunity was granted for a public presentation of the industry's adopted guidance for these products. The full transcript of the meeting can be found at: http://www.4woman.gov/owh/public/index.htm

In addition, the comment period related to the regulation of products containing ephedra closed on September 30. The American Herbal Products Association (AHPA) provided comments that: reported on the results of a survey conducted for AHPA by Arthur Andersen LLP that tabulated total sales of 3 billion servings of ephedra supplements in 1999; recommended that consumption levels be a factor in the development of regulations; communicated the standards that have been adopted by industry for such products, including serving size and daily consumption limits; cautionary labelling and prohibitions against synthetic ingredients and inappropriate claims.

Other products that regulations are focused on are comfrey and other plants containing pyrrolizidine alkaloids. These may be the focus of interest by the Federal Trade Commission (FTC). Communications initiated with that agency in early September found that there is a particular concern with products that bear explicit or implied claims that such products are 'safe'.

St. John´s Wort and saw palmetto were the subject of industry guidance adopted by the American Herbal Products Association (AHPA) in July, 2000. AHPA´s Board offered the following 'or significantly similar' labelling proposals to its members:

For products containing St. John's Wort: 'Do not use this product while taking any prescription drug(s) without the advise of your prescribing physician. Avoid excessive exposure to UV irradiation (e.g. sunlight, tanning) when using this product.'

For products containing saw palmetto: 'The National Institute on Aging recommends that men get regular medical checkups with a thorough prostate exam. You should inform your health care practitioner that you are using this product.'

If any other IADSA member is aware of required or recommended labelling for products containing these two herbs in any other country, AHPA has expressed an interest in being informed of such policies.

SURVEY OF US MARKET FOR BOTANICAL SUPPLEMENTS CONDUCTED BY AHPA

The American Herbal Products Association (AHPA) has initiated a partnership with the Natural Marketing Institute to conduct an integrated survey of the US market for botanical supplements.

The survey will tabulate actual sales data for various botanical product categories in each of several trade channels, including the health food industry retailers, pharmacies, groceries, and direct sales (i.e. multi-level marketing). In addition, input from 2-3000 consumers will be gathered by utilising standard consumer survey mechanisms.

For further information on the AHPA/NMI Herb Market Survey, contact Michael McGuffin at AHPA.

SOUTH WEST PACIFIC

AUSTRALIA

LEGISLATION ON CLAIMS LEADS TO MIXED RESULTS

The Australian government has carried out an 18 month advertising review. Legislation on claims requires that evidence must be held to substantiate any claims that are made. A guideline has been developed which advises the type and level of evidence required for a certain type of claim. Better quality and stronger evidence is required for more serious claims, and medical claims of treatment, cure and prevention of serious diseases require full evaluation of both products and efficacy data.

The Guideline on evidence has been developed to apply to complementary healthcare products, pharmaceuticals and prescription drugs (which can not even be advertised in Australia) and has resulted in a complex, confusing, inappropriate and extremely expensive system, which even the regulators are having difficulty in interpreting consistently.

The advertising review has removed a lot of previously prohibited claims and introduced a system which allows a wider range of claims so long as they are balanced, truthful and not misleading. However, many claims that have been accepted for ten or more years are no longer acceptable and there is a real danger that many multi-component products will be lost as industry has 4 years to comply with the new requirements.

Contact: Val Johanson, Complementary Healthcare Council of Australia
(CHC)
Tel: +61 2 6260 4022, Fax: +61 2 6260 4122,
Email: val.johanson@chc.org.au

CHC CALLS FOR CANADIAN SYSTEM OF COMPLEMENTARY HEALTHCARE PRODUCTS IN AUSTRALIA

In the May 2000 budget, the Australian government announced a review of the administrative arrangements that apply to the regulation of foods, chemicals, medicines and gene technology with the objective of rationalising the numerous agencies that are currently involved.

According to the Complementary Healthcare Council (CHC), ten years experience with the current Australian regulatory system that applies to dietary supplements, or complementary healthcare products, has confirmed that these low risk products do not fit into a medical regulatory framework. Regulatory burden and costs continue to escalate under a system that does not recognise the difference between pharmaceutical drugs and natural health products.

Therefore, the CHC has put in a submission calling for an Office of Complementary Healthcare products, separate from both food and drugs, and similar to the system recently introduced in Canada. The industry will be lobbying hard for a similar system as in Canada, which recognises the philosophical differences between drugs and natural healthcare products, and is based on a wellness model of enhancing health and reducing disease.

The CHC has proposed an overarching office similar to the FDA, with the three separate offices of equal standing: food, medicine and complementary healthcare products. It is proposed to have a separate and appropriate regulatory framework for these products, retaining GMP, a simple product register or licensing system and allowing claims that can be substantiated.

Under trans Tasman harmonisation, New Zealand industry will not agree to the current system but will agree to a system such as that proposed by the CHC with a joint Australia/NZ Office of complementary healthcare products.

The main objective of the CHC position is to get out of the pharmaceutical paradigm that is crippling the industry and denying consumers' access to products that are freely available in other comparable countries.

Contact: Val Johanson, Complementary Healthcare Council of Australia (CHC)
Tel: +61 2 6260 4022, Fax: +61 2 6260 4122,
Email: val.johanson@chc.org.au

TAX INTRODUCED ON LOW RISK NUTRITIONAL PRODUCTS

A 10% tax on low risk products that are used for nutritional support for chronic disease and have the potential to reduce such diseases, has been imposed.

The impact has been a 15-30% downturn in the industry at a time when it battles against more regulatory burden and higher costs. Foods, prescription medicines and some other over the counter pharmaceuticals have been exempted from the tax. The Complementary Healthcare Council (CHC) will continue to lobby for exemption of complementary healthcare products.

Contact: Val Johanson, Complementary Healthcare Council of Australia (CHC)
Tel: +61 2 6260 4022, Fax: +61 2 6260 4122,
Email: val.johanson@chc.org.au

Prepared by the
INTERNATIONAL ALLIANCE
OF DIETARY/FOOD SUPPLEMENT ASSOCIATIONS
IADSA SECRETARIAT
RUE DE L´ASSOCIATION 50
B-1000 BRUSSELS
Tel: +322-209 11 55, Fax: +322-223 30 64,
E-mail: cschneiders@eas.be, Website: www.iadsa.org