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LEF's Codex Comments As Submitted to FDA

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How the German Proposal at Codex would limit global access to herbs & botanicals

Copyright ©1996 The Law Loft Johnstown, CO

The Life Extension Foundation, a non-profit alternative health consumer organization, submits the following position paper in response to the United States Food and Drug Administration's invitation for public comment from interested Organizations in preparation for the finalization and presentation of the official position of the United States of America at the meeting of the Codex Alimentarius Committee on Nutrition and Foods for Special Dietary Use in Bonn, Germany 7-11 October of 1996.

This submission is directed specifically to agenda item number 8, "Sale of Potentially Harmful Herbs & Botanical Preparations as Foods" prepared by Canada, submitted to the Codex Co-ordinating Committee for North America and the Southwest Pacific now under referral to NFSDU and to such other agenda items to which remarks herein are applicable.

Agenda Item Number 3: Sale of Potentially Harmful Herbs and Botanical Preparations as Foods:

At the Third Session of the Codex Coordinating Committee for North America and the South-west Pacific in 1994, Canada submitted "Sale of Potentially Harmful Herbs and Botanical Preparations as Foods" (CX/NASWP 94/12.)

Within this document, Canada raised the following points:
  • that the bales of herbs and botanicals as foods has become an area of concern for regulatory authorities in a number of countries;
  • that because the drug regulatory systems of many countries are not adapted to handing herbal and botanical preparations because it is difficult to provide safety and efficacy data. herb and botanical preparations default to a food classification;
  • that because of the costs associated with generating safety/efficacy data and the lack of proprietorial rights (e.g. patent protection) for these products, manufacturers and distributors are inhibited from seeking drug classification for herbs and botanicals;
  • sales of "health foods" (including herbs and botanicals) have increased dramatically in a number of countries including Canada and the United States; and that although sale as "health foods" generally inhibits the use of therapeutic indications on labels for herb and botanicals, therapeutic indications are generally provided by "reference centers" located within the same retail establishment.


Finally, Canada has suggested that the creation of a "negative list" to protect consumers from herbs and botanicals that have either short term or long term toxicity should be given serious consideration. Canada points out in its closing remarks that "the availability of such an internationally recognized list would serve as a very useful reference and would, of course, have obvious implications under the SPS provisions of both the NAFTA and the GATT."

Is Canada's suggestion a good one? In order to evaluate the Canadian suggestion, we need to:
  • understand that Codex guidelines and standards are used by countries with vastly different populations, health care systems and regulatory framework and that Codex decisions have new import under the SPS provisions of NAFTA and GATT;
  • look at the needs and resources of different kinds of countries, not just industrialized ones but developing countries as well:
  • determine the role that herbs and botanical have played in a variety of cultures;
  • determine the availability of safe and effective pharmaceuticals; and
  • ask ourselves whether it would be feasible or advisable for all of the nations within the Codex community to restrict access to herbs and botanicals with therapeutic indications or uses.

I. Can the world's health systems deliver safe and effective pharmaceuticals in the absence of herbal and botanical remedies?

The World Health Assembly of 1994 (the 47th) concluded that less than 50 percent of the world's population has access to safe, essential drugs.(1) The developing world with 75 percent of the world's population gets only 21 percent of the world's pharmaceuticals. Even that 21 percent is poorly distributed. (2) Half of that 21 percent goes to only seven countries. Even within those seven developing countries, only about 50 percent of the drugs delivered contain the labeling essential for proper use. Delivery problems are further compounded by counterfeiting and of expired products or sale of products that fad! to conform to minimum manufactured standards. Although DAP, WHO's Action Programme on Essential Drugs, is hard at work on solutions this problem, real solutions are not going to be achieved in the foreseeable future. Clearly the present day delivery of standard, well manufactured pharmaceuticals to the developing world falls far short of need.

Even in the developed nations, the high price of medical care, including the high price of pharmaceuticals, is causing stresses and strains on nations' economies. Oftentimes, delivery to the poor and the elderly is especially inadequate. In the United States where delivery to the elderly is an acknowledged problem and where the elderly are the primary consumers of pharmaceuticals, the aging of the population will make delivery problems even worse in the near future.

Although the high price of pharmaceuticals is a multi factorial problem, the high cost of bringing a new drug product through development to market a significant cost factor. Current estimates of the cost of R & D through actual marketing range from $ 140 to $ 500 million per drug.(3)

II What role do herbs and botanicals play in the world's health care systems?

In 1985 the World Health Organization estimated that 80 percent of the world's population use herbal medicines in some aspect of primary health care.(4) Even in developed countries like the United States, there has been a shift toward herbs, botanicals and 'natural remedies.' Although available figures are inconclusive estimates based on surveys, these figures seem to indicate that about 60 percent of America's population now turns to alternative remedies on a regular basis.

Why is there such dependence on herbal and botanical remedies? In some countries, herbs and botanicals are part of a well established system of traditional medicine. In part, the contemporary emphasis on traditional medicine in developing and/or non-western countries has been part of a post-colonial reassertion of the inherent value and validity of traditional cultural patterns. In other countries, the use of traditional herbs and botanicals recognized as a necessary "fail-safe" against either shortages or outright unavailability of modern pharmaceuticals. In many parts of the developing world, traditional remedies are true and familiar while western pharmaceuticals are viewed as alien and suspect. (5)

As Canada has pointed out, even within the fully industrialized parts of North America, significant proportions of the population have turned to alternative remedies in an effort to take charge of their own health, promote better health and prevention and avoid the well publicized side effects associated with ingestion of pharmaceutical drugs. Apparently Europeans are taking a similar growing interest in herbs and botanicals. In 1992, the European Scientific Cooperative on Phytotherapy reported a growth rate in the sale of herbal medicines of from 5% to 22%. Similar developments have been noted in Japan as well.

If then, herbs and botanicals are here to stay at least for the foreseeable present, the questions become:
  • Should we leave herbs and botanicals as a separate track that is not included in national health care systems but remains available to the public?
  • Should we make an effort to expedite the flow of herbs and botanicals in international commerce by creating international guidelines for the harmonization of national standards on import and export of herbs and botanicals as foods?
  • Should we work toward the integration of herbs and botanicals as foods into national health care systems?
  • Or, should we work toward integration of herbs and botanicals as drugs into national health care systems?
  • How do we successfully integrate the good herbs and botanicals into national health care delivery systems given the fact that national systems vary greatly from country to country? Clearly, in the global economy a "successful integration" requires harmonization so that products can travel easily from system to system without encountering unnecessary and incompatible regulatory barriers
  • Which international entity or entities should take the lead in this process? DAP? ICH? ICDRA? Are all international entities created equal or does Codex have something unique to over? Given the fact that the WHO has been working on herb/botanical integration issues for years, should Codex leave the field of herbs and botanicals entirely to WHO and its subsidiary and related bodies?

III. WHO has taken the lead in the movement to integrate safe and effective herbal and botanical remedies into the world's national health systems.

With the promulgation of the Declaration of Alma Alta in 1978, the World Health Organization announced to the world at large its commitment to the idea that "proven traditional remedies should be integrated into national drug policies and regulatory measure." As stated in the prior section, the rationale for such a position is obvious: there is a critical short fall of pharmaceuticals that are safe and effective, many nation's health care systems are based in whole or in part whether formally or informally on traditional remedies, the interest in and use of traditional remedies is growing across the planet not shrinking.

In the years following the Declaration of Alma Alta, the WHO has struggled with the problems that 'integration' presents.

These problems include considering:
  • if herbal and botanical remedies are to be classified as drugs, does this mean that the requirements for drug approval have to be lowered or that a new drug category has to be created,
  • should traditional treatises be used as verification of safety and efficacy;
  • should all herbs and botanicals be prescreened using the same rigorous testing that applies to new drugs;
  • do standard new drug testing parameters 'work' for botanicals and herbs? Is the testing model appropriate;
  • should herbs and botanicals be transferred to drug companies who can afford to do sophisticated testing;
  • if herbs and botanicals are transferred to drug companies, how are costs to be contained?

Although WHO has run into serious conflicts, differences of opinion, and differences in approach to the problems posed by integration, virtually all proposals agree that herbs and botanicals should be treated as drugs. Most proposals favor subjecting herbal and botanical remedies to rigorous pharmacological testing that is identical to that required for new drugs. Most seem to presume that there is now and always must be a hard and fast line between foods and drugs.

Is the assumption that foods and drugs are now and should always been distinct and separate categories correct? Is it supported by modern science? Even a brief look at contemporary research indicates that the line between foods and drugs is blurring.

IV. Food or Drug? Is the line of demarcation between the two axiomatic, obvious and immutable?

Even the briefest look at contemporary research on the role of foods, even common, ordinary foods, in the prevention, amelioration, or cure of disease will show us that there is no longer a scientific justification for drawing a hard and fast line between foods and drugs.

Let's start out here by taking a look at the humble garlic clove. For many millennia, the folk medicine of a number of countries have "prescribed garlic" for its therapeutic effect in the prevention of heart disease and the treatment of infections. As recently as World War II, garlic was used successfully by British physicians to ward off septic poisoning and gangrene in battle wounds. (7)

Modern research conducted in accord with accepted scientific principles is confirming the age old belief that garlic can prevent heart disease and does, indeed, have powerful anti-infectious properties. It is hard to read today's newspaper without finding some new scientific reference that establishes or at least strongly suggestion that ordinary foods can have extraordinary applications as preventive or therapeutic agents in the battle against disease. Last week, Brazilian researchers at the European Conference on Cardiology meeting in Birmingham, England disclosed that the results of their study of the cardiovascular effects of red wine ingestion on rabbits showed a definite prophylactic effect against atherosclerotic plaquing with regular ingestion of red wine. (8)

Although we could fill this submission with endless or almost endless references to seemingly valid scientific research either establishing or suggesting the preventive, ameliorative, or curative effects found in ordinary foods, the essential point is obvious: this is not the time in the history of science to lock Codex, an entity that depends on good science into restrictive unscientific definitions of foods versus drugs. Such a course would defeat Codex's twin mandates to promote international trade and ensure the delivery of safe, good quality foods in international commerce by setting appropriate standards based on good science.

Apparently the Executive Committee of the Codex Alimentarius Commission is aware of the issue, that is, of the need to re-examine the 'interface between foods and medicines.' [CX/3 CL1996/20-NFSDU, June 1996]

Unfortunately, at present, Codex is in the process of nailing down the safety valves and ambiguities in its essential operative definitions in favor of unscientific and unworkable definitions of foods and drugs that would result in the classification of the more potent vitamins, minerals, herbs and botanicals as drugs. [The Committee may wish to take into account the botanical preparations sold as food in the Guidelines (on Dietary Supplements.)" CX/3 CL1996/20-NFSDU]

V. If the goal here is to expand access to safe and effective herbs and botanicals, does it follow that herbs and botanicals with preventive, ameliorative or therapeutic indications should be treated in the same manner as new pharmaceutical drugs?



If the goal is to expand access to safe herbs and botanicals on an international basis and to develop a rational approach to harmonization of regulations and guidelines, we need to take a look at the history of the use of herbs and botanicals before we a assume that in order to render them safe and assure that they are effective then we must submit them to the same form of testing that has been developed for new pharmaceutical drugs.

Perhaps we should start our inquiry by asking ourselves why, we all got talked into that expensive, prolonged drug paradigm in the first place. (The paradigm that nobody but a government or a drug company can afford.)

One of the primary reasons for testing a new drug is just because its new. We cannot know in advance whether a new drug:
  • will operate in the therapeutic manner intended because a new drug has no track record;
  • will have either obvious or non-obvious acute or subacute toxicity. Again, nobody knows for sure because its new.

The terms safety and efficacy are the nomenclature conventionally assigned to describe these issues.

Because of these two considerations safety and efficacy, we have made the societal judgment to allow drug companies to:
  • spend enormous amounts of money in drug testing;
  • reward themselves with exclusive patent rights and a monopoly over sales for 20 years from the date of first patent application; and
  • reward themselves with very high prices indeed so that they can "recoup" the costs of research, development, administrative applications and advertising.

When one starts to think about this issue afresh, one sees that either this reasoning does not apply in the case of herbs and botanicals or applies but in not quite the same way in the case of the average herb or botanical.

Thus reversing the coin, in the case of traditional herbs and botanicals which are not new and are often a millennium or more old:

we have a good idea at the very start how the substance will work by looking at the traditional texts. In the case of our earlier example, garlic, we can look at the almost 3,500 year old Eber papyrus that tell us that garlic is probably an immune function enhancer. Or, we can look at another 2000 year old text that tells us that garlic is probably effective as an antibiotic. Or, we can look at a 1,900 year old text from another part of the world that tells us that garlic has an effect on heart disease. Or, looking at the clinical records of our own century, we can look at evidence drawn from World War I and World War II clinicians that tells us again that garlic has antibiotic effects.

And the point of all of this? Not, that no testing should ever be done but rather than using modern modeling techniques, we can confirm therapeutic indications and efficacy for a substance like garlic without years of expensive testing. (In the case of garlic, we will see that some modern scientific testing has in fact been done.)

And, what about toxicity, acute and subacute? Certainly we are entitled to make some assumptions based on millennia of use per se. After all, one of our sources on garlic is an ancient Indian medical manuscript that is part of a medical system that not only considered the issue of toxicity, but specifically forbade the cross utilization of certain plant medicines because of their synergistic toxicity. It is not a really radical notion to assume that if there were serious toxicity associated with the use of garlic, the ancients would have noticed it and written about it.

Shouldn't we think seriously about abbreviating our premarket toxicity studies and combine approval with a compulsory system of international postmarketing surveillance? Certainly such an approach would help:
  • eliminate unnecessary costs of development;
  • keep products in the public domain when competition should help to keep the price down;
  • facilitate free trade in plant, herbal and botanical products.
Perhaps we can help ourselves consider the idea of a making a rebuttable presumption of safety and efficacy by comparing the present medical reliability of two 'remedies' one herbal and one a synthetic pharmaceutical used for the same condition.

the condition: benign prostate enlargement
the herbal treatment: saw palmetto (serenoa repens)
the drug treatment: proscar (finasteride)
the cost: saw palmetto - $ 12.00 per month proscar - $ 60.00 per month. (9)
efficacy: 60 - 90% with saw palmetto 37% to zero with proscar (10) (per the New England Journal of Medicine, August 22, 1996 which found proscar to be no more effective than a placebo)
side effects: saw palmetto - none to slight proscar 5% suffer from decreased libido, ejaculation disorders, impotence

Had we taken the traditional literature more seriously, many more patients would have been helped at lower cost with fewer side effects.

VI. There is some evidence, albeit theoretical, that conventional drug screening does not work in the case of herbs and botanicals There is even evidence not so theoretical that conventional premarket drug screening doesn't work very well period.

A recent WHO publication by a respected, pro-drug researcher 11 has strongly suggested that standard drug research models do not work well for botanicals and herbs taken from traditional therapies for the following reasons:
  • errors in nomenclature are common (Either the plant has more than one name or the name given the plant is applied to more than one plant);
  • if the plant extract studied isn't fresh, it's pharmacological activity may be gone before it's studied;
  • in some cases, more than one part of the same plant is part of the active ingredient(s);
  • in some cases, the medium for delivery of the traditional remedy is part of the active combination of ingredients;
  • the plant extract isn't prepared according to the classical formulation;
  • fractionating the sample is destroying its chemical/therapeutic activity.

In 1990, the Government Accounting Office (GAO) released FDA Drug Review, Postapproval Risks 1976-1985, Report to the Chairman, Subcommittee on Human Resources and Intergovernmental Relations, Committee on Government Operations, House of Representatives in which the GAO reviewed all 198 drugs approved from 1976 to 1985 and subsequently marketed for a substantial period. Of the 198 drugs reviewed, 102 were found to have sufficiently serious side effects to warrant either complete withdrawal from the marketplace or significant label changes so as to advise physicians and the public of new dangers associated with their use.

We can clearly conclude here that a fresh approach to the question of what kind of review and testing should precede the approval of herbs and botanicals either as medicines or as foods with preventive or therapeutic indications is warranted.

However, we have yet to consider the question whether any of WHO's many affiliated organizations and subdivisions should perform this task of whether it should be addressed by Codex.

VII. Although at present WHO virtually occupies the field of standard setting and harmonization of guidelines to integrate traditional remedies in the form of herbs and botanicals into nations' health care systems and international commerce, given the special relationship of the Codex to standard setting for international food trade, Codex is clearly the better body to perform this task.

As stated above, WHO has been at work on development of research guidelines and technical requirements for the registration of herbs and botanicals as drugs since 1978. This multifaceted project is now far advanced with work in progress in the following areas relating to herbs and drugs:
  • licensing of herbals as drugs with guiding principles for small nation regulatory authorities as part of the WHO Revised Drug Strategy;
  • continuing development of INN's, International Nonproprietary Names and preparation of monographs for the International Pharmacopeia;
  • the WHO Certification Scheme which creates quality control standards, anti-counterfeit provisions, and systems to assure compliance with certification requirements;
  • the WHO International Drug Monitoring Programme which includes international post marketing surveillance and the WHO Data Base on International Drug Monitoring;
  • DAP, the WHO Action Programme on Essential Drugs and the WHO Model List of Essential Drugs;
  • WHO Guidelines for the Assessment of Herbal Medicines;
  • WHO Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines; and
  • the non-WHO International Conference on Harmonization which brings together European, Japanese and American Drug Regulators and representatives of the pharmaceutical industry in order to harmonize drug standards.

Part of the problem with the established WHO approach is that it has now departed from its earlier seeming flexibility and has settled on the principle that herbs and botanicals must be subjected to the same standards for efficacy, quality and safety as synthetic pharmaceuticals. WHO has also determined that the same type of pre-marketing investigations must be performed on herbals and botanicals as are used on new synthetic drugs. What we see here is a progressive hardening of WHO's position as we move forward from document to document. Thus the promise of a more expeditious, inexpensive and benevolent regulatory scheme as partially described in the 1991 WHO Guidelines for the Assessment of Herbal Medicines published in Geneva, had hardened into more outmoded 'classical new drug kinds of thinking' by the time of the 6th ICDRA Conference in Ottawa that same year and showed still further hardening into new synthetic new drug model thinking by the time of publication of the 1993 WHO Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines.

Thus not only is WHO moving in a progressively more restrictive, expensive, and outmoded direction at odds with the new directions of foods as drugs research at a time when the world community desperately needs greater access to inexpensive herbs and botanicals as an adjunct to synthetic pharmaceutical products, but WHO is not now and never has been the appropriate forum for the setting of such standards and guidelines for international commerce in foods. This is because only Codex has the necessary nexus to the Sanitary/Phytosanitary Agreements of the GATT and NAFTA to make a firm and positive contribution to the international trading of safe, inexpensive herbs and botanicals as foods.

VIII. In order to understand the full effect of decisions taken at Codex Alimentarius or at WHO, it is absolutely necessary to understand the new interrelationships between WHO and The Agreement on Technical Barriers to Trade [GATT] and the relationships between Codex Alimentarius and the Agreement on the Application of Sanitary and Phytosanitary Measures [GATT] and the [Agreement on] Agriculture and Sanitary and Phytosanitary Measures [NAFTA].

If ever there was a time when the activities of WHO and Codex Alimentarius were of purely theoretical interest, that time is now past. With the ratification of the North American Free Trade Agreement and the ratification of the Results of the Uruguay Round of the General Agreement on Tariffs and Trade, we have entered into a new era when the direct and indirect ramifications of decisions (and even decisions to abdicate decision making authority) of either of these organizations have taken on a far reaching and profound significance under international and domestic laws around the globe.

One of the very first things that has to be grasped about these new relationships is that they have not set up a directly binding international low that acts or functions in the same way as or penalizes "misconduct" in the same way as national laws and nation based court systems.

Under the new system, many significant preliminary steps are taken by consensus. In the absence of consensus there is no forward movement.

However, other important steps are taken based upon principles of coercion. That is to say that if accommodation and conciliation fail, then arbitration (an informal form of litigation with looser rules of procedure and generally "relaxed" rules of evidence) occurs followed by formal decision, followed by the imposition of trade sanctions (or the withdrawing of trade privileges) which remain in place until they have coerced compliance with the arbitrators' decision or have compelled settlement of the dispute between the parties.

In a world where nation functioned based upon the principle of autarky (self -sufficiency and self-reliance in all essential things with no real economic dependence on trade with others), then the coercive effect of trade sanctions would be insufficient to compel compliance. That is to say, that as a practical matter, they would not have coercive force.

However, in a world in which nations move progressively toward complete or substantial economic integration, no nation can long afford to fail to comply with the decision of an arbitration panel. As a matter of simple economics, it simply cannot afford not to comply.

It is the later situation that we face with GATT and NAFTA. Thus we must understand that entities like WHO and Codex Whose rule making activities are integrated within GATT and NAFTA have profound effects. Although the office of the American Trade Representative has feigned not to understand these realities, WHO has directly acknowledged the importance of these new relationships:
"The new trade agreements issuing from the Uruguay Round of multilateral negotiations are intended to further liberalize international trade and provide greater access of all parties to markets...
The recommendations and guidelines established by the Joint FA/WHO Codex Alimentarius Commission are specifically cited in the Agreement on the Application of Sanitary and Phytosanitary Measures as the reference for national food safety regulations. With world food trade amounting to some $ 250 billion a year, there are strong economic reasons for countries to ensure that their food exports meet these norms."

THE WORLD HEALTH REPORT 1996
[The Report of the Director General of WHO]

In general and somewhat simplified terms these interrelationships between WHO and Codex and NAFTA and GATT can be explained as follows:

WHO and the Agreement on Technical Barriers to Trade:

As part of the GATT agreement, nations signed an agreement called the "Agreement on Technical Barriers to Trade," (TBT). The TBT is nothing less than a call for the harmonization of laws, regulations and rules that govern human health and safety (among other things) on a global basis. The idea was and is that national laws (including laws of states and localities) would be remade in the images set for them not by elected representatives in legislative bodies, but by delegates drawn from subject matter bureaucracies representing their respective countries meeting with international bureaucrats and representatives of private industry, all of whom working together would craft the new regulations and rules which would then be adopted by each country that had signed on to the TBT.

While the WHO is not mentioned by name anywhere in the TBT, the references within the TBT to 'standardizing body' and 'international body or system' which is defined within the TBT as 'body or system whose membership is open to the relevant bodies of at least all Members' is commonly understood to include WHO, and WHO has described itself as being within the parameters of these definitions:
"For instance, WHO's quality standards for pharmaceutical, biological and food products are the kind of internationally agreed standard that the Agreement on Technical Barriers to Trade encourages governments to adopt as a basis for national regulations."

THE WORLD HEALTH REPORT 1996

Apparently WHO has had some success in getting regional common markets to adopt its standards as the standards of the market group:

"The South American countries belonging to the Mercosur common market, for example, adopted WHO's requirements for good manufacturing practices for pharmaceutical products in order to harmonize regulations within their trade group, and a number OECO countries decided to eliminate customs duties on pharmaceutical ingredients bearing a WHO international nonproprietary (generic) name."

THE WORLD HEALTH REPORT 1996

It is to be emphasized here that while the final meanings of many key features of the TBT have yet to be fleshed out, the coercive/enforceable nature of TBT commitments was specifically referenced in the Message from the President of the United States transmitting the Uruguay Round Trade Agreements, 103 Congress, House Document 103-316, Volume I:
"Second [drawing distinctions to the earlier 1979 Agreement on Technical Barriers to Trade] will be enforceable through the provisions of the WTO Dispute Settlement Understanding. [The agreement that created the adjudicative body, the DSB of the WTO] (emphasis added)"

at page 777
While the importance of the Agreement on Technical Barriers to Trade can hardly be overstated, it is important to note before moving on that it does not apply to sanitary and phytosanitary issues,

Sanitary and Phytosanitary issues are covered by the Agreement on Sanitary and Phytosanitary Measures, one of two agreements within which Codex Alimentarius takes on a new role.

As quoted from The World Health Report above, Codex Alimentarius is the reference for national food safety regulations under the Sanitary and Phytosanitary Agreement of the GATT [SPS]. Like the TBT, the SPS is an agreement whose terms are enforceable at the WTO's Dispute Settlement Body, an adjudicative body with coercive enforcement powers via the mechanism of trade sanctions.

Some of the principal effects that arise from this relationship are:
  • Nations that set their food safety standards in conformity with Codex standards are presumed to be in compliance with the SPS agreement;
  • Nations that set higher standards that Codex standards must take into account the risk assessment techniques established by Codex on food safety; and
  • Nations which set higher standards for food safety than those set forth by Codex run the risk that the DSB will determine that the standards set exceeded that nation's "appropriate level of protection" and face the concomitant risk of imposition of trade sanctions.

According to the interpretive notes contained in the President's transmittal to the Congress (House Document 103316), the TBT relies primarily on a test of whether a measure discriminates against imported products while by contrast, the S&P agreement focuses on whether a measure is based on scientific principles and on a risk assessment.' [at page 120]

In addition to those portions of the GATT discussed above, in order to more fully understand Codex new role, we need to look at the NAFTA as well. Some of the key features of NAFTA's Sanitary and Phytosanitary [Agreement] are:
  • Codex is a specified reference international standard setting organization, however, it is not necessarily the only one due to the presence of an escape clause which says: "[standard. guideline or recommendation] established by or developed under any other international organization agreed on by the Parties" Thus it does not necessarily follow that Codex will occupy the field of international standard setting organization alone. In addition, the agreement references North American standardizing organizations without providing an all encompassing definition of what organizations are meant. [At least not within the text of the SPS agreement, See paragraph 5.] Thus while the NAFTA agreement is like the GATT in making Codex a reference standard setting international organization, it is unlike the GATT in that it does not necessarily follow that Codex will be or remain the only standard setting organization for food safety.
  • Codex sets standards for food safety, including additives, contaminants, hygienic practice and methods of analysis and sampling. Unlike GATT, there is no direct reference to setting standards for food labeling as it relates to safety although this may be implicit in the NAFTA SPS.
  • Like GATT's SPS, nations whose food safety standards are identica1 to Codex standards are presumed to be in compliance with their obligations under NAFTA's SPS.
  • Like GATT's SPS, NAFTA's SPS is enforceable under procedures created by the Free Trade Commission.
  • Like GATT, NAFTA's SPS requires that risk assessments take into account relevant risk assessment technologies developed by Codex.
Thus if Codex chooses to preserve its jurisdiction over herbs and botanicals and to create labeling standards that permit preventive or therapeutic claims and to create standard for quality control and select those herbs and botanicals (and foods in general) that may carry preventive or therapeutic indications or be specifically manufactured to enhance therapeutic values, then Codex standards for medicinal foods will have significant international legal effects.

If, however, Codex decides to abdicate the field leaving it entirely to WHO, then we can expect that WHO's standards will sooner or later take on significant international legal effects under the TBT or as part of WHO's general convention making powers or simply as a part of the current wave of harmonization of laws throughout the world.

IX. What can we expect down the road if Codex abdicates its responsibility for herbs and botanicals simply because some are therapeutic or preventive?

Given the totality of international trends' it can be assumed:
  • herbs and botanicals will become less available and much more expensive;
  • herbs and botanicals will gradually disappear out of the public domain and become proprietary products (whether under patent protection or otherwise) of large pharmaceutical companies and a few European (principally German) natural remedies companies:
  • health care and nutrition options around the world will be deprived of a significant proportion of this valuable resource; and
  • sooner of later, the FDA's new regulatory scheme for vitamins, minerals, herbs and botanicals will be under a significant and probably overwhelming attack (While it cannot be said that either GATT or NAFTA per se will compel this result (because neither GATT nor NAFTA compels replacement of standards that are lower than relevant international standards), the overwhelming pattern of recent health and food safety related legislation is that it is patterning itself of emerging international and regional standards. We need to recall here too that the WHO Constitution, Articles 19 and 20, gives the WHO a kind of treaty making power and gives each member 18 months within which to adopt the new 'convention or agreement.' Remember also that other non-UN harmonizing organizations that are relevant to these issues exist like the International Conference on Harmonization.)

X. Some suggestions on what to do now:

  1. Resist all efforts to truncate Codex jurisdictional base down to low potency vitamins, minerals, herbs and botanicals and/or to restrict labeling for foods to purely non-therapeutic, non preventive, non-ameliorative claims.
  2. Defeat the German proposal on dietary supplements.
  3. Defeat the Canadian proposal on herbs and botanicals.
  4. Start work in the Codex labeling committee, at a time when the USA has the chair, on a positive list of structure/function claims for a new foodstuffs with indisputable pedigree and good scientific research behind them. Do not lock yourselves into a negative list or a self limiting positive list.
  5. Start work in the Codex labeling committee, at a time when the USA has the chair, on creation of a new classification of labeling claim that covers preventive and/or medicinal claims for foods for general dietary use.
  6. Develop support among developing nations and the British for a gradual growth of positive structure/function claims
  7. Redesign America's position on who qualifies for non-voting delegate status at Codex so as to include genuine representatives of grassroots organizations and persons knowledgeable in the interstices of the law/political/international regulations issues along with the customary representatives of the larger companies and industry.
  8. Be alert to all legislation in the American Congress that would lock us into approval of standards derived from the International Conference on Harmonization and WHO entities that would harden the line between foods and drugs and/or set up expensive scientifically unwarranted restrictions on food trade.
  9. Resist all efforts, whether overt or disguised, to make unnecessary subject matter transfers to drug companies from the public domain of preventive or therapeutically useful foods that already have a reasonable backing of traditional literature and/or scientific studies performed using good science.
  10. Resist setting NRVs or RDAs at fixed levels that are premature, especially in cases where these standards can automatically become binding upper level limits on generally available dietary supplements or herbal or botanical preparations.
  11. Consider an interface with the Office of Alternative Medicine that would support the completion and issuance of good scientific research in support of preventive or medicinal foods. [Check the records of the Department of Agriculture for databases that would support the creation of a preventive or medicinal foods category.]
  12. Be alert to all opportunities to assume a leadership role in these areas either alone or in conjunction with other nations that have a vital stake in the preservation of inexpensive, safe, generally available medicinal foods.
  13. Develop and maintain a database that tracks and monitors the creation of other standard setting entities (e.g., a standard setting entity for foods within the NAFTA context) in the food area.
  14. Monitor all efforts to expand the number of 'reference setting entities' by agreement of the parties such as is provided for in the NAFTA framework.
  15. Never forget that while national efforts to create preferential and unfair trade barriers are subject to attack in international adjudicative bodies, those same efforts conducted within the context of international standards, guidelines and recommendation are probably not subject attack as unfair trade barriers. Expect that from here on out, many seemingly neutral, innocuous, or purely scientific proposals may have an intentional preferential trade barrier built into the proposal.

Submitted by, SUZANNE HARRIS, J.D., on behalf of the Life Extension Foundation Pertinent addresses: The Political Office of the Life Extension Foundation 2411 Monroe Street, # 2 Hollywood, Florida 33020



Life Extension Foundation 995 S.W. 24th Street Fort Lauderdale,Florida 33315

Suzanne Harris c/o The Law Loft P O. Box 709 Johnstown, Colorado 80534

Footnotes:

(1) EDM-17 DISCUSSIONS AT 47TH WORLD HEALTH ASSEMBLY (1994) http//www.who.ch/programmes/dap/dm17b.html

(2) Drug Labeling in Developing Countries, USOTA (1993)

(3) WALL STREET JOURNAL, Nov 9, 1993, "Vital statistics: disputed cost of creating a drug

(4) Farnsworth, N.R., et al, "Medicinal plants in therapy," BULL. WORLD HEALTH ORGAN., 63(6) 985-981 (1985)

(5) Chaudhury, Ragit Roy, (1992 Herbal Medicine for Human Health, WHO, (SEARO, No.2O)

(6) While it can certainly be argued that there is evidence that WHO showed signs of commitment to integration of herbal remedies prior to the declaration of Alma Alta, WHO's activities in 1978 and the Alma Alta Declaration are commonly perceived to be crucial commitment making events.

(7) See Chapter 1, "Herbal Medicine" of Alternative Medicine (1992), NIH (USA), 183. Even popular literature shows some well documented insight into this issue. See for example, Carper, Jean, 1888,. The Food Pharmacy, 199.

(8) REUTERS, August 26, 1996, "More evidence of benefits of Red Wine"

(9) LIFE EXTENSION UPDATE, Vol. 7, No.l2, 12/94

(10) On saw palmetto, see: Braeckman, "The extract of serenoa repens in the treatment of benign prostatic hyperplasia" 55/7 CURR. THER. CLIN. EXP.(USA), 776-785, (1994), Bruhwryler, l9/5 DRUG FUTR (Spain), 452-453 , (1994). On proscar see Lepor, "The efficacy of.. finasteride., 335/8 NEW ENGLAND JOURNAL OF MEDICINE, (1996)

(11) Chaudhury, op. cit.

LEF/USFDA/NFSDU

Copyright ©1996 The Law Loft Johnstown, CO



(Information provided by John C. Hammell, legislative advocate,
Life Extension Foundation Political Office, 2411 Monroe St. #2,
Hollywood, FL 33020 USA, john@lef.org, 800-222-2553
954-929-2905, 954-929-0507 FAX, http://www.lef.org)