The Life Extension Foundation and The National Health Federation Reply to Commission on Dietary Supplement Labels Draft Report to the President, the Congress and the Secretary of Human Services



by Suzanne Harris, JD, The Law Loft
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The Law Loft submits the following comments on behalf of the National Health Federation and the Life Extension Foundation in reply to the draft report of the Commission on Dietary Supplement Labels:



IS IT REALLY A GOOD IDEA TO TREAT BOTANICALS AS O-T-C DRUGS?

In its draft report, the Commission on Dietary Supplement Labels appears to have abandoned its statutory mandate to examine label claims et al for dietary supplements within the food classification. Instead the Commission has recommended a comprehensive evaluation of botanicals in other nations, that botanicals by reclassified from foods to OTC drugs in many (perhaps most) cases, that the FDA should make establishment of an O-T-C review panel for botanicals a priority, and that it may be desirable to consider some statutory changes in the way that O-T-C drugs are reviewed so as to accommodate traditional claims without necessarily imposing the same burden of proof required of pharmaceutical O-T-C products. In other words, the Commission recommends even if somewhat tentatively that botanicals (or many of them) should be treated as O-T-C drugs but leaves open the question of whether or not some relaxation of standards is necessary or desirable in the case of botanicals that have a history of use as traditional remedies.

While the Commission discusses the regulatory systems in effect in a number of other countries and mentions in passing the World Health Organization's emerging monograph system on botanicals, the Commission does not fully develop or explore the development of botanical regulatory schemes at the international level nor does it discuss or explore how international and regional developments have affected and will effect the treatment of botanical legal and regulatory issues.

Without such a discussion any treatment of the issue of botanical regulation is incomplete and runs the risk of becoming a premise for further study that lacks key parameters that are necessary for a realistic study project.

THE INTERNATIONAL BACKGROUND: HOW W.H.O. THROUGH A STEP BY STEP PROCESS IS CREATING AN INTERNATIONAL REGULATORY SCHEME FOR BOTANICALS

Starting in 1976, the World Health Organization began to focus attention on botanicals when it acknowledged the potential value of traditional remedies to health care delivery. (WHA 29.72) By 1977, that new look included the convening of a consultation on the promotion and development of traditional medicine. The 1977 consultation made a series of recommendations that became the foundation for years of work at WHO in this field. These recommendations were:

By 1978 at the now famous International Conference on Primary Health Care held at Alma Ata in the Soviet Union, the WHO conferees recommended:

Several years later in 1986, a new WHO sponsored body, the International Conference of Drug Regulating Authorities took up the issue of traditional medicine at its 4th conference held in Tokyo, Japan. At ICDRA 4th, the conferees who included not only drug regulators from around the world but pharmaceutical company representatives as well concluded:

By 1988, the issues of ecology and plant conservation has entered the picture as the Declaration of Chaing Mai, the outcome of the International Consultation on the Conservation of Medicinal Plants held at Chaing Mai, Thailand recommended that international organizations take action for the conservation of medicinal plants. [By 1993 that idea had hardened into the notion that model legislation should be developed that would strictly license and control who could grow and harvest medicinal plants in the name of conservation.]

By 1990, the notions of technology transfer and patent protection had entered the picture too. In essence the new idea on the block was that ancient and traditional botanical formulas should be given up by the indigenous peoples who held them in the public domain and that in the name of safety and efficacy assurance, valuable formulations should be transferred to foreign pharmaceutical companies and other private interests with full protection for the intellectual property rights of these new stakeholders.

In 1991 the 6th ICDRA again tackled the issue of how to handle traditional medicines and WHO's Programme on Traditional Medicines published its Guidelines for the Assessment of Herbal Medicines. Although these two publications diverge somewhat in their recommendations, taken together they say:

By 1993 some considerably more restrictive guidelines were also released by WHO which recommended expensive full blown drug trials for traditional remedies in order to determine safety and efficacy. (Note, it is unclear here whether or not this more rigorous approval system was to be used across the board for O-T-C class traditional remedies or just for prescription botanicals.)

By 1997 WHO in its annual The World Health Report was advocating a strict protocol for essential drug regulation (which might well include traditional remedies, see ICDRA 4th, above) that included:

Taking these developments as a whole and summarizing them we find a combination of what appear to be solidly defined areas and gray areas. In summary we can say:

While it is interesting to note that the current draft of the Commission's report focuses precisely on the gray area left in the international plan, we can legitimately ask ourselves: Are international organizations really leading the way and defining the parameters of legal and regulatory issues or is the notion that WHO or any other international body will set the standards to be followed by national regulators just a pipe dream of no real relevancy to what any specific nation decides?

DO SOVEREIGN NATIONS STILL DECIDE FOR THEMSELVES HOW TO REGULATE BOTANICALS OR DO INTERNATIONAL ENFORCEMENT MECHANISMS NOW FORCE HARMONIZATION?

Only a few years ago, observers of the national and international scene would have probably answered that sovereign nations make these decisions for themselves and it is entirely ridiculous to suppose that international organizations or any other supranational force can force a nation to take a particular direction in the regulation of botanicals or on any other regulatory topic.

While it is perhaps almost still true that in most instances conformity cannot be enforced, it is clearly true that the power and impact of international and regional directives have gained in authority and influence at the expense of national regulating authorities. Since these developments are recent and profound in their effect, we must look at them in order to assess the direction that any legislative or regulatory body should take. And, we need to take a look at conformity and harmonization trends and see how they are likely to progress in the future.

THE GATT SHIFT

With the ratification of the results of the Uruguay Round of the General Agreement on Tariffs and Trade, new international adjudicative tools have taken shape that have a profound regulatory impact.

CREATION OF THE WTO AND THE DSB MECHANISM

With ratification of the results of the Uruguay Round, the Dispute Settlement Body of the World Trade Organization came into effect as an international adjudicative body. Nations which effect health and safety measures that are found not to be in conformity with international standards set by international standards setting bodies can be sanctioned at the international level. For example, nowadays any nation sets a food standard that is higher than a Codex reference standard at its peril. Any nation that sets a higher standard than a Codex food safety standard bears the burden of proof in an international adjudication that its standard:

So far, these international adjudicative measures probably do not bear as heavily in the area of drugs as opposed to foods because:

Nevertheless, an emerging pattern of harmonization for both food and drug law is clearly present. This is so because both the TBT and the general trend of expanding global trading relationships favor recognition of equivalency and harmonization of laws and regulations.

For example, the TBT, Technical Barriers to Trade Agreement recognizes not only in its preamble but in key articles that international harmonization to internationally achieved standards is the goal:

Recognizing the important contribution that international standards and conformity assessment systems can make...

Desiring therefore to encourage the development of such international standards and conformity assessment systems;

Recognizing the contribution which international standardization can make to the transfer of technology from developed to developing countries;

2.4 Where technical regulations are required and relevant international standards exist or their completion is imminent, Members shall use them, or the relevant part of them, as a basis for their technical regulations...

The TBT agreement also recognizes that the direct adoption of international standards may not always be the best way to achieve harmonization. So, in paragraphs 6.1 and 6.3, TBT encourages drug regulating authorities (along with other regulating authorities) to recognize the equivalence of other nation's conformity assessment procedures.

6.1 Without prejudice to the provisions of Article 6, paragraphs 3 and 4, Members shall ensure, whenever possible that the results of conformity assessment procedures in other Members are accepted even when those procedures differ from their own provided they are satisfied that those procedures offer an assurance of conformity with applicable technical regulations or standards equivalent to their own procedures.

6.3 Members are encouraged, at the request of other Members, to be willing to enter into negotiations for the conclusion of agreements for the mutual recognition of results of each other's conformity assessment procedure. Members may require that such agreements fulfill the criteria of Article 6 paragraph 1 and give mutual satisfaction regarding their potential for facilitating trade in the products concerned.

In fact the United States has taken an active role in recognition of the equivalence of other nation's drug regulations. At the Denver Group of 8 Conference in June, the United States announced the signing of a MRA, Mutual Recognition Agreement with the European Union that contains a sectoral annex on Pharmaceutical Good Manufacturing Practices. This annex sets up a phase-in protocol for use of other foreign drug regulatory inspectors to assure conformity with US standards for good manufacturing practices for drugs and vice versa and openly states that the end goal is harmonization and merger of EU and US standards for good manufacturing practices for pharmaceuticals.

It is quite clear here that ultimately across the board international harmonization of both food and drug standards is what is being sought.

We need look no further than the currently pending FDA Modernization and Accountability Act of 1997 (S.830) to see that this is true:

(1) the Secretary of Health and Human Services, in consultation with the Secretary of Commerce should move toward the acceptance of mutual recognition agreements relating to the regulation of drugs, biological products, devices, foods, food additives, and color additives, and the regulation of good manufacturing practices, reached between the European Union and the United States.

(2) The Secretary of Health and Human Services should regularly participate in meetings with representatives of other foreign governments to discuss and reach agreement on methods and approaches to harmonize regulatory requirements and

(3) the Office of International Relations of the Department of Health and Human Services should have the responsibility of ensuring that the process of harmonizing international requirements is continuous.

It is clear that nothing less than a shift in emphasis in the work of the FDA is contemplated here. Whereas hithertofore it could be argued that FDA's primary emphasis was on safety and efficacy of products manufactured or sold in the United States, nowadays the emphasis has shifted to increasing market access and market share for American products by facilitating the flow of products by eliminating conflicts in regulations wherever possible.

Can we stop our analysis here? No, we must look further down the road in order to appreciate that international standards will come into play more and more as the US carries out its stated objective of market expansion through expansion of regional trading blocks.

HOW EXPANSION OF REGIONAL TRADING BLOCS WILL FOSTER THE ACCEPTANCE OF INTERNATIONAL STANDARDS:

During the period 1990-1994, more new regional trading blocs were notified to the GATT under Article 24 than at any other time in its history. While from 1947 to the present it can be stated that some trading blocs fizzled while others flourished, there is now a definite trend toward increasing and increasingly successful regional integration.

In our own region- North America, consultations aimed at the development of NAFTA, the North American Free Trade Agreement began in the spring of 1990 and concluded with entry into force of the agreement on January 1, 1994. The NAFTA agreement itself contained both a TBT, Technical Barriers to Trade, and SPS, Sanitary Phytosanitary Agreement.

Like the TBT in GATT, the TBT in NAFTA recognized explicitly the importance of using international standards as the basis for domestic regulations:

1. Each party shall use, as a basis for its standards related measures, relevant international standards or international standards whose completion is imminent....

2. Without reducing the level of safety or of protection of human, animal, or plant life or health, the environment or consumers, without prejudice to the rights of any Party under this Chapter, and taking into account international standardization activities, the Parties shall, to the greatest extent practicable, make compatible their respective standards-related measures, so as to facilitate trade in a good or service between the Parties.

While it must be freely admitted that the above language contains a number of escape clauses, escape will be much harder than that language would suggest due to several less well known characteristics of the regionalization process now in progress.

REGIONALIZATION IS INTENDED TO BECOME MUCH MORE EXTENSIVE THAN IS GENERALLY REALIZED:

NAFTA in Chapter One, Objectives, states quite clearly that his regional bloc consisting of Canada, the United States and Mexico is intended to expand further:

Article 102 Objectives

1. The objective(s) of this Agreement,... are to:

(f ) establish a framework for further trilateral, regional and multi cultural cooperation to expand and enhance the benefits of this Agreement.

In fact just two weeks after the launch of NAFTA negotiations on June of 1990, the Enterprise of the Americas Initiative created the structure through which the United States established framework agreements with most of the countries in the region. In November of 1994, a Free Trade Agreement for the Americas (FTAA) to be established by 2005 was agreed.

Although it is still uncertain whether expansion will be accomplished through full regional integration or a hub and spoke arrangement between member countries and other trading blocs, it is quite clear that the process of regional integration of the Americas is moving forward. Within the last two months, Canada has concluded a new trade agreement with Chile (which is an intended ultimate NAFTA member) and the United States Caribbean Partnership Act which offers members of CAFICOM, the customs union of the Caribbean, tariff and quota treatment equivalent to NAFTA (with certain exceptions) pending their eventual accession to NAFTA.

As America expands the scope of its regional integration agreements, it will discover that in a number of key instances, the WHO and WHO's internationally achieved pharmaceutical standards have gotten there ahead of the USA and the FDA. For example, MERCOSUR, the common market of Argentina, Brazil, Paraguay and Uruguay has already adopted the WHO's requirements for good manufacturing practices for pharmaceutical products as the basis for its internal harmonization of pharmaceutical regulations.

Is America trapped then by its existing commitment to harmonization into a WHO derived model that would treat botanicals as drugs? In order to answer that question, we need take a look at the impact of drug status on botanicals and then examine the alternatives.

WHAT DRUG STATUS WOULD DO TO BOTANICALS

In the FDA's regulatory scheme, drugs are:

"articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man...";

Food, Drug, and Cosmetic Act, § 201 (g)(1)(B) [21 SC § 321(g)(1)(B).

Within the drug class per se, drugs are divided up by mode of access into two classes; prescription only drugs and over-the-counter drugs. Prescription only drugs are those that:

Over-the-Counter drugs are:

In general, prescription drugs are used for serious medical conditions, may well have side effects that require monitoring by a physician, and can be available in high potencies or dosages. By contrast, O-T-C drugs are used for minor medical conditions, have little or no side effects or transitory side effects, and are generally available in lower dosages or potencies unless the product is harmless at higher dosage levels.

With the distinctions between the indications, dosage levels, and side effects for the two classes of drugs come significant differences in the approval process. New prescription drugs go through elaborate and expensive pre-approval processes including toxicity studies and clinical trials. O-T-C drugs are generally approved under a monograph system and occasionally approved under the more expensive new drug application system.

By contrast, foods are subjected to much less burdensome regulations with primary emphasis on hygiene, good manufacturing practices, adulteration, and the nature of additives present.

In DSHEA, botanicals are described as foods within the dietary supplement class of foods:

a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following ingredients

(A) a vitamin;
(B) a mineral;
(C) an herb or other botanical

This classification has pluses and minuses from the point of view of both the public and the manufacturer. The pluses are wide product availability and a wide range of available products at low cost. The main minus is that usage claims which would provide descriptive information on the preventive information on the preventive and therapeutic uses of botanicals are largely absent or couched in very veiled terms in an effort to fit within the parameters of DSHEA's structure/function claims rules.

Under the DSHEA system newer botanicals may be classified as drugs/and or as both drugs and dietary supplements by the Secretary.

WHY WOULD ANYBODY WANT TO CHANGE THIS SYSTEM?

In general consumers do not want to see botanicals reclassified as drugs. General accessibility of information on uses and indications for herbal products apart from package labels is not only feasible but practical. Consumer usage under these terms is growing at a rapid rate.

Manufacturers, on the other hand, understand that there is a direct correlation between sale of a specific product and the ability to make precise preventive and therapeutic claims on the label. (Many seem to have appreciated this fact without fully understanding the significant cost or other burdens associated with the transfer to drug status.)

However there is a significant class of botanical manufacturers who would clearly benefit from reclassification of botanicals from food to drug. They are the European botanical manufacturers and their subsidiaries and joint venturers in the United States. A look at the German regulatory scheme provides the clearest example here.

In 1976, Germany passed a new drug law called the Drug Law of 1976. Under this scheme phytotherapeutic medicines were recognized as a separate class of medicines. An expert panel was appointed in Germany from within the ranks of that class. Monographs were prepared on each botanical with manufacturers pooling resources to prepare the monographs which included labeling for indications. The 1976 law required that all botanicals existing on the market be approved under the new law by 1990.

Once the dust settled as to which botanicals would be reapproved and which would not, an international bidding war among transnational pharmaceutical companies broke out as to who would buy out which of the surviving companies. A majority of those companies are either owned by transnational pharmaceutical companies or engaged in joint venture arrangements with them or with American dietary supplement companies. The presumptions fueling this international bidding frenzy were:

So we need to ask ourselves do we really want to re-write America's laws on botanicals so that the Europeans can take over our domestic markets and is there a viable alternative approach? The answers are no to the first question and yes to the second.

America's regulatory framework can be fine tuned within the food class so as to promote the competitive advantage and market potential of American products overseas. We can create a framework that will require others to harmonize with us and not vice versa.

Perhaps the first and most important thing for you to recognize here is the fact that the consumer preference for specialized foods including health foods, botanicals and other dietary supplements is a growing phenomenon on a world wide basis. It is estimated that a $250 billion dollar market exists now for these and other functional foods in the US alone. The EU represents another $250 billion dollar market for these products. Japan represents another $4 billion dollar market.

The second thing that needs to be recognized here is that existing already agreed to mechanisms to promote international food trade can benefit the growth of the market for these products overseas. This is how it works:

Along with the ratification of the NAFTA and Uruguay round results of the GATT, American and other nations signed the Sanitary Phytosanitary Measures Agreement which created the new important mechanisms to promote food trade. These were the Committee on Sanitary Phytosanitary Measures within the World Trade Organization and the establishment of the pre-existing Codex Alimentarius Committee as the body that sets international reference standards for safety in international food trade.

Under the terms of the Sanitary Phytosanitary Agreement, any nation that adopts a Codex reference standard, guideline or recommendation for food safety is presumed not to have erected an unfair trade barrier. Conversely, any nation that erects a higher food safety standard than that prescribed by the Codex runs the risk of having that standard found to be an unfair trade barrier by the WTO. That this new system has teeth and claws was recently discovered by the EU when the WTO decided in a preliminary decision that EU legislative barriers to beef containing certain beef hormones were an unfair trade barrier, not in conformity with the Codex standard, not sufficiently justified by science and did not constitute a consistent risk management decision when compared to other EU standards.

Even in the absence of a specific Codex standard on a food safety issue, the WTO's DSB will still make a determination of the appropriateness of a food safety standard under the Sanitary Phytosanitary Agreement. Herein lies a key to promotion of American food classification for botanicals. The real key is in the operative definitions.

Food is Defined by Codex as:

"Any substance, whether processed, semi-processed or raw, which is intended for human consumption, and includes drink, chewing gum, and any other substance which has been used in the manufacture, preparation, or treatment of 'food' but does not include cosmetics or tobacco or substances used only as drugs." [emphasis added]

Foods for Special Dietary Uses a subclass of food is defined as:

"Those foods which are specially processed or formulated to satisfy particular dietary requirements which exist because of a particular physical or physiological condition and/or specific diseases or disorders which are presented as such. The composition of these food stuffs must differ significantly from the composition of ordinary foods of comparable nature if such foods exist."

It is clear that herbs including botanicals fall within the general food classification and they are in fact along with other dietary supplements traded in the international market as foods. A recent German sponsored effort to limit the combinations of potencies and combination of vitamins and minerals at the Codex level was downgraded from step 5 to step 3 at the recent meeting of the Codex Alimentarius Commission in June in Geneva, Switzerland. Similarly, a Canadian sponsored proposal to create a negative no-trade list for botanicals was eliminated from the Codex work agenda entirely.

Thus for the present, botanicals stand an excellent chance of surviving in international trade as foods as to vitamins and minerals. But what about labeling requirements?

In general the Codex system frowns on food claims that state that a particular food is of use in the prevention, alleviation or treatment of a disease, disorder, or particular physiological condition. However, the Codex rules on labeling of foods contain a significant escape clause:

PROHIBITED CLAIMS

3. The following claims should be prohibited:

3.1. Claims stating that any given food will provide an adequate source of all essential nutrients, except in the case of well defined products for which a Codex standard regulates and claims as admissible claims or where appropriate authorities have accepted the product to be an adequate source of all essential nutrients.

3.3 Claims implying that a balanced diet of ordinary foods cannot supply adequate amounts of all nutrients.

3.4 Claims as to the suitability of food for use in the prevention, alleviation, treatment or cure of a disease, disorder, or particular physiological condition unless they are:

(a) in accordance with the provisions of Codex standards or guidelines for foods under the jurisdiction of the Committee on Foods for Special Dietary Uses and follow the principles set forth in these guidelines; or,

(b) in the absence of an applicable Codex standard or guideline, permitted under the laws of the country in which the food is distributed. [emphasis added.].

Thus in the absence of an international labeling standard, Codex presumes that labeling issues revert to the laws of the importing nation. However, here again there is a significant catch and that is that Codex labeling standards as distinguished from other Codex standards do not have international reference standard status under the Sanitary and Phytosanitary Agreement

Annex A to the Sanitary Phytosanitary Agreement defines a sanitary or phytosanitary measure as:

Any measure applied:

-to protect human life or health within the territory of the Member from risks arising from additives, contaminants, toxins, or disease causing organisms in food...

And within the same annex, those areas in which the Codex can create international reference standards, guidelines and recommendations are limited to:

food safety, the standards, guidelines and recommendations established by the Codex Alimentarius Commission relating to food additives, veterinary drugs and pesticide residues, contaminants, codex of hygienic practice.

Thus it is generally believed within the Codex itself and by the Committee on Sanitary and Phytosanitary Measures that Codex guidelines on labeling to not have international reference status. This means that any enforcement action against a domestic food labeling law cannot (except in rare cases) be based on a Codex food labeling standard. Put another way, America is free to expand the scope of structure/function and wellness labeling for botanicals and dietary supplements as foods without running afoul of international agreements.

CAN WE GET OTHERS TO HARMONIZE TO US?

Interestingly, a recent review commissioned by the Canadian government concluded that the present American regulatory framework was much more conducive to the development of functional foods, including dietary supplements than Canada's and recommended that Canada's regulatory structure be better aligned with ours (harmonized to ours) and that in the interests of commercial growth and exploitation, that America should expand the permitted scope of wellness claims for foods.

As to other nations which may be less inclined to let dietary supplements including botanicals into their jurisdictions with food claims, we can act against them at the WTO premising our position on the argument that our botanicals and other dietary supplements are food and that their regulations are disguised trade barriers lacking a sound scientific basis and constitute an inconsistent risk management decision when compared to other foods.

This Administration has announced a policy of aggressive pursuit of both negotiated settlements with countries with policies that restrict the flow of US agricultural products and a willingness to file suit as necessary at the WTO to force market access for food products.

In sum then, the proposal suggested by the Commission on Dietary Supplement Labeling is in fact opposite to the policy that should be followed here. We should:

Ironically, this is probably what it was intended that the Commission on Dietary Supplements do in the first place when it was assigned the task of studying and recommending new regulations for label claims and statements used in connection with the sale of dietary supplements [as foods.] Instead the Commission has violated both the letter and the spirit of its assignment and proposes changes calculated to cripple American industry, prevent international market expansion and hand the comparative advantage in a burgeoning international market to foreign pharmaceutical interests.

CONSUMERS CAN HELP IN THE ACHIEVEMENT OF THE TASK AHEAD

Consumers can assist in the achievement of the task ahead that is the broadening of market access for botanicals and other dietary supplements as foods in the international market place.

In general, consumers demand:

One may well ask can consumers be a force here? The answer is a resounding yes. Consumers and not industry and not industry front organizations led the charge that defeated the Canadian botanicals proposal at Codex and sent the German proposal on vitamins and minerals back to step 3. Increasingly consumers are networking nationally and internationally and are developing their own positions and policies based on what is best for them and what is feasible in the current rapidly changing world.

Consumers can and will work together to achieve the goals stated herein and conversely will fight with all of the political power at their disposal against anti-consumer, market shirking, proposals designed to benefit foreign interests or specialized commercial interests at the expense of their own.



Dated: August 3, 1997

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