Key Factors Threatening your Choice for Natural Health

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Article by Robert Verkerk BSc MSc DIC PhD,
Executive Director, Alliance for Natural Health.
Used by permission.

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Dietary supplements are in a three-way squeeze.  Ingredients, doses and health claims are increasingly coming under fire, and the sharp end of the action is most certainly Europe and the United Nation's Codex Alimentarius Commission.  The question for many US doctors and practitioners is: Is the US immune from ever-more restrictive regulations developing on the other side of the Atlantic?

The answer is a resounding "No", and this article helps to explain why.  Actually, it appears that the US may be coming to the end of a 10-year Nirvana that accompanied the passage of the Dietary Supplement & Health Education Act (DSHEA) in 1994, which was, after all, won only after a major fight and huge consumer pressure on Congress.

What is driving increased regulation of dietary supplements

At the outset, it is important to appreciate the sources of regulatory pressure.  In summary, there are four key drivers:

1. Safety: Despite a remarkable safety record, which shows that dietary supplements are by far the safest group of products consumed by humans, many times safer even than foods, their safety is being increasingly questioned.  Why?  In the EU, where the curvature of bananas is subject to regulation, the reasons are somewhat easier to fathom.  However, in the US (as well as in Europe), it seems that a very small number of ingredients or products, for which there may have been genuine health concerns (e.g. some forms of ephedra and L-tryptophan), are being used as scapegoats for the whole class of foods known as dietary supplements.  Meta-analyses are increasingly being used to re-publicize old findings, which may be flawed or irrelevant, as seen in the recent antioxidants and vitamin E reports.
2. Harmonization: As global trade increases, the WHO and other global bodies, supported by many of the world's leading economies, continue to push for trade harmonization laws.  But which harmonization standards should be applied?  Those of countries with a long-held and very restricted view on dietary supplements (e.g. Germany, France, Denmark) or those which have traditionally been more liberal, such as the USA, South Africa, UK and the Netherlands.  The Codex Alimentarius Commission is charged with developing international guidelines for foods, purportedly to protect consumers and facilitate trade, and is leading the development of international guidelines for dietary supplements.  Initially, these guidelines will be restricted to vitamins and minerals, and there is debate as to whether they will be legally binding for United Nations members.  Nevertheless, there will be strong commercial pressures to conform.
3. Quality Assurance: There have been very limited, but nonetheless significant, cases of adverse effects caused by contaminants in herbs and dietary supplements (notably one batch of synthetic tryptophan), so regulation to prevent such problems is clearly beneficial.  However, controlling Good Manufacturing Practice (GMP), according to pharmaceutical standards, is not necessarily the solution, as it is incompatible with large numbers of natural products that contain variable quantities of particular components that work synergistically with the "key", standardized ingredients.
4. Industry/Regulator Pressure: Regulators, and particular industry sectors, have been pushing for increased regulation of dietary supplements, supposedly to protect consumer health.  There has been no requirement to justify properly the health hazard, or to consider the potential costs of restricting consumer access to large numbers of nutrients.  Conceivably, the risk of stringent regulation is much greater than the risk of not regulating stringently.

How are ingredients being regulated in the US and the EU?

A practitioner's ability to select ingredients of his or her choice is paramount to his or her ability to practice effectively.  Limiting choice to specific forms makes sense if the forms that are to be disallowed were to pose a risk to health.  But there is no evidence that forms that will be lost, initially in Europe, are causing any harm.

As of August 2005, dietary supplements in the European Union will be regulated by the Food Supplements Directive, which is one of more than 30,000 EU Directives.  This one Directive will control the fate of dietary supplements for the 450 million or so Europeans dispersed among 25 EU member countries.  The Directive has one key similarity with DSHEA, in that it is a "safe harbor" for dietary supplements outside a medicines regime.  Its key problem for innovative suppliers of supplements is that the harbor is so narrow that many of the most valuable forms of supplements will be disallowed.  In one stroke, on August 1, 2005, 75% of vitamin and mineral forms, the first nutrient groups to be dealt with by the Directive, will be banned.  Many of the forms to be banned, ironically, are the natural food forms, such as natural vitamin complexes and a huge array of organically-bound minerals.  Some US companies trading into Europe will have some 60% of their product lines affected.  Most are not prepared to reformulate, as product efficacy will be affected adversely.

The European Commission has, however, provided another way in.  If a company can muster together sufficient funds to prepare a technical dossier (monograph) for an ingredient that has already been on the market — and that dossier is submitted by July 12, 2005 — the ingredient can be used until December 2009.  After that it's anyone's guess.  For the majority of companies, investing in dossiers is simply too expensive or too risky.  This is demonstrated by the very small number of dossiers being prepared.

What the Food Supplements Directive effectively does is put the onus for data provision onto industry.  This is a very fundamental change: freedom effectively becomes prescriptive rather than residual.  It's a little like banning broccoli unless you can prove it's safe.  By far, the most resource-rich ingredient manufacturers are the drugs companies, which still control the supply of a very large proportion of ingredients used, particularly in mainstream products.  So, if the drugs companies choose not to supply dossiers, and the smaller companies cannot afford to produce dossiers, consumers, practitioners and doctors lose access to key ingredients.  This is exactly what is happening in Europe, and is the key reason the Alliance for Natural Health (ANH) has launched its landmark legal challenge against the Food Supplements Directive, which will be heard in the European Courts of Justice on January 25, 2006.

Would such folly ever be considered in the US?  The plans are already on the drawing board, and they come in the form of the Proposed US Framework for Evaluation of Dietary Supplements (Institute of Medicine (IOM)/National Research Council).  Firstly, like the EU Food Supplements Directive, this framework places considerable onus on industry to supply data on safety — prohibitively expensive for all but the largest manufacturers.  Secondly, safety issues are considered in isolation — there is no concomitant consideration of safety and beneficial effects.  The FDA argues, like the European Commission, that this comparison is valid only for drugs.  The IOM framework, as per the EU equivalent, comes into effect gradually, the "compliance period" supposedly giving industry sufficient time to adjust (or expire?).

How are doses being regulated in the US and the EU?

In the future, a dosage borderline between dietary supplements as foods and dietary supplements as medicines appears highly likely.  The IOM and the European Food Safety Authority are now getting their heads together with other parties, many representing some of the largest commercial interests in the healthcare field, under the auspices of a United Nations project headed up by the Food & Agricultural Organization (FAO) and World Health Organization (WHO).

The ANH has submitted a ground-breaking report to the joint FAO/WHO nutrient risk assessment project which shows, with copious scientific evidence, the scientific irrationality of the approach being considered and why a completely new paradigm in risk assessment is required.

The report has now been formally endorsed by some many of the leading US doctors working in the natural health field, including Drs Abram Hoffer, Jeff Bland, Jonathan Wright, Julian Whitaker, Steve Levine, Garry Gordon and Alan Gaby.

The FAO/WHO have tentatively proposed a 5-day workshop in May 2005, which will aim to thrash out the final form of the risk assessment.  It is critical that the recommendations in the ANH submission are taken into account.

Health claims: user pays

Health claims regulations are being promoted as a means of facilitating trade and protecting consumer health.  Laws and guidelines on health claims are under consideration in the EU, US and Codex.  The common denominator is the requirement for scientific substantiation of health claims, which sounds reasonable enough.  However, again, putting the onus for data on industry will put this beyond the purse of many leading dietary supplement companies.  Health claims help to educate and inform consumers, but increasingly they will be controlled by those with deep pockets.  Health claims proposals appear increasingly to be a mechanism that will restrict freedom of information.  Instead of consumers benefiting from legislative proposals, consumers may become the biggest victims.

Concluding comment

While the sharp end of the problem is in Europe and within Codex, it is of paramount importance that US citizens become increasingly involved in the global defense campaign.  In turn, activities and tasks in the EU, Codex, US and elsewhere must be prioritized to ensure efficient use of limited resources.  Proper coordination of activities is essential.

What are the stakes?  At risk is nothing less than the future of healthcare.  2005 is the key year for concerted, coordinated and positive action.  Please join us at the ANH.