New Life Health And Wellness

Natural Remedies Being Threatened

By Lynne Higgins, Assistant Editor

Nutritional supplement regulation and availability is a crucial and continuing concern. The mainstream media has remained strangely silent on these issues. In response to the letter from “Silver” and to many currently circulating e-mails, we did some research to bring you the as-nearly-as-possible un-biased facts on these matters.

Many of our readers will remember the petitions, sponsored by National Nutritional Foods Association (NNFA) and American College for Advancement in Medicine (ACAM) members, which were circulating several months ago at health & fitness centers, nutrition shops and complementary & alternative practitioners. These petitions concerned Senate bill S. 722 and House bill H.R. 3377 that proposed legislation to give the Food and Drug Administration (FDA) sweeping authority to regulate maximum dosages, manufacturing standards, form (organic or chemical), and the vitamin, mineral, enzyme, nutrient and herbal content of supplements. Under “harmonized” regulations and these bills, dosages higher than an arbitrarily determined maximum would be available on a “prescription only” basis prescribed by AMA medical doctors at prescription drug prices, although most MD’s have little or no education in the area of nutrition and nutritional supplements. (It was only in 2002 that JAMA (the Journal of the American Medical Association) announced that nutritional supplements may be beneficial). The consumer response was so overwhelming that these bills died in committee . . . for the time being. These bills could be attached as riders to other legislation in the future. Eternal vigilance is the price of freedom of choice.

The following excerpts from an article by Dr. Robert Verkerk, Executive Director, Alliance for Natural Health (ANH), that appeared in the January 2005 newsletter of ACAM and provide a relatively unbiased discussion of the EU - CODEX situation and its importance for worldwide freedom of choice for nutritional supplements.

Leading US doctors endorse Alliance for Natural Health

Paper for American College for Advancement in Medicine (ACAM) newsletter, January 2005

By Robert Verkerk BSc MSc DIC PhD, Executive Director, Alliance for Natural Health

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:

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.
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 which have traditionally been more liberal, such as the USA, South Africa, UK and the Netherlands. The Codex Alimentarius Commission [of the United Nations] 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.
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.

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 1 August 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 12 July 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 on to 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 drug 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 25 January.

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 food and Drug Administration (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 Alliance for Natural Health (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 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.

Footnotes:

1 Bjelakovic G, Nikolova D, Simonetti RG, Gluud C. Antioxidant supplements for prevention of gastrointestinal cancers: a systematic review and meta-analysis. Lancet, 2004; 364: 1219-28.

See ANH rebuttal at: www.alliance-natural-health.org/index.cfm?action=news&ID=97.

2 Miller ER; Pastor-Barriuso, Dalal D, Riemersma RA, Appel LA, Guallar E. Meta-analysis: High-dosage Vitamin E supplementation may increase all-cause mortality. Annals of Internal Medicine, 2005; 142(1), in press. (electronic version: www.annals.org/cgi/content/full/0000605-200501040-00110v1). See ANH rebuttal at: www.alliance-natural-health.org/index.cfm?action=news&ID=112

3 Joint FAO/WHO nutrient risk assessment project: www.who.int/ipcs/highlights/nutrientraproject/en/.

4 ANH submission to Joint FAO/WHO nutrient risk assessment project, December 2004: www.alliance-natural-health.org/_docs/ANHwebsiteDoc_125.pdf.

For more information about the vital Alliance for Natural Health campaign, see www.alliance-natural-health.org, or email info@alliance-natural-health.org.

Dr. Robert Verkerk’s detailed paper presented at the American College for Advancement in Medicine (ACAM) meeting on 19 November 2004, San Diego may be download from Key Downloads on homepage of www.alliance-natural-health.org).

“Harmonization” is another factor to consider in the supplement regulation tug-of-war. Europe has the European Union and the US has the Free Trade Area of the Americas (FTAA) for the western hemisphere. According to International Advocates for Health Freedom’s John C.Hammell, “. . . In a speech given in 2002 before the Organization of American States, President Bush announced an intention to finalize negotiations to create the FTAA by January 2005. . . last summer Health Canada harmonized Canada to restrictive Australian regulations, and the MERCOSUR nations in South America are harmonizing to the EU. The US is going to be caught in a pincer movement via harmonization of our laws unless we take immediate action to fight back. IAHF is working closely with allied groups including Life Extension Foundation, Citizens for Health, The American Holistic Health Association, The National Health Freedom Coalition, the National Health Federation, and the Alliance for Natural Health to address this complex emerging threat.” More information on the FTAA and harmonization can be found on-line at the websites of the above listed organizations and at http://thenewamericancom/currentissue/ .

CITIZENS FOR HEALTH launched an advocacy campaign to prevent FDA regulation of nutritional supplements. Ana Micka, President and CEO, Citizens for Health reports the following in a lettr to petition signatories: “Thanks to your efforts, we exceeded - in fact doubled - our goal of sending 25,000 letters to ensure that the voice of the natural health consumer was heard. Over 52,000 consumers from across the country flooded the FDA with comments before the February 1st [2005] deadline.
. . . We can create better health policies, expand access to natural health solutions and prevent the government and powerful pharmaceutical and medical special interests from trespassing on our rights to make independent health decisions. [Full text of this letter at : http://healthactioncenter.org]

Urge the U.S. Codex Delegation to protect DSHEA
Let’s write to Dr. Barbara Schneeman at the FDA now! Dr. Schneeman is one of our key U.S. representatives to Codex. Let’s ask her to please work diligently to ensure that our nation's hard-won health freedoms, a good example of which is the Dietary Health and Education Act of 1994 (DSHEA), are not only protected here at home but inform every meeting and decision at Codex. Codex Alimentarius (Latin for "Food Code") was originally created as the United Nations’ attempt to establish international guidelines to "help governments consider the formulation and adoption of similar international standards of “purity for all foods" To many, this sounds like a good idea. Agreement on trade, safety and purity would seem beneficial for the world in so many ways, right? Wrong! Not in the ways Codex is being constructed now. If accepted as an international standard by the U.S. Codex Delegation and implemented in the U.S. (called harmonization), our future access to innovative and health-enhancing dietary supplements could, in time, be dramatically restricted http://healthactioncenter.org

Support Fair Tax Treatment for Dietary Supplements!
Contact your Representatives today and encourage them to co-sponsor the bi-partisan bill H.R. 2627, the Dietary Supplement Tax Fairness Act. This important legislation would allow consumers to write off dietary supplements and some other natural health products as medical expenses on their taxes and give consumers tax breaks on these healthcare options. This initiative will save you hundreds of dollars every year on your health products and will allow many consumers to afford natural, less expensive, preventative healthcare options often paid for out-of-pocket, not just the conventional and pharmaceutical options that are covered by traditional health insurance. TAKE ACTION! Send a letter to your Representative and ask that they support H.R. 2627, the Dietary Supplement Tax Fairness Act http://healthactioncenter.org

Congress is Writing the WRONG Prescription for Health!
As the debate over Senate Bill 722 heats up, one thing is certain- the right to use safe dietary supplements is clearly under attack. This legislation threatens DSHEA and your access to safe dietary supplements. We need you to send a clear message to Washington: Congress is writing the WRONG prescription for health! http://healthactioncenter.org

You can monitor these Consumer & Nutritional Supplement Industry advocacy organization websites to keep up-to-date on supplement regulation and healthcare choice issues:

The Health Action Center posts alerts from The Campaign for Better Health and Citizens for Health where your action can make a difference. To make sure you stay up-to-date on urgent issues needing your immediate action, sign up for Health Action Center email updates. Website: http://healthactioncenter.org

The National Nutritional Foods Association (NNFA)at www.nnfa.org and www.capwiz.com/nnfa/issues/alert is the nation’s largest and oldest non-profit organization dedicated to the natural products industry. NNFA represents nearly 8,000 retailers, manufacturers, wholesalers and distributors of natural products including foods, dietary supplements, and health and beauty aids.

Alliance for Natural Health (AFH) at www.alliance-natural-health.org

ANH's landmark challenge to the Food Supplements Directive in the European Court of Justice was heard on 25 January 2005. A decision is expected in April. ANH is also leading initiatives to offset proposed limits on dosages and health claims through Codex and other EU legislation. These critical events in Europe are increasingly likely to lead to restrictions in the US and elsewhere in the world.

Complementary Alternative Medical Association (CAMA)at www.camaweb.orgis an advocacy and educational organization for healthcare freedom of choice and access in the State of Georgia. See also the Coalition for Natural Health at www.naturalhalth.org.

American College for Advancement in Medicine (ACAM) . www.acam.org, www.marketwire.com. for ACAM press releases.The American College for Advancement in Medicine (ACAM) is a not-for-profit medical society dedicated to educating physicians and other health care professionals on the latest scientific research and emerging breakthroughs in integrative medicine. Celebrating more than a quarter century of service, ACAM represents more than 1,000 physicians in 30 countries. ACAM is the largest and oldest organization of its kind in the world dedicated exclusively to advancing the field of medicine by educating physicians about groundbreaking research and scientific discoveries in integrative medicine

The Dietary Supplement Information Bureau (DSIB)at www.supplementinfo.orgwas created to provide accurate information about vitamins, minerals, herbs and other supplements for consumers and the professional healthcare community. The DSIB Scientific Advisory Board comprises nationally-recognized physicians and researchers who are experts in dietary supplements.

Bjelakovic G, Nikolova D, Simonetti RG, Gluud C. Antioxidant supplements for prevention of gastrointestinal cancers: a systematic review and meta-analysis. Lancet, 2004; 364: 1219-28.

See ANH rebuttal at: www.alliance-natural-health.org/index.cfm?action=news&ID=97.

Miller ER; Pastor-Barriuso, Dalal D, Riemersma RA, Appel LA, Guallar E. Meta-analysis: High-dosage Vitamin E supplementation may increase all-cause mortality. Annals of Internal Medicine, 2005; 142(1), in press. (electronic version: www.annals.org/cgi/content/full/0000605-200501040-00110v1). See ANH rebuttal at: www.alliance-natural-health.org/index.cfm?action=news&ID=112

Joint FAO/WHO nutrient risk assessment project: www.who.int/ipcs/highlights/nutrientraproject/en/.

ANH submission to Joint FAO/WHO nutrient risk assessment project, December 2004: www.alliance-natural-health.org/docs/ANHwebsiteDoc_125.pdf.