By Dr Robert Verkerk 

ANH executive and scientific director

A powerful, pro-food safety lobby group, known as the Center for Science in the Public Interest (CSPI) is pushing hard to eliminate what it calls "misleading" structure/function and qualified health claims regimes that many Americans see as being central to informed consumer choice in the natural health sector. 

The organisation has fingered some of the biggest food industry players for making what it says are false or misleading health-related claims on food packages. In CSPI’s sights are none other than Kelloggs and Nestlé, as well as several other 'Big Food' manufacturers. But it is the hundreds of much smaller companies that will feel the pinch if CSPI gets its way. To help its cause, it’s laid a 158-page report detailing examples of what it considers to be false or misleading claims at the door of the USA’s Food & Drug Administration (FDA), which considers itself responsible for regulating around $1 trillion worth of food and drug products. The report, it should be said, focuses on conventional foods, rather than dietary supplements.

Health claims regimes in the USA

The US health food industry has for many years enjoyed one of the least restrictive  claims environments in the world. This regulatory environment hasn’t come by accident. It’s been hard won. The passage of the Dietary Supplement Health and Education Act (DSHEA) of 1994 gave unique status to dietary supplements, allowing their marketing to include the use of health claims that provide the consumer with information about the benefits of particular products. But it took close to  a revolution to bring this about. More people sent letters to Congress than on any other issue in US history, expressing their  concerns that drug laws would be used to regulate and ultimately eliminate  natural health products. Such a situation would undoubtedly result in the loss of many thousands of products from the market given the prohibitive costs of a drugs regime for most small to medium sized companies that had until this time been the real pioneers in the natural health sector. In fact, it would have decimated the industry as we know it, leaving only a sprinkling of very large corporations as players in the market. 

Later in the same decade, there were a series of landmark legal actions headed by leading constitutional lawyer Jonathan Emord. The Pearson v. Shalala case (1999) was initially lost—but it was then won on appeal. The case revealed the extent by which agencies such as the FDA are prepared to flout fundamental principles of free speech (in breach of the First Amendment of the US Constitution) that most in the western world regard as among the most important pillars of democratic and civilised society.

Who says US health claims are unregulated?

Contrary to what some allege, health claims in the US are not completely unregulated. As with all industries, there will be some irresponsible players. But there are already ample mechanisms in place to deal with false and misleading claims. It may be that enforcement could be fine tuned in certain areas—and the concept of using health claims because of minute quantities of healthful ingredients on labels of products that are essentially junk foods, as revealed by CSPI, is deplorable.

But massively changing the regulatory system itself could bring with it many additional difficulties particularly if it removes opportunities for smaller health food manufacturers to educate consumers. This could create the kind of exclusive health claims club that is to the advantage of transnational corporations like Unilever in Europe under the Article 14 procedure of the Nutrition and Health Claims Regulation.

In the case of product advertising, the Federal Trade Commission has enormous power to penalise companies unable to substantiate claims, and highly publicised prosecutions have had the expected effect in making the vast majority of companies responsible in their use of claims.

The FDA itself details the range of claims allowed, including structure/function claims (not subject to FDA review and authorisation) and qualified health claims. 

The latter are supposed to be qualified according to the conclusiveness of scientific evidence, subject to the discretion of the FDA following public review.  Both these categories have been available for use by dietary supplements, but structure/function claims are increasingly coming under attack by anti-dietary supplement congressmen and senators, and now the CSPI.  In fact the CSPI set out in its report the reasons why it wants to see the entire structure/function and qualified claims regimes disbanded.

Regardless of what those who might want to to see the end of the structure/function claims environment might say, these claims are not unregulated. They are however, unlike the European system, not subject to pre-market authorisation. First, the FDA must be notified (within 30 days of the claim being used in the marketplace) and second, the claims must be able to be substantiated scientifically, and thus are open to challenge by the FDA and FTC if they are considered either false or misleading.

It could be argued that qualified health claims have the potential to give the consumer some of the most useful information of any claim type given that nutrient/food-disease risk reduction relationships can be mentioned, along with wording that infers the strength of the evidence supporting the relationship. But key qualified health claims for supplements, notably the selenium and cancer claim, and the antioxidant vitamin and cancer claim, are being increasingly limited by the FDA. For example, the selenium and cancer claim is being limited by the FDA to such an extent that its proposal makes the claims next to useless for companies selling selenium containing supplements. It is becoming increasingly clear that this process is controlled by pharmaceutical interests or their sympathisers conducting studies that are intended to yield negative results. These data are then used by the pharma industry’s accomplices at the FDA to give the supplement industry yet another knocking.

Defending fundamental rights and freedoms

Such attacks on health claims are nothing short of blatant attacks on freedom of speech and therefore the First Amendment, as established by the Founding Fathers in the late the 1700s. Because they violate fundamental rights and freedoms, these attacks cannot be left unchallenged, hence the recent initiation of legal action by our US branch, ANH-USA and other parties.

It’s worth pointing out that the FDA allows another type of health claim for health foods, this being ones based on ‘authoritative statements’ (from major health authorities). But dietary supplements have already been declared as ineligible for these claims, irrespective of the evidence. 

So you can see where health conscious consumers—who use dietary supplements in conjunction with healthy diets and lifestyles—will be left if both structure/function and qualified health claims for supplements are blown into oblivion by the FDA and its anti-natural health supporters. Ignorance is never bliss.

Where’s it all coming from?

There are two main places to look when you evaluate the pattern of incremental damage and attack on claims presently being experienced in the US. These two places are: the European Union (EU) and Codex Alimentarius, the international food standards and guidelines system developed by the world’s most powerful governments in cahoots with the largest transnational corporations in the food industry to facilitate the global food trade.

When we talk of the EU, we of course don’t mean the nearly 500 million people spread out across the European Union’s 27 Member States. We are actually referring, by and large, to a small number of unelected officials based in the European Commission in Brussels. These officials, often in association with some very substantial big business interests and senior bureaucrats in dominant Member States, managed to carve out, as of 2006, probably the most restrictive law yet seen anywhere in the world on health claims. The law is called the Nutrition and Health Claims Regulation and we have previously characterised it as a ‘passport system for big business’.  The Regulation effectively bans all types of health claims, made in any medium, whether in text or packaging, pictorial or—remarkably—even verbal, unless it has been specifically allowed by one European institution, the European Food Safety Authority (EFSA). It works according to the principle of Napoleonic law, which upholds that a person is guilty until proven innocent. In the case of foods, any claim could be regarded as false or misleading unless it has been proven. Since the scientific requirements for proving claims are so onerous, few claims are likely to be approved.

On the issue of controlling verbal claims in a commercial context, there are dire consequences. Among the most alarming is the likelihood that most educational seminars run by the natural products trade in training practitioners and doctors will be stopped. It won’t be possible to create DVDs of such training events for risk of being caught for making ‘unauthorised claims’. And probably, of greatest concern, a practitioner will not be able to communicate to his or her patient or client, the benefits of a given food or supplement, unless the claim is approved. This stands even in cases where a practitioner has on hand or is aware of a clutch of clinical trials demonstrating efficacy!

This issue brings us head-on into one of the biggest problems created by regulatory authorities with health claims. It is the basis by which a claim is deemed as true. In Europe, the Nutrition and Health Claims Regulation requires ‘generally accepted scientific data’ from human studies to support the relationship. This is a lot harder than it might seem and particularly when randomised controlled studies (RCTs) are held in such high regard by the authorities. We should remember RCTs are primarily a tool for the drug companies to prove efficacy and have not generally been applied to foods, especially given the innate difficulty in avoiding nutrients in the control arm of the study.  In the US, the equally poorly defined concept of ‘significant scientific agreement’ exists. Global harmonisation of food laws, as you can see, was started some time ago.

Although the Nutrition and Health Claims Regulation is not fully implemented because EFSA is still busy evaluating claims, the first tranche of its opinions are deeply worrying. Many have been returned with negative opinions, especially in cases where they are supported largely by animal studies, biochemical evidence or emerging science.

Jonathan Emord

US lawyer Jonathan Emord, like ourselves at ANH, believes there are grounds for a legal challenge. For those of us who care about what our children and future generations are going to be able to learn about healthy living, sitting on the sidelines is not an option.

One of the key committee’s at Codex, the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU), is a long way down the track of turning the fundamentals of the EU health claims regime into a Codex guideline. In its 30th meeting, in Cape Town, Recommendations on the Scientific Substantiation of Health Claims were pushed through to the final step of the 8-step Codex procedure. The scientific requirements for substantiation are modeled very closely on the EU system on which generally accepted data based from human studies are required for substantiation. In developing the Codex recommendations, inputs have also come from the World Health Organization and the FDA. Not surprisingly, these recommendations were enthusiastically supported by the governments of the USA and Canada when they were put to vote. Of interest is a publication issued in November 2009 by the head of CCNFSDU, Dr Rolf Grossklaus. It did allude to some of the problems with the consensus approach, implying that better systems are required to ensure approval of claims for emerging science. We’re hoping this is more than just lip service.

Regulatory convergence

We have often reminded people of the phenomenon of regulatory convergence. Many see it as an inevitable consequence of globalisation. In truth, it needn’t be, and sometimes, when you look beneath the surface, you discover it’s more about a system of rules that are in the interests of some of the most powerful governments and corporations in the world. We see it in virtually all areas in which big business is dominant, or has a lot to lose—or gain. The push to harmonise laws on carbon dioxide emissions is a recent and key example.

How does it work? There’s no doubt that a good deal of horse trading between corporations and governments goes on behind closed doors. But every now and then, we see these parties coming together in a more open forum.

Coming back to the issue of health claims, the forthcoming meeting being organised by the international, pro-big business consultancy outfit Cantox, in Brussels is such an example.

On 23rd February 2010 we will see the FDA, Health Canada, the European Commission and the EFSA all coming together to discuss health claims. They will be planning for all our futures. Can you imagine anyone of these parties deciding to opt out of the increasingly restrictive health claims environment we’ve seen developing in Europe, with likely export to Canada and the USA? One that is based on a system that is already the subject of international recommendations through Codex. It’s most unlikely, is it not…..?

We need your help

Legal action remains one of the few tools we have available to us when it comes to trying to reverse regulatory trends that are being developed by those few who seem to have a very specific agenda that is not necessarily in the public interest. Time will tell how much success any of us will have in both initiating—and even more importantly—succeeding in such actions.

Financial and other support for legal actions is needed urgently. We are presently developing a strategy in conjunction with Washington-based attorneys Emord and Associates aimed at initiating an action in Europe. Companies or individuals with an interest in helping support such an action, financially or otherwise, should contact either ANH-Intl or Emord and Associates. Apart from the challenges already underway against the FDA, challenging the EU claims environment may be the very best way to protect the USA from the draconian European health claims model.

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