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Will Regulators Ruin Vitamins and Supplements?

If you're a consumer of supplements; vitamins, minerals, phytonutrients, isoflavones or any of the other varieties of nutritional supplement products sold for the purpose of promoting and maintaining health and you spend any time at all on the internet, you may have seen some alarming articles predicting imminent disaster for supplement users. The articles warn that something called the Codex regulations are about to be adopted and your freedom to purchase and use supplements is about to come to an abrupt end. Web sites, newsletters and chat rooms are ablaze with talk of how these regulations are going to curtail or even end our access to supplements, turning them into regulated substances available only by prescription.

And it's not just the internet. I've seen folks outside the health-food and natural-food grocery stores, earnestly requesting signatures on petitions to "stop Codex before it's too late." Naturally, as a consumer of various supplements, I've been concerned. While there is no doubt that the supplement and herbal industries need some greater oversight for quality control and labeling, is Codex the answer? Or is it a politically savvy method of protecting the pharmaceutical companies?

To find out, I interviewed Leila Saldanha, PhD, a nutritionist and scientific and technical regulatory affairs professional with more than 20 years experience in the food and dietary supplements industries.

WHAT IS CODEX?

While it sounds like a spell from the latest Harry Potter book, the Codex Alimentarius Commission was first created in 1963 by two United Nations (UN) organizations, the Food and Agricultural Organization (FAO) and the World Health Organization (WHO) to develop guidelines that protect consumer health and ensure fair trade practices between countries. It's a body of government representatives and non-governmental organizations charged by the UN with establishing international guidelines on food law and setting standards of operation for the health industry. To date, it has adopted almost 250 standards covering different aspects of the food industry, including considering, for example, an international standard for what can be labeled "parmesan cheese."

In the early 1990s, the Codex Committee on Nutrition and Foods for Special Dietary Uses began discussions on setting guidelines for vitamin and mineral supplements. This committee studies nutritional issues, drafts provisions and develops recommended standards. The committee just recently completed work on its final draft of its advisory document and submitted it for adoption by the Codex Commission, where the recommendations were adopted in July.

These guidelines are more restrictive than those currently in use in the US (more on that in a moment). So what exactly do we have to fear from them?

According to Dr. Saldanha, not much. "Often when a standard puts new limits on vitamins and dietary supplements, there is a movement to do something about it," she explained to me. "But it is important to remember that Codex is not regulation. Codex drafts standards and guidelines. It is up to individual countries to decide whether or not they want to adopt them or not." Dr. Saldanha, along with many other knowledgeable experts, does not think there is much chance that the Codex regulations will become US law.

DSHEA TO THE RESCUE

The reason? "We have in place a law called DSHEA (Dietary Supplement Health and Education Act) of 1994," she said. This act covers any supplement composed of vitamins, minerals, an herb or other botanical, amino acid, concentrate, metabolite, constituent, extract or combination of above. DSHEA severely limits the authority of the FDA over dietary supplements except in demonstrable cases of safety or misleading advertising, and it also gives manufacturers a fairly wide berth. Depending on where you stand, this is good news or bad news. Most informed consumers and responsible manufacturers support DSHEA. Some anti-supplement forces see the regulations as too lax, but no one seriously believes they have the political muscle to overturn it.The point is, replacing DSHEA with a more restrictive international set of recommendations is not likely to happen.

THE PROPOSED STANDARDS

Exactly how restrictive are the new Codex standards? And why is there so much concern about them here in the US?

"The Codex standards Guidelines for Vitamin and Mineral Food Supplements don't set maximum levels on daily doses of vitamins and minerals," said Dr. Saldanha. "They do, however, set a minimum level -- 15% of the FAO/WHO recommended daily intakes. The maximum levels are to be based on safety evaluations through scientific risk assessment. As these values have not been set by FAO/WHO, manufacturers can determine these using established methods."

There's no doubt that the Codex standard is much more restrictive than the US's DSHEA. The concern, which may be justified, is that the conservative Codex group will at some point recommend even more restrictions on dietary supplements, including possibly converting the definition of many to prescription drugs. And there is concern by many that there will be eventual pressure on the US to conform to the international standard, since many countries may not allow the sale of imported products from the US that don't meet their own restrictive regulations.

But the US does not arbitrarily adopt standards of international bodies that it doesn't agree with, particularly where there would be widespread opposition to do so, as is clearly the case with dietary supplements. What Codex seeks to do and what it can do are two very different things. Codex standards are voluntary, which means that if the US doesn't adopt them, they will simply not govern the regulation of vitamins, minerals or dietary supplements in the US.

(Note: Codex does not apply to herbal remedies.)

For now, the good news is that we seem to be free from the fear of Codex. The bad news is that there is still room for improved quality control in the supplement and botanical world to ensure that consistent high-quality product is produced.

Click here to read more on DSHEA.