Seller beware: what do tough European supplement laws say about safety in the US?

A few months after Ed Chayet, 58, started taking chromium picolinate--a chromium salt touted for its ability to "burn" body fat--his heart started beating irregularly, sometimes pounding, sometimes even racing.

After some sleuthing, his doctor traced the problem to the dietary supplement. "It all went away when I stopped taking the chromium," Chayet recalls.

Chayet, like millions of consumers in the United States, is baffled, and sometimes endangered, by an array of dietary supplements promoted with myriad health claims, conflicting research studies, scandals that taint ethical manufacturers and general confusion about government regulations versus company self-policing.

But the American way isn't the only way.

In Europe, where dietary supplements are generally more accepted, regulations are different--and offer American consumers an informative perspective on vitamins, minerals and herbals.

Consumer safety is Europe's primary concern, and individual countries have already banned several supplements available in the United States. European countries follow the "precautionary principle," which means that when they suspect a product may cause harm, they don't wait for proof before they take action against it.

In America, the US Food and Drug Administration (FDA) must prove that products are unsafe before removing them from the shelves. "That often means that people have to be injured before the FDA can act," according to Bruce Silverglade of the Center for Science in the Public Interest, a consumer watchdog group based in Washington, DC.

For example, the FDA warned American consumers in March 2002 that supplements containing kava, promoted as a relaxant, may cause liver injury--sometimes so severe that a transplant is required, sometimes even fatal. But while the FDA didn't go so far as to recall kava products, several European countries, including Germany and France, banned the sale of kava outright. Now, the European Commission (EC)--which passes laws that govern countries in the European Union (EU) and ensures that they are implemented--is bent on getting all member nations to follow suit. And kava is just one of the many substances that concerns the EC.

"Because of the increasingly pervasive subculture in modern society, what is natural is `good,' and every year thousands of deaths are caused by abnormal use of so-called natural products," says EC's Giuseppe Nistico in a recent report--explaining the seriousness with which Europe approaches these substances. "In the United States, the most widely used products are those based on ephedrine (Ephedra sinica), for which more than 1,200 cases of toxic effects, including 70 deaths, have been reported," Nistico says.

consistent continent

While US law lumps all supplements together under the Dietary Supplements Health and Education Act (DSHEA) of 1994, the EC has divided them into two groups for the purpose of regulation. It treats vitamins and minerals separately and differently from herbal remedies.

In Europe, vitamins and minerals "are considered food," says Beate Kettlitz, food policy adviser for Bureau Europeen des Unions de Consommateurs (BEUC), the Brussels-based Consumers' Organization. "It was important for us to have easy access to the products, but this also meant being much more restrictive. You can't give the same concentrations as you would under medical supervision."

The EC also aimed to provide a uniform standard of quality and safety for all member countries, since each one previously had its own laws, regulations and traditions of use. So, on June 10, 2002, the EC issued its directive on food supplements (Directive 2002/46/EC), relating specifically to vitamins and minerals. This standard enables a product approved in one country to be sold in other member countries. Londoners buying vitamin C tablets in Paris, for example, could be confident they were getting a product as safe and effective as the one they bought at home.

vitamin lists

Does everyone even need vitamin and mineral supplements? The EC doesn't think so. Everything in its directive follows from the basic principle that under normal circumstances a balanced diet can provide the necessary nutrients for development and health. So the directive forbids manufacturers to state or even suggest the contrary. Nor may a manufacturer state that a supplement is a substitute for a varied diet, or that it can prevent, treat or cure a disease.

But the European approach goes even further. Rather than setting only general guidelines, the directive lists exactly which vitamins and minerals may be sold in member countries, and in what form. According to Kettlitz, the list is based on scientific literature and pre-existing legislation. Substances that do not appear on the list will eventually be banned.

Manufacturers weren't pleased that some substances were left out, Kettlitz says. But they will have an opportunity to add to the list. "It can be extended following scientific evaluation [of a product]," she says. Meanwhile, chromium chloride and chromium sulfate, for example, appear on the acceptable list. Chromium picolinate, which caused Ed Chayet's irregular heartbeat, doesn't, and its sale is to be banned as of July 31, 2004, unless manufacturers can present proof that the substance is safe.