May 2002 | Health Conscious

Freedom to Buy Supplements?

by Rebecca Ephraim, RD, CCN

Many Americans are taking charge of their health by using nutritional supplements on a regular basis. Most of us take for granted the access we have to supplements — our freedom to walk into a natural foods store and pluck whatever we want from the supplement shelves has so far gone unchallenged. This is not always the case in other industrialized countries.

In Ireland there are bans on Saint John’s wort and amino acids and limits on purchasing B vitamins. There are heavy restrictions on virtually all supplements in Norway, Finland, Greece, Spain, Portugal, and Canada where many supplements are regulated as pharmaceuticals. To illustrate just one common example, in Germany and Norway vitamin C is not available in amounts of more than 200 milligrams unless acquired by prescription or through a pharmacist. In addition, it costs from five to ten times what it cost before the restrictions were implemented a few years ago.

If you’re a vitamin C devotee, you know that so-called megadoses of ascorbic acid are considered to have potent therapeutic properties. Among practitioners of nutritional medicine, recommended daily dosages of 1,000 milligrams (one gram) to 10,000 milligrams (ten grams) and beyond are not uncommon; such doses are used to treat a wide range of health problems, from certain cancers and heart disease to low sperm counts and diabetes.

For those who believe in the healing properties of nutritional supplementation, in this case vitamin C, the laws in many European countries have been devastating.

A growing body of concerned individuals in this country is warning that U.S. consumers may eventually be saddled with similar restrictive laws governing access to nutritional supplements. Depending on the scenario, the people issuing these warnings could be considered either alarmists or soothsayers.

These people base their judgments on rules that are being implemented by the Codex Alimentarius ("food code" in Latin). Codex, which was established in 1961, is an international commission jointly created by the Food and Agriculture Organization and the World Health Organization of the United Nations as a food standards program. The objective of Codex is for its 160-plus member countries (including the United States) to agree on trade standards for raw and processed foods, pesticide residues, labeling, and nutritional content and dosage levels of nutritional supplements. This is supposed to result in what Codex terms "harmonization" which will facilitate international trade.

Detractors have framed the word "harmonization" as an Orwellian double-speak that conjures up forced compliance and police-state enforcement. You need go no further than your computer and the Internet to witness the vast array of Web sites preaching imminent Codex doomsday for health freedom in the United States as it relates to supplements.

Because the Codex Commission meets in Europe and has not been widely reported on in the United States, the dealings of this commission tend to be complicated and rather obscure to most Americans. This has in turn created a climate in which detractors of Codex can and do make allegations that range from wild and flimsy to serious and substantial. To be sure, as far as nutritional supplements are concerned, Codex seeks to control global trading of these products. It wants to establish world guidelines that would mandate that no dietary supplements be sold for therapeutic purposes (which is the very basis of nutritional medicine). In order to make this happen, Codex is trying to standardize or harmonize the world’s regulations on nutritional supplements as well as foods and drugs.

The worst-case scenario is that if the Codex guidelines are put into place, the United States will be forced to change its laws to match these global guidelines. The theory is that if the United States disagrees with or refuses to follow Codex standards, pressure to conform would be intense, trade privileges would be withdrawn, and crippling trade sanctions would be imposed on this country. Moreover, it’s alleged that pharmaceutical companies have a vested interest in seeing that harmonization takes place so that therapeutic doses of supplements do not compete with the drug industry.

Washington, D.C.-based attorney Tony Martinez is a food and drug law expert — especially as it relates to dietary supplements and complementary healthcare. He dismisses any view that drug companies are plotting to use the Codex to their advantage. "I don’t ascribe to conspiracy theories.... I don’t agree that there’s a little room with certain individuals plotting and scheming to take over the whole world market for dietary supplements.... Pharmaceutical companies are the major main raw materials suppliers for dietary supplements. So why would they want to do things that would be hurting their own business?"

Debra Bass is another Washington food and drug law attorney who specializes in the regulatory and labeling issues of natural products. She believes that the U.S. law governing the sale and distribution of nutritional supplements could be vulnerable. She claims this is true for two reasons. The first reason is that warning labels on supplements are inadequate. The second reason is that U.S. consumers who abuse the privilege of supplementation freedom by using them indiscriminately and getting sick as a result are gambling with everyone’s rights. "If the consumers want [continued] access [to supplements] they better start taking responsibility or the choice is going to be taken away from them." In other words, for public safety purposes, the government will have no option but to force stricter regulations on these products in order to avoid irresponsible use by consumers.

As an example, Bass cites the recent concern over deaths thought to be caused by kava-kava, an herbal ingredient promoted as a sleep and relaxation aid. Kava is known to be associated with liver-related injuries and can be toxic when mixed with alcohol. She points out that at least one death occurred — that of an elderly woman, an alcoholic with liver cirrhosis, who ingested the herb apparently without knowing that kava and alcohol do not mix. If such incidents continue, Bass predicts less freedom. "Supplements are going to be regulated so you can only get the basic RDA [recommended dietary allowance] for the vitamins and you won’t be able to get herbals."

Yet Bass maintains that the objective of Codex is not evil. They’re trying to protect people. "But people, being consumers," she says, "need to take responsibility for themselves and not abuse and irresponsibly use dietary supplements. [They need to] know the interactions and get information so they can use the products responsibly instead of blaming the product when something goes wrong."

Citizens for Health, a high-profile public watchdog group, is telling U.S. consumers not to worry about Codex casting its long dark shadow over our health freedoms. Citizens for Health’s position is that our rights to nutritional supplements will not be threatened at any time in the future, and the organization is confident that the U.S. law regulating dietary supplements will remain unchanged and unaffected by the Codex process. Besides, Citizens says, it will remain "aggressively involved" with Codex to ensure that U.S. law does not become susceptible to "harmonization."

Although it’s dry reading, the progress of Codex can be reviewed on its Web site.

Disclaimer: This column is for information only and no part of its contents should be construed as medical advice, diagnosis, recommendation or endorsement by Ms. Ephraim.

Rebecca Ephraim is a registered dietitian, certified clinical nutritionist and a nutrition reporter specializing in integrative medicine issues.

© Rebecca Ephraim. All rights reserved.

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