Sunday, August 14, 2005
The vitamin police
Tell me, again, just why the United Nations is so concerned about nutritional supplements
ALAN BOCK
Sr. editorial writer
The Orange County Register
 abock@ocregister.com
If you take vitamin supplements, as I do, you'll want to pay attention to an emerging debate over how closely vitamins might be regulated in this country.

The outcome could be as severe as the Food and Drug Administration regulating vitamins like prescription drugs or as simple as more detailed labeling about vitamin supplements and their effects.

Whichever way it goes, the controversy is gathering momentum.

Every day I get several e-mails warning that a shadowy international body, Codex Alimentarius, is on the verge of cutting off availability of vitamins and other nutritional supplements to American consumers, restricting our health freedom, or dictating formulas so large dosages just won't be available.

Most of the vitamin consumers worried about Codex are also concerned with the recently passed Central American Free Trade Agreement. As Texas Republican Rep. Ron Paul put it, CAFTA "increases the possibility that Codex regulations will be imposed on the American public."

How real are these threats? In brief, the threats exist but are not yet cataclysmic. But it could take mobilizing vitamin and supplement consumers to neutralize them.

Where does the main threat come from? Codex Alimentarius, Latin for "food code" or "food law," is a United Nations-affiliated international organization formed in 1963 under the aegis of the Food and Agriculture Organization and World Health Organization. It promulgates international regulatory guidelines on a range of food-related issues. At its July 4-9 meeting in Rome it dealt mostly with uncontroversial minutiae like "proposed draft maximum level for total aflatoxins in unprocessed almonds, hazelnuts and pistachios" and "maximum residue levels in/on dried chili peppers" and a lot of organizational detail.

It spent about five minutes on July 4 passing a proposal to promulgate guidelines for regulating vitamins and mineral food supplements. As the FAO/WHO reported, "The guidelines recommend labeling that contains information on maximum consumption levels of vitamins and mineral food supplements, assisting countries to increase consumer information, which will help consumers use them in a safe and effective way...

"The guidelines say that people should be encouraged to select a balanced diet to get the sufficient amount of vitamins and minerals. Only in cases where food does not provide sufficient vitamins and minerals should supplements be used."

That wording is a red flag to many users of vitamins and other supplements.

There are two distinct approaches to vitamins, both with nuances. One approach sees the main purpose of supplements as preventing diseases caused by deficiencies, like scurvy, beriberi and pellagra. The early quasi-official "recommended daily allowances," which have been revised only slightly, are based loosely, without allowance for individual biochemical or environmental differences, on the amounts of nutrients needed to prevent deficiencies that lead to deadly diseases.

Other researchers, including Linus Pauling (who developed the concept of "molecular disease" after DNA was discovered), Denham Harman (the free-radical theory of aging) and Roger Williams (biochemical and nutritional individuality) began to develop and test the idea that there might be levels of nutrients that not only prevented deadly diseases but improved health and ameliorated the aging process. Since the late 1950s studies have suggested strongly that the intake of certain vitamins can reduce the risk of numerous diseases, including heart disease and cancer.

Europe acts

with caution

As there are different approaches to the usefulness of vitamins, there are different approaches to the most desirable way to regulate vitamins (assuming there's a need to regulate; the fact that the American Association of Poison Control Centers has reported no deaths due to vitamins for the last 8 years suggests the putative dangers of "overdose" are somewhat overblown).

One faction believes that vitamins are useful only to prevent deficiency diseases, that there must be potential dangers to doses markedly higher than deficiency-prevention doses, that claims about disease prevention are mainly the work of charlatans, and that vitamins should, by and large, be used only under medical supervision. This is a variation on the "precautionary principle," which suggests that substances should not be allowed on the market until they are proven safe and effective beyond doubt, though how that can apply to natural substances that occur in food and are already readily available is a question.

Most European countries and Australia regulate vitamins similarly to the way the United States regulates prescription drugs. A set of EU guidelines, the Food Supplements Directive, based on 1998 German regulations that emphasize "maximum upper limits" and would have taken as many as 5,000 products off the European market, went into effect August 1, but its impact might be mitigated by litigation.

U.S. treats

vitamins as food

The United States, on the other hand, at least since the 1994 Dietary Supplement Health and Education Act, treats vitamins as food, not drugs. The act was passed in one of the more remarkable instances of grassroots politicking - vitamin manufacturers mobilized many of their customers - in response to efforts by the FDA to assume more control over vitamins and supplements, which would probably have led to pharmaceutical-like restrictions if the FDA had had its druthers. Since the 1994 act vitamins and supplements have grown from a $3.4 billion to a $20 billion industry. And the FDA would still love to get its regulatory mitts on vitamins and supplements.

The Codex Commission obviously leans toward the European model. Its guidelines - still not written, and there's a chance, if minuscule, of influencing them with a barrage of scientific evidence - are likely to recommend dosages similar to current RDAs, with the strong suggestion that higher dosage formulas not be allowed.

Even if such formulations are not mandated, they will come with a great deal of "education" to the effect that the authorities have determined that vitamins with higher dosages are a waste that leaves consumers literally urinating away their money. Many vitamin consumers who pay little attention will believe this, according to Bill Sardi, a nutrition journalist, author and consumer advocate in San Dimas (www.knowledgeofhealth.com). If those who believe there are therapeutic and disease-preventing dosages are right, a great deal of unnecessary illness will ensue.

U.S. will be

divided on Codex

The Codex guidelines will find a friendly reception in some quarters in the United States. The FDA would certainly like to exercise more regulatory oversight on supplements than is authorized by current law. This April the Department of Health and Human Services wrote a report urging more power for the FDA. Most big pharmaceutical companies, which are accustomed to dealing with the FDA in pharmaceuticals, wouldn't mind this; they would probably increase their market share as smaller vitamin companies found the regulations too onerous to deal with and thus close up, find a partner, or sell out to a larger company.

The 1994 Dietary Supplement Health and Education Act would deter such efforts to "harmonize" U.S. law with international guidelines, but laws can be changed and determined bureaucrats can be skillful at following their own agendas without quite going so far as to violate the law too obviously. The FDA lost an appeals court decision in Pearson v. Shalala in 1999 that challenged its practice of forbidding health claims on vitamin packages. The court said the First Amendment applied even to FDA efforts to restrict such free speech. But it responded by setting up a bureaucratic process to govern "qualified health claims" and to date has approved only nine of them.

Those who dismiss concerns about Codex as alarmist note that Codex guidelines would be voluntary, so health freedom in the U.S. would not be threatened. Skeptics point out that the Codex guidelines, even prior to being formulated, were specifically mentioned as the "gold standard" of desirable vitamin guidelines in the CAFTA treaty.

International

pressures

Is it out of the question to speculate that some other country might challenge the "antiquated" and "dangerously permissive" U.S. law as intruding on the freedom of trade that would be promoted by uniform standards?

Scott Tips, counsel for the National Health Federation (www.thenhf.com), a 50-year-old advocate for consumer choice in health care, who has attended Codex meetings since 2000, thinks not. "Most European officials see the freedom allowed under the [Dietary Supplement Health and Education Act]as dangerous, and quite sincerely," he told me.

Might the World Trade Organization then authorize the complaining country to impose countervailing duties as a punishment? If these were politically targeted - as were the duties proposed by the EU when the WTO said it could impose trade sanctions after the U.S. imposed steel tariffs - they might persuade Congress to change U.S. law.

Even absent a WTO action, U.S. companies that sell in international markets might find it convenient to adopt Codex's guidelines. If they started producing mostly "upper limit" vitamins, that would make it inconvenient and more expensive for consumers who believe "megadoses" are desirable.

Health choices

in the balance

The threat to nutritional freedom posed by Codex is indirect but real. The antagonism toward vitamins and supplements - partly explainable by the fact that some vitamin advocates have displayed signs of quackery and some enthusiasms or fads for certain supplements have turned out to be overblown after heavy promotion - seen in some quarters of the regulatory bureaucracy, certain politicians and most of the media, is an important factor. These elements will pounce on the Codex guidelines eagerly and seek to make U.S. law conform.

Contrary to Internet articles with titles like "Kiss Your Vitamins Good Bye," however, this fight is just beginning. Vitamin consumers may have to mobilize again, as they did in 1994. But there are more of them now than there were then, especially as the boomers age.

Whether its guidelines take root in the United States or not, the Codex influence could make it more important than ever that consumers inform themselves independently and not assume the duly constituted authorities know what they're talking about. It could take some political acumen to maintain and expand health freedom, but it's far from impossible.