The Assualt on Natural Medicine
In Canada, such widely used herbs as feverfew, St. John's Wort and gingko have disappeared from health food store shelves. In Germany, it is reported that the price of Vitamin C has tripled. Some natural health advocates insist that soon, common vitamins and herbs will be restricted and available in the United States only from a pharmacist and at very high prices. The rumors are fast and furious on the Internet and in the natural health community.There's talk of a global movement, spearheaded by international pharmaceutical manufacturers, to restrict access and increase prices on a variety of food supplements, vitamins and natural remedies. The facts, fortunately, are far less alarming. But there is indeed an international effort called Codex to standardize the dosage of some popular vitamins, including C, E and folic acid. And the worry is that if this effort is not watched closely, it could explode into something far more dangerous to the booming natural health industry. So, what is this Codex thing that's causing so much agonizing? What's filling all that space on the Web pages of American health agencies?Codex is a 151-nation United Nations commission set up in 1962 to establish regulations to safeguard health and standardize the international trade in food. Based in Rome, its full name is Codex Alimentarius, which is Latin for "food codes." In 1966 the Codex commission established a 38-country committee on nutrition and foods for special dietary uses hosted by Germany. Its brief is to examine several essential vitamins and minerals -- such as C, E and folic acid -- in order to develop safe, international standards for nutrients in food products bought and sold throughout the world. Contrary to some frantic Internet rumor, the committee is not studying amino acids, metabolites, herbs or botanicals. It is, so far, discussing only 12 nutrients that seriously influence the quality of human health.In the last 31 years there have been 19 meetings to deliberate on possible guidelines. Since, 1993, however, the commission began focusing on two specific areas that are responsible for all the present commotion. The first area under scrutiny defines what constitutes the upper limits of ingredient amounts in dietary supplements: in other words, what is the highest Recommended Daily Allowance (RDA). The second area attempts to restrict the use of essential vitamins and minerals by "not allowing any labeling information about therapeutic uses of certain of these supplements." That is to say, if a particular nutrient will "cure" or abate a disease, then it's a drug and subject to all drug restrictions.The Importance of VitaminsA central concern with both the responsible protesters and crisis-mongers is the commission's failure to recognize the importance vitamins play in modern health. Once upon a time, swallowing a multivitamin and following the old-style food pyramid was as involved as most people got. Megadoses of vitamin C, for example, were the stuff of fringe "health nuts." Even as recently as the '70's, doctors and nutritionists accepted -- and some still do -- that all the nutrients we need come from a good diet. But studies have long since debunked that naive assumption.Susan Hagar, executive director of Citizens for Health, a Boulder, Colo., watchdog group, asserts that a balanced diet is no longer possible. "In our current agricultural systems, the nutrients are not there any more," Hagar explains. "There's also pollution. These cause serious health losses" that need to be replaced with vitamin therapy. Another source reinforces the idea that vitamins are playing a new role in human health. Dr. John Hathcock is the director of Nutritional and Regulatory Science for the Council for Responsible Nutrition (the trade association for the nutritional supplement industry). He explains that RDAs of vitamins and minerals were never intended to be permanent upper limits or measures of safety."We feel it's important to set up limits based on recent science and a proper definition of safety limits," he explains. "We now know that folic acid taken in 400 microgram doses can prevent some birth defects. The 'official' RDA is 180. The same goes for calcium. Taken in larger portions than the RDA, it helps prevent osteoporosis." The essence of his argument is that with each new scientific finding, it gets more difficult for a governing body to codify what constitutes a "proper" dosage. "Last October," he relates, "I was able to get the committee to rethink their assessments. On the table, now, is how to define 'appropriate risk assessment,' or Recommended Daily Allowances."Codex is slow to changeBut the Codex committee is very slow to accept change. Hathcock thinks it's because the commission insists that basic nutrition is easily defined and standardized but that any nutrient used as large-dose "therapy" puts it in the realm of a drug which must be regulated. Is this reasonable?"The phrases we use now are 'acceptable intake' and 'upper limit,'" Hathcock says. "We feel we are setting upper limits based on recent science. Everyone likes to be right and lead people their way. Germany, being the host country, is comfortable with their way of doing business, and it's what shows in their [suggestions for] regulations," he says. The doctor's statement highlights another objection Americans hold.Some protesters are especially wary of the makeup of the European contingent to the Codex committee. The American side claims that Germany, France and Italy have "delegates" who aren't government-sponsored scientists or ethicists but representatives of huge pharmaceutical conglomerates. They point to the German Bayer Pharmaceutical Company as an example of ballot-box stuffing.But the Federal Drug Administration disputes this contention. "Show me the documentation," argues Dr. Robert Moore from the FDA's Office of Special Nutritionals in Washington, D.C. He's the alternate delegate from the United States to the Codex meetings. "The only people who have a vote or a voice are each country's delegate." Moore maintains that while pharmaceutical companies from both Europe and the United States are certainly at the Codex meetings, they don't have any vote, and "you will see the special interests groups from the supplement side far outweigh the number of pharmaceuticals." According to Moore, "Codex is trying to come up with a scientific level that can stand up to scrutiny."The Politics of Food SupplementsKarl Reidel, chair of the International Committee for the National Nutritional Foods Association in California, attended the June 1997 Codex discussion in Geneva. He observed a polarization. "There are six countries allied with the United States. They are Japan, South Africa, the Netherlands, New Zealand and Canada. Then, there are six European countries allied with Germany. The rest, mostly from Third World countries, are silent. They must be educated because most of these countries regard anything in pill form as a drug." Whatever the politics, the biggest bone of contention surrounding Codex is standardizing diet supplement strengths. Americans involved in the health business are spooked. Can a group of highly vocal and very powerful European pharmaceutical companies dictate to Americans what we can and cannot buy and use? And in what strengths? Most American Codex attendees accept that some standardization is necessary. For example, Reidel believes there are three positive results from codification: "It makes it easy for Third World countries to just adopt the standards, it improves world health, and it lowers the barriers to food trade."With generally agreed standards, Reidel points out, the United States can sell rice, wheat or even beer to other countries without grappling with arcane requirements at the border. Why have tons of wheat or rice sitting on a dock in Japan because our vitamin content is too high or too low to meet Japanese health requirements? Very few concerned groups argue with that angle. What they do contest are two other points.Drugs Supplements and PricesThe first is the idea that a European governing body decides what will effect U.S. laws. The second is the worry that if easily obtained over-the-counter supplements suddenly become a drug, the costs will go up exponentially with their inaccessibility. "The claims of the popular press [about these points] are not based on fact," Moore contends. "Codex is not binding on any nation. The U.S. cannot and will not implement a regulation that can change our laws." "Our" law is the 1994 Dietary Supplement Health and Education Act, which regulates dietary supplements as a special class of product. Any restriction enacted by Codex will have absolutely no effect in the United States. As a result, individuals cannot and will not be restricted from buying whatever supplement they need in the strengths they need. Where this issue could get sticky, however, is with our global trade. The United States is a partner in both General Agreement on Tariffs and Trade (GATT) and the North American Free Trade Agreement. Most of the countries participating in the Codex commission are also signers of at least one of these agreements.If a country like Germany or England accedes to the regulations which Codex could impose, then they may not be able to allow U.S.-manufactured dietary supplements into their countries. Our usual ally, England, is already between a rock and a hard place. They belong to the European Union and must accept Union decisions. If the Union likes what Codex eventually decides, then it will be difficult for England to continue to trade vitamins with us. Again, Moore questions this."GATT says you cannot erect a barrier solely to protect a local industry. You have to base it on impartial scientific regulations." In matters of international treaties, Codex dietary supplement regulations could be a protection, according to Moore.What's Happened in CanadaBut some worried watchdog agencies would question this. Canada, they say, is a perfect example of a country willing to surrender its sovereignty to remain in the global market. It appears that innumerable dietary supplements have been pulled from Canadian shelves since serious Codex discussion about vitamins and minerals has developed. But one Canadian nutritionist thinks appearances can be deceiving. Nutritionist Carola Barczak has been in private practice for 30 years in Toronto. She also teaches at both the Homeopathic College and the Naturopathic College in Toronto. Barczak acknowledges that the Canadian government has pulled dietary supplements away from consumers. Herbs such as cayenne and wild yam have been labeled drugs and given a Drug Identity Number (DIN). To Barczak these moves are not part of a worldwide conspiracy to control health. Rather, she sees it as strictly an in-country revenue-grabbing scheme. "To manufacture these herbs, now, you must apply for a DIN. This costs money, often thousands of dollars, and the company must renew the DIN regularly. More money for the government. Canada's government always needs money."This change in status from dietary supplement to drug has been going on since 1980, when Canada established the Natural Product Section of the Health and Protection Branch (equivalent to our FDA). This section removed comfrey and feverfew, then cayenne, ginkgo and St. John's Wort from the market. "All that's left for depression and menopause are Prozac and Premarin -- real drugs," Barczak points out. She contends that, in Canada at least, the changes have nothing to do with Codex and everything to do with greed and the aging baby boomer generation. "By the time the boomers get geriatric," she maintains, "the Canadian drug industry will control the whole thing either with drugs or vitamins." Whether it's a government working to control its own population or an international body hoping to enhance worldwide nutrition, nothing about Codex is simple. Barbara Gerber of The Marketplace whole food grocery store in Santa Fe reflects the complexity."It's hard to know who to believe or who to trust. But if new supplements could be banned if they don't conform to Codex regulations, it would hit the industry hard," Gerber said. Herbal consultant Sandy Anderson said she's been hearing of the Codex meetings for some time. Then "a customer came in with a fax which was pretty scary." Another customer came to her with a petition for everyone to sign -- the Internet was broadcasting the "fact" that the U.S. had only 10 days to act before the Codex regulations became law in this country."That's the level of information out there. ... People need to stay alert, but do more research," Anderson Said.How Codex will workEven the Codex decision-making process is not as simple as alarmists would have us believe. Basically there is an eight-step process before any regulation becomes standard practice, and nothing is decided until the committee has full consensus. The commission has been wrangling with these particular dietary supplement issues since 1993. So far, committee discussions are at Step 3. In June of this year the German contingent tried to steamroll their definition up to Step 5, but they were refused by the Codex commission. "This is good," Reidel maintains. "Now, the list of ingredients must be re-negotiated and rediscussed. When they reach consensus, it will be presented at the next meeting in October of 1998." If it's taken four years to get to Step 3, and even Step 3 isn't fully accepted, then there's a very long way to go before there is any serious resolution. Further, if laws were ever to change in this country, there's a very long process involved. First any proposed changes to federal law must be published in the Federal Register. Then, the FDA would have to accept all public comment on the issue and consider the input before publishing a final ruling. Hagar agrees."The FDA needs to meet a lot of provisions before it can pull a supplement off the shelf or change a law," She said. What everyone with real clout in this contentious issue agrees on is that irresponsible crisis-mongering on the Internet serves no one's interest. It will be literally years before even the basic wording of international standardization reaches a full consensus of both the Codex dietary supplement committee and the Codex Alimentarius Commission. In the meantime, we should all be aware of the implications of these issues. As Santa Fe environmental physician W.A. Schrader observes, "There are tons of stuff out there which show that vitamins do a lot of good ... and there's very big money behind the European pharmaceutical companies. But we all need to know more."