by Bill Sardi
The U.S. Food & Drug Administration? Nope.
The National Institutes of Health? Nope.
The National Research Council/ National Academy of Sciences? Nope.
How about foreign dictocrats at the United Nations and the World Health Organization? Yep, and it's all being done under the name of free trade "harmonization," in a so-called attempt to preserve U.S. vitamin manufacturers sales to foreign countries.
According to guidelines just released by the U.S. CODEX delegation, as part of treaties under the General Agreements on Tariffs and Trade (GATT), which would be binding upon all members of the World Trade Organization (WTO), foreign "experts" would dictate to American companies the maximum amount of vitamins and minerals that can be placed in food supplements. Foreign manufacturers could challenge the WTO that more potent U.S.-made brands represent unfair competition. Since many foreign countries already restrict the dosage of vitamins and minerals in food supplements, the new guidelines are likely to be used to water down the dosage of U.S-made brands so that foreign companies can compete with U.S. manufacturers.
Currently, many foreign travelers covet U.S.-made food supplements and bring them back to their native lands because of their high quality and maximum dosage. This would all change under the guidelines just released by the U.S. CODEX delegation (July 2002). U.S. food supplement manufacturers would likely lose their prime position in the world marketplace. Oddly, CODEX claims its guidelines have been drafted to protect U.S. manufacturers and consumers.
CODEX Guidelines Legally Binding
The CODEX guidelines, while voluntary for the moment, are potentially binding. Some three years ago The Center for Science In The Public Interest (CSPI) submitted written objections concerning CODEX guidelines which could be used to weaken food safety laws in the U.S., such as permitting products with undesirable trans fatty acids to be labeled as "low fat foods," forcing un-Pasteurized milk on U.S. consumers and allowing imported bottled waters to be labeled as "mineral water" when they provides less minerals than tap water. [International Harmonization of Food Safety and Labeling Standards, Center for Science in the Public Interest, June 1997] CSPI cited numerous international trade agreements and codes which could be used to enforce standards upon U.S. manufacturers of food products and now on food supplements. The WTO's Dispute Settlement Body could impose trade sanctions on industries unrelated to food supplements which could cause Congress to buckle and give in to restrictions on food supplements.
Upper Limits Being Established
CODEX guidelines attempt to establish upper limits on the dosage of food supplements. "Upper limit" is defined as "the maximum level of daily nutrient intake that is unlikely to pose risks of adverse health effects to almost all of the individuals in the group for whom it is designed." While the upper limit on vitamins appears to be established to protect consumers from potential side effects from over-dosage, the very establishment of maximum dosage would likely be misunderstood by the public. Food supplement companies would be required to list the maximum dosage permitted on their labels and would be compelled to limit the actual recommended dosage of vitamins and minerals. Printing upper limits on food supplement labels would likely scare many consumers away from these products. Consumers may falsely believe the maximum level is the toxic level and consume much smaller amounts, fearing serious side effects. But the upper limit would have a built-in safety factor many times below any toxicity.
Furthermore, many of the reported side effects from mega-dose vitamins and minerals are often transient (such as diarrhea), non-life threatening (such as headache) and are reversible. But U.S. consumers would have no way of determining the severity of any potential side effects. A maximum dose limit on a particular supplement may help prevent something as innocuous as nausea occurring in a small percentage of subjects.
False Assumption Of Safety
Another false assumption that could emanate from the establishment of upper limits is that food supplements are safe when taken in dosages below the maximum limit. Actually, minerals such as iron, taken in doses under the proposed maximum limits, could pose long-term problems for unsuspecting consumers. For example, full-grown males and post-menopausal females should avoid supplemental iron.
Another Non-Problem That Needs Fixing
Yet another criticism of the CODEX guidelines is the false assumption that there are thousands of cases of serious side effects emanating from over-dosage of food supplements and that the public needs immediate protection. The U.S. CODEX delegation approved language that mistakenly cited selenium and vitamin A could harm consumers when consumed in large amounts. In fact, never have vitamin A or selenium supplements ever been reported to cause a death and only a few reversible side effects. While only some 30 to 40 adults annually experience liver toxicity from taking excessive amounts of vitamin A, the FDA continues to warn adults of vitamin A toxicity when millions of Americans suffer frank deficiencies of this vitamin.
Vitamin and mineral supplements are far safer than aspirin and ibuprofen (which cause thousands of cases of stomach ulcers and death from hemorrhage annually), acetaminophen (causes 70,000+ cases of liver toxicity annually and a few hundred deaths yearly), chlorinated tap water (causes 20,000+ new cases of bladder and kidney cancer annually), table salt (contributes to millions of cases of hypertension that can lead to strokes), and aspartame artificial sweetener (produces thousands of reports of adverse effects annually), all which are over-the-counter items like food supplements.
Take Only On The Advice Of An Expert
Another guideline proposed by the U.S. CODEX delegation is to require labeling that would urge consumers to take supplements only on the advice of a physician, dietician and nutritionist. In the past, at the statewide level lobbyists for certified clinical nutritionists have unsuccessfully attempted to restrict store clerks from advising people on the use of food supplements, a restriction that may violate the freedom of speech. Yet the U.S. CODEX delegation included this provision in its recent guidelines.
Is A Good Diet All You Need To Stay Healthy?
The CODEX Draft continued to spread the mistaken idea that all the public needs to maintain health is a good diet. While food supplements do not replace meals, still less than 1 in 5 Americans consume the recommended five to seven servings of fresh fruits and vegetables daily. An estimated 8 in 10 Americans are short on magnesium, 4 in 10 are deficient in vitamin D and vitamin B12, and virtually all humans suffer from a genetic mutation that blocks the natural conversion of blood sugars into vitamin C that most animals exhibit.
Many Americans may still remain deficient in essential vitamins and minerals even when taking these nutrients at the maximum recommended dosage. For example, because of their dark skin pigmentation, blacks may be deficient in vitamin D, especially blacks who live at northern latitudes (ultraviolet sun rays produce vitamin D via skin exposure). They may experience diminished immunity and weakened bones. The proposed upper limit for vitamin D, 2000 units, may not be sufficient for blacks living in cloudy northern climates during the winter months. Currently the FDA restricts the dosage of vitamin D in food supplements to 2000 units over unfounded fears of liver toxicity when a recent study showed vitamin D toxicity doesn't begin till 40,000 units are consumed daily over a long period of time.
Costs Would Rise
If upper limits on food supplements are established then consumers who still want to consume higher doses of certain supplemental vitamins or minerals would be required to take more pills which would of course raise the cost to consumers.
CODEX Disregards Congress
In 1998 Congressman Ron Paul wrote the U.S. Food & Drug Administration, which provides the impetus for CODEX, to withdraw portions of the proposed CODEX guidelines which committed the United States to adoption of upper safe limits on vitamins and minerals, reminding the FDA that Congress explicitly forbid the FDA from harmonizing any of its regulations regarding food supplements with other countries. Instead, the FDA and the U.S. CODEX delegation disregarded the wishes of Congress and moved ahead with the CODEX guidelines which were recently re-released with edits (July 2002), but still contained provisions for upper limits and other restrictions.
Vitamins have been a hot political issue in the past. More letters have been received by Congress on vitamins than any other issue on Capitol Hill. It's time to the public to pull out their pens once again.
August 19, 2002
Copyright © 2002 Bill Sardi Word of Knowledge Agency, San Dimas, California. Not for commercial reproduction without permission of the author.