By Gregory A. Hession, J.D. | The John Birch Society | Jan. 25, 2008

In the endless war between liberty and government regulation, we have an opportunity to win an important battle, one that will promote the health of Americans. This one is over the freedom to choose one’s diet and food supplements, and the opponents are a formidable assemblage of world powers: the U.S. Food and Drug Administration, the European Union, groups pushing for a North American Union, and the large international pharmaceutical companies. The ringleader is an obscure, but powerful, United Nations bureaucracy with the curious moniker of “Codex Alimentarius.”

This battle has been conducted quietly around the globe, without much media attention or input from Americans, other than those in the nutrition field. However, it has far-reaching consequences for the health of our citizens, in that these groups seek to heavily regulate the availability of vitamins and herbal supplements, and to radically lower their potencies.

The European Union has already enacted severe restrictions on the nutrients that can go into supplements. The UN’s Codex Alimentarius group has recently followed suit, aided by aggressive multi-national pharmaceutical companies. The World Trade Organization (WTO) and other groups can now force compliance with the new standards. And in this hemisphere, an obscure trade agreement between the United States, Canada, and Mexico, called the Trilateral Cooperation Charter, could usurp our food and supplement laws even further.

No widespread problems plague the supplement industry, but the UN and European regulators, along with the FDA, are intent on looking for them and fixing them anyway. Groucho Marx was surely thinking of agencies like these when he quipped, “Politics is the art of looking for trouble, finding it everywhere, diagnosing it incorrectly, and applying the wrong remedies.” What follows is a tour through the maze of government and supra-government organizations that intend to regulate food and supplements for the entire world.

What Is Codex Alimentarius?

Codex Alimentarius is Latin for “food code” or “food book.” It is a global United Nations agency, comprised of member states, which establishes international quality standards for food and food products. It was created in 1963 by the UN World Health Organization and the UN Food and Agriculture Organization (FAO).

The Codex Alimentarius Commission (Codex) is located in FAO headquarters in Rome, and is actually a fairly small bureaucracy. Its stated purpose is to protect consumers and to promote fair practices in the trade of food. To that end, it issues hundreds of standards covering thousands of food products. Two dangerous trends by Codex now converge to the detriment of the consumer — adoption of a new political, rather than scientific method of determining food supplement standards, and newfound power to enforce these standards on member states.

As to Codex’s power, its decisions started out as voluntary and nonbinding on member states, and were intended merely to create a uniform set of standards to facilitate international trade. As often happens, the regulators increased their control and coercion by means of World Trade Organization agreements, which were now binding on all countries including the United States. We are now bound to honor all Codex standards as law, at the risk of multilateral retaliation from our trading partners.

Even a reliably establishment publication like the New York University Law Review has noted this intensifying coercion by Codex with alarm. In a May 2006 article entitled, “Authority and Legitimacy of Global Governance: Deliberation, Institutional Differentiation, and the Codex Alimentarius,” it notes that WTO restrictions now give the Codex “coercive authority for the first time.” This happened when it changed from a “forum for the discussion of scientific information and best practices,” to a new regime of “embedding Codex standards in the system of rules and incentives of the WTO.”

The second disturbing trend by Codex is its effort to impose a new paradigm of “risk management,” to drastically reduce the quantity of nutrients allowed in regulated supplements. In July 2007, the commission met in Rome, Italy, and passed these new risk-management proposals in a rush. Scott Tips, an attorney and president of California-based National Health Federation, the only “health freedom” organization allowed to participate in the Codex meetings, was at the Rome meeting. He reported:

Heaping platefuls of Codex standards and guidelines were advanced to their final stages as if starving people were gathered around a banquet table.... Chairman Claude Mosha was most definitely a man on a mission. And that mission was to take that hill,... with the hill being a pile of standards and related texts submitted by the various Codex Committees for approval by the Commission itself. Attacking the pile like a man possessed, the Chairman considered each standard passed up from the committee level for adoption here only long enough to pronounce the words “adopted,” so that he could then move on to the next standard for its approval.

The standards and guidelines passed by the Codex Commission impose severe restrictions on nutrients in food supplements, and will find their way to our country. The solution to restore our sovereignty would be to get out of the WTO, but that would disrupt the internationalist juggernaut which is determined to homogenize all world trade.

EU Winning the Regulatory Race

When the Codex Commission took up its voting frenzy on supplement standards, the European Union had already beat it to the punch by several years. The EU is becoming the international standard of regulation in the marketplace, including food and supplements. A September 20, 2007 article in The Economist, entitled “Brussels Rules OK — How the European Union Is Becoming the World’s Chief Regulator,” argues that the EU (based in Brussels, Belgium) is becoming the world regulator that other countries — and Codex — now look to and emulate.

The European Parliament beat Codex by years when it adopted the European Directive 2002/46/EC relating to food supplements on June 10, 2002. That directive started the process of harmonizing the rules of the member EU nations for food supplements and restricting their contents.

The new EU model is based on the hyper-cautious theory of “risk management,” in contrast to the American model of cost-benefit analysis. It sets maximum permitted levels of various nutrients, based on a quasi-scientific process, with the goal of avoiding any risk to any person under any circumstances who takes a supplement. Rather than vary the recommendations for age, sex, sensitivities, and type of ailments, the EU applied an unscientific one-size-fits-all approach.

The standards set by these regulations are considered wholly inadequate for human health by many nutritionists and scientists. An October 27, 2007 report from the Alliance for National Heath, entitled “Proposed European Model for MPL’s Not Fit for Purpose,” illustrates these unrealistic limits. For example, the regulated upper limit of beta-carotene is 2 mg — less than half the 4.7 mg of beta-carotene contained in a single carrot. The upper limit for selenium is one-fifth the amount contained in a single Brazil nut. Vitamin C limits are set at 225 mg per day, whereas many nutritionists recommend at least 10 times that amount.

The Codex regulations passed last July, referenced above, injected the EU “risk management” model into the Codex rules. They have already affected retailers in Europe, and are now changing the supplement business in America. Jonathan Evans, business representative of the Herbarium, an herb and supplement retailer in Chicopee, Massachusetts, who also maintains business ties in Ireland, says that retailers there lost the majority of their supplements after the 2005 EU regulations went into effect. He has already noticed downward potency changes in many of the products that his store handles, although the law does not mandate it.

FDA Partnering With Codex

The FDA is also joining the EU and Codex in their worldwide regulation of supplements. The FDA brags on its website that it regulates the sale of a trillion dollars, worth of products a year, accounting for 25 cents of every dollar spent by American consumers, including food, cosmetics, medicines, medical devices, pet food, and drugs. The FDA is responsible for regulating these products in the public interest, but politics and business often play a role in its stance on issues like supplements.

The FDA is set to follow the European and UN pattern of multi-national coercion, if it is not stopped. The FDA has a Codex office, with a separate web page to tout progress toward merging our laws with those of other countries. One of the FDA’s standards, published in the Federal Register, declares that “where a relevant international standard exists, or completion is imminent, it will generally be used in preference to a domestic standard.” The FDA will apparently default to standards used elsewhere, rather than develop its own standards based on America’s needs.

Congressman Ron Paul (R-Texas), who has consistently opposed the loss of health freedom, stated on July 19, 2005, “[The] FDA and Congress are also working (FDA quite openly, Congress more covertly) toward the goal of harmonizing our health laws with Codex Alimentarius standards and guidelines.”

However, there is a legal obstacle to the plans of the international regulators. In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA), a law which protects dietary supplements, including vitamins, minerals, herbs, enzymes, and other similar substances, from the intensive regulations and testing imposed on prescription drugs. DSHEA also allows potencies and label claims that would never be otherwise tolerated in the European or Codex models. Big Pharma and the international regulators have this law in their sights and want to eliminate it.

In his July 2005 remarks, Congressman Paul also stated: “Make no mistake about it: those international standards are moving steadily toward the Codex regime and its draconian restrictions on health freedom. Pharmaceutical companies have spent billions of dollars trying to get Washington to regulate your dietary supplements. So far, that effort has failed, in part because of a 1994 law called the Dietary Supplement Health and Education Act. Big Pharma and the medical establishment hate this Act, because it allows consumers some measure of freedom to buy the supplements they want.”

Byron J. Richards, a Certified Clinical Nutritionist in Minneapolis, Minnesota, and author of Fight for Your Health: Exposing the FDA’s Betrayal of America, concurs. He asserts that the FDA has worked on behalf of the big drug companies to gut DSHEA and has pushed to treat supplements as drugs, with all the same expensive and time-consuming regulation. His close scrutiny of the situation has convinced Richards that the FDA is trying to set up Codex standards as the legal rule in the United States.

U.S. Joins in Regulating Supplements

In February of 2004, the food and drug regulation agencies of the governments of the United States, Mexico, and Canada put together a virtually secret tri-part union between the three countries, called the “Trilateral Cooperation Charter,” to jointly regulate “drugs, biologics, medical devices, food safety and nutrition.” This happened without the legally required U.S. Senate approval for a treaty. The FDA website devoted to this pact displays the flags of all three countries, and urges collaboration and harmonizing of positions. If that happens, our supplement industry will be threatened because Mexico and Canada already heavily regulate dietary supplements and vitamins as drugs. If this treaty is enforced, it will eventually challenge our sovereignty and void the protections in our DSHEA law.

The Trilateral Cooperation Charter is likely designed to work within the “Security and Prosperity Partnership” framework instituted by the same three North American countries in 2005 in order to harmonize other aspects of our culture and economy.*

Do Americans Need Supplements?

Recent government and pharmaceutical industry efforts to restrict availability and potency of nutritional supplements are harmful to those who need these products. Supplements demonstrably aid optimum health, by providing needed nutrients depleted by the stresses of modern life, by environmental degradation, by nutrient-stripped soil, and by the use of manufactured foods in place of natural ones, says Byron J. Richards.

The use of supplements has gained mainstream acceptance to treat many illnesses and conditions. Bill Nagler, M.D., a nutrition and weight loss doctor, author, and president of Diet Results in Livonia, Michigan, states that supplements often work better than prescription drugs for many applications. Most Americans are seriously nutritionally deficient, he says, which leads to more infections, digestive disorders, cancer, excess weight, arthritis, women’s problems, and chronic fatigue. Proper dietary supplementation has reduced the incidence of these ailments considerably for his patients. Richards agrees, suggesting that supplements prevent and heal many diseases by supporting the body’s own ability to repair and recover health.

Will It Happen Here?

The dietary supplement industry has become a $182 billion global market and a growing $20.3 billion U.S. market, so it can no longer be considered an “alternative” health business.

The trend toward internationalization of our health and supplement industry is becoming more visible, while the FDA continues to tighten the screws on American manufacturers. Byron Richards explains that an industry bombshell lurks in a recently issued 800-page FDA “rule” about good manufacturing practices for dietary supplements. The report admits that up to 50 percent of smaller manufacturers may go out of business under its strictures. The larger companies, some of which are owned by pharmaceutical giants, can afford to comply with its complex regulations. The FDA wants to have fewer players to regulate, and the drug companies want less competition, according to Richards.

Certain vitamin and mineral products which Jonathan Evans has sold at his store, the Herbarium, for years are already being formulated in the lower potencies. These doses are far less than what is needed for optimal health, according to Dr. Nagler. For example, he says that the new vitamin D standard of 400 I.U. per day is “grossly deficient,” and that inadequate intake of vitamin D is the worst nutritional deficiency in America right now. According to Dr. Nagler, studies show that low doses of that vitamin are linked to increased rates of cancer, arthritis, depression, fatigue, fibromyalgia, and multiple sclerosis. Some vitamin D can be obtained from the sun, but not enough, he says, especially in northern areas. Dr. Nagler insists that daily intake of tens of thousands of I.U. are needed for good health, not the tiny standard amount imposed by the regulators.

All efforts at regulation, whether by government or private efforts, are subject to manipulation, negligence, or inconsistency. As with virtually every aspect of human existence, freedom, education, and self regulation work better than government fiat. The question now becomes whether we will formulate our vitamin, mineral, and herbal supplements through good scientific research, based on nutritional needs, or by political fiat. With enough outcries from consumers, Congress and the FDA may stand against the hijacking of our supplement industry by forces of global food imperialism.