Are the American people going to be forced to accept the provisions of Codex? Is this a looming reality?

The dietary supplement industry is in trouble because the FDA harbors an unscientific bias against supplements, principally arising from its desire to protect the agency’s foremost regulatee, the drug industry. I remember when folks were arguing that the GMPs were a good idea because industry leaders had connections with FDA and could assure that the agency would not abuse its power. The dietary supplement industry has never had a very effective lobby and is a Lilliputian compared to the Leviathan drug industry. I have often used the following metaphor to describe the power triangle at work. The drug industry is like an enormous elephant, and the FDA is like a blind jockey atop the elephant incapable of altering the elephant’s course. The dietary supplement industry is like a flea on the elephant. So long as the flea does not irritate the elephant, everything proceeds smoothly, but as soon as the flea causes irritation, the elephant signals its displeasure and the blind jockey whacks about the surface of the elephant with his riding crop until he nails the flea. Some in the trades and in the dietary supplement industry have an inflated view of their influence over FDA. The drug industry they are not, and to the drug industry they are entirely beholden for any regulatory crumb that falls off that industry’s table.




RAPPOPORT: Many commentaries about Codex have circulated on the Web over the past decade.



What is Codex and what is its goal, vis-à-vis nutritional supplements?



Are the American people going to be forced to accept the provisions of Codex? Is this a looming reality?








EMORD: The Codex Alimentarius Commission is an organization of the United Nations Food and Agriculture Organization and the World Health Organization. It is a standard setting body. The standards it adopts each member state is expected to implement or, if not, to explain why it has chosen not to do so. If the failure to adopt a standard caused a member state to discriminate against imports, that state could be challenged for its failure before the World Trade Organization. More commonly, however, the Codex Commission serves as a forum for member states to exercise influence over one another in the adoption of domestic standards governing the availability of dietary supplements and the dose levels in the market. By adopting a standard, as Codex has done, recommending that member states determine whether vitamins and minerals are safe at particular dose levels and ban them at dose levels not determined safe, the Commission places the onus on members to implement regulatory regimes based on dose and, implicitly, on the government-preferred precautionary principle. That has encouraged the development of extensive EU prior restraints on the availability of dietary supplements in the market and has advanced the European attachment to and advocacy for the precautionary principle as the best means to assess toxicity. In short, Codex has become a coercive force in favor of restrictions on dietary supplements and what can be said [what health claims can be made] about them.



The U.S. Food and Drug Administration admires the European system of controls and can alter its interpretative construction of existing regulations to “harmonize” the American model more closely with the European model of regulation. U.S. delegates to Codex should be opposing the movement toward greater restrictions on supplements and claims. Instead, they quietly acquiesce in those restrictions and work toward effecting similar restrictions within the United States through reinterpretation of existing agency rules.



RAPPOPORT: What can you tell us about the legal status of nutritional supplements in Europe? Is the EU really destroying the public’s right to buy a wide range of nutrients? What’s the situation? Are there serious implications for America?



EMORD: Under the European Union Directive governing dietary supplements, no dietary supplement is legal to market without first being found safe and bioavailable by the European Food Safety Authority [EFSA]. Moreover, no claim—not even structure/function claims—concerning health effects of a dietary supplement may appear on labels, in labeling, or in advertising of a dietary supplement in Europe without first being approved by EFSA. This massive system of prior restraint has imposed a nutrition Dark Age on Europe. As the EFSA determinations continue to be enforced by the EU member states, hundreds of products that had been safely consumed for decades will be removed from the market. Also, claims will disappear, leaving Europeans in the dark as to the potential of nutrients to affect health and disease.



This system is a form of Lysenkoism or state created orthodoxy over science. It is dumbing down the European market and removing from it health enhancing substances. In the end, there will be a rise in age-related diseases for which risk is diminished by supplementation, such as cancer and cardiovascular disease. EFSA will be responsible for creating a very unhealthy environment all in the guise of protected European consumers from anything less than certain science.



In truth almost nothing in science is certain; nearly everything is inconclusive, yet we make decisions every day based on the inconclusive science—based on personal bets on the extent to which we think evidence of association [is] correctly indicative of ultimate outcome. Remove from us that evidence of association by force of law and we become incapable of making informed bets.



EU censorship of all information in the market not proven conclusively true necessarily censors information on nutrient-disease relationships that will in time be proven true. That present censorship will cause those who would bet on the ultimate truths to be denied the opportunity of guessing right and, thus, they will lose out in potentially fatal ways.



That is precisely what happened to the FDA. We sued the FDA when it refused to authorize a claim associating folic acid with a reduction in the risk of neural tube defects [NTD]. FDA took the position that the association had not been proven that folic acid containing supplements could reduce NTD risk. FDA censored the information for some six years, contributing to over 2,500 preventable NTDs each year and to countless NTD related abortions. We ultimately defeated FDA’s censorship in Pearson v. Shalala. That then led in time to FDA allowance of the claims when we beat the agency a second time for refusing to permit the claims. The result has been a steady reduction in the incidence of NTDs in the United States as more and more women of child bearing age learn of the need to take folic acid supplements containing 400 (and preferably 800) mcgs each day before they become pregnant.







What will the scientists within EFSA think of themselves if five, ten, twenty, or more years from now proof positive arises that certain nutrients they have condemned are associated with significant reductions in the risk of cancer and cardiovascular disease such that tens of thousands of Europeans could have lived had they been given market access to information concerning the association years prior?












The EU ban on supplements and supplement claims (unless pre-approved by EFSA) is now in place. EU depends on its member states for enforcement. Each state is variously engaged in enforcement with some using more aggressive methods than others. Over the next several years, however, we can expect to see crack downs in each of the member states with products being removed from the market following each crack down. For Part two click below.