In July of 2005, the Chair of Citizens for Health' Board of Directors, Jim Turner, joined the U.S. Codex delegation in a trip to Rome. Jim sent back these reports.
July 12
The Rome 2005 Codex Supplement Guidelines Aftermath: Risk and Opportunity
Washington, DC, July 12, 2005: The 2005 Rome Codex meeting ended early Saturday afternoon, July 9. Delegates took Friday off, as the Codex Secretariat prepared definitive drafts of the four days of deliberations for final official Saturday approval. During the half-day Saturday meeting, the parmesan cheese standard took the largest amount of time while the vitamin and mineral guidelines and the WHO/FAO initiative to create a bigger role for nutrition in future Codex guidelines drew barely a notice. FAO/WHO reported the supplement guidelines approval:
“The CAC adopted global guidelines for vitamin and mineral food supplements as one of its first decisions. The guidelines recommend labeling that contains information on maximum consumption levels of vitamin and mineral food supplements, assisting countries to increase consumer information, which will help consumers use them in a safe and effective way.
”According to WHO, the guidelines ensure that consumers receive beneficial health effects from vitamins and minerals.
”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.”
The vitamin and mineral guidelines, while not overriding national legislation, provide national governments with a blueprint for domestic vitamin and mineral regulation which is much more restrictive than American dietary supplement law. The restrictions in the guidelines create a risk for supplement consumers worldwide. As nations begin adopting laws consistent with the guidelines to avoid losing international trade disputes, there is a risk that the world market in supplements will sink to a lowest common denominator of a relatively few low potency products. As the market contracts around such limitations, pressure will mount on the U.S. to adjust its law to the international standard. The American supplement industry advocates of the international Codex guidelines say they will resist such pressures but, critics fear, they have little commercial incentive to do so.
The industry Codex advocates assert that consumers and manufacturers worldwide will benefit from adoption of the guidelines, because they require acceptance of science as a rational approach to setting upper intake limits, create freedom of trade for the industry, and increase freedom of choice for the public. This might turn out to be true for countries such as Greece, Norway, Spain, or France, which currently significantly restrict dietary supplement products. However, countries just beginning to establish dietary supplement regulations will be inclined to adopt the Codex standard rather than laws similar to the much less restrictive U.S. Dietary Supplement Health and Education Act (DSHEA).
In response to this concern, industry guidelines advocates argue that it could have been much worse. They site maximum levels of nutrients set on the basis of safety evaluation through risk assessment as far superior to maximum levels set the basis of Recommended Dietary Allowances (RDA), as called for in the original proposed Codex guidelines. The population reference intakes (PRI) and RDA, they point out, are based on nutritional need, and are not scientifically valid for assessing safety and setting maximum levels of intake. The current guidelines also treat supplements as food and minimize the impact of the precautionary principle, which blocks products from marketing until proven safe even if there is no suggestion of harm. These are significant accomplishments. However, the cost for these successes is enormous.
Under the Codex guidelines, vitamins and minerals will be evaluated for safety as if they were toxic chemicals. Nothing prevents the unbridled use of this approach from discovering very low safe upper limits (it is technically possible, though unlikely, that they could even, in some instances, be lower than the RDA). Fifty years of U.S. legislative and judicial determinations, culminating in the passage of DSHEA, oppose this concept. The opposition often had to overcome the repeated and shrill objections of the U.S. Food and Drug Administration. It appears to critics of the Codex guidelines that, having failed domestically, the U.S. FDA now hopes to get the international community to treat nutrients as poisons. The critics point out that a senior FDA official supportive of treating nutrients as toxins has taken FDA leave in order to run the Codex-supported toxicological review of vitamins and minerals. The critics find this fact troubling. Industry supporters of the guidelines say they will stand firm against unfair treatment of nutrients as toxins. A battle looms.
In addition to the battle over safety standards, supplement guidelines critics support the FAO/WHO observation that Codex must do more to include nutrition standards in its commercial trade guidelines. In this context, supplement advocates, while opposing the use of improper standards for the safety evaluation of supplements, support the role of dietary supplements in the campaign to end world hunger and promote world health. They point out that researchers have shown that $1 of vitamin A supplementation equals $30 of development aid. They argue that similar results are likely for all essential vitamin and mineral supplements but that the Codex guideline could make it more difficult to achieve these benefits. This position is one they believe is not antithetical to supplement industry interests. The dietary supplement community of consumers, producers, researchers, sellers and others could play a leading role in the FAO/WHO contribution to the global effort to end world hunger. This appears to be a position that the manufacturers who support the current guidelines could embrace.
During the first day of the Codex meeting’s five minute supplement guidelines discussion, China, while not objecting, gave a glimpse of the unfolding discourse. It stated that every government, in making decisions about vitamins and minerals, should be allowed to take into account the dietary limitations of their own countries, that governments be allowed to select vitamins and minerals according to the customs and habits of their country, and that definitions of the sources of vitamins be permitted and publicized. This is not the way the Codex guidelines envision the international supplement trade unfolding. International trade rules permit a country to diverge from an international standard if it has a sound scientific basis to do so. It is possible that some countries—possibly China?—might diverge from the guidelines in way more supportive of dietary supplements than is Codex.
The road out of Rome runs between the Palatine, the hill from which Romulus and Remus launched the Roman adventure, and Claudius’ palace, overlooking the Circus Maximus. Authorities removed the final remains of 2005’s Live8 Roma from Circus Maximus on Wednesday. FAO world headquarters sits at the bottom of the hill, cattycorner from Claudius’ palace and the Roman Forum. This was the center of the Roman Republic. A banner on the side of the FAO headquarters invites each individual to become a partner with FAO in ending world hunger.
July 6
Supplement Activists Assess Codex Strategies Going Forward
by James S. Turner, Esq., Board Chair, Citizens for Health
Rome, July 5, 2005: After the second day of Codex Commission Rome meetings, in a room provided by the US Codex delegation, fifteen North American and European advocates for the consumer right to dietary supplement choice met and explored several possible avenues of action to blunt the impact of the Commission’s approval of restrictive vitamin and mineral trade guidelines. While the guidelines are the first step toward worldwide restriction of dietary supplement access, they have only indirect impact on national supplement regulation until adopted by national governments.
This reality, the advocates suggested, opens several opportunities for action to limit the damage the guidelines will cause.
First, direct steps can be taken to limit the reach of the Codex guidelines. At the national level, non-restrictive legal alternatives to the Codex guidelines can be offered to countries, particularly those in Africa and Asia, establishing new laws on dietary supplements.
Several of the activists present agreed to begin development of a model international guideline supported by legal and scientific memoranda that allow it to meet international standards. Activists reported that a number of developing country representatives expressed private sentiments that were less than happy with the Codex guidelines. A movement to spread an expansive vitamin-mineral guideline could blunt the limitations contained in the Codex guidelines. International consumers and consumer groups could be mobilized, the activists believe, to advance such an effort.
Second, the structure of Codex itself can be brought under scrutiny.
The FAO and WHO governor generals' representatives to the Codex meeting delivered surprisingly critical comments from the dais during a discussion of the Codex budget. The FAO representative said the agency had provided Codex with double its usual amount of money in the last few years, hoping to get a greater emphasis on problems of food and health. FAO is still waiting for a return on this money, its representative said. The WHO spokesperson urged Codex participants to get more involved with the health initiatives of their home countries. There is, she said, virtually no visibility of or interest in Codex shown at the World Health Assembly, the WHO governing body. If Codex does not address the near absence of health considerations in its guidelines, its budget could begin to dry up.
Third, supplement industry leaders taking pleasure in the adoption of the guidelines may have joined a sinking ship. The FAO and WHO spokespersons not only urged more emphasis on health from Codex and underscored growing budgetary pressure, but also spoke of Codex as a child of the FAO/WHO parents. They sounded almost ready to cut it loose to survive on its own. A consultant’s study of Codex commissioned by the "parents" in 2001 raised a number of tough questions about the viability of Codex and urged a set of serious reforms that Codex is attempting to implement.
In this context, the successful effort of the supplement industry to eliminate Recommended Dietary Allowances (RDAs) as the upper limits of available vitamins and minerals, to block the application of the precautionary principle (which prohibits the use of a substance until science proves it safe) to vitamins and minerals, and to get an international standard that treats vitamins and minerals essentially as foods rather than drugs is something of an achievement for supplement consumers. It does not, however, according to the activists, truly protect the rights, the desires and the health of dietary supplement consumers. The low upper limits and poor quality of product envisioned by the guidelines will undermine consumer health, according to the activists.
Because it will take time to implement the guidelines, a major opportunity to change the direction of the guidelines exists.
As one supplement business leader put it, "there are no Codex numbers for anything in supplements at this time (and none likely for the next few years)." In the time it takes for the FAO/WHO project on nutrient risk assessment to develop an internationally agreed method to establish upper intake limits for vitamins and minerals, it may be possible, the activists think, to change the equation. The toxic chemical approach being taken by the risk assessment project is highly expensive and will discover few if any vitamin, mineral and other dietary supplement safety problems. At the same time, if successful, it will set back efforts to end hunger, eliminate nutrient deficiency and advance health.
In short, the effort to establish upper intake limits on nutrient supplements, activists believe, is scientifically inappropriate, excessively expensive and counterproductive to individual, national and WHO and FAO objectives. Therefore, it should be possible to mount a successful campaign directed at the industry, national governments and FAO/WHO leaders The goal of such a campaign would be the recognition that the inappropriate toxic-chemical review adopted in the new Codex guidelines should be replaced with a nutrition-science program that will be less costly, more health producing and hunger eliminating and will create a robust, diverse international market for dietary supplements and dietary supplement health information. Such a program would bring income to business, health to consumers, budget surpluses to countries and fulfillment of FAO/WHO goals.
If Codex were to embrace such an approach, it might become a leader in, rather than a barrier to, the use of new knowledge to end hunger and expand health. If Codex fails to take on this task, others will, possibly with some better spent FAO/WHO money.
The activists ended their three hour meeting in a much more optimistic frame of mind than they
began.
July 5
“The Struggle Begins”
by James S. Turner, Esq., Board Chair, Citizens for Health
Rome, July 4, 2005: “The struggle has just begun.” With these words, one dietary supplement activist expressed the outrage and resolve that dietary supplement activists present at the Codex Commission meeting feel about the Commission’s limiting of the international dietary supplement market to supplement products restricted by safety factors as if they were toxic chemicals.
Consumer activists present at the Rome meeting shared post-vote impressions at an informal ad hoc meeting during the FAO Deputy Director-General’s evening reception. On a balcony overlooking the Circus Maximus and the Roman Forum, the small band of activists wondered why no government or business official evaluated the effect of the Codex guidelines on the goal of ending world hunger. In the FAO world headquarters building, which proudly proclaims the organization’s mission as contributing to “an expanding world economy and ending world hunger,” it does not appear that world hunger ever appeared as a subject matter in the written or spoken argument for the vitamin and mineral guidelines that narrow the world economy in nutrient supplements. Correcting this oversight appeared as one goal of consumer activists reviewing the Codex supplement guidelines vote.
Activists also pointed out that the toxic chemical standard included in the guidelines, which severely limits consumer access to dietary supplements, replaces consumer choice with government fiat about which nutrients a consumer can consume, and creates a one-size-fits-all rejection of biochemical individuality, must now be developed by international food safety regulators. Their forums and procedures currently appear no more open to consumer/citizen input than the Codex processes, but they are calling for comments, holding meetings and in fact face an impossible task. Activists intend to exploit each of these opportunities to create a world-wide standard for trade in dietary supplements that will expand the world market in supplements and advance the goal of ending world hunger. The fifty years of USregulation of dietary supplements that culminated in the passage of the US Dietary Supplement Health and Education Act of 1994 presents a road map and creates a regulatory regimen that the international regulators need to follow if they are to contribute to rather than retard world health.
The activists gathering at the FAO reception will hold further meetings while in Rome, with the intention of exploring strategies that can turn the adoption of a flawed supplement standard into the first step for creating world wide access to all the dietary supplement products necessary for advancing the health of each consumer who desires them. Thus the struggle begins.
July 4
Codex Commission Adopts Supplement Guideline
Rome July 4 2005: The Codex Alementarius Commission, consisting of 85 of 171 country members (one short of a quorum) assembled in Rome today adopted without objection the restrictive Vitamins and Minerals Guidelines recommended by its Nutrition and Food for Special Dietary Foods Committee. While expected the action disappointed American dietary supplement consumer group representatives and observers resent. Attorney Scott Tips of the National Health Federation made a last minute plea to return, for technical and substantive reasons, the guideline to its authoring committee. His plea fell on deaf ears. No country objected to adoption of the guideline.
Mr. Tips was followed by a representative for the International Alliance of Dietary/Food Supplement Associations (IADSA) refuting concerns about the guidelines and seeking approval from the Commission for "ten years of concerted effort" to bring the guideline to fruition.
Industry representatives from the Council for Responsible Nutrition and other trade groups appeared elated and on their way to partying.
Consumer representatives in attendance at the Rome Codex session announced that they will meet to prepare strategies for continuing the battle to maintain worldwide access to all currently available dietary supplements products and to remove the barriers to innovation they see created by the adopted guideline. More action will follow.
Jim Turner
July 3
Codex Commission Executive Committee Endorses Restrictive Vitamin-Mineral Guidelines
by James S. Turner, Esq., Board Chair, Citizens for Health
Rome, July 3, 2005. Dr. Ed Scarbrough, US Codex Office administrator and administrative leader of the US Delegation to the 28th session of the Codex Alimentarius Commission, today told the delegation at its pre-meeting session that the Codex Commission Executive Committee had endorsed the vitamin and mineral guidelines recommended to it for adoption by its Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU). The endorsed guidelines call for upper intake limits based on toxic chemical risk assessment, prohibit health claims for foods, and urge consumers to restrict their intake of nutrients to the foods they eat. The endorsement of the guidelines by the Executive Committee virtually ensures their adoption by the full Commission at its July 4 meeting.
Dr. Scarbrough commented on Chinese and other Asian country desires to have greater flexibility, based on unique dietary habits, to add other categories than vitamins and minerals to the guidelines, and Australia’s “perennial” desire to restrict the guidelines to countries that treat vitamins and minerals only as foods. These arguments, he reported, did not move the Codex Executive Committee away from endorsing the guidelines. Nor did Canada’s lack of support for the guidelines. Canadaargued that “given the differences in diets, food supplies, attitudes, and consumption patterns around the world, such guidelines were best left to national governments.” This argument failed to move the Executive Committee to recommend delay or rejection of the guidelines. In the opinion of the Canadian government, the guidelines will not apply to Canadabecause it regulates vitamin and minerals supplements as “natural health products, not as foods.”
Dr. Scarbrough also reported Executive Committee recommendations that, going forward, the Codex nutrition committee (CCNFSDU) consider how it can contribute to the World Health Organization Global Strategy for Diet Exercise and Health, and that more study be undertaken on the role of nutrition in Codex and the relationship of Codex to other international bodies. Dr. Scarbrough also reported a serious Executive Committee discussion about a consultant’s report on the future of Codex. Several countries, Mexicoand Brazilamong them, desire clearer rules on the consensus process used by Codex to make decision. Some observers believe that the current consensus rules favor Europe and the USand marginalize the interests of developing countries. There is a movement to switch away from consensus to voting. The opponents of this move say it would create combative factions and politicize the Codex process.
The delegation meeting, attended by forty delegation members and observers, took place at the trendy Hotel 47 (www.fortysevenhotel.com) at 47 Via Petroselli, Rome, just one block away from Circus Maximus, the site of Rome’s contribution to Live 8 Roma (http://www.live8live.com/theconcerts/index.shtml), singer Bob Geldof’s effort to use global music performances to focus world attention on hunger and poverty in Africa. Several of the dietary supplement consumer group representatives attending the delegation meeting felt strongly that Codex could contribute most effectively to ending world hunger and poverty by adopting less restrictive vitamin and mineral guidelines. This issue will have to be debated after the Commission meeting. The meeting agenda and consensus process allows time only to adopt or delay the guidelines or send them back to committee with no serious discussion. The Executive Committee endorsement makes adoption of the vitamin and mineral guidelines all but inevitable.
