The Growing Threats to DSHEA

By Paul Anthony Taylor

 The passage of the Dietary Supplement Health and Education Act (DSHEA) in the United States in 1994 was arguably the single most important legislative development in the history of health freedom. (1). Since 1994, interest in natural healthcare therapies has grown dramatically in the United States, to the point where it is now estimated that 70 percent of the US population use dietary supplements at least occasionally, and 40 percent use them on a regular basis. ( 2). Nevertheless, and as this article will demonstrate, there are now numerous threats to DSHEA from a wide variety of sources.

Under DSHEA, the FDA has the power to seize any dietary supplement that it considers poses an "unreasonable or significant risk of illness or injury." (3). Given therefore that what constitutes an “unreasonable or significant risk of illness or injury" is not actually defined in DSHEA it can easily be seen that this phrase is potentially open to a wide variety of different interpretations. Moreover, DSHEA also allows the FDA to prescribe, via the issuing of regulations, good manufacturing practices for dietary supplements, and to remove from the market any dietary supplements that it considers do not meet these. (4). In this respect it should be noted that on March 7, 2003 the FDA issued a proposed rule, “ Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements” (5), the “standards” outlined in which are so severe as to actually exceed those imposed upon the pharmaceutical industry. Were these proposals to be passed into law then many smaller companies could potentially find the requirements to be so prohibitively expensive that they may be forced to cease business. Clearly therefore the FDA already has more power under DSHEA than is commonly realized. Moreover, all it needs in order to wield this power is sufficient excuse. Indeed, and as we shall examine next, this ‘excuse' may now have presented itself, in the form of the Codex Guidelines for Vitamin and Mineral Food Supplements. The Codex Alimentarius Commission The Codex Alimentarius Commission is the international body charged with setting global food standards, and is jointly sponsored by the United Nations Food and Agriculture Organization (FAO) and the World Health Organization (WHO). Codex Alimentarius literally means "food code", and the Commission was established in 1963 following resolutions passed at the Eleventh Session of the Conference of the Food and Agriculture Organization of the United Nations in 1961, and at the Sixteenth World Health Assembly in 1963. (6). The legal basis for enforcement of the food standards and guidelines created by Codex comes from the ‘Agreement on the Application of Sanitary and Phytosanitary Measures' (SPS Agreement) (7) and the ‘Agreement on Technical Barriers to Trade' (TBT Agreement). (8). Both the SPS Agreement and the TBT Agreement were included among the Multilateral Agreements on Trade in Goods, which was annexed to the 1994 Marrakesh Agreement that established the World Trade Organization (WTO). (9). Although Codex standards and guidelines are theoretically voluntary, the WTO uses them as a means of resolving international trade disputes (10), and WTO Members are legally obliged to abide by WTO rulings . (11). There are currently a total of 27 different active Codex committees and Task Forces (12); each one of which is tasked by the Codex Alimentarius Commission to set standards and guidelines for different aspects of the global food trade. For example, Codex committees are currently engaged in the act of setting global standards for foods including fruits and vegetables; fruit and vegetable juices; fats and oils; meat and poultry; fish; cereals, pulses and legumes; milk and milk products; natural mineral waters; sugars; cocoa products and chocolate, amongst others. Similarly there are other Codex committees who are tasked to deal with areas such as food hygiene, food labelling, pesticide residues, residues of veterinary drugs found in foods, food additives, regional coordination work, and so on. Of all of these committees, it is the work of the Codex Committee on Nutrition and Foods for Special Dietary Uses that is arguably amongst the most controversial of all, as it has recently completed work on a set of guidelines to govern the sale of food supplements. These guidelines, the Draft Guidelines for Vitamin and Mineral Food Supplements (13), were subsequently adopted at a meeting of the Codex Alimentarius Commission that took place in Rome from 4-9 July 2005 (14), and, as such, restrictions along the lines of those contained in the European Union's Food Supplements Directive (15) could in time have to be adopted by all countries that are members of the World Trade Organization. The European Union's Food Supplements Directive was the blueprint for the Draft Guidelines for Vitamin and Mineral Food Supplements, and was passed by the European Parliament on 13 th March 2002. Fully implemented across the European Union from 1 st August 2005, it could, by the end of 2009, have the effect of prohibiting around 300 nutrient sources and an estimated 5000 products from the UK alone. (16, 17). The text of the Codex Draft Guidelines for Vitamin and Mineral Food Supplements bears some notable resemblances to that of the Food Supplements Directive, thus raising the possibility that its eventual global effect could in time be similarly restrictive. Are countries obliged to implement Codex standards and guidelines? A great deal of discussion is currently taking place within the natural products industry, both in the United States and elsewhere, as to whether or not countries are actually obliged to adopt Codex standards and guidelines. In fact, it is arguably true that there is no single categoric obligation for governments to adopt Codex standards and guidelines. However, the preamble to the SPS Agreement (to which all WTO Members are signatories) specifically mentions Codex, and states that WTO Members (and hence all SPS signatories) desire “ to further the use of harmonized sanitary and phytosanitary measures between Members, on the basis of international standards, guidelines and recommendations developed by the relevant international organizations, including the Codex Alimentarius Commission ”. (18). Article 3.1 of the Agreement goes even further than this however, and states that “ To harmonize sanitary and phytosanitary measures on as wide a basis as possible, Members shall base their sanitary or phytosanitary measures on international standards, guidelines or recommendations, where they exist ”. (19). The key word here, from a legal perspective, would appear to be “shall”, the use of which could arguably be said to make the Draft Guidelines for Vitamin and Mineral Food Supplements mandatory for all WTO member countries. However, even if a country decides not to use a Codex standard the measure that it operates in place of that standard remains subject to a range of conditions set out in detail in Article 5 of the SPS Agreement. In relation to dietary supplements one of the most important of these conditions would appear to be a requirement to take into account risk assessment techniques developed by “ the relevant international organizations ”. (20). Essentially then, even in the event of a country choosing not to implement the Guidelines for Vitamin and Mineral Food Supplements, the legislation that it chose to implement instead could still remain subject to Codex risk assessment guidelines, as the Codex Alimentarius Commission are listed as one of the ‘relevant international organizations' in the preamble to the SPS Agreement. (21). Significantly therefore, guidelines on risk analysis are already under discussion at meetings of the Codex Committee on Nutrition and Foods for Special Dietary Uses (22), and the committee has recently indicated that this work will be concentrating upon “the development of methodological aspects for over dosage of nutrients.” (23). In addition one could even argue a case that countries were already expected to adopt Codex standards before either the WTO or the SPS Agreement came into existence, on the grounds that in 1985 a UN General Assembly resolution gave rise to the United Nations Guidelines for Consumer Protection. (24, 25). These guidelines stated that " Governments should take into account the need of all consumers for food security and should support and, as far as possible, adopt standards from the ... Codex Alimentarius ." (25). To be fair however it could also be said that the use of the word “should” in this text, as opposed to the word “shall”, could arguably be said to amount to something less than a mandatory requirement. Nevertheless, the United Nations Guidelines for Consumer Protection were later expanded in 1999, and the reference to Codex was retained. (26). Recent developments make the issue of “adoption” somewhat more academic however, as the Codex Alimentarius Commission have recently deleted the notification and acceptance procedures from the Codex Procedural Manual. (27). Prior to this there had been three levels of acceptance for Codex texts (28), and countries were theoretically supposed to inform the Codex Alimentarius Commission of which level of acceptance they would be applying to each individual Codex standard within its territorial jurisdiction. Clearly therefore, although in practice the notification and acceptance procedures had effectively been ignored by governments for some years, the fact that they have now been abolished provides still further evidence that in light of the SPS Agreement compliance with Codex standards and guidelines is effectively assumed to be mandatory. (29). Finally, it should be noted that the text of the Codex Guidelines for Vitamin and Mineral Food Supplements specifically states, in paragraph 1.2, that "These Guidelines do apply in those jurisdictions where products defined in 2.1 [i.e., vitamin and mineral food supplements] are regulated as foods." (Emphasis added). (30). As such, given that the United States regulates dietary supplements as foods it seems clear that the Guidelines will indeed apply there. In summary therefore, the numerous coercions for governments to adopt Codex texts appear to be such that they leave little option but to comply. The official reports that are released following Codex meetings are not always strictly accurate, and frequently do not reflect either the discussions that took place or the manner in which things were ‘decided'. Moreover, some important discussions that take place during the meeting are not even mentioned in the report. The National Health Federation (NHF), for example, who are the only consistently pro-health freedom non-governmental organization attending Codex, specifically requested during the November 2004 meeting of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) that it should be stated either in the text of the Guidelines for Vitamin and Mineral Food Supplements or in the committee's report whether or not it was mandatory for countries to implement the Guidelines. Dr. Jeronimas Maskeliunas, Food Standards Officer for the Joint FAO/WHO Food Standards Programme, answered the NHF's question on behalf of the Codex Secretariat, and stated that all documents that the Committee is elaborating are "not mandatory." He also stated that "member countries decide how to use them." The NHF therefore requested that this should be stated in the report. When the draft report was distributed on the final day of the meeting however there was no mention to be found in it of either the NHF's question or Dr. Maskeliunas' answer. The NHF therefore raised this with the Chairman of the committee, Dr. Rolf Grossklaus, and made repeated requests to him to include mention of this important issue in the official report to be released following the meeting. Nevertheless, Dr. Grossklaus refused to allow this, saying that it was not mandatory for him to heed such requests. As far as the official report of this meeting is concerned therefore it is as if this vital matter had not even been discussed. As a result we are forced to ask why, if the Guidelines for Vitamin and Mineral Food Supplements are not mandatory, as the Codex Secretariat claimed, was Dr. Grossklaus so opposed to this being stated in the committee's report? By way of contrast, however, the Codex Alimentarius Commission itself appears to be in no doubt that countries are indeed required to base their domestic regulations on Codex standards, as demonstrated by the following extract from one of the official documents issued at the Commission's meeting in Geneva in 2004: Members of the World Trade Organisation (WTO) are REQUIRED to base their domestic technical regulations or standards on standards developed by international organisations. These organisations include the Joint FAO/WHO Codex Alimentarius Commission for food safety; the Office International des Epizooties (OIE) for animal health; and the International Plant Protection Convention (IPPC) for plant health. (33) . (EMPHASIS ADDED). Moreover, and as we shall examine next, the Codex Alimentarius Commission are not the only people who appear to see the implementation of Codex texts as mandatory. Does the FDA see the implementation of Codex texts as mandatory? Seemingly unbeknownst to many people in the natural products industry, the FDA has already acknowledged that the United States is obliged to implement Codex standards, codes and guidelines under international agreements. Michael A. Friedman, M.D., for example, a former Acting Deputy Commissioner for Operations in the Department of Health and Human Services , spoke before the Committee on Labor and Human Resources in the U.S. Senate on March 19, 1997, and stated the following: FDA has been a strong supporter of, and participant in, the Codex Alimentarius Commission (Codex). Codex is an international standards-setting organization for food safety composed of national governments from more than 150 countries. The work of Codex is increasingly important with the recognition of Codex as the relevant international standards-setting body for food safety in the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS) resulting from the Uruguay Round of multilateral trade negotiations. Since its inception, Codex has developed in excess of 200 Commodity Standards, more than 40 codes and guidelines, about 2,500 pesticide/commodity maximum limits, and has reviewed the safety of over 500 food additives and contaminants. FDA, through its participation on most Codex Committees, provides scientific and regulatory expertise and forcefully presents U.S. views at the committee meetings. FDA plans to amend its regulations and procedures for consideration of standards adopted by Codex. This action is being taken to provide for the systematic review of the Codex Standards in order to enhance consumer protection, promote international harmonization and fulfill obligations of the United States under international agreements. (34). Statement by Michael A. Friedman, M.D. This statement is then further reinforced by the FDA on a webpage dealing with international harmonization, which states: The harmonization of laws, regulations and standards between and among trading partners requires intense, complex, time-consuming negotiations by CFSAN officials. Harmonization must simultaneously facilitate international trade and promote mutual understanding, while protecting national interests and establish a basis to resolve food issues on sound scientific evidence in an objective atmosphere. Failure to reach a consistent, harmonized set of laws, regulations and standards within the freetrade agreements and the World Trade Organization Agreements can result in considerable economic repercussions. (35). U.S. Food and Drug Administration Moreover, the United States Federal Register, October 11, 1995, specifically describes the FDA's policy on the development and use of standards with respect to the international harmonization of regulatory requirements and guidelines, and states that "where a relevant international standard exists, or completion is imminent, it will generally be used in preference to a domestic standard...." (36). As such therefore, although the FDA has recently claimed that the Codex Guidelines for Vitamin and Mineral Food Supplements will not place pressure on the US to alter DSHEA (37) it is clear that many of its other public statements are at odds with this assertion. The World Trade Organization As discussed earlier, the World Trade Organization (WTO) uses Codex texts as a means of resolving international trade disputes (10) , and WTO Members are legally obliged to abide by WTO rulings . (11). The net result of this is that now the Codex Guidelines on Vitamin and Mineral Food Supplements have been adopted by the Codex Alimentarius Commission, any WTO member country producing vitamin and mineral supplements that conform to these new global standards can theoretically file a complaint with the WTO whenever another member country refuses to allow their goods to be imported and sold within its borders. In the process of resolving such a dispute, the WTO Dispute Settlement Body would refer to the Codex Guidelines for Vitamin and Mineral Food Supplements, and would find in favour of the country that was acting in conformity with them. The losing country could then be forced to adopt whatever requirements the WTO Dispute Settlement Body decide upon, which can include changing its domestic laws. If a country failed to adopt these requirements however it can then become subject to punitive economic sanctions. (38). As such there now exists a very real risk that Codex restrictions upon the manufacture and sale of vitamin and mineral supplements could, in the future, be quite literally forced upon the United States via the WTO. So how might this happen? According to some observers, the most likely scenario to occur would be one where a trade dispute against the United States was triggered by the FDA refusing to allow a foreign manufacturer to export a vitamin and/or mineral supplement containing what the FDA regarded to be a “New Dietary Ingredient”. Under DSHEA, the FDA has the power to prevent a “New Dietary Ingredient” from being sold in the United States if it considers that it has not received sufficient safety data in advance. (39). The term “New Dietary Ingredient” is defined in DSHEA as being “ a dietary ingredient that was not marketed in the United States before October 15, 1994 ”. Clearly therefore, this clause could allow the FDA to block such a product from entering the US, potentially triggering a trade dispute. Although a trade dispute that forced the US to accept a new dietary ingredient could also be arguably seen as a positive step (so long as the new ingredient was safe) the danger is that in ruling against the US the WTO would also have the power to force it to alter DSHEA. An alternative scenario meanwhile could be one where a country whose market was fully compliant with the restrictive Codex Guidelines for Vitamin and Mineral Food Supplements brought a trade dispute against the United States under article 5.4 of the SPS Agreement, which states that “ Members should, when determining the appropriate level of sanitary or phytosanitary protection, take into account the objective of minimizing negative trade effects .” (40). In such a situation a country might argue, for example, that DSHEA has the effect of causing negative trade effects, in that the higher-dose products available in the US are acting as a disincentive for US consumers to purchase lower-dose (read: safer ) products produced by Codex-compliant countries. In addition, and given that the Codex Guidelines for Vitamin and Mineral Food Supplements call for upper safe levels to be set for vitamin and mineral supplements (41) , it can easily be seen that in any trade dispute high-dose products that were not in conformity with the Guidelines could potentially be viewed by the WTO Dispute Settlement Body as being unsafe, and hence in contravention of article 5.1 of the SPS Agreement: 5.1. Members shall ensure that their sanitary or phytosanitary measures are based on an assessment, as appropriate to the circumstances, of the risks to human, animal or plant life or health, taking into account risk assessment techniques developed by the relevant international organizations. (42). SPS Agreement Furthermore, once the Codex Guidelines for Vitamin and Mineral Food Supplements start to ‘bite' globally, US manufacturers could find themselves in a position where they had to market two sets of products; one set of higher-dose products for the US market and a second set of lower-dose products for export. As such it could then be possible for a Codex-compliant country to argue that by applying different upper limits to vitamin and mineral supplements sold internally compared to those exported abroad, the US was effectively making unjustifiable distinctions in the level of risk it applied to different situations. If this charge was proven the US would then be in clear contravention of article 5.5 of the SPS Agreement, which states: 5.5 With the objective of achieving consistency in the application of the concept of appropriate level of sanitary or phytosanitary protection against risks to human life or health, or to animal and plant life or health, each Member shall avoid arbitrary or unjustifiable distinctions in the levels it considers to be appropriate in different situations, if such distinctions result in discrimination or a disguised restriction on international trade. (43). SPS Agreement Again then, and as with the previous example, the higher-dose products available in the US would effectively be acting as a disincentive for US consumers to purchase lower-dose products produced by Codex-compliant countries, thus producing a disguised restriction on international trade. In reality however, most trade disputes at the WTO are brought on several grounds simultaneously, rather than on one single ground alone. (44). As such it is quite possible that any future trade dispute involving dietary supplements could be brought against the United States on several of the above grounds. Finally, it should be noted that the WTO would allow trade sanctions to be imposed upon the US dietary supplement sector even when a trade dispute has nothing to do with dietary supplements. Such an eventuality is outlined on the WTO website as follows: If the country that is the target of the complaint loses, it must follow the recommendations of the panel report or the appeals report. It must state its intention to do so at a Dispute Settlement Body meeting held within 30 days of the report's adoption. If complying with the recommendation immediately proves impractical, the member will be given a “reasonable period of time” to do so. If it fails to act within this period, it has to enter into negotiations with the complaining country (or countries) in order to determine mutually-acceptable compensation — for instance, tariff reductions in areas of particular interest to the complaining side. If after 20 days, no satisfactory compensation is agreed, the complaining side may ask the Dispute Settlement Body for permission to impose limited trade sanctions (“suspend concessions or obligations”) against the other side. The Dispute Settlement Body must grant this authorization within 30 days of the expiry of the “reasonable period of time” unless there is a consensus against the request. In principle, the sanctions should be imposed in the same sector as the dispute. If this is not practical or if it would not be effective, the sanctions can be imposed in a different sector of the same agreement. In turn, if this is not effective or practicable and if the circumstances are serious enough, the action can be taken under another agreement. The objective is to minimize the chances of actions spilling over into unrelated sectors while at the same time allowing the actions to be effective. World Trade Organization (45) . Potentially therefore, if, say, the US lost a trade dispute involving regular food products, for example, then the complaining country could ask the WTO Dispute Settlement body for permission to impose trade sanctions against the US dietary supplement sector. Whilst this would not in itself lead to DSHEA being amended, of course, it could perhaps result in increased political pressure, both in the US and internationally, to harmonize DSHEA to Codex standards. The FAO/WHO Nutrient Risk Assessment Project The Draft Guidelines for Vitamin and Mineral Food Supplements state that the upper safe levels for vitamins and minerals will be established via scientific risk assessment. (46). In this respect it is probably no coincidence therefore that in September 2004 the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) announced plans for a joint nutrient risk assessment project, the goal of which is described as follows: … to define a scientifically-based and internationally applicable approach for nutrient risk assessment. Such work will provide scientific advice on the principles and methodologies to be used in conducting risk assessment for nutrients and related substances. A key task is the convening of an interdisciplinary technical workshop to specifically develop a model for risk assessment for nutrients and related substances. (47). Nutrient Risk Assassment Project Because the FAO and the WHO are the joint administrators of the Codex Alimentarius Commission the results of their nutrient risk assessment project are expected to be very influential upon the maximum levels to be recommended by Codex in connection with the Guidelines for Vitamin and Mineral Food Supplements. Worryingly therefore, the references and annex sections of the background paper published by the FAO/WHO when the project was announced tend to suggest that the published Opinions of the European Commission Scientific Committee on Food (SCF) will in turn also be influential upon the outcome of the project. (48). This does nothing to inspire confidence in the venture however, as many of the SCF's published Opinions run completely contrary to not only the principles of Cellular Medicine but also to common sense itself. The SCF's Opinion on vitamin B3 for example suggests that the Upper Safe Level for niacin should be set at only 10mg, an amount that is just over half of the EU RDA. (49). Clearly therefore we must view the FAO/WHO nutrient risk assessment project with healthy doses of both suspicion and skepticism. The Free Trade Area of the Americas The groundwork for the Free Trade Area of the Americas (FTAA) was set in 1994, when leaders from the U.S., Latin America, Canada, and the Caribbean met at the First Summit of the Americas in Miami. (50). Although the ultimate goal of the FTAA negotiations is officially described as being to achieve an area of free trade and regional integration (51) , the recent evidence of the European Union (EU) project shows that this can only be achieved via the dismantling of the political and legal systems of participating nations and the replacing of these with a hemispheric government. In essence therefore, this is why many observers see the FTAA as an embryonic EU in the making. (52). As such, and in exactly the same way as the relatively liberal dietary supplement laws of the UK were overridden by the EU Food Supplements Directive, (as a result of successive treaties that the British Government had signed with its European neighbors), fears are now being raised amongst the US health freedom movement that participation in the FTAA could similarly lead to US dietary supplement law (ie DSHEA) becoming susceptible to harmonization with the more restrictive laws of South American countries such as Brazil. The text of the FTAA agreement has gone through several revisions since its inception. The current draft is the third of the series, and like the SPS Agreement it shows quite clearly that FTAA Members will be subject to the harmonized standards, guidelines and recommendations of the ‘relevant international organizations': [Article 19. Harmonization] [19.1. The Parties shall endeavour to work together in the framework of the regional and sub regional sanitary and phytosanitary organizations that exist in the Hemisphere in order to develop harmonized sanitary and phytosanitary standards, guidelines, and recommendations. Likewise, the Parties shall submit the harmonized standards, guidelines, and recommendations for consideration by the corresponding international organizations, as necessary.] [19.1. The Parties will work together in the framework of the regional and sub regional sanitary and phytosanitary organizations that exist in the Hemisphere in order to establish, recognize, and apply common sanitary measures. Likewise, the Parties shall submit the harmonized sanitary and phytosanitary measures for consideration by the corresponding international organizations, as necessary.] [19.2. The Parties agree to collaborate in monitoring, at the hemispheric level, the process of international harmonization as established by the Committee on Sanitary and Phytosanitary Measures of the WTO.] [Article 20.Equivalence] [20.1. The Parties agree that the general objective of equivalence agreements shall be to promote increased mutual trust and cooperation between national sanitary and phytosanitary authorities and thereby to facilitate trade and to efficiently attain the importer's country appropriate level of protection.] [20.2. To that effect, the Parties [undertake to abide by][take note of] the Decision on the Implementation of Article 4 of the WTO Agreement on the Application of Sanitary and Phytosanitary Measures adopted by the WTO SPS Committee (WTO/G/SPS/19 and WTO/G/SPS/19/Add.1) and the guidelines on equivalence that are established by Relevant International Bodies  recognized by the WTO Agreement on the Application of Sanitary and Phytosanitary Measures.] (53). Free Trade Area of the Americas - Draft Agreement As can be seen, the parallels between parts of the above extract and the equivalent sections of the SPS Agreement (54) are quite striking. Indeed, given the references to the WTO and the SPS Agreement, along with the use of phrases such as “Relevant International Bodies” (that as we have already seen refers to the Codex Alimentarius Commission, amongst others) we are forced to consider whether participation in the FTAA could be the very mechanism by which the US is eventually forced to harmonize DSHEA to the more restrictive laws of its South American neighbors. In this respect it is particularly sobering to note therefore that FTAA participant countries including Bolivia, Brazil, Canada, Chile, Costa Rica, Mexico and Venezuela all sent delegations to the November 2004 meeting of the Codex Committee on Nutrition and Foods for Special Dietary Uses that took place in Bonn, Germany, and none of them spoke out even remotely in favour of health freedom. (55). Moreover, comments submitted by Brazil before the November 2003 meeting of this committee stated that they were opposed to a “without-control-consumption by consumers”; that supplements should not contain more than 100% of the RDA for any nutrient; and that there is no evidence of benefit from ingesting amounts above the RDA. (56). Interestingly therefore, the final phase of the FTAA negotiations will be guided by the co-chairmanship of Brazil and the United States. (57). Finally, many observers believe that the Central American Free Trade Agreement (CAFTA) (58) makes the progression to FTAA almost inevitable. CAFTA extends the North American Free Trade Agreement (NAFTA) (59) to Central America, and as such can arguably be seen as a stepping-stone towards FTAA and the creation of a hemispheric government for the American continent. Who is interested in amending DSHEA? Naturally occurring forms of nutrients and herbs cannot be patented, and, as such, given their safety and effectiveness in the prevention and treatment of disease, dietary supplements represent a serious and growing threat to the multi-trillion dollar pharmaceutical industry, the profitability of which depends upon the sale of patented synthetic drugs. Undoubtedly, therefore, it can be seen that the pharmaceutical industry has a clear vested interest in DSHEA being amended restrictively. As a result of its efforts to defend and promote its drug market the pharmaceutical industry's tentacles of influence now reach right to the heart of most governments in the developed world. Drug companies now openly court influence on Capital Hill, for example, and provide corporate jets for Senators at cut-down prices, donations to political committees, funding for think tanks and contributions to politicians' election expenses. (60). In fact, pharmaceutical companies and their representatives contributed at least $17 million to federal candidates in last year's US elections, including nearly $1 million to President Bush alone. Moreover, it has been estimated that since 1998 drug companies have spent $758 million on lobbying in the United States; an amount that is more than that of any other industry. (61). The pharmaceutical industry now has a total of 1,274 lobbyists in Washington; a number that works out at more than two for every single member of Congress. Of these lobbyists, it turns out that 476, almost 40 percent, are former federal officials; whilst 40 are actually former members of Congress. (62). In addition, a "revolving door" essentially operates at key US regulatory agencies like the FDA, where regulators become pharmaceutical executives, and vice versa. Globally the situation is even worse, and new international regulations, such as those affecting dietary supplements, are now increasingly being planned in private between big business and bureaucrats. Once business interests have agreed to these templates they are subsequently drawn up as new international standards or guidelines at venues such as Codex. (63). Significantly therefore, attendees at key Codex meetings often include representatives of the pharmaceutical industry; some of whom sit on national delegations alongside regulators and other official government representatives. Clearly then, the influence of the pharmaceutical industry arguably represents the single biggest threat to DSHEA. Moreover, drug companies clearly have the most to gain if DSHEA was to be amended restrictively, and, conversely, the most to lose if it was not. Conclusion As we have seen, there are now a wide variety of forces at play, which together could in time potentially conspire to dismantle DSHEA. While some would argue of course that the vigorous and non-partisan campaign that was mounted in order to enact DSHEA continues to act as a disincentive for any administration who might wish to dismantle it, we should remember that the situation on Capital Hill itself has changed significantly since 1994. For example, as of May 2004 only 50 percent of the members of the U.S. House and Senate were in office when DSHEA was passed in 1994, and there had also been an 80 percent turnover in legislative staff since that time. (64). Following the US elections of November 2004 therefore we can only but guess what the new numbers might be. As such, US consumers and consumer groups must now urgently restart the process of educating legislators and legislative staff about the safety and effectiveness of dietary supplements, as those who oppose consumer access to these products are likely to seize on the adoption of the Codex Guidelines for Vitamin and Mineral Food Supplements as a reason for dismantling DSHEA. The S. 722 (65), H.R. 3377 (66) and S. 1538 (67) bills that were proposed during the Bush administration's first term serve as a grim reminder that there are now forces within the US Government who would like to see DSHEA amended at the earliest opportunity. Although none of these bills picked up enough Congressional support to be enacted during the Bush administration's first term similar bills are already being introduced during its second term, each of which presents a separate threat to DSHEA. H.R. 3156, for example, would severely and negatively impact upon DSHEA by giving the FDA the authority to ban any dietary supplement or dietary ingredient from the market if it failed an unreasonable and arbitrary risk/benefit assessment. (68). S. 729/H.R. 1507, meanwhile, would create a new federal food safety agency and undermine DSHEA by leaving supplements to be regulated by a newly-formed drug administration. (69, 70). Another dangerous bill, H.R. 2485, would give the FDA an extra $205 million between now and 2010 to regulate dietary supplements, on the dubious grounds that it has not adequately used its authority to enforce DSHEA due to a lack of resources (71). H.R. 2510, a similar proposal, would also appropriate more money to the FDA. (72). Clearly, while some Americans appear to believe that the passing of DSHEA won the health freedom war in America, history may yet turn out to show that it was merely one battle along the way. Moreover, and as at least one American health freedom commentator has stated recently, there is currently too much conflict among people who should be working together to solve the Codex problem, and as a result the American people are not yet ready to fight again for their health freedoms. (73). As to whether DSHEA will eventually be overturned or amended, only time, and the willingness of consumers and consumer organizations to recognize the various threats and act together to defend it against them, will tell. Let us hope then that an overall sense of unity will soon prevail amongst the American health freedom movement. The passing of DSHEA was a milestone in the history of health freedom, but health conscious Americans will henceforth need to be increasingly vigilant in future in order to ensure that their hard-won victory was not in vain. © Paul Anthony Taylor REFERENCES: DSHEA. http://www.fda.gov/opacom/laws/dshea.html Vitamins E and C are safe across a broad range of intakes. 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Draft Guidelines for Vitamin and Mineral Food Supplements. http://www.codexalimentarius.net/download/report/627/al28_26e.pdf ALINORM 05/28/41. Codex Alimentarius Commission. Twenty-eighth Session. FAO Headquarters, Rome, Italy, 4 – 9 July, 2005. Report. Paragraphs 51-54. http://www.codexalimentarius.net/download/report/644/al28_41e.pdf European Union Food Supplements Directive. http://europa.eu.int/eur-lex/pri/en/oj/dat/2002/l_183/l_18320020712en00510057.pdf European Scientific Advisory Group on Nutrients and Related Substances. Letter to the Rt. Hon. Tony Blair, MP. 5 th May, 2003. Page 3. http://www.healthchoice.org.uk/documents/letter_to_Prime_Minister.pdf European Union Food Supplements Directive. Article 4; paragraph 6. http://europa.eu.int/eur-lex/pri/en/oj/dat/2002/l_183/l_18320020712en00510057.pdf SPS Agreement. (Preamble). http://www.wto.org/english/tratop_e/sps_e/spsagr_e.htm SPS Agreement. (Article 3.1). http://www.wto.org/english/tratop_e/sps_e/spsagr_e.htm SPS Agreement. 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( Report from Suzan Walter, president of American Holistic Health Association, on her attendance November 1-3, 2004 at the session of the Codex Committee on Nutrition and Foods for Special Dietary Uses in Bonn, Germany). http://ahha.org/codexwalter2004.htm CAC/27 INF.5. Capacity Building for Food Quality and Food Safety: Activities of the Food and Agriculture Organization (FAO) and the World Health Organization (WHO). Paragraph 2. Codex Alimentarius Commission. Twenty-seventh Session. Centre International de Conférences, Genève, Switzerland, 28 June – 3 July 2004. ftp://ftp.fao.org/docrep/fao/meeting/008/j2434e.pdf FDA website. http://www.fda.gov/ola/1997/319.html FDA Center for Food Safety and Applied Nutrition website. http://www.cfsan.fda.gov/~comm/int-laws.html Obtained by going to http://www.gpoaccess.gov/fr/advanced.html selecting: 1995 FR, Vol. 60; searching by specific date: (ON) 10/11/1995; searching for: Policy on Standards. 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Agenda item 4. Paragraphs 23-35. http://www.codexalimentarius.net/download/report/627/al28_26e.pdf Codex Alimentarius Commission. CX/NFSDU 03/5. Pages 5-7. September 2003. ftp://ftp.fao.org/codex/ccnfsdu25/nf03_05e.pdf Free Trade Area of the Americas. http://www.ftaa-alca.org/View_e.asp Office of the United States Trade Representative. http://www.ustr.gov/Trade_Agreements/Bilateral/CAFTA/Briefing_Book/Section_Index.html North American Free Trade Agreement. (NAFTA). http://www.nafta-sec-alena.org/DefaultSite/index_e.aspx?CategoryId=42 Drugmakers go furthest to sway Congress. USA Today. 25 April, 2005. http://www.usatoday.com/money/industries/health/drugs/2005-04-25-drug-lobby-cover_x.htm Ibid. Ibid. Who Says Whatever Happens at Codex Does Not Affect US Law and Why Do They Say It? By Suzanne Harris, J.D. http://thelawloft.com/Freedom/050125_us_law.htm “Leaders in Dietary Supplement Industry Join Together to Form the Coalition to Preserve DSHEA.” (Article on NNFA website). 6 May 2004. http://www.nnfa.org/news/articles/2004/05-06-04_Coalition.htm Dietary Supplement Safety Act of 2003. (S. 722). http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=108_cong_bills&docid=f:s722is.txt.pdf Dietary Supplement Access and Awareness Act. (H. R. 3377). http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=108_cong_bills&docid=f:h3377ih.txt.pdf DSHEA Full Implementation and Enforcement Act of 2003. (S. 1538). http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=108_cong_bills&docid=f:s1538is.txt.pdf Dietary Supplement Access and Awareness Act. (H.R. 3156). http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=109_cong_bills&docid=f:h3156ih.txt.pdf Safe Food Act of 2005. (S. 729). http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=109_cong_bills&docid=f:s729is.txt.pdf Safe Food Act of 2005. (H.R. 1507). http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=109_cong_bills&docid=f:h1507ih.txt.pdf DSHEA Full Implementation and Enforcement Act of 2005. (H.R. 2485). http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=109_cong_bills&docid=f:h2485ih.txt.pdf Dietary Supplement Regulatory Implementation Act of 2005. (H.R. 2510). http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=109_cong_bills&docid=f:h2510ih.txt.pdf Codex Alimentarius: Big Pharma's Attempt to Subjugate Planet Earth. Opinion by Consumer Advocate Tim Bolen. Saturday, May 7th, 2005. http://www.quackpotwatch.org/opinionpieces/codexwash.htm To protect your health rights, send a letter to your U.S. Senator NOW!