Many companies that sell herbal products in the U.S. and internationally have contacted AHPA 1 in the past several weeks to ask questions about the Codex Alimentarius Commission. Numerous consumers of herbal products have also requested clarification of the impact that Codex will have on their access to dietary supplements that contain vitamins, minerals and herbs. This document was prepared by AHPA to address these enquiries, both for our members who market dietary supplements and for their healthconscious customers who use them. WHAT IS CODEX? The Codex Alimentarius Commission was created as a joint project of the Food and Agricultural Organization (FAO) of the United Nations and the World Health Organization (WHO) in 1963. There are 165 member countries in Codex, including the United States. Its stated purpose is to develop food standards, guidelines and related texts such as codes of practice 2 in the interest of protecting the health of consumers and ensuring fair practices in the food trade. 3 In the 42 years of its existence, Codex has adopted nearly 250 standards. These include standards for fresh fruits and vegetables, such as asparagus and ginger, as well as for processed foods like dried fruits (e.g., apricots), frozen vegetables (e.g., corn, green beans, and spinach) and various canned foods (e.g., applesauce, salmon and tomatoes). In addition, guideline levels have been set for various heavy metals and naturally-occurring toxins, such as aflatoxins, and numerous standards have also been set for food additives, as well as for sampling and analysis for pesticides. 4 QUICK FACTS ON CODEX Codex Alimentarius was founded in 1963 by the UN s FAO and the WHO. The US is a party to Codex. Codex will adopt international guidelines on vitamin and mineral food supplements this summer. The effect of these guidelines is that the US (and all countries in Codex) will be required to allow the import of all vitamin and mineral supplements that conform to the new guidelines. Codex can affect a country s domestic laws by forcing them to be relaxed, but only if those laws are more restrictive than a Codex standard or guideline. The Codex vitamin and mineral guidelines will not have a direct or immediate effect on US domestic law since US law is less restrictive than these Codex guidelines. When Codex sets maximum levels on vitamins and minerals it will do so based on science. The rights of American consumers are protected by DSHEA and only the US Congress can amend US laws. Read below for more details. 1 The American Herbal Products Association is the national trade association and voice of the herbal products industry, comprised of companies doing business as growers, processors, manufacturers, and marketers of herbs and herbal products. Contact AHPA at 301-588-1171 x106 or nhall@ahpa.org. 2 Codex Alimentarius website: http://www.codexalimentarius.net/web/index_en.jsp. Accessed March 24, 2005. 3 Statutes of the Codex Alimentarius Commission, http://www.fao.org/documents/show_cdr.asp?url_file=/docrep/005/y2200e/y2200e02.htm. Accessed March 24, 2005. 4 These and all adopted standards may be accessed at http://www.codexalimentarius.net/web/standard_list.do?lang=en.
WHAT IS THE RELEVANCE OF CODEX TO THE WTO? Standards developed by Codex are relevant to the agreements made through the World Trade Organization (WTO), of which the United States is also a member. Under WTO, Codex standards can have an impact on sanitary issues and can also be used to resolve international trade disputes. Certain Codex standards are referenced in the WTO s Agreement on the Application of Sanitary and Phytosanity Measures (SPS Agreement), which defines international standards, guidelines and recommendations for food safety as those established by Codex relating to food additives, veterinary drug and pesticide residues, contaminants, methods of analysis and sampling, and codes and guidelines of hygienic practice. 5 The SPS Agreement promotes international harmonization by stating that Members should base their domestic sanitary or phytosanitary measures on international standards, but it specifically applies only to all sanitary and phytosanitary measures which may, directly or indirectly, affect international trade (emphasis added). It also reserves the right for each country to establish higher sanitary standards, so long as there is a scientific basis for these. 6 Another WTO agreement is the Technical Barriers to Trade Agreement (TBT Agreement). 7 This document expresses a desire to ensure that technical regulations and standards... do not create unnecessary obstacles to international trade, and aims to prevent such measures from being applied in a manner which would constitute a means of arbitrary or unjustifiable discrimination... or a disguised restriction on international trade. WTO has used a Codex standard to adjudicate the only international trade dispute that has arisen to date under the TBT Agreement. In that case the European Communities (EC) had established a requirement that only one species of sardines that found in European waters, such as the Eastern North Atlantic and the Black and Mediterranean Seas could be labeled as sardines. In response to a complaint by Peru, a WTO panel ruled in 2002 that the standard that had been set by Codex for sardines in 1981 and revised in 1995, which included 21 species of sardines from around the world, constituted a relevant international standard under the TBT Agreement. The EC regulation was therefore deemed to be inconsistent with the TBT Agreement and Peruvian sardines were then allowed to be labeled as such in EC markets. 8 It is important to note that the above described case reflects an instance in which the existence of a Codex standard was used to prevent the establishment of a more restrictive standard. There are no instances in which a Codex standard has been used under the TBT Agreement to force a more restrictive standard or repeal a more liberal regulation in any country s domestic laws. 5 The Codex document that is most relevant to hygienic practice is the Recommended International Code of Practice: General Principles of Food Hygiene, first adopted in 1969 and most recently revised in 2003. This document addresses all of the basic issues usually found in regulations on good manufacturing practice for foods, such as hygiene and training of personnel; facility design and maintenance; proper control, handling and storage of ingredients; etc. The document also strongly emphasizes the value of hazard analysis and critical control point (HACCP) systems, and recommends a HACCP-based approach wherever possible to enhance food safety. 6 The WTO SPS Agreement may be accessed at http://www.wto.org/english/tratop_e/sps_e/spsagr_e.htm. 7 The WTO TBT Agreement may be accessed at http://www.wto.org/english/docs_e/legal_e/17-tbt_e.htm. 8 WTO Report of the Appellate Body. European Communities Trade Description of Sardines. September 26, 2002. Accessible at http://www.worldtradelaw.net/reports/wtoab/ec-sardines(ab).pdf. AMERICAN HERBAL PRODUCTS ASSOCIATION - 2 -
WHAT DOES CODEX HAVE TO DO WITH DIETARY SUPPLEMENTS? The Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) has developed Draft Guidelines for Vitamin and Mineral Food Supplements. This draft, first proposed in 1993, is at Step 8 of the Codex process and can be downloaded at: http://www.ahpa.org/04_1101-04_vms_guidelines_step8.pdf. This is the final step prior to adoption of the guidelines, which is expected in July 2005 at the annual Codex session in Rome. The draft guidelines consist of two pages and starts with a paragraph that downplays the need for vitamin and mineral supplements: Most people who have access to a balanced diet can usually obtain all the nutrients they require from their normal diet. Because foods contain many substances that promote health, people should therefore be encouraged to select a balanced diet from food before considering any vitamin and mineral supplement. In cases where the intake from the diet is insufficient or where consumers consider their diet requires supplementation, vitamin and mineral food supplements serve to supplement the daily diet. In defining its scope, the draft clarifies that the guidelines will apply to food supplements that contain vitamins and minerals, with or without other ingredients, but only in those jurisdictions where supplements are regulated as foods. Packaging and labeling are also addressed, so the draft states that containers should be safe and hygienic, and that the amounts of vitamins and minerals should be stated on the label, among other details. Composition of these supplements is also addressed in the draft, which states that the vitamins and minerals may be obtained from either natural or synthetic sources with consideration given to safety and bioavailability. The draft does not limit the variety of ingredients by the establishment of a positive list. 9 Similarly, formulation of supplements is broadly described, so that products may contain a single nutrient or appropriate combinations of ingredients. The one element of the discussion of composition that has aroused the most controversy is the section on maximum amounts of vitamins and minerals in food supplements. The relevant passage is as follows: Maximum amounts of vitamins and minerals in vitamin and mineral food supplements per daily portion of consumption as recommended by the manufacturer shall be set, taking the following criteria into account: (a) upper safe levels of vitamins and minerals established by scientific risk assessment based on generally accepted scientific data, taking into consideration, as appropriate, the varying degrees of sensitivity of different consumer groups; (b) the daily intake of vitamins and minerals from other dietary sources. 9 The inclusion of a positive list in the EU Directive on Food Supplements, and the means by which the initial list can be amended, have been the focus of significant concern and controversy. This issue is not, however, relevant to the Codex guidelines that are the subject of this discussion. See the last section of this document for additional information on this EU Directive. AMERICAN HERBAL PRODUCTS ASSOCIATION - 3 -
When the maximum levels are set, due account may be taken of the reference intake values of vitamins and minerals for the population. This provision should not lead to setting of maximum levels that are solely based on recommended nutrient intakes (e. g. Population Reference Intake or Recommended Daily Allowance values). Note that this guidance does not at this time establish maximum amounts for any vitamin or mineral, but instead only sets forth the criteria for doing so in the future. An earlier draft of these guidelines had proposed that maximum levels of vitamins and minerals would not exceed 100% of recommended daily intakes (RDIs; e.g., the maximum level of Vitamin C would have been 60 mg). But since RDIs are determined based on nutritional needs, and not on safety, this original proposal was revised and the maximum levels will eventually be set based on sound scientific principles. AHPA and its members will focus great attention on assuring that this process is truly based on science. IS THE U. S. REQUIRED TO CHANGE ITS LAWS TO ADOPT CODEX STANDARDS? Recent internet articles have widely reported that the adoption of the Codex Guidelines for Vitamin and Mineral Food Supplements will force the United States to change its laws to adopt this Codex standard as our domestic law. Another implication of these articles is that there are limitations already set within this standard that will cause the immediate loss of many products immediately upon the finalization of this process this summer. Both of these scenarios are simply untrue. As a member of the WTO, the United States must refrain from blocking the importation of foods, including dietary supplements, by adopting standards or regulations that would be arbitrary or unjustifiable barriers to trade. As was seen when the EC proposed to limit the number of fish species that can be sold in Europe as sardines, the actual effect of a Codex standard is to serve as a minimum standard that must be met by an importer, and may be used to force one country (or a group of countries) to accept goods for import that conform to the standard, even if they do not conform to that country s higher standard. If the U.S. were to block the import of a food product that meets the standards established by Codex for that product, it would need to provide (and win) valid science- and safety-based arguments to support such refusal. In other words, if a country s domestic law is more restrictive than a liberal Codex standard, then an importer that wishes to sell a product that conforms to the Codex standard may be able to force that country, through WTO, to relax its domestic law. The often expressed concern about Codex, however, is that it will be more restrictive than the current U.S. law, the Dietary Supplement Health and Education Act (DSHEA). But in any cases in which a domestic law is more liberal than a restrictive Codex standard, any import that conforms to this restrictive standard will necessarily conform to that more liberal domestic law, and there would be no reason for an importer to bring a WTO challenge. Thus, if the final Codex guidelines on supplements were to establish severe limits on the kinds or amounts of vitamins or minerals that would conform to that standard, and set a limit of, for example (and for illustration only), 225 milligrams of Vitamin C in a supplement, then the U.S. would be required to allow the import and sale of a product containing 225 mg of Vitamin C. But the United States would not need to change its laws to conform to its WTO agreements it is already legal to sell such a product under DSHEA and other existing U.S. laws. AMERICAN HERBAL PRODUCTS ASSOCIATION - 4 -
DO OTHER CODEX GUIDELINES HAVE AN EFFECT ON THE U.S. DIETARY SUPPLEMENT LAW? Codex has also produced guidelines on claims made on food labeling. Because dietary supplements are classified as foods in the U.S., and are allowed to make claims commonly known as structure-function claims as well as FDA-authorized health claims and nutrientcontent claims, it is useful to evaluate those Codex guidelines that address claims for foods. One such document is the Codex Guidelines for Use of Nutrition Claims, adopted in 1997. 10 These guidelines relate to the use of nutrition claims in food labeling, and define the term nutrient function claim as a nutrition claim that describes the physiological role of the nutrient in growth, development and normal functions of the body. The document goes on to state that only essential nutrients, limited to the letter vitamins and a number of basic minerals, should be the subject of a nutrient function claim. This is a much more restrictive standard than exists in the U.S. under DSHEA. Dietary supplements marketed domestically are allowed to bear claims that, among other options, describe the role of a nutrient or dietary ingredient intended to affect the structure or function in humans. This type of structure-function claim is allowed for any dietary ingredient, and is not limited to essential nutrients. Thus Codex is more restrictive than DSHEA in this matter, since DSHEA allows claims that describe the physiological role on normal functions of the body of ingredients such as herbs, amino acids, and other dietary ingredients that are not essential vitamins or minerals. And what was the effect of the adoption of this Codex standard in 1997? To begin with, there was no requirement for the U.S. to change its domestic laws to adopt this more restrictive standard about the claims that can be made for dietary supplements and neither the Congress nor the Food and Drug Administration acted in any manner that suggested that they believed such a requirement existed. In addition, no consumer in the United States found less information on the claimed uses of marketed dietary supplements because of these guidelines. And importers were allowed to sell any of their products that met this restrictive Codex standard, because all of the claims allowed by Codex were already allowed by DSHEA for products sold in the U.S. HOW WILL CODEX AFFECT THE CHOICES OF U.S. CONSUMERS OF DIETARY SUPPPLEMENTS? The presumed final adoption this summer of the Codex Guidelines on Vitamin and Mineral Food Supplements will have no direct or immediate effect on the dietary supplement choices of consumers in the United States. In spite of many internet-based communications to the contrary, the U.S. is under absolutely no obligation to change its existing laws and replace them with Codex guidelines, but is required to accept for import any products that conform to such guidelines. 10 This document is in the process of being revised and expanded to include health claims, which are claims that a relationship exists between a food and health. In this revision nutrient function claims are proposed be reclassified under health claims, but will continue to be restricted under the new guidelines to claims associated with essential nutrients. A similar definition is proposed to be added, however, so that other function claims would be allowed for specific beneficial effects of the function of foods or their constituents. (See: Alinorm 04/27/22. Report of the Thirty-second Session of the Codex Committee on Food Labeling; Appendix III, pages 41-46. Available at http://www.codexalimentarius.net/web/archives.jsp?lang=en as Alinorm 04/22. ) AMERICAN HERBAL PRODUCTS ASSOCIATION - 5 -
AHPA and other trade associations, as well as numerous consumer groups, worked hard more than ten years ago to assure the passage of the Dietary Supplement Health and Education Act. Tens of thousands of consumers of vitamins and minerals and of herbal products and other dietary supplements also did their part, and the U.S. Congress was inundated with messages from its constituents the consumers of dietary supplement that they would not tolerate unnecessarily restrictive controls on their healthcare choices. The resulting law ensured the rights of the citizens of the United States to have broad access to a wide variety of supplements and truthful information about these products. DSHEA also placed a legal burden on manufacturers to assure that all such products are safe for their intended use. The rights that are protected in DSHEA, however, continue to be challenged and the dietary supplement industry and consumers must maintain their vigilance. There are several federal and state legislators, as well as organizations like the American Medical Association, that continue to advocate for more restrictive laws that might have the effect of reducing consumer choices. Is it realistic to assume that these critics of personal choice would, if Codex ends up setting unnecessarily low levels for vitamin and mineral supplements, hold this up as a model of how regulations should be made in the United States? It would be naïve to make any other assumption. In summary, there will be no immediate effect on U.S. consumers of the final approval of the Codex Guidelines on Vitamin and Mineral Food Supplements. That fact should not, however, lull consumers or marketers of dietary supplements away from the inevitability that any restrictive elements from these guidelines will be used by critics of this industry to try to change our domestic laws. WHAT DOES CODEX HAVE TO DO WITH HERBAL PRODUCTS? As mentioned above, the Draft Guidelines for Vitamin and Mineral Food Supplements includes in its scope, food supplements that contain vitamins and/or minerals and also other ingredients, so such products should also be in conformity with the specific rules on vitamins and minerals contained in this guidance (emphasis added). And as also noted earlier, there are occasional cropspecific Codex standards for a few herbs, such as ginger. In addition, Codex adopted in 1995 a Code of Hygienic Practice for Spices and Dried Aromatic Plants, which can arguably be considered to have some effect on the production and harvest of plants that are sometimes used not only as spices but also as ingredients in herbal supplements. Aside from these few examples, there are no Codex activities related to herbal products, and none of the many Codex committees have proposed any standards or guidelines specifically directed to the broad class of herbal products that are sold in the United States as dietary supplements. IS CODEX THE SAME AS THE EU DIRECTIVE? Another international rule related to vitamin and mineral products is also under development, but of more limited geographical scope. The Directive on Food Supplements has already been AMERICAN HERBAL PRODUCTS ASSOCIATION - 6 -
adopted by the European Parliament, and is due to go into effect this summer, on August 1, 2005. 11 This directive is significantly different from Codex in at least two ways. First, policies adopted by the European Parliament, unlike Codex, do have the force of law in all 25 of the countries that make up the European Union. All of these countries have agreed in advance that laws adopted by the central Parliament will replace their individual domestic laws. As a result, any U.S.-based company that wants to sell its products in any of those countries after August 1 st will need to ensure that its products are in full compliance with this new law. The other key difference is in the nature of the directive itself. The directive includes, among numerous other details, a positive list of vitamin and mineral ingredients that will be allowed to be contained in food supplements. This list excludes a considerable number of ingredients that are now allowed to be sold in countries with liberal dietary supplement laws, and it is estimated that consumers in countries such as Great Britain may lose access to hundreds of products. Ironically, the effect in countries with more conservative laws today will be exactly the opposite, and product selection for citizens there will be expanded. The potential impact on Codex of the adoption of this restrictive EU Directive on Food Supplements must not be overlooked, and AHPA and numerous of its members continue to pay close attention to these international processes. Once all 25 EU members generate uniform regulations under the EU Directive on Food Supplements, it can be expected that they may work to make the Codex guidelines quite similar. If they are successful in any such efforts, however, there would still be no basis upon which Codex could force the United Stated to adopt its standards as U.S. domestic law this continues to be controlled by the U.S. Congress. 11 A opinion rendered on April 5, 2005, by the EU s Advocate General has thrown the imminent implementation of this directive into question. This opinion specifically decried the absence of clear procedures to revise the positive list of allowable supplement ingredients. The Advocate General stated that the directive is seriously deficient and recommended that the European Court of Justice rule the law to be invalid. This court, which usually accepts the opinion of the Advocate General, is due to meet in June 2005 to decide on this matter. (See: Webb, Q. April 5, 2005. Throw out EU food supplement law, court aide says. Reuters Foundation Alert Net. http://www.alertnet.org/thenews/newsdesk/l05330869.htm.) AMERICAN HERBAL PRODUCTS ASSOCIATION - 7 -