Legal review provided by Susan Brienza, Esq. (Patton Boggs LLP)
?The government is coming for your vitamins!? Or ?Supplements will be illegal after this summer!? Or ?Relax, the government wants to help consumers by making vitamins safe.?
Sensationalism? Yes. Truth? Maybe.
Here?s what is true: An international body, the Codex Alimentarius Commission, is studying the place of dietary supplements on the global market. Some people are very upset by this.
And no matter which side of the story you believe, there are two more truths: Keeping a close eye on new developments is a very good idea. So is participating rather than pontificating.
Beyond those truths, it gets a bit murky. But stay awake—the background is important in any well-taken picture.
What is Codex?
The Food and Agriculture Organization and the World Health Organization of the United Nations jointly created the Codex Alimentarius Commission in 1963 to develop food standards, guidelines and codes of practice under the Joint FAO/WHO Food Standards Programme. The main purposes of this body as stated by the commission ?are protecting health of the consumers and ensuring fair trade practices in the food trade, and promoting coordination of all food standards work undertaken by international governmental and nongovernmental organizations.?
The commission meets every two years, alternately at FAO headquarters in Rome and at WHO headquarters in Geneva. Codex, shorthand for the CAC, is composed of two types of committees. Codex Committees prepare draft standards for submission to the CAC. Coordinating Committees act as a forum through which regions or groups of countries coordinate food standards activities in the region. There are nine Codex Committees, such as the Committee on General Principles, the Committee on Food Labelling, the Committee on Residues of Veterinary Drugs in Food and, in this case most importantly, the Committee on Nutrition and Foods for Special Dietary Uses. Each committee is hosted by a member nation. The CCNFSDU is hosted by Germany. Commodity Committees, under the purview of Codex Committees, create standards for specific commodities, such as fats, fish, sugars and natural mineral waters. In November 2004 the Committee on Nutrition and Foods for Special Dietary Uses completed the Draft Guidelines for Vitamin and Mineral Food Supplements and submitted them for adoption by the CAC at its meeting in July. This document states:
1.1 These guidelines apply to vitamin and mineral food supplements intended for use in supplementing the daily diet with vitamins and/or minerals.
1.2 Food supplements containing vitamins and/or minerals as well as other ingredients should also be in conformity with the specific rules on vitamins and minerals laid down in these guidelines.
1.3 These guidelines apply in those jurisdictions where products defined in 2.1 are regulated as foods.
1.4 Foods for special dietary uses as defined in the General Standard for the Labelling of and Claims for Prepackaged Foods for Special Dietary Uses (CODEX STAN 146-1985) are not covered by these guidelines.
(This standard states, ?Foods for Special Dietary Uses are those foods which are specially processed or formulated to satisfy particular dietary requirements which exist because of a particular physical or physiological condition and/or specific diseases and disorders and which are presented as such.?)
The next section of the CCNFSDU document states:
2.1 Vitamin and mineral food supplements for the purpose of these guidelines derive their nutritional relevance primarily from the minerals and/or vitamins they contain. Vitamin and mineral food supplements are sources in concentrated forms of those nutrients alone or in combinations, marketed in forms such as capsules, tablets, powders, solutions, etc., that are designed to be taken in measured small-unit quantities but are not in a conventional food form and whose purpose is to supplement the intake of vitamins and/or minerals from the normal diet.
?Small-unit quantities? is footnoted as referring ?to the physical forms of the vitamin and mineral food supplements, not to the potency of the supplements.?
Three other subsections of note are in the section dealing with the composition of dietary supplements. They state:
3.1.1 Vitamin and mineral food supplements should contain vitamins/provitamins and minerals whose nutritional value for human beings has been proven by scientific data and whose status as vitamins and minerals is recognized by FAO and WHO.
3.2.1 The minimum level of each vitamin and/or mineral contained in a vitamin and mineral food supplement per daily portion of consumption as suggested by the manufacturer should be 15 percent of the recommended daily intake as determined by FAO/WHO.
3.2.2 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.
It is important to remember that the Codex standards and guidelines are not legally binding. All are voluntary. Sort of.
Enter the World Trade Organization.
The WTO and Codex
The World Trade Organization was born in 1995 out of the General Agreement on Tariffs and Trade, which had, from 1948 until then, governed international trade. A de facto international organization, known informally as GATT, grew out of the General Agreements and lasted until the WTO?s creation at the Uruguay Round of GATT multinational trade negotiations, which lasted from 1986 to 1994. GATT had mainly dealt with trade in goods, but the WTO and its agreements cover ?trade in services and in traded inventions, creations and designs (intellectual property).?
The center of the WTO is its agreements, which are negotiated and signed by member nation governments. The ground rules for international commerce are contained in those agreements, which are essentially contracts, binding governments to keep their trade policies within agreed limits.
The Agreement on the Application of Sanitary and Phytosanitary Measures, known as SPS, and the Agreement on Technical Barriers to Trade ?both encourage the international harmonization of food standards.? Also born of the Uruguay Round, the SPS Agreement states that the preferred international measures for facilitating international trade in food shall be the Codex standards.
Codex might not be legally binding in the United States, but WTO agreements are. And since the WTO cites Codex as the benchmarks for food regulations, Codex becomes legally binding by extension.
Whatever rules the CAC develops are not just an academic exercise to foster trade and help poorer nations develop standards. They are an important part of a cascade of legalities, necessitating analysis of the intersections among international organizations, signed treaties and U.S. legislation.
>Down with DSHEA?
The Dietary Supplement Health and Education Act enacted by Congress in 1994 is the U.S. law governing supplements. Codex, although legally binding in one sense, would not affect DSHEA directly.
The workings of WTO and its form of international legality state that in the case of a trade dispute, one member nation may bring a complaint against another member nation, at which point a series of consultations and panels takes place, lasting approximately one year, not counting an appeal. A subsequent appeal takes about three months.
According to WTO, ?A dispute arises when one country adopts a trade policy measure or takes some action that one or more WTO members considers to be breaking the WTO agreements, or to be a failure to live up to obligations. A third group of countries can declare that they have an interest in the case and enjoy some rights.?
If a case were to be brought against, and lost by, the United States regarding dietary supplements and, therefore, DSHEA, Congress would then have to decide whether to vote to change U.S. law or accept WTO-imposed punitive duties on U.S. exports.
The tricky part
It would seem from a strictly literal reading of the law that there should be little concern for Codex?s effects on U.S. statutes and, thus, on U.S. consumers? continued ability to obtain supplements, natural or synthetic, in current amounts and incarnations?save those that have been banned by FDA. However, there is concern in some quarters that this is not true, that Codex may mean a severely curtailed supplements market. What follows are three views of Codex?s effect.
President of Nature?s Life, a division of Nutraceutical
Riedel is a proponent of what may be called the ?all is well? camp in relation to the new CCNFSDU draft guidelines and Codex?s effect on U.S. consumers and manufacturers.
?The primary goals of Codex are twofold: to reduce international trade barriers in food trade and to develop standards and guidelines for use primarily by those countries that have not yet developed them on their own,? Riedel said. He notes that a key and positive portion of the guidelines is that, for the first time, an international body will call supplements foods, not drugs—an important distinction when one considers the gamut of international supplements rules, Riedel said.
From the U.S perspective, Riedel said, the big question is ? ?Are my supplements safe here?? Bottom line is yes.? He explains that Codex guidelines are set up to get around restrictive trade standards and that Codex, by establishing an international standard, will override those restrictive national standards. ?But since our national standard is already much more liberal than the Codex standard, it doesn?t even impact domestic sales. But it will impact countries like Italy or Austria or Germany or Egypt or India where these products are sold as drugs now. Or Australia, where they are sold as a unique category called therapeutic goods.?
Riedel said vigilance should continue on several fronts, including language in the guidelines regarding different populations? dietary needs, language leaving a seeming loophole for countries that classify supplements as drugs, and during talks regarding science-based risk-assessment models.
?We need to get more people involved,? Riedel said. ?I think that it?s good that people are questioning what is happening with the Codex guidelines and their possible implications, and the reason that it?s good, to quote Thomas Jefferson, is ?The price of freedom is eternal vigilance.??
Consumer advocate and health journalist
?The whole thing will come down to science,? Sardi said. ?They?re going to select a group of scientists that will look at the wrong science.?
Sardi falls squarely in the ?Codex is to be feared? camp. He said that deciding upper limits for supplements is a ?flawed? idea. The state of the science at this point is far too contradictory and controversial, Sardi said, and the experts are trained on outdated science and modes of thought. Further, trying to decide upper limits for each population will be extremely difficult, if not impossible. ?For example, [consider] vitamin D. Blacks living in northern latitudes need 10 times more sunlight to get the same amount of vitamin D [as those living farther south]. They do not get enough vitamin D,? Sardi said. ?If we set the upper limits, we would affect the health of blacks living in northern latitudes who probably need 4,000 to 10,000 units of vitamin D a day to maintain health.?
The more insidious problem with Codex, according to Sardi, is its intangible effect on consumers. ?The thing that I?m concerned about is that Codex said it does not apply to the United States and therefore we don?t have to accept it. But there will be a big headline, this will be blasted all over the world, every news media agency will cover it and say these upper limits have been established by a world trade body, Codex. And everybody who reads a newspaper or watches a television will hear. ? And these na?ve consumers will back away from doses, regardless of whether there?s a law, because they?ve been told [by an international body].?
In the end, Sardi wants upper limits thrown out entirely. ?The issue is that the public has a right to decide, after acquiring knowledge, as to whether they want to use dietary supplements for more than preventive use, but rather therapeutic use. What the upper limits makes difficult is for consumers to practice prevention and therapeutics on their own.?
Attorney at Greenberg Traurig LLP
Prochnow said the main uproar is the possibility that if the new Codex guidelines pass they will change U.S. law. Prochnow states firmly that this just isn?t true, but also said it could create an issue with WTO, which has compulsory jurisdiction and the power to impose sanctions. ?An important thing to remember with the WTO is that any action for violations of WTO treaties or agreements only occurs between countries, not individual companies,? he said. ?It would entail an individual country suing another country.? If that country lost in WTO dispute-settlement court, then WTO could potentially impose sanctions for not adopting Codex standards. ?But even [a situation such as that] wouldn?t change U.S. law. It just makes the U.S. subject to sanctions, and then it becomes an issue of: Do the sanctions become onerous enough that the U.S. decides to change the law to conform with [the guidelines] because they don?t want to absorb these [economic] sanctions??
Prochnow, who spoke about Codex at Natural Products Expo West, said his eyes were opened to fears that passage of the new guidelines could become a legal ?slippery slope? if it served as a model for new laws. ?There are a couple bills pending in Congress right now ? that are trying to, I guess, take some of the teeth out of DSHEA. Certainly, the thought is ? that these same people would take Codex and say, ?Look, here?s an international standard that most countries are adopting, and the U.S. still isn?t doing this. We should conform with the rest of the world.? And if you have something that?s already passed, that [international standard] makes it easier to [undermine DSHEA].?
As for the other concern—that FDA will change its regulations to conform to Codex—Prochnow said that from a legal standpoint, it just isn?t possible. ?The FDA has to go through the formal rule-making process ? which isn?t a quick process. So it?s certainly not something they can do the next day.? He said FDA wouldn?t be able adopt anything that?s in opposition to DSHEA, adding ?I believe there is not an intent to do that right now. I think the FDA knows it would have a real battle on its hands.?
He concludes that legally there?s not much to worry about and that the current fears are speculative. ?Codex passage has no specific effect on U.S. law. The concern is the intangible.?
Natural Foods Merchandiser volume XXVI/number 5/p. 1, 14, 16, 57