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... GLOBAL NEWS . ... NEWS EU'S NEW FOOD DIRECTIVE HAS GLOBAL IMPLICATIONS lhe European Union food supplements directive was approved in its second reading in the EU Parliament on March 13, 2002, with only one proposed amendment: the extension of a time limit for submitting dossiers for the approval of vitamin and mineral sources not yet included in the directive's appendix (see http://www.laleva.cc/supple- ments/c5-0640-01_en.pdf). Vitamin and mineral sources found on the market, but not included in the directive's appendix, number about 300, mainly the more advanced min- eral formulations (see http://www. laleva.cc/supplements/forgotten_substances. html). Two aspects most likely to influence the supplements industry at this point are: * Dosages: The directive mandates that maximum dosages shall be set after consulta- tion by the European Scientific Committee for Foods (SCF). The actual decision, how- ever, is left to administrative action by the European Commission, which is a kind of rudimentary government for the European Union. There is a large margin of discretion in this setting of dosage limits; article 5 of the directive states that dosages should be set with regard to safety, but after considering intake of vitamins from sources other than supplements (i.e., from food) and after taking due account of recommended daily intakes (RDI). So there is really no telling yet where the mood will swing on this; the rules can be interpreted in a variety of ways. ¢ Ingredients: The directive establishes lists of vitamin and mineral sources that may be utilised in the formulation of supplements. The first draft list, which is an annexe to the text of the directive, itemises the most ineffective forms (especially for minerals) from a viewpoint of bioavailability—forms which have for years been used in pharmaceutical drugs and in dietetic products. To add a vitamin or mineral source to the list, a scientific dossier needs to be submitted to the Scientific Committee for Foods. The SCF has laid down strict requirements, including toxicological assays, for these dossiers (see http://www.europa.eu.int/comm/food/fs/sc/scf/ out100_en.pdf). But there is more to be considered. There are at least two legislative proposals already in the works at the EU which are likely to influence supplements negatively: * The first one is a proposal for the medicinal registration of herbal products. This has been proposed by the EC and it appears to be an attempt to extend to the rest of Europe the restrictive German system, where all herbal products are registered medi- cines (but not restricted only to sale in pharmacies). European industry seems set to oppose this proposal. The time frame for approval is about two years, if it does advance as planned. * The second legislative proposal is even more insidious. It is a general revision of the European medicines code, and one of the proposed changes is in the definition of what constitutes a medicinal product—which would seem to incorporate any substance that can be used for the purposes of staying or getting healthy, even if not presented in this way. It would also affirm a new principle: that a product can be considered medic- inal if it fits the (very extensive) definition, even if it is already subject to other legisla- tion. In other words, any health product that turns out to become serious competition to a pharmaceutical product could be picked out and reclassified as a medicine, practically without any possibility of legal recourse. The recent and ongoing EU legislative changes in the field of supplements, herbs, foods and medicines will hit the supplements industry in its most vulnerable area, reducing the critically important capacity to innovate. If the legislative trend continues on its present course, innovation of natural and nutritional products will be extremely difficult, if not impossible, for smaller companies. The costs involved will slow inno- vation down to the pace of the biggest players, which have been notoriously reluctant to allow any changes in the status quo. Another ominous development on the horizon is a UN-related Codex Alimentarius guideline very similar to the EU's directive on food supplements. This may, in time, become even more important than the EU directive, which affects commerce only inside the European Union. Use of World Trade Organization mechanisms to force a change in a country's vitamin laws cannot be ruled out. (Source: from Josef Hasslberger, March 14, 2002, http://www.hasslberger.com; see also http:/www.lavela.cc, Health Sciences Institute, http:/www.hsibaltimore.com, and Health Confidential, May 2002, http://www.healthchoice.org.uk) Results from animal studies have been astounding. Injected with viruses, human tumours in mice have shrunk and vanished completely without harming the animals. And viruses have worked against not just one cancer but nearly every malignancy medicine knows, whether breast, lung, liver, colon, ovarian or even brain. Researchers at the University of Calgary, Canada, have completed the first trial designed to test the safety of a reovirus—a bug common to the human gut and nasal passages. Last Christmas, nine cancer patients in Ottawa received infusions with the same virus. Eighteen patients with sar- comas (cancers of the bone and soft tissue) or breast, skin, head or neck cancer suf- fered no serious side effects over a 14- week trial. Some of their tumours even showed signs of shrinking, and one tumour disappeared completely. The Alberta group is now conducting a Phase 2 trial, testing 45 prostate cancer patients and, in another experiment, testing patients with brain cancer. "The results are encouraging, but this is a whole new area that we're exploring," said Dr John Bell, a senior scientist with Cancer Care Ontario, which is involved in the Ottawa trials. Still, he says, in the lab "there hasn't been a cancer that isn't vulner- able to a virus". California's Onyx Pharmaceuticals Inc. and Stanford University are testing a genet- ically altered adenovirus—better known as a common cold bug—in patients with head, neck or liver cancer. Harvard is running trials with a modified herpes virus, and lab research is underway on a weakened polio virus at Duke University and on measles at the Mayo Clinic. "Tumour cells have already undergone genetic changes to become cancerous," said Dr Bell, who is also a professor of medicine at the University of Ottawa. "They have thrown out genes that inhibit their growth, but at the same time they've thrown out their antiviral programming." Unlike bacteria that can multiply on a doorknob, a subway seat or a bowl of soup, viruses are parasites that depend on a host cell for their survival. But once a single virus particle busts through a cell wall, it can replicate from 1,000 to 10,000 times within two days. (Source: The Globe and Mail, Canada, April 27, 2002, http://www. theglobeandmail.com) JUNE - JULY 2002 NEXUS ¢ 9 www.nexusmagazine.com