Part 6: Legal & Regulatory (May 2005)

[5/31/2005] Health Canada Warns Consumers Not To Use Any Natural Health Products from Tedco, Inc.
Regulatory agency Health Canada Health Canada is warning consumers not to use any natural health products exported or sold by Tedco, Inc. of Louisiana, due to the risk that they could contain harmful bacteria, and the products are not authorized for sale in Canada.
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[5/27/2005] Blair Speaks Out Against EU Over-Regulation
According to an article in The Sctosman, British Prime Minister Tony Blair, at a speech to the Public Policy Research in London, continued to criticize cumbersome regulations imposed by the European Union, noting specifically the efforts to restrict consumption of vitamins. According to the article, Blair is determined to reduce regulatory burden when Britain takes over the revolving EU presidency later this year, including impact assessments for EU measures.
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[5/24/2005] China: Quality of Traditional Chinese Medicine Needs Improving
According to an article on China's The People's Daily, the latest national survey of traditional Chinese medicine products has determined that 17% of the 2,455 samples evaluated were substandard, in terms of contents, properties and impurities. According to the article, the State Food and Drug Administration inspected 17 national traditional medicine markets in the last quarter of 2004.
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[5/20/2005] Albion Advanced Nutrition is Granted Derogations in United Kingdom
US-based Albion Advanced Nutrition has announced that the company has been granted derogations in the UK, by the UK Food Standards Agency for Calcium Amino Acid Chelate, Magnesium Amino Acid Chelate, Iron Amino Acid Chelate (Ferrochel™), Manganese Amino Acid Chelate, Zinc Amino Acid Chelate, Copper Amino Acid Chelate, and Chromium Amino Acid Chelate (Chromium Chelavite™).
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[5/19/2005] The Master's Miracle Issues Nationwide Health Alert Against Applying Their Products to the Eyes
US-based The Master's Miracle (TMM) company has issued a notice to the public warning against applying the company's TMM brand Fortified Mineral Neutralize! and Ultra Fortified Mineral Neutralizer to the eyes because of possible bacterial contamination. The products are labeled as dietary supplement, but apparently, certain TMM distributors are promoting the products for ophthalmic use and the products are not sterile, as would be required for such use.
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[5/18/2005] Trade Associations Unite on Ephedra
Trade associations The American Herbal Products Association (AHPA) the Council for Responsible Nutrition and the National Nutritional Foods Association have sent a unified message to the Food and Drug Administration (FDA) about the recent Utah District Court ruling on low-dose ephedra products. The joint letter urging FDA to address issues raised by that ruling promptly, was sent to Lester Crawford, Acting Commissioner of the Food and Drug Administration, with a copy to Michael Leavitt, Secretary of Health and Human Services. The letter notes that each organization has cautioned member companies that the court’s ruling is quite limited, and that the court’s order appears to be relevant to only low dosage products containing 10 milligrams or less per daily dose of ephedrine alkaloids, and that organizations believe that it is prudent to refrain from commerce in any ephedrine-containing dietary supplements pending further developments.
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[5/16/2005] China: More Than One Quarter of Health Supplements Are Fake
According to an article on, a report issued by the China Health Care Association (CHCA) indicates that 767 out of 2,951 health supplements manufactured by 2,025 companies either do not have or use unauthorized permit numbers or unauthorized product names. According to the article, the report was based on a survey conducted from June last year until March this year in pharmacies, supermarkets, and health food stores in more than 300 cities, with weight loss supplements accounting for 193 of the 767 fake products. The CHCA Secretary General, zhu Kangnian stated, ""These fake health products generally falsify or use other businesses' production license number instead of counterfeiting famous brand names."
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[5/16/2005] Banned Swimmer Wins Supplements Case
According to an article on South Carolina's, a swimmer who claimed that a positive banned substances test result was due to a contaminated vitamin product has won a lawsuit against Ultimate Nutrition with Orange County jurors awarding the athlete $578,635 in damages. According to the article, Kicker Vencill tested positive for the substance 19-norandrosterone in January 2003, and private lab tests of the multivitamin he was taking confirmed the presence of the material.
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[5/13/2005] Chemi's Brazilian Production Facility Passes Rigorous FDA Inspection
Italy-based Chemi S.p.A. has announced that the company's manufacturing facility, ITF Chemical Ltda., Camacari, Bahia, Brazil, has been inspected by the Department of Health & Human Services, Public Health Service, of the Food and Drug Administration, and has been granted acceptable status under FDA’s inspection guidelines. According to the company, the Brazilian Health Ministry / ANVISA - National Agency of Sanitary Surveillance, has issued a specific authorization for the manufacture of phosphatidylserine (PS) and related products.
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[5/13/2005] PIVEG Successfully Defends Patent Infringement Lawsuit
Mexico-based Pigmentos Vegetales del Centro (PIVEG) has announced a U.S. District Court ruling in Iowa that allows the company to continue marketing its purified lutein produced without the use of propylene glycol, as the court declares that in order to infringe on Kemin Industries U.S. Patent No. 5,648,564, propylene glycol must be used in the process.
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[5/12/2005] Pakistan: Non-allopathic Medicines’ Registration Bill Ready
According to an article in Pakistan's Daily Times, that country's National Assembly’s (NA) standing committee for health has passed a bill for registration and regulation of all no-allopathic and ayurvedic medicines. According to the article, manufacturers found guilty of illegal or substandard manufacturing would face a sentence of 6 to 36 months in jail.
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[5/12/2005] UK Food Standards Agency Makes Phytosterol decision
The Uk food Standards Agency has announced an initial decision in favor of approving an application for phytosterols to be added to fruit juices, fruit nectars and tomato juice. According to the notice, Coca-Cola Services S.A proposes to add 0.4% of phytosterols, supplied by Cargill Ltd., to fruit juices, including tomato juice and nectars, and the Agency has issued the positive initial opinion for this novel food application.
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[5/10/2005] Sabinsa's Selenium SeLECT® Exempt From European Union Food Supplements Directive
Ingredient supplier Sabinsa corporation has announced that the company's Selenium SeLECT brand L-(+)-Selenomethionine for use in dietary supplements, has been granted derogation by the United Kingdom and Denmark and therefore exemption under the European Union Food Supplements Directive. On August 1, 2005, the European Union is scheduled to ban numerous supplement ingredients with the company's product on that list to be banned.
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[5/9/2005] California First State to Pass Steroid Rules for Teen Athletes
According to an article in the Chicago Sun Times, the California Interscholastic Federation approved Friday three regulations which 1) require parents school officials and players to sign contracts promising that athletes won't use steroids, 2) regulate what supplements coaches can distribute to athletes and 3) require coaches to earn certification that includes steroids-abuse education.
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[5/4/2005] Ottawa must protect Natural Health Products Regulations with long-promised law for separate category
Industry association testifies that federal government should protect and enhance regulations for natural health products, separate from drugs, and not as foods as indicated by proposed Bill C-420.
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[5/3/2005] CFIA Alleges Supplements and Meal Replacement Products Tested Do Not Comply With Canadian Regulations
The Canadian Food Inspection Agency (CFIA) has released results of a 'sweep' of nutritional supplements and meal replacement products, claiming that 71% of the products evaluated did not comply with Canadian regulations, specifically noting products not meeting label claim of having improper labels or non-permitted ingredients. Products cited as failing to comply include those manufactured under the President's Choice label, PowerBar and Jamieson Slim Down Bars. Jamieson Vitamins has responded to the allegations noting dialogue with CFIA in recent months over discrepancies in test methods, particularly for microencapsulated vitmain A which Jamieson claims CFIA analytical methods cannot accurately determine. PowerBar has also responded to the allegations, stating that all communication from CFIA indicates they are compliant with Canadian regulations.
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