Part 6: Legal & Regulatory (Mar. 2005)

Companies in the News: Berkeley Premium Nutraceuticals,, The Council for Responsible Nutrition, Nutrition 21, Inc., Bausch & Lomb, Bioresco, Arla Food Ingredients, Inverness Medical Innovations, Inc., Metabolife International, Inc., Forbes Medi-Tech Inc., ATS Fitness Products Inc.

[3/23/2005] Bill Aims to Prohibit Supplement Promotion
According to an article in The Oregonian, a bill has been presented to the Oregon Senate which, if passed, would ban "school administrators, teachers, employees and volunteers from promoting, suggesting or supplying performance-enhancing supplements to students". The bill, according to the article, was unanimously passed by the Education and Workforce Committee, and the next step is a vote on the Senate floor. Motivation behind the bill is said to be a fall 2003 incident when a high School football coach, also part owner of a supplement company, came under scrutiny for selling creatine-based supplements to his players.
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[3/21/2005] Business Owner to Serve Jail Time and Pay Restitution
According to an article last week in Mississippi's Clarksdale Press Register, a local business owner has pled guilty in federal court to wire fraud in connection with the sale of herbal supplements. According to the article, the owner, in a plea agreement, the owner has agreed to serve three years in prison and pay $1.8 million in restitution to victims. The article specifically notes an incident of credit card charges which the owner refused to refund.
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[3/21/2005] Government Launches Consultation on Folic acid Fortification
According to an article on, the government of Ireland has initiated a consultation regarding folic acid fortification, requesting all those submitting comments to make views known before June 24, 2005. According to the article the country has one of the the highest incidences of neural tube defects in Europe.
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[3/17/2005] Customer Complaints Lead to Raids on 3 Local Berkeley Sites
According to an article in the Cincinnati Post, Postal inspectors, along with agents of the Federal Bureau of Investigation, Internal Revenue Service, Food and Drug and Administration and local police have raided three facilities of supplement company Berkeley Premium Nutraceuticals. According to the article, the raid is in response to thousands of consumer complaints and allegations of questionable business practices.
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[3/16/2005] FTC Dismisses Complaint By CRN Against
According to a release issued by, the Federal Trade Commission has sent a letter to trade association The Council for Responsible Nutrition (CRN), stating that it refused to take action with respect to a complaint by the group against
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[3/15/2005] Confirmation Hearings Set for Lester Crawford
According to a release issued by the American Herbal Products Association (AHPA), Lester Crawford, DVM, PhD, will go before the Senate Health, Education, Labor and Pensions Committee on Thursday, March 17, beginning at 10 a.m. (Eastern) in a confirmation hearing on his nomination to be FDA Commissioner.
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[3/15/2005] U.K. Food Standards Agency Approves Continued Sale of Chromax® Chromium Picolinate
US-based Nutrition 21, Inc. (NASDAQ: NXXI) has announced that the UK Food Standards Agency (FSA) has granted 'derogation' for the company's Chromax® chromium picolinate in England, Scotland, Wales and Northern Ireland. This approval for continued sale provides a four year period for the European Food Safety Authority (EFSA) to review the dossier for potential approval of the product into EU legislation. According to the company, this milestone is critical to the company's overall international expansion strategies.
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[3/14/2005] Bausch & Lomb Withdraws Patent Infringement Lawsuit
According to a release issued by Bausch & Lomb (BOL), the company has dismissed without prejudice a patent infringement lawsuit it filed last week regarding its antioxidant and mineral formula in Bausch & Lomb's Ocuvite(R) PreserVision(TM) nutritional supplements.
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[3/11/2005] Canadian Parliament Debates Easing Rules Governing Herbal Supplements
According to an article in the National Post, the Canadian House of Commons has resumed debate on controversial Bill C-420, an Act to amend Canada's Food and Drug Act, that would, if passed, undo much of the new regulations governing natural health products in that country. The Bill's supporters note the outdated food and Drug Act, and claim that the bill would modernize the regulatory environment which some claim is cautious and even punitive, largely by placing the products under the 'Food' category. Those against the bill note that the current regulations regarding natural health products, which came into effect January 2004, were the end result of a lengthy consultative process, including significant consumer feedback, and were intended to ensure wide availability of safe and effective products. The Bill, they argue, would not ensure this.
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[3/11/2005] Australia Raises Regulatory Bar on Herbal Products
The Australian Government has responded to recommendations from an Expert Committee on Complementary Medicines in the Health System, which was formed in response to the 2003 recall of products manufactured by Pan Pharmaceuticals. The recall included natural product-based medicines, and the Expert Committee tabled 49 recommendations to which the government has now responded. Included in the response is a commitment, with the input of stakeholder groups, to develop and review quality standards for ingredients, and implementing new guidelines to review claims.
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[3/10/2005] Agency Seeking Views on Novel Food Applications
The Food Standards Agency (UK) is seeking views on two food ingredients that are pending approval as novel food ingredients. One submission, from Bioresco, on behalf of Arla Food Ingredients, deals with D-tagatose for a variety of products including baked goods, drinks, confectionery and ready-to-eat cereals. The other deals with an opinion on equivalence of an unfermented noni juice (from the fruit of Morinda citrifolia L), specifically, an unfermented, pasteurized noni juice called ‘green noni’ as a novel food ingredient, to be used in pasteurized fruit drinks.
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[3/9/2005] Ohio Bill Would Decriminalize Alternative Health Practices
According to an article on Columbus Business First, Republicans in Ohio have put forward a bill to decriminalize alternative medicine in that state. According to the article, currently, alternative medicinal providers can face charges for the unlicensed practice of medicine, and the bill, which would apply to herbalism, nutrition counseling, traditional Chinese medicine, reiki and Ayurveda, would allow them to practice so long as they provide full disclosure to patients.
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[3/9/2005] Bausch & Lomb Sues Eye Vitamin Makers for Patent Infringement
Eye product company Bausch & Lomb (BOL) has announced that it has filed a patent infringement suit against Inverness Medical Innovations, Inc., and its subsidiary IVC Industries, Inc., alleging infringement of Bausch & Lomb's patent rights to the antioxidant and mineral formula in Bausch & Lomb's Ocuvite(R) PreserVision(TM) nutritional supplements. The Suit Was later dropped.
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[3/7/2005] Appeals Court Reverses Verdict Against Metabolife
According to an article on, the 11th Circuit Court of appeals has ruled that there was no credible scientific evidence against Metabolife International, Inc., reversing a 2002, $4 million verdict against the company. According to the article, the appeals court rejected arguments that Metabolife 356 caused plaintiffs to suffer various ailments including strokes and heart attacks, and noted that the case should not have been allowed to proceed to trial, given the lack of evidence.
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[3/2/2005] Forbes Medi-Tech Receives European Approval for Reducol(tm) in Seven Major Food Groups
Canada-based Forbes Medi-Tech Inc. (TSX: FMI; NASDAQ: FMTI) has announced that it has received an opinion of substantial equivalence from European regulatory authorities that allows it to market its cholesterol-lowering ingredient, Reducol(tm), in several approved food groups including: yellow fat spreads (margarine), fermented milk type products, soy drinks, low-fat cheese type products, yoghurt type products, spicy sauces, and salad dressings.
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[3/2/2005] Seized Ephedra Containing Supplements Were for Sale in Poland
According to an article on, the ephedra containing supplements under FDA scrutiny last week at Oakmont, Pennsylvania's ATS Fitness Products Inc., were intended for sale in Poland, where ephedra containing products are legal. According to the article, some of the products, when tested by the Agency, did not contain ephedrine alkaloids, leading the FDA to call them mislabeled.
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[3/2/2005] UK: Vitamin and Mineral Dossiers Submitted
The UK Food Standards Agency (FSA) has published a list of vitamins and minerals sources allowed by the Agency to stay on the market until 31 December 2009, under Article 4 of the 2002 European directive on food supplements. So far the FSA has received 14 dossiers to which it has granted derogation.
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