Part 6: Legal & Regulatory

[9/29/2005] Alliance Principle Ingredients Receives Approval for Melatonin Use in Dietary Supplements in Canada
Alliance Principle Ingredients announced that it has received approval from the Natural Health Products Directorate, in Canada, for melatonin. This allows Canadian manufacturers using melatonin from Alliance Principle Ingredients to receive Natural Health Product Numbers (NPN’s) for its products containing the ingredient.
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[9/29/2005] Von Eschenbach Named Acting FDA Commissioner
The President intends to designate Andrew von Eschenbach,of Texas, currently the director of the National Cancer Institute, to be Acting Commissioner of Food and Drugs at the Food and Drug Administration at the Department of Health and Human Services.
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[9/23/2005] HK Studies Food Safety Regulation Models
According to an article on, the Hong kong government is currently examining various international models in an attempt to adopt its own food safety regulatory framework, leaning towards a government department overseer rather than an independent statutory body.
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[9/22/2005] Three Cortislim Defendants to Give up $4.5 Million in Cash and Other Assets
California-based Pinnacle Marketing Concepts, Inc., its president, Thomas F. Cheng, and Shawn M. Talbott will give up $4.5 million in cash and other assets to settle Federal Trade Commission (FTC) charges stemming from their roles in the marketing of CortiSlim and CortiStress. In its originaol complaint, FTC alleged that the defendants made false or unsubstantiated product claims and used deceptively formatted infomercials in pitching the dietary supplements. FTC’s litigation is continuing against four remaining defendants.
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[9/22/2005] New AHPA FDA Inspection Guidance Available
The American Herbal Products Association (AHPA) has announced the availability of its Guidance for Addressing FDA Inspections of Dietary Supplement Facilities. The Guidance also includes a “standard operating procedure” (SOP) template that companies can customize to their specific needs to establish a written SOP for FDA inspections.
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[9/20/2005] Tagatose Takes Major Step Toward Approval In Europe
US-based Spherix Incorporated (Nasdaq: SPEX) has announced that the Food Standards Agency in the United Kingdom has signed off on an application by Arla Foods Ingredients of Denmark for the use of tagatose as a "novel food ingredient" in the European Union (EU).
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[9/19/2005] Swiss Voters to Decide on Alternative Medicine
According to an article on NZZ Online, backers of complementary medicines in Switzerland have collected 140,000 signatures in order to force a nationwide vote on whether five types of therapy should be re-recognized and reimbursed under compulsory health insurance. A successful vote would enshrine complementary insurance in the constitution, while requiring recognized doctors to dispense treatments in order to qualify for reimbursement.
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[9/13/2005] FDA Publishes Guidance for Bioterrorism Recordkeeping Requirements
The US Food and drug Administration has announced the publication of a guidance document on the recordkeeping requirements of the Bioterrorism Act. The guidance topics include who must comply with and who is excluded from the rule, and what information is required to be kept and made available to FDA during a Bioterrorism investigation.
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[9/12/2005] Canada's NHPD Launches Monthly Communiqué
Canada's Natural Health Products Directorate (NHPD) has introduced a monthly communiqué intended to keep stakeholders informed about the things they need to know in order to prepare complete and high quality product licence applications, site licence applications, and clinical trial applications. The first communiqué has been posted and includes a list of frequent errors and omissions from submissions received by NHPD.
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[9/7/2005] FDA Probes Foreign Gelatin Plants
According to an article in the Sioux City Journal, the US Food and Drug Administration has begun conducting compliance inspections at seven gelatin manufacturers in India that export to the United States, in a program that also covers suppliers of cattle bones for the plants. The inspections come as imported gelatin continues to grow, from just 300 metric tons in 2002 to nearly 4,000 metric tons last year, with general manufacturing concerns as well as concern over compliance with federal rules dealing with bovine spongiform encephalopathy.
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