NSF's Dietary Supplement Standard is Updated to Keep Pace with FDA GMP Regulations
[2008/05/08] [NSF International]
NSF International has announced that the 2008 version of NSF's American National Standard for Dietary Supplements now includes new good manufacturing practices (GMP) requirements to ensure consistency with the U. S. Food and Drug Administration's (FDA) regulations.
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Farrah Marfatia Joins dicentra
[2008/05/07] [dicentra]
In line with dicentra’s expansion into pharmaceutical and international regulatory services, Farrah Marfatia joins dicentra as a regulatory affairs associate, bringing expertise in strategy and filing of over-the-counter (OTC) drug submissions, including Rx-to-OTC Switch, New Drug, and Provincial Scheduling Submissions.
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AHD Luravida™ Omega 3 Cranberry Oil Receives GRAS Approval
[2008/05/07] [AHD International]
AHD International has announced that, based on an independent and collective scientific evaluation, an Expert Panel has concluded that AHD’s Luravida™ Omega 3 Cranberry Seed Oil, produced in accordance with current GMP, has been GRAS (generally accepted as safe) approved.
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Pharmaceutical Consulting Services, LLC Presents Dietary Supplement GMPs
[2008/05/05] [Pharmaceutical Consulting Services, LLC]
In continuation to promote GMP Programs for companies to become compliant or to continue compliance with the new regulations for Dietary Supplements, PCS announces its presentation of “Dietary Supplement GMPs that Work for YOU!”, at the Sheraton Park Hotel in Anaheim, CA on July 1, 2008.
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AHPA Requests OEHHA Withdraw Proposed Prop 65 Language on Beneficial Nutrients
[2008/05/05] [American Herbal Products Association (AHPA)]
The American Herbal Products Association (AHPA) has submitted comments to the California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) requesting the office withdraw its proposed regulatory language on Proposition 65 warnings for chemicals that are both “beneficial to human health” and known by the state of California to cause cancer or reproductive toxicity.
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Sabinsa Notifies Alchem As To Status of Its Forskohlin [ForsLean(R)] Patent
[2008/05/05] [Sabinsa Corporation]
Sabinsa Corporation announced today that it has notified Alchem International as to the status of its patent covering the use of Forskohlin [ForsLean(R)], and has demanded that Alchem cease any activities that mislead the public.
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FDA Completes Final Analysis of "Total Body Formula" and "Total Body Mega Formula" Products
[2008/05/02] [Food and Drug Administration (FDA)]
The U.S. Food and Drug Administration’s final analysis of certain flavors of "Total Body Formula" and "Total Body Mega Formula” has detected hazardous amounts of chromium in addition to selenium.
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FDA Embarks on Major Hiring Initiative for its Public Health Mission
[2008/05/01] [Food and Drug Administration (FDA)]
The FDA is hiring hundreds of individuals with science and medical backgrounds to help meet the agency's responsibilities to assure the safety and/or efficacy of human and veterinary drugs, biological products, medical devices, food, cosmetics and products that emit radiation.
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EU: New proposals on novel foods
[2008/04/28] [Food Standards Agency (UK)]
The European Commission is proposing to update the approvals process for novel foods, and clarify the definition of novel foods, including the latest developments in the area such as cloning and nanotechnology. The Agency has issued a consultation on the proposals.
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Council For Responsible Nutrition To Defend Weight Loss Claims For Dietary Supplements
[2008/04/29] [Council for Responsible Nutrition]
In response to a joint citizen’s petition filed by the American Dietetic Association (ADA), The Obesity Society, Shaping America’s Health and GlaxoSmithKline Consumer Healthcare, LP, which asks the Food and Drug Administration (FDA) to treat weight loss claims for dietary supplements as disease claims, the Council for Responsible Nutrition (CRN) responds: "CRN plans to oppose this petition to re-classify weight loss claims as either disease claims or health claims requiring FDA approval. We believe weight loss claims are legitimate and appropriate claims for products in the dietary supplement category, provided these products have substantiation to support the truthfulness of these claims.....
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