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Published April 25, 2012
FDA must reconsider imposing the pre-market approval paradigm of food additives to dietary supplements as proposed in its New Dietary Ingredient (NDI) Draft Guidance, according to a commentary by the Council for Responsible Nutrition (CRN), Wa… Read More »
Published March 1, 2012
In a letter to FDA Commissioner Margaret Hamburg, MD, Senators Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa)—the principal authors of the Dietary Supplement Health and Education Act (DSHEA)—asked Dr. Hamburg to withdraw the agency’s… Read More »
Published January 2, 2012
FDA has taken legal action against a dietary supplement maker and owner for substituting ingredients and products without noting the changes on the final product labels. The permanent injunction, filed on behalf of FDA by the U.S. Department of Justi… Read More »
Published December 2, 2011
Amarin Corporation, Bedminster, NJ, a late-stage biopharmaceutical company focused on cardiovascular disease, has revealed that its New Drug Application (NDA) for AMR101 has been accepted for filing by FDA. The acceptance of the NDA reflects the FDA&… Read More »
Published October 3, 2011
FDA has extended the period to submit comments regarding the New Dietary Ingredient (NDI) Notification Guidance by 60 days, to December 2, 2011. Industry groups began calling for an extended comment period shortly after the agency issued its draft gu… Read More »
Published October 3, 2011
FDA has grossly underestimated the burden of its New Dietary Ingredient (NDI) notification process on the dietary supplement industry in terms of time resources, according to the Council for Responsible Nutrition (CRN), Washington, D.C., which submit… Read More »
Published September 1, 2011
Trade associations respond, requesting an extended comment period. Read More »
Published September 1, 2011
Agency believes its proposed rule published in 2007 remains valid. Read More »
Published July 1, 2011
Florham Park, NJ-based Gerber Products Company, a part of the Nestlé family, has received notice from FDA that Gerber Good Start milk-based formulas meet the criteria for a qualified health claim related to a reduced risk of atopic dermatitis.… Read More »
Published May 6, 2011
The Council for Responsible Nutrition (CRN), Washington, D.C., recently submitted comments to FDA regarding the agency’s proposed rule for the health claim on phytosterols and risk of coronary heart disease. Douglas MacKay, ND, vice president,… Read More »
Published March 1, 2011
The dietary supplement industry’s leading trade associations have joined forces with FDA to support heightened efforts aimed at addressing significant public health problems posed by products that are illegally marketed as dietary supplements b… Read More »
Published November 9, 2010
BioScreen Testing Services, Los Angeles, CA, recently hosted a delegation of 25 officials from the Chinese Food and Drug Administration of Chongqing City P.R. China. Over a three-week period, the officials travelled throughout the U.S. to gain a bett… Read More »
Published June 1, 2010
FDA should apply the same rigor to evaluating the science behind health claims of foods and dietary supplements as it devotes to assessing medication and medical technology approvals, a new report from the Institute of Medicine (IOM) stated. The comm… Read More »
Published June 1, 2010
FDA has requested comments and information about front-of-package nutrition labeling and on shelf tags in retail stores. The agency is seeking public participation as it deliberates about how to enhance the usefulness to consumers of point-of-purchas… Read More »
Published May 3, 2010
According to the American Herbal Products Association (AHPA), Silver Spring, MD, the healthcare reform bill signed into law March 23 by President Barack Obama, the “Patient Protection and Affordable Care Act,” includes several provisions… Read More »
