From Nutraceuticals World
By Todd Harrison
On July 1, 2011, FDA published its long-awaited Draft Guidance on New Dietary Ingredient (NDI) Notifications. The notice of availability of the Draft Guidance was published in the Federal Register on July 5, 2011. While comments on the guidance may be submitted to the agency at any time, to ensure consideration by the agency, comments should be submitted by October 2, 2011.
First and foremost, the positions articulated by FDA in the Draft Guidance can be expected to have a significant impact on all those who manufacture or distribute dietary supplement products. As such, the Draft Guidance must be evaluated very carefully to determine the effects it may have on your company.
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Strategy. Communications. Trade Relations.
Showing posts with label nutraceuticals world. Show all posts
Showing posts with label nutraceuticals world. Show all posts
Thursday, September 1, 2011
Associations Oppose Supplement Labeling Bill
From Nutraceuticals World
The Natural Products Association (NPA), Washington, D.C., has launched a grassroots campaign to oppose the “Dietary Supplement Labeling Act” recently introduced in Congress by Senator Richard Durbin (D-IL). NPA is urging its more than 1900 members to ask their legislators to oppose the bill by sending them a letter. Among other provisions, the bill would direct the Department of Health and Human Services (and presumably FDA) to create a list of ingredients and proprietary blends of ingredients that “could cause potentially serious adverse events.” According to NPA, this overly broad language (e.g., no definition is offered of “could cause”) takes the regulation of supplements well beyond the current, effective rules governing the industry.
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The Natural Products Association (NPA), Washington, D.C., has launched a grassroots campaign to oppose the “Dietary Supplement Labeling Act” recently introduced in Congress by Senator Richard Durbin (D-IL). NPA is urging its more than 1900 members to ask their legislators to oppose the bill by sending them a letter. Among other provisions, the bill would direct the Department of Health and Human Services (and presumably FDA) to create a list of ingredients and proprietary blends of ingredients that “could cause potentially serious adverse events.” According to NPA, this overly broad language (e.g., no definition is offered of “could cause”) takes the regulation of supplements well beyond the current, effective rules governing the industry.
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Friday, July 1, 2011
On-Trend Products Defying Economic Downturn
From Nutraceuticals World
According to Netherlands-based Innova Market Insights, new food products with an ethical or premium positioning are on the rise despite the difficult economic situation. New data show that consumers, while pinching pennies elsewhere, are readily snatching up value-added products positioned on ethical platforms.
As a percentage of total U.S. launches, new food products with an ethical positioning grew from more than 3% in 2008 to 6% of introductions tracked in the first quarter of 2011. This paradigm shift comes as the wellness category is blurring to encompass new areas not typically considered as health and nutrition, such as “minimally processed,” “locally sourced” and “sustainable” and appealing to a more “responsible” American consumer increasingly concerned about the environment and sustainability.
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According to Netherlands-based Innova Market Insights, new food products with an ethical or premium positioning are on the rise despite the difficult economic situation. New data show that consumers, while pinching pennies elsewhere, are readily snatching up value-added products positioned on ethical platforms.
As a percentage of total U.S. launches, new food products with an ethical positioning grew from more than 3% in 2008 to 6% of introductions tracked in the first quarter of 2011. This paradigm shift comes as the wellness category is blurring to encompass new areas not typically considered as health and nutrition, such as “minimally processed,” “locally sourced” and “sustainable” and appealing to a more “responsible” American consumer increasingly concerned about the environment and sustainability.
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Negative EU Claims List Won’t Come Before Summer 2012
From Nutraceuticals World
The threat of an EU-wide ban on the use of article 13.1 claims on the European Commission’s negative register is not expected before next summer, according to international food policy consultancy EAS. Stefanie Geiser, EAS regulatory affairs manager, said as the European Commission has indicated it intends to present its proposal for an article 13.1 “Union list” of claims to the Standing Committee for discussion and potential adoption only by the end of 2011, it was unlikely that any ban on rejected claims would come into force before spring or summer 2012.
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The threat of an EU-wide ban on the use of article 13.1 claims on the European Commission’s negative register is not expected before next summer, according to international food policy consultancy EAS. Stefanie Geiser, EAS regulatory affairs manager, said as the European Commission has indicated it intends to present its proposal for an article 13.1 “Union list” of claims to the Standing Committee for discussion and potential adoption only by the end of 2011, it was unlikely that any ban on rejected claims would come into force before spring or summer 2012.
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Wednesday, June 1, 2011
SIDI Working Group Comments on FSMA
From Nutraceuticals World
The Standardized Information on Dietary Ingredients (SIDI) Working Group, composed of dietary supplement firms and industry trade associations, recently submitted comments to FDA regarding the Food Safety Modernization Act (FSMA): “Title III—A New Paradigm for Importers.” SIDI supports establishing a strong program for qualifying raw material suppliers, testing incoming ingredients and verifying the contents of finished products in order to reduce the risks of contamination, adulteration and other supply chain failures.
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The Standardized Information on Dietary Ingredients (SIDI) Working Group, composed of dietary supplement firms and industry trade associations, recently submitted comments to FDA regarding the Food Safety Modernization Act (FSMA): “Title III—A New Paradigm for Importers.” SIDI supports establishing a strong program for qualifying raw material suppliers, testing incoming ingredients and verifying the contents of finished products in order to reduce the risks of contamination, adulteration and other supply chain failures.
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Thursday, January 20, 2011
NOW Foods Develops Screening Method Against Adulteration
From Nutraceuticals World
Scientists at NOW Foods, Bloomingdale, IL, have developed a method for screening dietary supplement ingredients for adulteration, addressing an increasingly problematic practice by fringe companies. A scientific report describing the method has been accepted for publication in the peer-reviewed journal, Vibrational Spectroscopy. The method requires only thirty seconds grinding in an analytical mill before performing the scan. Including milling the samples, the entire screening process can be performed in less than 10 minutes per sample.
Scientists at NOW Foods, Bloomingdale, IL, have developed a method for screening dietary supplement ingredients for adulteration, addressing an increasingly problematic practice by fringe companies. A scientific report describing the method has been accepted for publication in the peer-reviewed journal, Vibrational Spectroscopy. The method requires only thirty seconds grinding in an analytical mill before performing the scan. Including milling the samples, the entire screening process can be performed in less than 10 minutes per sample.
Wednesday, December 1, 2010
Nutrition 21 to Enter Cough/Cold Market
From Nutraceuticals World
Expanding its product portfolio, Nutrition 21, Inc., Purchase, NY, has received an exclusive license in the U.S. from Denmark-based Provita Development ApS for Coldizin, an ingredient combination patented in the U.S. and Europe for enhancing upper-respiratory health. A patent is pending in Canada. The exclusive license allows Nutrition 21 to expand its product portfolio with a novel, clinically substantiated ingredient for the $4.5 billion U.S. cough and cold category.
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Expanding its product portfolio, Nutrition 21, Inc., Purchase, NY, has received an exclusive license in the U.S. from Denmark-based Provita Development ApS for Coldizin, an ingredient combination patented in the U.S. and Europe for enhancing upper-respiratory health. A patent is pending in Canada. The exclusive license allows Nutrition 21 to expand its product portfolio with a novel, clinically substantiated ingredient for the $4.5 billion U.S. cough and cold category.
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Monday, November 1, 2010
Supplement Usage Remains Steady
From Nutraceuticals World
A consistent percentage of U.S. adults label themselves as supplement users, with 66% classifying themselves as such, according to a survey conducted by Ipsos-Public Affairs for the Council for Responsible Nutrition (CRN), Washington, D.C. In 2009, 65% identified themselves as supplement users compared with 64% in 2008, 68% in 2007 and 66% in 2006.
According to results from the 2010 CRN Consumer Survey on Dietary Supplements, regular supplement usage also remains steady. The online survey showed that nearly three-quarters of supplement users (74%) classify themselves as “regular” users, as opposed to occasional users (21%) or seasonal users (5%). In 2009, 73% of supplement users indicated they took supplements regularly; in 2008, 75%, and in 2007, 77% indicated similarly.
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A consistent percentage of U.S. adults label themselves as supplement users, with 66% classifying themselves as such, according to a survey conducted by Ipsos-Public Affairs for the Council for Responsible Nutrition (CRN), Washington, D.C. In 2009, 65% identified themselves as supplement users compared with 64% in 2008, 68% in 2007 and 66% in 2006.
According to results from the 2010 CRN Consumer Survey on Dietary Supplements, regular supplement usage also remains steady. The online survey showed that nearly three-quarters of supplement users (74%) classify themselves as “regular” users, as opposed to occasional users (21%) or seasonal users (5%). In 2009, 73% of supplement users indicated they took supplements regularly; in 2008, 75%, and in 2007, 77% indicated similarly.
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Wednesday, October 20, 2010
WILD Flavors, Sterling Technology Form Partnership
From Nutraceuticals World
Adding to its Health Ingredient Technology & Solutions (H.I.T.S.) lineup, WILD Flavors, Erlanger, KY, has established a partnership with Sterling Technology, Brookings, SD, making WILD the exclusive provider of Immunel and Tegricel bioactive milk peptide products. The new partnership will combine Sterling's scientific research expertise in bioactive milk peptides with WILD’s product development and flavor expertise.
Adding to its Health Ingredient Technology & Solutions (H.I.T.S.) lineup, WILD Flavors, Erlanger, KY, has established a partnership with Sterling Technology, Brookings, SD, making WILD the exclusive provider of Immunel and Tegricel bioactive milk peptide products. The new partnership will combine Sterling's scientific research expertise in bioactive milk peptides with WILD’s product development and flavor expertise.
Monday, October 18, 2010
ChromaDex Begins Clinical Trial on Pterostilbene
From Nutraceuticals World
ChromaDex Corporation, Irvine, CA, has initiated a clinical study at the University of Mississippi for pTeroPure pterostilbene, which is chemically related to resveratrol. The novel ingredient is based on the grant of an exclusive worldwide license to all patent rights of pterostilbene from the University of Mississippi. In laboratory tests, pterostilbene has shown promise for improving cardiovascular health, glucose levels, anti-aging and cognitive function—and for possessing cancer-fighting properties.
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ChromaDex Corporation, Irvine, CA, has initiated a clinical study at the University of Mississippi for pTeroPure pterostilbene, which is chemically related to resveratrol. The novel ingredient is based on the grant of an exclusive worldwide license to all patent rights of pterostilbene from the University of Mississippi. In laboratory tests, pterostilbene has shown promise for improving cardiovascular health, glucose levels, anti-aging and cognitive function—and for possessing cancer-fighting properties.
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