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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Strategy. Communications. Trade Relations.
Wednesday, June 1, 2011
Tuesday, April 26, 2011
Nutrition 21’s Chromium Histidinate Protects Brain
From Natural Products INSIDER
Chromium histidinate, from Nutrition 21 Inc., helped to protect the brain from damage caused by hypoglycemia (low blood sugar) induced by a high dose of insulin, according to a study presented at the Federation of American Societies for Experimental Biology (FASEB) annual meeting in Washington.
Researchers at Firat University tested the ability of chromium histidinate to protect the brain against hypoglycemia caused by a high dose of injected insulin. They found that rats fed chromium histidinate prior to the insulin injection had significantly less insulin-induced brain damage compared to the untreated control group.
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Chromium histidinate, from Nutrition 21 Inc., helped to protect the brain from damage caused by hypoglycemia (low blood sugar) induced by a high dose of insulin, according to a study presented at the Federation of American Societies for Experimental Biology (FASEB) annual meeting in Washington.
Researchers at Firat University tested the ability of chromium histidinate to protect the brain against hypoglycemia caused by a high dose of injected insulin. They found that rats fed chromium histidinate prior to the insulin injection had significantly less insulin-induced brain damage compared to the untreated control group.
Read More
Friday, April 1, 2011
FDA New Dietary Ingredient Guidance Leaked
From The Benninger Blog
A copy of the FDA's much anticipated guidance on New Dietary Ingredients has made its way out of the agency and some of its contents are raising eyebrows. The agency had been given a deadline of 180 days after the Food Safety Modernization Act (FMSA) became law to release the document.
The first 307 pages of the 308 page document focus on interpreting the meaning of the word "new." The agency refers frequently to Webster's Ninth New Collegiate Dictionary published in 1986, for example citing the second definition of "new" from page 796 of the reference book: "new: having been seen, known or used for a short time"
The agency then refers to the Webster definition of "time", specifically definition b: "a continuum which lacks spatial dimensions and in which events succeed one another from past through present to future."
After the 300+ pages of footnoted justification, the document concludes by stating that "based on the agency's determination that all ingredients have been seen, known or used for a short continuum lacking spatial dimensions, the agency concludes that by definition all ingredients are New Dietary Ingredients, and therefore 99.99999% of products currently on the market are adulterated."
April Fools.
A copy of the FDA's much anticipated guidance on New Dietary Ingredients has made its way out of the agency and some of its contents are raising eyebrows. The agency had been given a deadline of 180 days after the Food Safety Modernization Act (FMSA) became law to release the document.
The first 307 pages of the 308 page document focus on interpreting the meaning of the word "new." The agency refers frequently to Webster's Ninth New Collegiate Dictionary published in 1986, for example citing the second definition of "new" from page 796 of the reference book: "new: having been seen, known or used for a short time"
The agency then refers to the Webster definition of "time", specifically definition b: "a continuum which lacks spatial dimensions and in which events succeed one another from past through present to future."
After the 300+ pages of footnoted justification, the document concludes by stating that "based on the agency's determination that all ingredients have been seen, known or used for a short continuum lacking spatial dimensions, the agency concludes that by definition all ingredients are New Dietary Ingredients, and therefore 99.99999% of products currently on the market are adulterated."
April Fools.
Tuesday, March 1, 2011
More Regulation on the Way For Global Supplement Market
From Natural Products INSIDER
Growing market sizes, heightened attention to product safety and the continuing harmonization of food supplement regulations show a global trend toward more regulation, according to the International Alliance of Dietary/Food Supplement Associations (IADSA). While food supplement harmonization is already underway in the European Union, decisions are expected this year on key aspects of the Association of South East Asian Nations’ (ASEAN) similar harmonization process toward a regional legislation.
“Many countries are in the process of developing new regulatory frameworks, and regulators are increasingly monitoring the successes and challenges of similar initiatives across the globe,” said Peter Zambetti, IADSA chairman.
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Growing market sizes, heightened attention to product safety and the continuing harmonization of food supplement regulations show a global trend toward more regulation, according to the International Alliance of Dietary/Food Supplement Associations (IADSA). While food supplement harmonization is already underway in the European Union, decisions are expected this year on key aspects of the Association of South East Asian Nations’ (ASEAN) similar harmonization process toward a regional legislation.
“Many countries are in the process of developing new regulatory frameworks, and regulators are increasingly monitoring the successes and challenges of similar initiatives across the globe,” said Peter Zambetti, IADSA chairman.
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Wednesday, February 2, 2011
Daniel Fabricant Moves From NPA to FDA
From Natural Products INSIDER
Daniel Fabricant, Ph.D., resigned as vice president of Global Government and Scientific Affairs for the Natural Products Association (NPA) after five years to enter government service as FDA’s director of its Division of Dietary Supplement Programs. Fabricant will start his new position at the end of February.
Fabricant will transition his responsibilities to Cara Welch, Ph.D., and Liz Hurst who will continue to manage and oversee NPA's collective scientific, regulatory and government affairs portfolio.
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Daniel Fabricant, Ph.D., resigned as vice president of Global Government and Scientific Affairs for the Natural Products Association (NPA) after five years to enter government service as FDA’s director of its Division of Dietary Supplement Programs. Fabricant will start his new position at the end of February.
Fabricant will transition his responsibilities to Cara Welch, Ph.D., and Liz Hurst who will continue to manage and oversee NPA's collective scientific, regulatory and government affairs portfolio.
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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.
Monday, January 3, 2011
Can FDA Afford to Implement New Food Safety Measures?
From Natural Products INSIDER
By Steve Myers
The passage of an ambitious new food safety act (Food Safety Modernization Act) presents a new challenge to an old problem at FDA: will the agency receive the funding it needs to implement the new system and effectively undertake its new enforcement activities?
In a press teleconference today, FDA Chief Peggy Hamburg said some of the mandated activities the bill requires of FDA were previously set in motion by the agency, so they will be theoretically introduced more quickly and efficiently. However, a Congressional Budget Office (CBO) estimated the cost of the new food safety system at around $1.4 billion over five years. Hamburg, who said Congress has basically told FDA to build a new system for monitoring and enforcing food safety, was not terribly forthcoming about her agency’s expectations for receiving the funding needed to meet this cost.
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By Steve Myers
The passage of an ambitious new food safety act (Food Safety Modernization Act) presents a new challenge to an old problem at FDA: will the agency receive the funding it needs to implement the new system and effectively undertake its new enforcement activities?
In a press teleconference today, FDA Chief Peggy Hamburg said some of the mandated activities the bill requires of FDA were previously set in motion by the agency, so they will be theoretically introduced more quickly and efficiently. However, a Congressional Budget Office (CBO) estimated the cost of the new food safety system at around $1.4 billion over five years. Hamburg, who said Congress has basically told FDA to build a new system for monitoring and enforcing food safety, was not terribly forthcoming about her agency’s expectations for receiving the funding needed to meet this cost.
Read More
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