By Stephen Daniells
From Nutraingredients-USA.
California-based Jarrow Formulas has submitted a 128-item Freedom of Information [Act] Request to the U.S. FDA with questions it deems "vital" to any comments it seeks to file in response to the New Dietary Ingredient (NDI) draft guidance.
The Freedom of Information [Act] Request (FOIA) seeks clarification on the potential impact of the draft guidance on a number of topics, including economic, business and public health, the costs of testing and costs of actual notifications, safety issues and probiotics.
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Strategy. Communications. Trade Relations.
Showing posts with label fda ndi guidance. Show all posts
Showing posts with label fda ndi guidance. Show all posts
Friday, September 16, 2011
Wednesday, September 7, 2011
Trade Associations: 45-Day NDI Draft Guidance Extension Request Reasonable
From Nutraingredients-USA
By Stephen Daniells
Spokespeople from the Natural Products Association (NPA), the Council for Responsible Nutrition (CRN), and the United Natural Products Alliance (UNPA) were responding to requests from other quarters of the industry to extend the comment period from 90 days to one year.
Last week, supplement manufacturer Jarrow Formulas added its voice to those of an initial request on July 26, 2011 by law firm Hyman, Phelps and McNamara, P.C. to extend the comment [period] until July 5, 2012.
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By Stephen Daniells
Spokespeople from the Natural Products Association (NPA), the Council for Responsible Nutrition (CRN), and the United Natural Products Alliance (UNPA) were responding to requests from other quarters of the industry to extend the comment period from 90 days to one year.
Last week, supplement manufacturer Jarrow Formulas added its voice to those of an initial request on July 26, 2011 by law firm Hyman, Phelps and McNamara, P.C. to extend the comment [period] until July 5, 2012.
Read More
Thursday, September 1, 2011
Jarrow Formulas Calls for 1-Year NDI Draft Comment Extension
From NutraIngredients-USA
By Stephen Daniells
California's Jarrow Formulas has called for an extension of the comment period on the FDA's NDI draft guidance to one year. Citing the scope of the draft guidance, its complexity, and its potential impact, a letter on behalf of Jarrow Formulas Inc. (JFI) said that the current 90-day comment period is insufficient, and that it is "respectfully requesting" an extensio to July 5, 2012.
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By Stephen Daniells
California's Jarrow Formulas has called for an extension of the comment period on the FDA's NDI draft guidance to one year. Citing the scope of the draft guidance, its complexity, and its potential impact, a letter on behalf of Jarrow Formulas Inc. (JFI) said that the current 90-day comment period is insufficient, and that it is "respectfully requesting" an extensio to July 5, 2012.
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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.
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