Strategy. Communications. Trade Relations.
Saturday, September 24, 2011
Wednesday, September 21, 2011
Friday, September 16, 2011
Jarrow Formulas Challenges FDA on NDIs With 128-Item Freedom of Information Request
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FDA with questions it deems "vital" to any comments it seeks to file in response to the New Dietary Ingredient (NDI) draft guidance.
The Freedom of Information [Act] Request (FOIA) seeks clarification on the potential impact of the draft guidance on a number of topics, including economic, business and public health, the costs of testing and costs of actual notifications, safety issues and probiotics.
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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FDA with questions it deems "vital" to any comments it seeks to file in response to the New Dietary Ingredient (NDI) draft guidance.
The Freedom of Information [Act] Request (FOIA) seeks clarification on the potential impact of the draft guidance on a number of topics, including economic, business and public health, the costs of testing and costs of actual notifications, safety issues and probiotics.
Read More
Monday, September 12, 2011
Norman R. Farnsworth, Renowned Medicinal Plant Researcher, Dies at 81
From American Botanical Council
Renowned pharmacognosist and internationally-respected medicinal plant research expert, Norman R. Farnsworth, PhD, died on September 10 at a Chicago hospital. He was 81 and had been in declining health for months, suffering from long-term congestive heart failure and type 2 diabetes.
Dr. Farnsworth was born on March 23, 1930 in Massachusetts. Norman Farnsworth was a veteran of the Korean War, drafted in the US Army at age 18 in 1949. PFC Farnsworth served in the Third Infantry Division, Seventh Regimental Combat Team. Although he was seriously wounded in the winter of 1950, Farnsworth survived. Corporal Farnsworth was awarded the Korean Ribbon with Four Battle Stars, the Combat Medical Badge, and Bronze Star with a "V" device.
He received his degree in pharmacy from the Massachusetts College of Pharmacy in 1953 and his PhD in pharmacognosy, the study of drugs from natural origins (including medicinal plants, microbes, marine organisms, and fungi), from the University of Pittsburgh in 1959. At Pitt, he helped to institute a pharmacognosy PhD program at the university and was the first to chair it.
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Dr. Farnsworth was born on March 23, 1930 in Massachusetts. Norman Farnsworth was a veteran of the Korean War, drafted in the US Army at age 18 in 1949. PFC Farnsworth served in the Third Infantry Division, Seventh Regimental Combat Team. Although he was seriously wounded in the winter of 1950, Farnsworth survived. Corporal Farnsworth was awarded the Korean Ribbon with Four Battle Stars, the Combat Medical Badge, and Bronze Star with a "V" device.
He received his degree in pharmacy from the Massachusetts College of Pharmacy in 1953 and his PhD in pharmacognosy, the study of drugs from natural origins (including medicinal plants, microbes, marine organisms, and fungi), from the University of Pittsburgh in 1959. At Pitt, he helped to institute a pharmacognosy PhD program at the university and was the first to chair it.
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Thursday, September 8, 2011
FDA Extends NDI Draft Guidance Comment Period by 60 Days
Adapted from Natural Products INSIDER
FDA extended the comment period for its New Dietary Ingredient (NDI) Draft Guidance by 60 days to Dec. 2, 2011. The extension came one month after five industry trade organizations requested FDA to extend the comment period by 45 days.
NPA, along with the American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA) , the Council for Responsible Nutrition (CRN) and the United Natural Products Alliance (UNPA) requested a 45-day extension for comments, asking for a deadline of Nov. 17, 2011.
Last week, Jarrow Formulas, a dietary supplement company, requested FDA extend the comment period by one year; however, FDA chose to extend the comment period by an additional two months.
The original 90-day deadline for comments regarding FDA’s “Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related Issues," was Oct. 3, 2011.
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FDA extended the comment period for its New Dietary Ingredient (NDI) Draft Guidance by 60 days to Dec. 2, 2011. The extension came one month after five industry trade organizations requested FDA to extend the comment period by 45 days.
NPA, along with the American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA) , the Council for Responsible Nutrition (CRN) and the United Natural Products Alliance (UNPA) requested a 45-day extension for comments, asking for a deadline of Nov. 17, 2011.
Last week, Jarrow Formulas, a dietary supplement company, requested FDA extend the comment period by one year; however, FDA chose to extend the comment period by an additional two months.
The original 90-day deadline for comments regarding FDA’s “Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related Issues," was Oct. 3, 2011.
Read More
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.
Read More
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
Monday, September 5, 2011
Thursday, September 1, 2011
Capitol Comments: Dissecting FDA’s NDI Guidance
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.
Read More
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.
Read More
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.
Read More
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.
Read More
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