Citizens for Health: NDI guidance ‘contravenes spirit and letter of DSHEA'

Citizens for Health: NDI guidance ‘contravenes spirit and letter of DSHEA'

Citizens for Health Launches Campaign Against FDA’s NDI Guidance

Citizens for Health Launches Campaign Against FDA’s NDI Guidance

Jarrow Formulas Challenges FDA on NDIs With 128-Item Freedom of Informatio​n 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FDA with questions it deems "vital" to any comments it seeks to file in response to the New Dietary Ingredient (NDI) draft guidance.

The Freedom of Information [Act] Request (FOIA) seeks clarification on the potential impact of the draft guidance on a number of topics, including economic, business and public health, the costs of testing and costs of actual notifications, safety issues and probiotics.

Read More

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.
Read More

FDA Extends NDI Draft Guidance Comment Period by 60 Days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FDA extended the comment period for its New Dietary Ingredient (NDI) Draft Guidance by 60 days to Dec. 2, 2011.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.
Read More

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

FDA Must Withdraw NDI Guidance or Extend Comment Period to July 2012

FDA Must Withdraw NDI Guidance or Extend Comment Period to July 2012