Breaking News:
Dr. Claire Kruger, CEO, was quoted again recently regarding the FDA's draft NDI guidance:
Harvard professor: ‘NDI draft guidance doesn’t go far enough’
It might have been roundly slammed by the trade as draconian and unworkable, but according to one academic, the Food and Drug Administration’s (FDA’s) controversial draft guidance on new dietary ingredients (NDIs) does not go far enough.
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Kruger, C.L., Booth, N., and Hayes, A.W., "Exceptions to the New Dietary Ingredient Notification Requirement: Utilizing GRAS as a Path Forward," Food Technology, pages 16-18, January 2012.
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A. Wallace Hayes, PhD, Visiting Scientist, Harvard School of Public Health
Claire L. Kruger, PhD, Chief Executive Officer, Spherix Consulting, Inc.
Harvard Extension School Classes Beginning January 23, 2012
January 23, 2012
1) Harvard Extension School (http://www.extension.harvard.edu/about-us) can go to the website and sign up for the course.
ENVR E-159 Environmental Toxicology and Risk Management
Spring term (23613)
A. Wallace Hayes, PhD, Visiting Scientist, Harvard School of Public Health.
Claire L. Kruger, PhD, Chief Executive Officer, Spherix Consulting Inc.
Class times: Mondays beginning Jan. 23, 5:30-7:30 pm.
Course tuition: noncredit $1,025, undergraduate credit $1,025, graduate credit $1,950.
WebsitePrintable versionCheck availability and location
The course introduces students to the principles and methods used to determine whether a causal relationship exists between an agent and an adverse effect in humans and to independently carry out a risk assessment. Students develop an understanding of current approaches to risk management and risk communication. (4 credits)
March 12, 2012
2) Title: Lessons learned from the acceptance of genetic toxicity testing as part of a regulatory framework
Authors: A. Wallace Hayes and Claire L. Kruger
Symposium Title: 21 st Century Validation Strategies--One Size No Longer Fits All
Society of Toxicology Annual Meeting, March 12, 2012, San Francisco, CA
March 19, 2012
3) Title: Principles of Toxicology
Authors: A. Wallace Hayes and Claire L. Kruger
Course: Risk Assessment
Harvard School of Public Health, March 19, 2012, Boston, MA
March 31, 2012
4) Title: Alternative Models
Authors: A. Wallace Hayes and Claire L. Kruger
4th Symposium of the Latin American Society of Toxicologic Pathology--A Panoramic View of
Toxicology Pathology Program
March 31, 2012, Sao Paulo, Brazil
April 23, 2012
5) Title: Principles of Toxicology
Authors: A. Wallace Hayes and Claire L. Kruger
American College of Toxicology, Toxicology for Industrial and Regulatory Scientists 2012
April 23, 2012, Noblis Center, Falls Church, VA
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Spherix Consulting presented at the Food and Drug Law Institute’s one-day workshop on New Dietary Ingredient (NDI) Regulation and Compliance to be held in Washington, DC on December 12, 2011
FDLI Presentation (Click Here)
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ACN Nutrition Conference November 18, 2011
ACN Booth Presentation (Click Here)
ACN Kruger Presentation (Click Here)
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Kruger, C.L., Booth, N. and Hayes, A.W., “Policing Ourselves: Is GRAS Robust Enough?,” Food Technology, pages 18-19, August 2011.
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Spherix Consulting has been invited to present at American Herbal Product Association's New Dietary Ingredient seminar to be held on September 8, 2011, in Chicago, IL.
AHPA NDI Event Discusses Notification Requirements
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Press coverage of the UNPA event by Natural Products Insider
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July 26-27, 2011
Kruger, C.L., Booth, N.L. and Hayes, A.W., “Toxicology and Safety Studies: What Does FDA Really Expect, and Do You Need to Do It?” UPNA Seminar: NDI Guidance: Understanding The New Safety Paradigm, Salt Lake City, Utah, July 26-27, 2011.
PDF (Click Here)
July 26-27, 2011
Kruger, C.L., Booth, N.L. and Hayes, A.W., “GRAS Affirmation and NDIs: What is the Difference? When and How to Use GRAS vs. NDI, and Understanding the Food Ingredient/Dietary Ingredient Distinction,” UPNA Seminar: NDI Guidance: Understanding The New Safety Paradigm, Salt Lake City, Utah, July 26-27, 2011.
PDF (Click Here)
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"Drs. A. Wallace Hayes and Claire L. Kruger to teach an continuing education course entitled "ENVR E-159 Environmental Toxicology and Risk Management" at the Harvard University Extension School, Mondays beginning January 23, 2012."
Link (Click Here)
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Toxicologist: FDA’s NDI guidance is entirely reasonable
Many dietary ingredients used in supplements today bear little resemblance to ingredients that were assumed to be ‘grandfathered in’ post the 1994 Dietary Supplements Health and Education Act, making a fresh safety analysis eminently reasonable if extraction methods have changed, according to one toxicologist.
(click here to view entire article)
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(click here to view our latest publication)
Manuscript Supplement, Hayes, A.W., A.D. Dayan, W.C. Hall, R.L. Kodell, W.J. Waddell, G.M. Williams, R.S Slesinski, and C.L. Kruger. A Review of Mammalian Carcinogenicity Study Design and Potential Effects of Alternate Test Procedures of Food Ingredients. Regulatory Pharmacology and Toxicology 59, 142-175, 2011.
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