Library Documents

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Stephen L. DeFelice, M.D.: An Open Letter to President Donald Trump: Making TrumpCare Work

Nutraceutical Research and Educational Act

Doctornauts: Good for Patients and Health Care Cost Reduction
May, 2009 commentary by Stephen L. DeFelice M.D.

Medical Verses Scientific Clinical research: Time for an Immediate Change!
October, 2006 commentary by Stephen L. DeFelice M.D.

The Mass Media: An Unwitting Enemy of the patient
December 25, 2005 commentary by Stephen L. DeFelice M.D.

The Nutraceutical Revolution: The Hidden Medical Miracles in Everyday Foods
Reprinted from Mother Earth News
January 12, 2006

The Doctornaut Act
A Proposal by FIM, the Foundation for Innovation in Medicine to Accelerate medical Discovery
October 1, 2003

Bioterrorism: The Potential Role of L-Acetylcarnitine in the Treatment of Sepsis and Septic Shock
March 13, 2003 commentary by Stephen L. DeFelice M.D.

Slowing Down or Reversing the Aging Process
March 13, 2003 commentary by Stephen L. DeFelice, M.D.

The Promise of the Combination of Adriamycin and Carnitine For the Treatment of Cancer
October 23, 2002 commentary by Stephen L. DeFelice, M.D.

Doctornauts, Physician Volunteers for Clinical research: The Time Has Come for Congress to Act
July 4, 2002 commentary by Stephen L. DeFelice, M.D.

The Moral Dilemma of Embryonic Stem and Fetal Cell research: A Proposed Solution
June 2002 commentary by Stephen L. DeFelice, M.D.

The Nature of the Nutraceutical Revolution in the Year 2000
January 1, 2000 commentary by Stephen L. DeFelice, M.D.

The Dietary Supplements, Special Foods and Diets Dilemma
What Should We Do?

By Stephen L. DeFelice, M.D.

Op-Ed article from The SanFrancisco Chronicle
By Stephen L. DeFelice, M.D.

Clinical Research & Nutraceutical Trademarks
December 20, 1999 commentary by Stephen L. DeFelice, M.D

Press Release: New FDA Regulations January 6th Willl Be Analyzed at FIM’s February 3rd /4th Nutraceutical Conference
January 7, 2000

Time to Correct the Epistemologic Chaos That Prevents Nutraceutical Clinical Discovery
October 12, 1999 commentary by Stephen L. DeFelice, M.D.

Bill H.R.3001 – The Nutraceutical Research and Education Act
Oct. 1, 1999 (introduced to Congress)
This bill is to amend the Federal Food, Drug, and Cosmetic Act to promote clinical research and development on dietary supplements and foods for their health benefits; to establish a new legal classification for dietary supplements and foods with health benefits, and for other purposes.

FIM Rationale And Proposed Guidelines For The Nutraceutical Research & Education Act – NREA
Nov. 10, 2002
By Stephen L. DeFelice, M.D.
Presented at FIM’s 10th Nutraceutical Conference: Nutraceuticals & Pharmaceuticals Taken Together: A New Health Sector. Plus: A New FIM Congressional Proposal: The Nutraceutical Research & Education Act – NREA

Oct. 30, 2002
FDA announced it intends to seize cholesterol lowering Benecol margarine and ban it as a dietary supplement.

FIM’s Principles for Sufficient Evidence for Nutraceutical (Medical-Health) Claims
Because of the absence of guidelines regarding what is sufficient evidence for making claims FIM has proposed principles which are acceptable to most authorities and should be adopted by corporations as a guideline to making claims. Dr. DeFelice believes there is little or no difference between a health and medical claim.
FIM’s Response to the FDA Advanced Notice of Proposed Rulemaking (ANPR) on Medical Foods
April 10, 1997
In a letter to Dr. Yetley of the FDA Dr. DeFelice applauds certain aspects of the ANPR but also strongly warns that certain proposals contained therein will have a powerful negative impact on nutraceutical research.
FIM’s Response to the Draft Document of the President’s Commission on Dietary Supplement Labels Regarding Dietary Supplements (DSHEA)
July 24, 1997
In a letter to Dr. Fisher, Executive Director, Commission on Dietary Supplement Labels, Dr. DeFelice proposes ways in which to improve DSHEA which involve two issues — a. the need to correctly disseminate truthful medical – health claims and b. the need to encourage research to generate the data to support the medical – health claims.
The Need For a Research-Intensive Nutraceutical Industry:
What Can Congress Do?

(The Claims-Research Connection)
A FIM Proposal – July 1996
The cardinal principle of FIM is that nutraceutical research can only thrive if our system reasonably permits institutions, particularly corporations, to make medical-health claims based on preclinical – clinical research.
What Is a True Nutraceutical?
What Is the Nature & Size of the U.S. Nutraceutical Market?

A press release dated March 1994
Stephen L. DeFelice, M.D.
Nutraceuticals – Opportunities In An Emerging Market
Stephen L. DeFelice, M.D., Scrip Magazine, September 1992
Dr. DeFelice believed and still believes that the first prototype nutraceutical company has not yet been born. In this article he discusses the nature of the market and ways to approach it.
Conference Summary
The Nutraceutical Revolution: Where Do We Go From Here?

August 1990
In this conference it was concluded that there was an urgent need to modify our system in order to encourage nutraceutical research.
Proceedings of the Symposium:
A Comparison of the U.S., European & Japanese Nutraceutical Health and Medical Claim Rules

Published in Regulatory Affairs, Vol. 5, Summer 1993
The NutraCeutical Revolution: Fueling a Powerful, New International Market
Stephen L. DeFelice, M.D.
Presented at the Harvard University Advanced Program in Biomedical Research Management and Development in Italy, jointly organized by Harvard University Biomedical Management Faculty and Farmindustria, Associazione Nazionale dell’Industtia Farmaceutica, with the collaboration of The Foundation for Innovation in Medicine, March 1989, at Villa Olmo, Como, Italy.
The Promise and Problems of Natural Substances in Medicine
This volume represents the findings of a symposium held at Columbia University on May 17, 1983. It is the first of a series of symposia which will dealt with the state of the innovative process in medicine.