






  
  2007D-0125
  
   Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims

  

  
  
  

  
  

  
  

  
  FDA Comment Number : 
  
  EC2252
  


  
  Submitter : 
  
  Mr. Michael Gibson
  
  Date & Time: 
  
  08/30/2007 02:08:17
  


  
  Organization : 
  
  Mr. Michael Gibson
  


  
  Category : 
  
  Federal Government
  


  
  Issue Areas/Comments 
  

  
  

  
  GENERAL
  

  
  


  
  GENERAL
  

  
  


  
   Dear Member of Congress and Receiver of Dockets

Re:FDA Draft Guidance "Evidence-Based Review System for the Scientific

Evaluation of Health Claims", Docket 2007D-0125,

   

These comments are submitted as suggested by Major General Albert N.

Stubblebine, Rima Laibow, MD and Ralph Fucetola, JD, trustees, of the

Natural Solutions Foundation with regard to the Food and Drug

Administration's above noted draft Guidance with reference to the

 request of FDA for comments on the proposed Guidance via fax with a copy to Dr. Barbara Schneeman, Department Head of the dietary Supplements area at the FDA. 



The Natural Solutions Foundation is a tax exempt, recognized Non

Governmental Organization active in the United States and internationally,

communicating Natural Solutions to its hundreds of thousands of supporters

and beyond.  Natural Solutions supporters, of whom I am one, understand that

American's myriad health problems are, in large part, caused by government

intervention, with emphasis on FDA and Codex Alimentarius's  dangerous,

wrong-headed, and all too often lethal, over-regulation of  natural foods,

remedies and supplements and industry-friendly emphasis on permitting and

using dangerous pharmaceutical interventions in preference to natural ones. 



Consumers like me need, and have a right to, access to truthful health

claims without unconstitutional prior restraint of information.  The Draft

Guidance referred to above sets the stage for the corrupt use of "science",

"credible science" and "significant scientific agreement" to be manipulated

to keep consumers from having the information they need to make the best

possible informed choices for their health.



The FDA's history of conflict of interest and regulatory oversight of food

supplements for the benefit of the pharmaceutical industry (since supplements are major economic competitors to drugs) makes this draft guidance a very dangerous one for the health and information access of consumers.




  

  
  

  
  

  
  

  
  

  
  

  
  

  
  

  
  

  
  

  
  

  
  

  
  

  
  

  
  

  
  

  
  

  
  

  
  

  
  

  
  

  
  

  
  

  
  

  
  

  
  

  
  

  
  

  
  

  
  

  
  

  
  

  
  

  
  

  
  

  
  

  
  

  
  

  
  

  
  

  
  

  
  

  
  







  
   Congressman Ron Paul, MD (R-TX) has entered HR 2117, The Health Freedom

Protection Act, which provides for a different paradigm for health claims:

the burden of proof that a health claim is inappropriate falls on the FDA

which can prohibit a health claim if the FDA determines there is no scientific evidence that supports the claim or that the claim is inherently misleading and incapable of being rendered non-misleading through the addition of a disclaimer.



The language of HR 2117 provides an excellent framework for the protection

of consumers and the vitiation of the corruption and conflict of interest

which the draft guideline as proposed will permit.



I strongly urge the FDA to replace the draft guideline as written with the

language of HR 2117 for health and Constitutional reasons.  I value my access to health information about nutrients, food and supplements as much as I value my Constitutional rights.  I am urging my Congressional representatives to 

co sponsor HR 2117 in the House and introduce identical legislation in the Senate since I know that this language protects me from the dangers of the draft guidance.



The draft guidance states, "This draft guidance document represents the

agency's current thinking on 

1) the process for evaluating the scientificevidence for a health claim, 

2) the meaning of the significant scientific agreement (SSA) standard in section 403(r)(3) of the Federal Food, Drug, and Cosmetic Act ?and 

3) credible scientific evidence to support a qualified health claim. ?"



"This guidance document describes the evidence-based review system which FDA intends to use to evaluate the publicly available scientific evidence for

SSA health claims or qualified health claims on the relationship between a

substance and a disease or health-related condition? This guidance document

explains the agency's current thinking on the scientific review approach FDA

should use and is intended to provide guidance to h



	Congressman Ron Paul, MD (R-TX) has entered HR 2117, The Health Freedom Protection Act, which provides for a different paradigm for health claims: the burden of proof that a health claim is inappropriate falls on the FDA which can prohibit a health claim if the FDA determines there is no scientific evidence that supports the claim or that the claim is inherently misleading and incapable of being rendered non-misleading through the addition of a disclaimer. The language of HR 2117 provides an excellent framework for the protection of consumers and the vitiation of the corruption and conflict of interest which the draft guideline as proposed will permit. I strongly urge the FDA to replace the draft guideline as written with the language of HR 2117 for health and Constitutional reasons. I value my access to health information about nutrients, food and supplements as much as I value my Constitutional rights. I am urging my Congressional representatives to co sponsor HR 2117 in the House and introduce identical legislation in the Senate since I know that this language protects me from the dangers of the draft guidance. The draft guidance states, "This draft guidance document represents the agency's current thinking on 1) the process for evaluating the scientificevidence for a health claim, 2) the meaning of the significant scientific agreement (SSA) standard in section 403(r)(3) of the Federal Food, Drug, and Cosmetic Act ?and 3) credible scientific evidence to support a qualified health claim. ?" "This guidance document describes the evidence-based review system which FDA intends to use to evaluate the publicly available scientific evidence for SSA health claims or qualified health claims on the relationship between a substance and a disease or health-related condition? This guidance document explains the agency's current thinking on the scientific review approach FDA should use and is intended to provide guidance to h