[Congressional Record Volume 142, Number 2 (Thursday, January 4, 1996)]
[Senate]
[Pages S70-S71]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                         FDA REVIEW OF OLESTRA

 Mr. GLENN. Mr. President, I rise to comment on the decision 
currently before the Food and Drug Administration regarding the Procter 
& Gamble Co.'s petition for its food additive, olestra.
  Olestra is a fat-free food additive invented by the Procter & Gamble 
Co. This synthetic cooking oil and the decision by FDA are the subject 
of this week's Time magazine cover story.
  The scientific issues under review by FDA are fascinating and I 
commend FDA for its management of the review by the Food Advisory 
Committee.
  The Procter & Gamble Co. undertook its efforts to better understand 
fat in the human body in the 1950's and developed olestra in the 
1960's. In 1971, Procter & Gamble began the approval process at FDA.
  More than two decades later, olestra has not yet been approved. 
Nobody is faulting the FDA; approval of olestra has posed unique and 
unprecedented scientific questions that had to be researched. 
Accordingly, the FDA has approached this unprecedented food additive 
with appropriate prudence, and 

[[Page S71]]
Procter & Gamble was required to invent new protocols to test olestra's 
safety for human consumption.
  Regulatory review by the FDA is necessary to ensure the public health 
and safety. At the same time I believe that we should encourage 
innovation by American industry. I believe that unnecessary delay in 
the approval of new products will have a negative impact on the 
investment in research and development. Without the FDA approval, 
olestra cannot be manufactured for and used by the Nation's consumers. 
Procter & Gamble has invested more than $200 million in the development 
of this product and expects to invest many more millions to construct 
manufacturing facilities should olestra be approved. Therefore, I am 
pleased that the FDA has indicated that it will complete its 
decisionmaking process very soon.
  Mr. President, I ask that the text of my letter of December 13, 1995, 
to Commissioner Kessler of the FDA be printed at the conclusion of my 
remarks.

                                                  U.S. Senate,

                                Washington, DC, December 13, 1995.
     David A. Kessler, M.D.,
     Commissioner of the Food and Drug Administration, Park Lawn 
         Building, Rockville, MD.
       Dear Mr. Commissioner: I am writing in regard to the food 
     additive petition for olestra, the non-calorie fat 
     substitute. Because of olestra's development by the Ohio 
     based Procter & Gamble Company, I have been interested in the 
     product and its review by the FDA. I am pleased to hear that 
     the Food Advisory Committee has recommended to the FDA that 
     olestra meets the statutory standard of ``reasonable 
     certainty of no harm.''
       I want to commend FDA for its management of the Food 
     Advisory Committee review process. It is my understanding 
     that based upon an objective scientific process, no 
     significant new safety issues were raised and no new data 
     raising concern were introduced. I further understand that 
     the issues of labeling statements and postmarketing 
     surveillance raised by Committee members were addressed and 
     agreed to by Procter & Gamble prior to the meeting.
       FDA's commitment to further the process is certainly 
     evidenced by the November 13 publication of the Federal 
     Register notice announcing that all data, information and 
     public comments on the petition were to be filed by December 
     1 in order to facilitate the FDA decision making process. I 
     am pleased that the notice also indicated that the FDA 
     intends to render a decision within 60 days of the conclusion 
     of the Food Advisory Committee meeting provided no 
     significant new safety issues are raised. Given the favorable 
     review by the advisory committee and the absence of 
     significant new safety issues or concerns, I believe that the 
     FDA should take the necessary steps to ensure that the 
     decision making process is completed within the timetable on 
     or about January 17, 1996. I look forward to the final agency 
     action on the olestra petition.
       Best regards.
           Sincerely,
                                                       John Glenn,
                                             U.S. Senator.
  (At the request of Mr. Daschle, the following statement was ordered 
to be printed in the Record.)

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