Concept Map 1
Concept Map 2
Back to Olestra 8. Olestra
Ahead to Olestra 10. Testing for Digestion
Ahead to Olestra 11. Testing for Solubility of Vitamins
Ahead to Olestra 12. Testing for Effectiveness as a Fat Substitute
We will see how researchers used these simple chemical concepts to invent and develop olestra and we will use these principles ourselves to evaluate and decide on nutritional issues
A critical recognition by the Proctor & Gamble scientists was that the Olestra molecule might dissolve fat-soluble vitamins. If so, these essential nutrients might not pass into the system to play their essential role. Can you suggest responsible research that must be undertaken once fact that vitamins are soluble in Olestra-like molecules was recognized?
|Olestra 9. - Olestra and
the FDA Approval Process
Procter & Gamble first patented Olestra in the 1970's with its proposed use as a cholesterol lowering drug. This proposed use was twofold in its purpose. One aspect was the face value potential use as a drug, while the second aspect was that this proposal would facilitate the extensive safety trials that would be required for later possible use as a food additive. Lets look at some aspects of the FDA approval process and the way that Procter and Gamble has responded to its requirements.
FDA Approval Process: The statute that governs food additive approvals in the United States includes the Food Additives amendment enacted by congress in 1958. This statute establishes a pre market approval system requiring that a company seeking to introduce a product must first gain approval from the FDA.
The FDA language is interesting in both its approach and its effect on the process that leads to determination of the safety of a potential product. You can read, for example, in the petition for Olestra approval, the FDA is not to approve a food additive petition " if a fair evaluation of the data before the Secretary fails to establish that the proposed used of the food additive, under the conditions of use to be specified in the regulation, will be safe " This provision is commonly referred to as the "general safety clause".
By requiring that the data concerning a food additive "establish" safety, Congress squarely placed the burden of proving safety on the sponsor of a food additive provision, in this case Proctor & Gamble. FDA need not prove that the additive is unsafe in order to deny approval. The Olestra petition goes on to discuss that the term "safe" is not defined except that it does not intend that the petitioner must demonstrate absolute harmlessness given the always changing present state of scientific knowledge.
So how did Procter & Gamble go about establishing the data that would establish this "safeness"?
When a new food additive is being proposed for approval there are many factors that need to be evaluated. Olestra, as a fat replacement molecule, has the potential to replace a significant portion of the diet. This is in contrast with most food additives such as spices or flavors that typically would form a small portion of any diet. This potential for Olestra led to some unique considerations in the approval process. The first consideration in any food additive safety evaluation is whether the product is toxic when consumed. A related concern is whether Olestra is absorbed and if the absorption products produce any toxicity. Proctor & Gamble determined that Olestra is not absorbed in the intestine. But lack of absorption means that a greater and greater concentration of Olestra builds up in the intestine. This increasing portion was evaluated for its effect on the digestion and elimination process and any associated nutrient interactions while Olestra was present in the digestive tract.
What do we mean by nutrient interactions? Specifically, many vitamins are fat soluble and Olestra is a fat-like molecule that is not absorbed in the intestine. This aspect of nutrient interactions led to extensive studies with the fat-soluble vitamins and a variety of fat-soluble drugs and other lipophilic substances. Studies were also completed after heating Olestra under conditions similar to those expected with food and snack frying. The expected Olestra consumption levels were also studied. Over 100 animal studies and 25 clinical (Human) trials were completed in an effort to establish the safety of Olestra in response to the way that the FDA places this burden on the petitioner, Procter & Gamble. We will review the data from these studies in the next sction.
After the petitioner had completed most of these studies and clinical trials, the approval and review process began.
A Regulatory Decision Team (RDT), composed of senior FDA managers, was established for the purpose of recommending a decision on the approval of the Olestra petition. The FDA retained the services of several outside scientific consultants from outside the FDA to help with the agencies deliberation process. After this process the RDT gave its recommendation to the Food Additives Commission of the FDA. The FDA convened a public meeting of its FAC and a special Olestra Working Group. This FAC included a standing membership and temporary members and consultants that represented scientific disciplines appropriate to the evaluation of a macro-ingredient fat substitute such as Olestra. At this public meeting Procter & Gamble presented a summary of its data it considered adequate to establish safety. The scientific members of the FAC also presented their findings on the adequacy of these studies. Interested members of the public, including the Center for Science in the Public Interest (CSPI), presented their evaluations and opinions of the data. The FDA also made a presentation on its evaluation of the data.
Finally after an extended public comment period and responses to questions and concerns raised, the FDA granted approval in 1996 for the use of Olestra in the preparation of ready-to-eat savory snacks.
But the FDA required special labeling on foods containing the new fat substitute, labeling indicating a chance of abdominal upset for consumers of these products.
Now lets go back to the Olestra Concept Map and look and some of the details of the many studies that were required as part of the approval process.
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