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The company agreed, partly because it would have been prohibitively expensive to market the oils along with the snacks, and partly because the FDA tends to be most comfortable taking one step at a time. Aspartame, for example, the sweetener better known by the trade name NutraSweet, was first approved for use as a table-top sweetener. As new petitions were filed, other uses were added. "There is always the potential to go back to the FDA," observes Chris Hassall, P&G's associate director of regulatory and clinical development. And indeed, that is precisely what industry observers expect the company to do.
BY LAST FALL, P&G HAD GENERated some 150,000 pages of studies--12 shopping carts' worth--and in November most of the FDA's 23-member food advisory committee holed up in a Holiday Inn in Alexandria, Virginia, to sift through the results. During a four-day marathon session, committee members and outside experts considered scientific reports from P&G and from the independent cspi and heard presentations on toxicology, nutrition and labeling. They grilled P&G's representatives. They interviewed outside consultants. And they listened to consumer and public-health activists. Says panelist Fergus Clydesdale, head of the food-science department at the University of Massachusetts at Amherst: "Every corner was heard from, every study was looked at and everyone had an opportunity to speak." Kessler himself was there for the last two days, peppering the panel and the witnesses with questions and reminding committee members more than once of what they were and were not there to decide.
A few points were settled without much argument. The panelists agreed, for example, that olestra is nontoxic. They agreed it has no effect on the body's absorption of vitamins B and C. They agreed it does not significantly interfere with the action of most medications.
Early in the testing process, however, P&G had uncovered some potentially disturbing side effects, including one that could have sunk olestra all by itself. "We had a great deal of trouble," says the University of California's Mattson, "with what we called anal leakage." In its original formulation, olestra was so light and liquid that it went straight through the digestive tract and out the other end, staining the underwear of those who ate foods made with it.
Mattson had also realized the novel concoction could cause vitamin deficiencies. While vitamin C, for example, is water soluble, vitamins A, D, E and K all dissolve in fat and enter the bloodstream by hitching a ride on the fat molecules that are naturally present in food. These vitamins latch on to olestra just as easily, though, and when that happens they sail through the digestive system.
P&G argues that it has addressed both of these problems. To counteract anal leakage, company scientists tinkered with olestra's molecular structure, making it a bit more viscous. That didn't eliminate leakage entirely, but that's not surprising, since a small number of people have the same problem when they eat too much fat of any kind. P&G dealt with vitamin blockage simply by pumping extra vitamins into olestra-based foods. Its molecular appetite thus sated, the olestra cannot absorb additional vitamins from food.