Word: fda
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Dates: during 1990-1999
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Even so, Kessler is taking no chances: he is currently having FDA scientists go over data one last time before he issues his decision. Drugs are generally used for a prescribed length of time by sick people who are willing to take some risks to feel better. Food, by contrast, is something everyone consumes every day for life. Thus, says the commissioner, decisions on food additives "are among the most important the agency makes. There's an enormous responsibility to be thorough and to be vigilant." Acknowledges Wayne Callaway, a George Washington University nutrition expert who chaired...
...financial stakes are enormous as well. P&G has already invested $200 million in developing, studying and testing olestra. If the FDA approves, the company plans to use the fat in its own chips and snacks under the trade name Olean and sell it to other food producers as well. The annual market for all these olestra products could be worth $1 billion within 10 years...
Whether olestra is needed isn't the FDA's concern, however. Like all food additives, fat-free fat falls under the federal Food, Drug and Cosmetic Act of 1938 and the food-additives amendment of 1958. According to those laws, olestra can be approved if it carries a "reasonable certainty of no harm" when used as intended. If olestra really makes people sick, as Jacobson and others assert, the agency might well reject it. But after much fretting over the precise definition of harm (and diarrhea as well), a majority of advisory-committee members decided that while the gastrointestinal...
Many experts believe that if Kessler decides to give the go-ahead to olestra, he may stipulate just such a re-evaluation. That's what happened in 1993, when the FDA approved BST, Monsanto's genetically engineered hormone that boosts milk production in cows. It required the company to report back in two years on the chemical's effects. As Kessler puts it, "There is this notion that up until the day we approve a product, the food or drug or device is unsafe. And all of a sudden, the day we approve a product, it's safe forever more...
Part of the anti-olestra faction's upset stems from the nature of the FDA's mandate. As Kessler reminded the panelists several times during the proceedings, their only task was to decide whether they were reasonably certain that olestra was harmless. Says the commissioner: "It was very important to me to make sure that everyone on that advisory committee understand that framework. The questions were not, 'Does this product make sense? Does this product contribute to the nutritional health of the nation?' That is not the standard...