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To: Just My Opinion who wrote (10095)	10/30/1998 8:14:00 PM
From: Janice Shell	Read Replies (1) \| Respond to of 26163

I think that if anybody was really interested, they should get the court proceedings, sit down with an attorney, and listen to what he has to say about the matter. I believe that the current transcripts won't be available till the fifth of November, but for the exact date you'll really have to ask Jeff.

To: Just My Opinion who wrote (10095)	10/31/1998 3:18:00 AM
From: Just My Opinion	Respond to of 26163

biz.yahoo.com Saturday October 31, 1:34 am Eastern Time Cholesterol-lowering spread hits FDA snag in U.S. (Adds FDA quotes, paras 6, 7, 16) By Maggie Fox, Health and Science Correspondent WASHINGTON, Oct 30 (Reuters) - The rollout of a new cholesterol-lowering margarine may have hit a big snag, with the U.S. Food and Drug Administration saying it is technically an ''adulterated'' food. Benecol has been a best seller in Finland, where it was developed. It is made from a byproduct of pine trees, processed into a margarinelike spread. U.S. makers McNeil Consumer Products, a unit of Johnson & Johnson (NYSE:JNJ - news), say they will work out any problems with the FDA and are going ahead with plans to start selling Benecol in the United States next week. ''We think that our product fully complies with the law for safety and dietary supplements.'' McNeil spokesman Ron Schmid said. ''The FDA has been aware of our plan to market the product as a dietary supplement,'' he said in a telephone interview. ''In our view, the label fully complies with the law and allows us to proceed with the plans to market this product.'' But the FDA does not agree. ''We do not think this product is a dietary supplement. It cannot be sold as a dietary supplement,'' William Schultz, the FDA's deputy commissioner for policy, said in a telephone interview. ''We have had discussions with them throughout. We have told them throughout we did not think this was a dietary supplement. What we did the other day is put it in writing. I don't think this comes as a surprise to them.'' Developed by Finnish food and chemicals group Raisio , Benecol uses plant stanol esters, which are naturally found in wood and vegetable oils such as corn oil and olive oil. Clinical tests have shown regular use of the spread can lower blood cholesterol by as much as 14 percent, and the company said there were no side effects. But the FDA sent McNeil a letter on Thursday saying that marketing the product under the prototype label the agency was shown ''would be illegal under the Federal Food, Drug and Cosmetic Act.'' ''We have reviewed the prototype label your company provided and have concluded that the Benecol spread, while labeled as a dietary supplement, bears label representations that establish the intent of this product to do more than supplement the diet,'' wrote Joseph Levitt, director of the FDA's center for food safety and applied nutrition. The proposed label would say Benecol helps ''you to manage your cholesterol naturally through the foods you eat.'' That, Levitt said, ''represents this product for use as a conventional food'' and thus it cannot be sold as a dietary supplement. Although the company does not need FDA pre-market approval to sell Benecol in the way it would to sell a drug, the product does have to be ''generally recognized as safe'' by experts. Plant stanols are not generally recognized as safe. ''Therefore, considered as a food, the Benecol spread is adulterated ... and cannot be legally marketed in the United States,'' Levitt said. ''They'd have to show us the safety of the product, and they would have to show us the validity of the claims,'' Schultz noted. He said the FDA would be happy to meet with McNeil to discuss the problem.