October 30, 2002

The FDA has announced it intends to seize the new cholesterol-lowering Benecol margarine product during its market test and ban it as a dietary supplement.

Dr. DeFelice believes this potential regulatory action by the FDA will reopen the door to the interpretation of the Dietary Supplement Health and Education Act (DSHEA) regarding health-medical claims for natural substances, foods and dietary supplements. The current situation is another reminder of the current epistemological chaos and the need for new legislation to clarify the rules for making health-medical claims for these products.

The conference program will be modified and expanded to address this issue and participants will have the opportunity to actively dialogue and debate with the speakers.

Representative Frank Pallone of New Jersey, a senior Democratic member of the House Commerce Health and Environment Subcommittee will be present during the discussions.

“Nutraceuticals” include foods, medical foods and dietary supplements.

One third of the U.S. population is taking vitamin E along with other substances such as folic acid and magnesium to prevent or treat heart disease. Many of them also are taking cardiovascular pharmaceuticals. It is estimated that 60 million U.S. citizens are taking botanical nutraceuticals or herbal remedies for a variety of reasons. Many of them are also taking pharmaceuticals for various medical conditions. How are these pharmaceuticals and nutraceuticals interacting? What is the benefit and what is the risk ?

Authorities from government, industry and academic medicine will discuss this phenomenon’s enormous potential impact on health in general as well as the new nutraceutical health sector.

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People want nutraceuticals to maintain their health primarily by preventing and treating disease. Clinical research is virtually the only way to find out whether nutraceuticals have such benefits.

Laws and regulations such as DSHEA, NLEA and Medical Foods have not yet spawned a research intensive nutraceutical industry. New laws are needed. FIM will propose the NREA as one possible solution.

The conference will be chaired by Stephen L. DeFelice, M.D. who coined and defined the term “nutraceuticals”.

Please see the following related news clippings which are now in our news clippings library. Just click on the titles.

J&J Is Told It Can’t Sell Benecol as Dietary Aid
Vanessa O’Connell and Rochelle Sharpe, Staff Reporters, The Wall Street Journal, Oct. 2002
Johnson & Johnson Could Face Delay In Bringing Benecol Products to Market
Rochelle Sharpe, Staff reporters, The Wall Street Journal, Oct. 2, 2002
FDA Threatens to Stop Launch of Margarine
Nanci Hellmich, USA Today, Oct 30. 2002