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FDA Reopens Comments For Plant Sterol Heart Health Claim

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By: Sean Moloughney

Editor, Nutraceuticals World

The U.S. Food and Drug Administration, Washington, D.C., has reopened—for 45 days—the comment period for the interim final rule authorizing a health claim on the association between plant sterol/stanol esters and the reduced risk of coronary heart disease (CHD). This interim final rule originally appeared in the Federal Register of September 8, 2000 (65 FR 54686) and interested persons were given until November 22, 2000 to comment on the health claim. After the comment period closed, the FDA received two requests from Unilever United States and Raisio Benecol, which included requests for an extension of the comment period. Both comments requested more time for submission of data comparing the daily intake levels of plant sterol esters and plant stanol esters that are effective in reducing the risk of CHD.

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