09.01.01
Despite a June 6 announcement that the final rule on plant sterol/stanol esters and coronary heart disease health claims would be published on July 25, the U.S. Food and Drug Administration (FDA), Washington D.C., has postponed the health claim ruling. The agency has stated that additional issues came up during the review process, which it believes necessitate an additional short comment period. FDA was expected to announce a reopening of the comment period for 30 to 45 days. FDA has said it does not believe this added period will markedly delay the final rule.
In response to this matter, Traco Labs, Champaign, IL, has submitted a letter to Secretary of Health and Human Services Tommy Thompson requesting that he intervene and direct FDA to respond to comments submitted requesting the authorization of the health claims. At the present time, FDA has issued an interim final rule restricting the use of such a claim to fat-based salad dressings and spreads containing plant sterol/stanol esters.
In response to this matter, Traco Labs, Champaign, IL, has submitted a letter to Secretary of Health and Human Services Tommy Thompson requesting that he intervene and direct FDA to respond to comments submitted requesting the authorization of the health claims. At the present time, FDA has issued an interim final rule restricting the use of such a claim to fat-based salad dressings and spreads containing plant sterol/stanol esters.