Traco Requests Response on Plant Sterol/Stanol Ester Comments

Traco Requests Response on Plant Sterol/Stanol Ester Comments

WASHINGTON--Traco Labs submitted a letter to Tommy Thompson, Secretary of Health and Human Services (HHS), requesting he direct the Food and Drug Administration (FDA) to respond to Traco's comments about the heart health claim associated with plant sterol/stanol esters. The current health claim is restricted to foods such as salad dressings and spreads.

Traco submitted comments to FDA in November 2000, asking FDA to expand its health claim to include free-form plant sterols and stanols, which are available in dietary supplements such as Traco's Cholestatin. As of late August, FDA had not released a final regulation on the health claim, which it had planned to issue by July 25. For more details, contact Ullman, Shapiro & Ullman, the firm that filed the HHS letter on behalf of Traco, at (212) 571-0068.

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