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r ~ `+ Public Health Service HUMAN SERVICES DEPARTMENT OF HEALTH & Food and Drug Administration College Park, MD 20740 , z. 3 4 .- , ,- :I i0 ? '" ? 9 MAR23~ . < Mr. John Morley President Inc, Natural Factors Nutritional Products, 1111 80'h Street S .W. Suite 100 Everett, Washington 98203 , Dear Mr . Morley : Drug of February 28, 2006 to the Food and This is in response to your letter the Federal U.S.C. 343(r)(6) (section 403(r)(6) of Administration (FDA) pursuant to 21 Act (the Act)). Food, Drug, and Cosmetic claims "Diets low in Formula with Sytrinol TM is using the The product Cholesterol consumed .with include SytrinolTM Cholesterol Formula saturated fat and cholesterol that disease" and levels and reduce the risk of heart cholesterol may lower meals at least two subject-to levels ." These statements are not claims "Helps maintain healthy cholesterol because they represent claims subject to 21 U.S.C . 343(r)(1)(B) 21 U.S .C . 343(r)(6), but condition (i .e., coronary the risk of a disease or health related will reduce product the that between a health claim about the relationship heart disease). FDA has authorized 101.83)'. A CFR esters and coronary heart disease (see 21 ` Phytosterol and phytostanol set forth in the the eligibility and message requirements meets that supplement dietary esters and the relationship between phytosterollstanol regulation may bear a claim for of a food or dietary claim on the label or in the labeling A health disease. heart coronary would with the requirements in 2.1 CFR 101 .83 supplement that is not in accordance Moreover, supplement under 21 U.S.C . 343(r)(1)(B) . misbrand the food or dietary .83 subjects CFR 141 accordance with the requirements in 21 failure to make a claim in the product is under 21 U.S.C . 321(g)(l)(B) because drug as a regulation to the,product disease. or mitigate a disease, coronary heart intended to treat, cure, prevent, respect to regarding enforcement discretion with 'Also see February 14, 2003 letter and reduced claim rule about plant steroUstanol esters health interim use of an expanded .htm1. http./lwww .cfsan .fda .gov/-drnslds-1tr30 risk of coronary heart disease; 97S 0163- LET Y70 -uary 28, 2006 .. d and Drug Administration :e of Special Nutritionals ter for Food Safety and Applied Nutrition C Street SW ;hington, DC 20204 _ r Sir or Madam: ; f ~ r. 1 u 7_.~ is to provide the required information to comply with our obligation under DSHEA ling regulations . plement: Everett, WA 98203 Phone : (425) 513-8800 Fax :(425)348-9050 Cholesterol Formula with SytrinolT"" ~ ~ '