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May 8, 2008

FDA Final Rule on Soluble Fiber Health Claims and fat content

Last week the FDA published a final rule on soluble fiber and coronory heart disease.  (http://edocket.access.gpo.gov/2008/pdf/E8-9590.pdf).  The interesting tidbit involves the fat content of foods that carry the label. Under  regulation, sec. 101.62, a food could only carry the soluble fiber/coronary heart disease health claim if the food also satisfied the definitions of "low fat," "low saturated fat," and "low cholesterol."

Oatmeal Quaker Oats filed a citizen petition requesting a change in the regulation because its new "reduced sugar" instant oatmeal did not qualify as "low fat" and therefore could not carry the health claim.  The reduced sugar product had the same amount of oats, same amount of fiber (from the oats), and the same amount of total fat as the regular instant oatmeal, but the package weighed less because of the missing sugar.  Instant oatmeal is "low fat" if it has no more than 3 grams of fat per 55 grams of instant oatmeal (the "reference amount commonly consumed"). 

So the new reduced sugar product, with no added fat, got caught up in the rule that was intended to keep health claims off of fat-laden oatmeal cookies.

The new regulation exempts oat products that do not contain added fat from the "low fat" rule.  These products can carry the health claim even though they do not qualify as "low fat" under the regulations, provided the fat in the oatmeal is the fat naturally occurring in the oats.

May 8, 2008 in Health Claims | Permalink


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