WASHINGTON — Acknowledging that existing rules have fallen prey to the "law of unintended consequences," the Food and Drug Administration has proposed a new rule that would expand the use of the health claim that may be used describing the relationship between soluble fiber from certain foods and risk of coronary heart disease (C.H.D.).
Under the proposed rule, detailed in the Feb. 6 issue of the Federal Register, certain cereals with a low sugar content, primarily hot cereals such as those made by The Quaker Oats Co., would be able to promote the benefits of soluble fiber on packages of foods with a higher proportion of fat than previously allowed.
The F.D.A. amendment proposes to exempt certain foods from the nutrient content requirement of "low fat." The exemption would apply if the food exceeds this requirement due to fat content derived from whole oat sources.
Because the existing rule restricts use of the claim based on the percentage of fat in a product, whole grain foods with no sugar added are disadvantaged versus like foods that are sweetened with sugar and therefore contain a smaller amount of fat as a percentage of calories.
This disadvantage was the subject of a November 2005 petition to the F.D.A. by Quaker, a unit of Purchase, N.Y.-based PepsiCo, Inc. In that petition, Quaker sought to expand the use of fiber claims because some of its reduced-sugar oatmeal flavors don’t qualify as low fat, while sugary varieties that have fewer whole oats, do.
According to Quaker, both products contained the same amount of rolled oats (28 grams) and total fat (2 grams) per packet, but differ in sugar content: 15 grams per packet of flavored unmodified instant oatmeal and 3 grams per packet of flavored reduced sugar instant oatmeal. Because the 12 gram difference in sugar content corresponds with a 12 gram difference in packet weight, total fat per 55 grams of reference amount customarily consumed (RACC) was 2.558 grams for flavored unmodified instant oatmeal and 3.548 grams for flavored reduced-sugar instant oatmeal. Because the total fat content of the flavored reduced-sugar instant oatmeal exceeds 3 grams per 55 grams RACC, this product is not eligible for the health claim.
Quaker stated that amending the C.H.D. health claim regulation to allow use of its claim on products with greater fat content due to a greater proportion of whole oat sources would do two things: Encourage food manufacturers to create products lower in added sugar while still retaining the heart-protective qualities of whole oat-based foods and enhance consumers’ ability to incorporate beta-glucan soluble fiber into their diets while reducing sugar consumption.
The F.D.A. agreed, saying it did not intend to disqualify reduced-sugar foods from applying the claims.
"The ineligibility of reduced-sugar oatmeal for this health claim, due to less added sugar, is an unintended consequence of the regulation," the F.D.A. wrote. "The current regulation, without amendment, causes distortion in the market, where products are essentially penalized for adding less sugar or filler. In certain instances where two products are identical at the package level, except for the amount of sugar added, only the product with more sugar is able to carry the C.H.D. health claim because the product with less sugar has more oats per RACC and exceeds the ‘low fat’ requirement. The proposed rule is needed to remove this unintended consequence."
The F.D.A. said the amendment primarily would affect hot cereal products and a few cold cereals. Other types of products containing whole oats, such as cereal and snack bars, muffins and cookies, are not expected to be affected by the proposed rule.
There will be a 75-day public comment period before the proposed change is adopted.