WASHINGTON — A little more than a year after acknowledging that existing rules have fallen prey to the "law of unintended consequences," the Food and Drug Administration on May 1 amended its regulation authorizing a health claim on the relationship between soluble fiber from certain foods and risk of coronary heart disease.
The amendment, detailed in the May 1 issue of the Federal Register, exempts certain foods from the nutrient content requirement of "low fat." According to the F.D.A., the exemption will apply if the food exceeds the "low fat" requirement due to fat content derived from whole oat sources.
Under the new rule, certain cereals with a low sugar content, primarily hot cereals such as those made by The Quaker Oats Co., now will be able to promote the benefits of soluble fiber on packages of foods with a higher proportion of fat than previously allowed.
Previously, the rule restricted the use of the claim based on the percentage of fat in a product. As a result, whole grain foods with no sugar added were 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.
In the proposed rule published in the Feb. 6, 2007, Federal Register, 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 in February 2007. "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 it does not know with certainty how many products currently marketed will be affected by the final rule, but through a search of the Internet and local grocery stores identified a single "lower sugar" hot cereal product that did not quality for the claim before, but now may.
"Beyond this single product, it is difficult to accurately predict how many products will be developed that would qualify for the claim under the final rule," the F.D.A. said, but estimated that between 1 and 10 current and future products will be affected.
"The final rule will greatly increase the efficiency of a consumer’s search for a product that is lower in sugar and also has all the qualities of a product carrying the C.H.D. claim," the F.D.A. noted.