FDA's Center for Food Safety and Applied Nutrition (CFSAN) authorized a qualified health claim (QHC) relating consumption of unsaturated fatty acids (UFAs) from corn oil (in substitution for saturated fatty acids (SFAs) while not increasing caloric intake) to reduced risk of coronary heart disease (CHD). The QHC may be used in labeling corn oil and certain corn oil-containing foods. The parameters for FDA's exercise of enforcement discretion concerning labeling use of the QHC are set forth in CFSAN's letter responding to a health claim petition filed by ACH Food Companies, Inc. (see http://www.cfsan.fda.gov/~dms/qhccorno.html). This health claim was summarized by Food Institute Counsel, OLSSON, FRANK & WEEDA, PC.
The authorized QHC provides:
'Very limited and preliminary scientific evidence suggests that eating about 1 tablespoon of corn oil daily may reduce the risk of heart disease due to the unsaturated fat content in corn oil. FDA concludes that there is little scientific evidence supporting this claim. To achieve this possible benefit, corn oil is to replace a similar amount of saturated fat and not increase the total number of calories you eat in a day. One serving of this product contains [x] grams of corn oil.'
Under CFSAN's Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements (available at http://www.cfsan.fda.gov/~dms/nuttf-e.html), the scientific ranking of studies submitted in the petition were deemed by the agency to make this is a 'Category D' QHC, thus triggering the requisite qualifying language (i.e., 'Very limited and preliminary scientific research suggests ... FDA concludes that there is little scientific evidence supporting this claim.').
Parameters governing FDA's exercise of enforcement discretion relative to use of the QHC in labeling conventional foods include:
Conventional foods eligible to bear the QHC are limited to corn oil and certain corn-oil-containing products, specifically vegetable oil blends, vegetable oil spreads, dressings for salads, shortenings and corn oil-containing foods. For purposes of enforcement discretion, the following definitions of these conventional foods apply: (1) 'corn oil' means products that are essentially pure corn oil and are labeled as such; (2) 'vegetable oil blends' means a blend of two or more vegetable oils formulated to contain corn oil; (3) 'vegetable oil spread' means margarine and margarine-like products formulated to contain corn oil; (4) 'dressings for salads' means dressings for salads formulated to contain corn oil; (5) 'shortenings' means vegetable oil shortenings formulated to contain corn oil; and (6) 'corn oil-containing foods' means all other foods, such as sauces or baked goods, formulated to contain corn oil, excluding corn oil, vegetable oil blends, vegetable oil spreads, dressings for salads and shortenings. The QHC is not available for use in labeling main dish products and meal products, nor it applicable to dietary supplements.
FDA determined that in order to receive the potential heart health benefit from consumption of UFAs from corn oil, the scientific evidence suggests that the daily minimum amount of UFAs from corn oil that should be consumed in place of foods high in SFAs, while not increasing caloric intake, is approximately 13.3 grams of UFAs, which corresponds to about 16 grams of corn oil. Sixteen grams of corn oil is equivalent to roughly one tablespoon, which also is the reference amount customarily consumed (RACC) for corn oil. The determination of the qualifying level of UFAs from corn oil for a conventional food to bear the QHC is based on four eating occasions per day. The minimum effective dose (16 grams corn oil per day) based on four eating occasions per day of corn oil or the eligible corn oil products is four grams of corn oil per RACC. This four-gram per RACC is the amount of corn oil that an eligible food must contain.
For consumers to know the amount of corn oil in a product, foods that bear the QHC should state the amount of corn oil per serving as part of the claim.
In order for the QHC to be truthful and not misleading, the QHC should specify that UFAs from corn oil need to replace SFAs as sources of fat in the diet while not increasing caloric intake.
Inasmuch as UFAs from corn oil are to replace SFAs in the diet while not increasing caloric intake, an individual's total fat intake may not increase based on the recommendations in the QHC.
Corn oil and corn oil products need not qualify as 'low fat.'
Corn oil and corn oil products need not have a total fat content below the disqualifying level otherwise generally applicable to health claims. However, vegetable oil blends, vegetable oil spreads, dressings for salads, shortenings and corn-oil-containing foods that exceed the total fat disqualifying level should bear the following disclosure statement immediately adjacent to and directly beneath the QHC, with no intervening material, in the same size, typeface and contrast as the QHC itself: 'See nutrition information for total fat content.'
Corn oil and corn oil products need not qualify as 'low saturated fat.' However, such foods bearing the QHC, including foods that are not 'low saturated fat,' should place the following statement immediately adjacent to the claim with no intervening material and in the same contrast as the claim itself: 'See nutrition information for saturated fat content.'
Corn oil, vegetable oil blends, vegetable oil spreads and shortenings should not exceed the saturated fat disqualifying level per RACC, but may exceed it per 50 grams. Dressings for salad should not exceed the saturated fat disqualifying level per RACC or per 50 grams. Corn oil-containing foods should not exceed the saturated fat disqualifying level.
Corn oil and corn oil products should qualify as 'low cholesterol.' Thus, such foods also should not exceed the cholesterol disqualifying level.
Corn oil and corn oil products should not exceed the sodium disqualifying level.
Corn oil, vegetable oil blends and shortenings need not contain, prior to any nutrient addition, at least 10% of the daily value for vitamin A, vitamin C, iron, calcium, protein or dietary fiber per RACC. However, vegetable oil spreads and corn oil-containing foods should meet this 10% minimum nutrient content requirement.
General requirements for health claims not otherwise altered by the foregoing remain applicable.
CFSAN indicated that it prospectively might add a trans fat threshold level as a factor considered in the exercise of enforcement discretion.
