Prepared by Cara Wilking, J.D., Staff Attorney What kinds of High Fructose Corn Syrup Are Generally Recognized as Safe for Use in the Food Supply? Substances “reasonably expected to become a component of food” are food additives subject to premarket approval by the Food and Drug Administration (FDA), unless they are generally recognized as safe (GRAS).[1] In 1983, the federal government listed high fructose corn syrup (HFCS) as GRAS, and the FDA affirmed that decision in 1996. Federal law defines HFCS as “a sweet, nutritive saccharide mixture containing either approximately 42 or 55 percent fructose.”[2] Accordingly, HFCS typically is commercially available as HFCS-42 (42% fructose) or HFCS-55 (55% fructose). The basic rationale behind granting HFCS GRAS status was that it contains essentially the same ratio of fructose to glucose as table sugar (table sugar is 50% fructose and 50% glucose). Consistent with this logic, in its 1996 review of the GRAS status of HFCS, the FDA expressly rejected a proposal to expand the definition of HFCS to include “HFCS-90” (90% fructose), “primarily because HFCS-90 does not contain approximately equimolar amounts of glucose and fructose.”[3] HFCS-90 does not have GRAS status, and FDA food labeling laws require that HFCS be listed as an ingredient separate from other sweeteners.[4] Do Fructose Levels in Popular Soft Drinks Containing HFCS Conform to the GRAS Standard? In a recent study published in the journal Obesity, Ventura et al. purchased a mix of twenty three bottled and fountain dispensed sweetened-beverages and had them tested by an independent laboratory to determine, among other things, the fructose to glucose ratio of popular full-calorie soft-drinks. Laboratory testing revealed that bottled full-calorie Pepsi, Coca-Cola and Sprite had fructose estimates of 64-65%, well in excess of the upper-level of 55% fructose generally recognized as safe by the Food and Drug Administration.[5] The study extrapolated from this finding that the elevated fructose levels equated to “18% higher fructose consumption than would be estimated assuming the value of 55% HFCS.”[6] This preliminary finding has potentially important public health implications,[7] and is important because a key part of the GRAS process is to estimate the population-wide consumption of the substance being evaluated. [8] What Legal Issues Would Be Implicated by Elevated Fructose Levels in Popular Soft-Drinks? Ventura et al.’s study reflects a very small sample size. Elevated fructose levels in popular soft drinks, if confirmed by additional testing implicate a number of legal issues for regulators and consumers. Federal Prohibition of False and Misleading Food Labeling The Federal Food Drug and Cosmetic Act prohibits false and misleading food labeling, and “food is misbranded if its labeling is false or misleading in any particular.”[9] Federal law specifically defines HFCS “as mixture containing either approximately 42 or 55 percent fructose.”[10] These are the only HFCS formulations that are GRAS and permitted for widespread use in the food supply without prior approval. Absent another source of fructose disclosed in the ingredients list, it would be false and misleading to list “HFCS” on the ingredient list when the product in fact contains a higher ratio of fructose to glucose than required by the legal definition of the ingredient. As such, under federal law the product would be misbranded. Federal Prohibition of Adulterated Foods The FDA summarized its adulterated food policy in a guidance document to the food industry as follows: \”Any substance added to a beverage or other conventional food that is an unapproved food additive (e.g., because it is not GRAS for its intended use) causes the food to be adulterated under section 402(a)(2)(C) of the FFDCA (21 U.S.C. 342(a)(2)(C)). Adulterated foods cannot be legally imported or marketed in the United States.\”[11] HFCS that does not conform to the GRAS ratio of no more than 55% fructose is not GRAS for widespread use in the food supply. Under a plain reading of the FDA’s adulterated food policy, use of such a sweetener in a beverage would constitute the use of an unapproved food additive rendering the product adulterated. False and Misleading Advertising Federal and state laws generally prohibit false and misleading advertising. In 2008, the Corn Refiners Association launched a national multimedia advertising and public relations campaign called “Changing the Conversation about High Fructose Corn Syrup.”[12] The central message of the campaign is that HFCS is essentially the same as table sugar with respect to the ratio of fructose to glucose and is therefore safe: \”High fructose corn syrup is nearly identical in composition to table sugar — both contain approximately 50% glucose and 50% fructose. Sugar and high fructose corn syrup have the same number of calories as most carbohydrates; both have four calories per gram. Because they are nearly compositionally equivalent, the human body cannot tell the difference between high fructose corn syrup and sugar.\”[13] If additional testing of foods and beverages sweetened with HFCS reveals widespread actual fructose levels in excess of 55%, then the representation that HFCS is “compositionally equivalent” to table sugar could amount to false and misleading advertising requiring action by the Federal Trade Commission and State Attorneys General. REFERENCES [1] US FDA, Determining the Regulatory Status of a Food Ingredient, http://www.fda.gov/Food/FoodIngredientsPackaging/FoodAdditives/ucm228269.htm (Oct. 8, 2010). [2] 21 CFR § 184.1866(a). [3] Direct Food Substances Affirmed as Generally Recognized as Safe; High Fructose Corn Syrup, 61 Fed. Reg. Volume 165, 43448 (Friday, August 23, 1996) (to be codified at 21 CFR pt. 182-184). [4] See US FDA, Letter to Food Manufacturers about “And/Or” Ingredient Labeling of Nutritive Sweeteners in Soft Drink Products, http://www.fda.gov/Food/LabelingNutrition/FoodLabelingGuidanceRegulatoryInformation/InspectionCompliance/WarningOtherLetters/ucm110252.htm (July 5, 2005). [5] Emily E. Ventura, Jaimie N. Davis & Michael I. Goran, Sugar Content of Popular Sweetened Beverages Based on Objective Laboratory Analysis: Focus on Fructose Content, __Obesity__, 5 (2010) . [6] Id. at 6. [7] See id. at 5-6 (discuss the various health consequences of the metabolic process triggered by fructose vs. glucose). [8] US FDA, Guidance for Industry: Estimating Dietary Intake of Substances in Food, http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/ucm074725.htm (August 2006). [9] US FDA, Guidance for Industry: Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding
