Monday, June 11, 2012

FDA Denies Petition to Rename Corn Sugar


The U.S. Food and Drug Administration (FDA) yesterday issued its much-anticipated response denying the Corn Refiners Association’s (CRA) petition to allow the term “corn sugar" as an alternate common or usual name for high-fructose corn syrup (HFCS). In its response, FDA said “there are not sufficient grounds to warrant this substitution" and the action would only serve to confuse U.S. consumers and could even pose a health risk to those suffering from fructose intolerance.

In its petition, filed in September 2010 and amended in July 2011, CRA requested FDA amend the generally recognized as safe (GRAS) affirmation regulation for HFCS to designate “corn sugar" as an optional name for HFCS; the standard of identity for dextrose monohydrate to eliminate “corn sugar" as an alternate name for dextrose; and the GRAS affirmation regulation for corn sugar (21 CFR 184.1857) to replace all references to “corn sugar" with “dextrose.

In the May 30 letter sent to CRA President Audrae Erickson, Michael M. Landa, director of FDA’s Center for Food Safety and Applied Nutrition, addressed all three arguments.

FDA said the use of the term “corn sugar" for HFCS would suggest that HFCS is a solid, dried, and crystallized sweetener obtained from corn. Instead, HFCS is an aqueous solution sweetener derived from corn after enzymatic hydrolysis of cornstarch, followed by enzymatic conversion of glucose (dextrose) to fructose. Thus, the use of the term “sugar" to describe HFCS, a product that is a syrup, would not accurately identify or describe the basic nature of the food or its characterizing properties. As such, using the term “sugar" would not be consistent with the general principles governing common or usual names under 21 CFR 102.5.

FDA also said the petition does not support amending FDA’s longstanding regulations, which describe and define corn sugar as “dextrose," to instead identify corn sugar as an alternative name for a sweetener that is different from dextrose. “We are not persuaded by the arguments in the petition that consumers do not associate ‘corn sugar’ with dextrose. The term ‘corn sugar’ has been used to describe dextrose for over 30 years. The Select Committee on GRAS Substances used the term “corn sugar" to describe dextrose as early as 1976.

Finally, FDA said “corn sugar" has been known to be an allowed ingredient for individuals with hereditary fructose intolerance or fructose malabsorption, who have been advised to avoid ingredients that contain fructose. Because such individuals have associated “corn sugar" to be an acceptable ingredient to their health when “high fructose corn syrup" is not, changing the name for HFCS to “corn sugar" could put these

Addressing FDA's decision, CRA issued a statement that read in part: "The Food & Drug Administration denied our petition to use the term corn sugar to describe high fructose corn syrup on narrow, technical grounds. They did not address or question the overwhelming scientific evidence that high fructose corn syrup is a form of sugar and is nutritionally the same as other sugars. The fact remains–which FDA did not challenge–that the vast majority of American consumers are confused about HFCS. Consumers have the right to know what is in their foods and beverages in simple, clear language that enables them to make well-informed dietary decisions. In light of the FDA’s technical decision, it is important to note that the agency continues to consider HFCS as a form of added sugar, and requires that it be identified to consumers in the category of sugars on the Nutrition Fact Panel on foods and beverages."

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