September 14, 2010
Division of Dockets Management
Food and Drug Administration
Department of Health and Human Services
5630 Fishers Lane, Room 1061
Rockville, MD 20852
The Corn Refiners Association, a national trade association representing the corn
refining (wet milling) industry of the United States, submits this petition under sections 201(s),
402, 409 and 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(s) 342, 348 and
371) to request the Commissioner of Food and Drugs to revise the Generally Recognized As
Safe (GRAS) affirmation regulation for high fructose corn syrup, 21 C.F.R. 184.1866, to
recognize “corn sugar” as an alternate common or usual name for high fructose corn syrup.
A. ACTION REQUESTED
The Corn Refiners Association proposes that:
(1) 21 C.F.R. 184.1866, the GRAS affirmation regulation for high fructose
corn syrup, be revised to read as follows:
§ 184.1866 High Fructose Corn Syrup
(a) High fructose corn syrup, also known as corn sugar, a sweet nutritive
saccharide mixture . . . .
(2) 21 C.F.R. 168.111, the standard of identity for dextrose monohydrate, be
revised to read as follows:
§ 168.111 Dextrose Monohydrate
1701 Pennsylvania Ave., NW, Suite 950, Washington, D.C. 20006-5805
Phone: (202) 331-1634 Facsimile (202) 331-2054 www.corn.org
(c) The name of the food is “Dextrose monohydrate or “Dextrose”.
B. STATEMENT OF GROUNDS
Although high fructose corn syrup has been safely used as a food ingredient in the
United States for decades, there is compelling evidence that many consumers are confused and
misled by the ingredient name. Contrary to its name, and contrary to what many consumers
believe, high fructose corn syrup is not high in fructose compared to other commonly used
nutritive sweeteners, such as sugar, honey, fruit juice concentrates, and agave nectar. The
proposed alternate name “corn sugar” more closely reflects reasonable consumer expectations
and more accurately describes the basic nature of the ingredient and its characterizing properties.
Accordingly, revision of the high fructose corn syrup GRAS affirmation regulation to recognize
“corn sugar” as an alternate common or usual name would promote honesty and fair dealing in
the interest of consumers.
1. EQUIVALENCE OF HIGH FRUCTOSE CORN SYRUP AND SUGAR
High fructose corn syrup and sugar are equivalent by every parameter of
relevance to consumers. High fructose corn syrup and sugar have equivalent ratios of fructose
and glucose. The most widely-used high fructose corn syrup products in the United States
contain 42% fructose (HFCS-42) and 55% fructose (HFCS-55). Many packaged foods contain
HFCS-42 which is lower in fructose than all other caloric sweeteners. The remaining
carbohydrates in high fructose corn syrup are free glucose and minor amounts of other simple
glucose-based carbohydrates. Sugar (sucrose) is a mixture of 50% glucose and 50% fructose. 1
Thus, the glucose-to-fructose ratio in high fructose corn syrup and sugar is similar, nearly 1:1. A
similar ratio is also found in many fruits, fruit juices, and vegetables.
John S. White, Straight talk about high-fructose corn syrup: what it is and what it ain’t, Am. J.
Clin. Nutr. 2008; 88(suppl): 1716S-21S.
The only practical distinction in composition between high fructose corn syrup
and sugar is that in sucrose, fructose and glucose are chemically bonded together, while in high
fructose corn syrup, the glucose and fructose are a simple mixture. During digestion and
absorption, however, enzymes in the digestive tract break the chemical bond in sucrose.
Sucrose, thus, enters the bloodstream as free fructose and glucose, just as high fructose corn
High fructose corn syrup and sugar have the same number of calories per gram.
High fructose corn syrup and sugar are both simple carbohydrates that contribute about 4
High fructose corn syrup and sugar have the same level of sweetness. Studies
measuring sweetness intensities found that in syrup form at 10% solids (the approximate
sweetener concentration in most carbonated beverages), HFCS-55 and sugar yielded the same
relative sweetness. 44 In addition, one study that measured, among other things, perceived
sweetness of three cola beverages (sweetened with sugar, HFCS-55, and HFCS-42) found that
the three beverages were perceived by study subjects as equally sweet. 55
High fructose corn syrup and fructose are metabolized the same way by the body.
For example, one study examined the effects in normal-weight women of high fructose corn
syrup and sugar on circulating levels of insulin, leptin, and ghrelin, hormones that regulate body
weight and appetite. The study found no significant differences between the sweeteners with
Schorin MD. 2005. High Fructose Corn Syrups, Part 1: Composition, Consumption, and
Metabolism. Nutrition Today 40(6):248-252.
White, infra note 1. Under the same experimental conditions, HFCS-42 was found to be less
sweet than sugar.
Pablo Monsivais, et al., Sugars and satiety: does the type of sweetener make a difference?, Am.
J. Clin. Nutr. 2007; 86: 116-23.
respect to circulating levels of these hormones.66 Studies in young men and in men and women
demonstrated similar results. 7,87, In the same way, studies comparing effects of sucrose and high
fructose corn syrup on triglycerides and uric acid showed no discernable differences in normal
weight women. 9,108, 9
Recent expert scientific panels convened by the American Medical Association,11 10
the International Life Sciences Institute (ILSI) and the United States Department of Agriculture
(USDA), 12 Experimental Biology, 13 and the Center of Food Nutrition and Agriculture Policy1413
uniformly concluded that high fructose corn syrup and sucrose are compositionally similar and
metabolically equivalent. And the just-published recommendations of the 2010 Dietary
Kathleen J. Melanson, et al., Effects of high-fructose corn syrup and sucrose consumption on
circulating glucose, insulin, leptin, and ghrelin and on appetite in normal-weight women,
Nutrition 23 (2007) 103-112.
Kimber L. Stanhope, et al., Twenty-four-hour endocrine and metabolic profiles following
consumption of high-fructose corn syrup-, sucrose-, fructose-, and glucose-sweetened beverages
with meals. Am. J. Clin. Nutr. 2008, Vol 87:1194-203
Tina Akhavan and G. Harvey Anderson, Effects of glucose-to-fructose ratios in solutions on
subjective satiety, food intake, and satiety hormones in young men, Am. J. Clin. Nutr. 2007;
86:1354-63; Stijn Soenen and Margriet S. Westerterp-Plantenga, No differences in satiety or
energy intake after high-fructose corn syrup, sucrose, or milk preloads, Am. J. Clin. Nutr. 2007;
Joshua Lowndes, et al., The effect of high-fructose corn syrup on uric acid levels in normal
weight women, Program Abstract #P2-45 (June 2007 meeting of the Endocrine Society).
Zukley L, et al. June 2007. The Effect of High Fructose Corn Syrup on Post-Prandial Lipemia
in Normal Weight Females. Presented at the June 2007 meeting of The Endocrine Society.
Program Abstract #P2-46. Abstract available
American Medical Association. 2008. Report 3 of the Council on Science and Public Health
(A-08): The Health Effects of High Fructose Syrup.
Julie M. Jones, Dietary Sweeteners Containing Fructose: Overview of a Workshop on the
State of the Science, J. Nutr. 2009; 139: 1210S-1213S.
Victor Fulgoni, High-fructose corn syrup: everything you wanted to know, but were afraid to
ask, Am. J. Clin. Nutr. 2008; 88(suppl): 1715S.
Richard Forshee, et al., A Critical Examination of the Evidence Relating High Fructose Corn
Syrup and Weight Gain, Critical Reviews in Food Science and Nutrition, 2007; 47:561-582.
Guidelines Committee made no distinction between sucrose and high fructose corn syrup. 1514
Published studies and reviews conducted by researchers and experts on high fructose corn syrup
are collected in Appendix A.
In affirming the GRAS status of high fructose corn syrup, FDA confirmed that the
saccharide composition (glucose to fructose ratio) of HFCS is approximately the same as that of
honey and sucrose and that HFCS is as safe as other commonly used sweeteners, including
sucrose and honey. 61 Fed. Reg. 43447; August 23, 1996.
2. MSR GROUP SURVEY
This petition is supported by a consumer research study conducted in 2010 by The
MSR Group on behalf of the Corn Refiners Association. The full report of the research study,
including the survey questionnaire, design and methodology, and detailed results, is attached as
Appendix B to this petition.
The purpose of the research was to determine if consumers are confused about the
nature and content of high fructose corn syrup, the extent to which the name contributes to
consumer confusion, and whether an alternate name more accurately describes the product. The
strong conclusions from The MSR Group research are that (1) consumers incorrectly perceive
that high fructose corn syrup is significantly higher in calories, fructose and sweetness than
sugar, and (2) the term “corn sugar” more accurately reflects the actual properties of high
fructose corn syrup than its current name.
The survey was weighted to represent United States adults age 18 and older on
key demographic characteristics. The internet was used for data collection, and the survey was
See Table D5.1 Carbohydrates: nomenclature and special issues; Report of the DGAC on the
Dietary Guidelines for Americans, 2010, at D5-3.
conducted in accordance with Office of Management and Budget (OMB) recommendations and
consistent with the design of recent FDA consumer surveys.
The results show that 40% - 60% of respondents are confused about the properties
of high fructose corn syrup compared to sugar. Although high fructose corn syrup and sugar
have the same number of calories per gram, contain approximately equal proportions of fructose
and glucose, and are the same sweetness, 57% of respondents say that high fructose corn syrup
has more fructose compared to table sugar. Also, over 40% of respondents incorrectly believe
that high fructose corn syrup has more calories than sugar and 45% believe it to be sweeter than
The MSR survey also demonstrates that the term “corn sugar” more accurately
reflects the actual properties of high fructose corn syrup than its current name based on consumer
ratings of this alternate name on the same attributes compared to sugar (i.e. fructose content,
calories per gram, and sweetness). Additionally, after reading a description of high fructose corn
syrup’s properties, 69.6% of the consumers surveyed did not pick “high fructose corn syrup” as
the best name for the product described.
3. OTHER EVIDENCE OF CONSUMER CONFUSION
In addition to the MSR survey, there is ample evidence of substantial (and
growing) consumer confusion regarding the characteristics of high fructose corn syrup. As
noted, contrary to the implication of its name, high fructose corn syrup is not high in fructose.
The two commonly sold forms of high fructose corn syrup, HFCS-42 and HFCS-55, are
metabolized similarly to sugar and honey in the body. Moreover, high fructose corn syrup, like
sugar, has been affirmed by FDA as GRAS. 21 C.F.R. 184.1866.
In spite of these fundamental similarities between high fructose corn syrup and
sugar, growing numbers of consumers incorrectly believe that high fructose corn syrup contains
significantly more fructose than sugar and is less safe than sugar. Consumer confusion regarding
the basic properties of high fructose corn syrup is reflected in the proliferation of erroneous
statements regarding high fructose corn syrup in the popular press, on the internet and in
scientific journals. Samples of typical statements reflecting confusion and misunderstanding
regarding high fructose corn syrup are collected in Appendix C.
4. RECOGNITION OF “CORN SUGAR” AS AN ALTERNATE
COMMON OR USUAL NAME FOR HIGH FRUCTOSE CORN SYRUP
IS SUPPORTED BY FDA’S COMMON OR USUAL NAME REGULATION
The FDA common or usual name regulation provides that “the common or usual
name of a food, which may be a coined term, shall accurately identify or describe, in as simple
and direct terms as possible, the basic nature of the food or its characterizing properties or
ingredients.” 21 C.F.R. 102.5(a). In the preamble to the final regulation, FDA indicated that a
common or usual name should “accurately reflect the reasonable expectations of consumers.” 37
Fed. Reg. 12327; June 22, 1972.
Recognition of the term “corn sugar” as an alternate common or usual name for
high fructose corn syrup would fully satisfy the criteria for a common or usual name when used
to describe high fructose corn syrup. The name “corn sugar” more accurately reflects the source
of the food (corn), identifies the basic nature of the food (a sugar), and discloses the food’s
function (a sweetener). Also, as shown in the MSR survey, the name “corn sugar” more
accurately reflects the reasonable expectation of consumers with respect to the basic properties
of high fructose corn syrup than does the name high fructose corn syrup, and would reduce the
pervasive consumer confusion and misunderstanding associated with the name “high fructose
In 1988, FDA amended the GRAS affirmation regulation for “low erucic acid
rapeseed oil” to permit use of the term “canola oil” as an alternate common or usual name. 53
Fed. Reg. 36067, September 16, 1988. The Petitioner contended that the term “low erucic acid
rapeseed oil” is unappealing and distasteful to many consumers, and FDA ultimately concluded
that the term “canola oil” “is the name preferred by industry, and the name that would be most
favorably perceived and easily understood by all consumers.” 53 Fed. Reg. 36068. There is an
equal or stronger justification to authorize use of the term “corn sugar” as an alternate common
or usual name for “high fructose corn syrup” based on the compelling evidence provided in
support of this petition that consumers are misled by the term “high fructose corn syrup” and
more favorably perceive and easily understand the name “corn sugar”.
In 2000, FDA approved the use of “dried plums” as an alternative name to prunes
for labeling purposes. 16 The California Prune Board (the Board) contended that consumers
associated the name “prunes” with negative imagery, which acted as a barrier to trial and
purchase. The Board submitted two consumer research studies to support its contention that the
term “prunes” is associated with negative imagery and that the name “dried plums” would be
received more favorably by consumers and without confusion. Similar justification to authorize
use of the term “corn sugar” as an alternate common or usual name for “high fructose corn
syrup” exists in this case. The evidence provided in support of this petition demonstrates that
consumers are confused and misled by the term “high fructose corn syrup,” which has resulted in
an increasingly negative connotation associated with the term. In contrast, evidence
demonstrates that consumers more favorably perceive and easily understand the name “corn
5. CONFORMING AMENDMENT TO DEXTROSE STANDARD OF IDENTITY
Letter from Christine J. Lewis, Ph.D., Director, Office of Nutritional Products, Labeling and
Dietary Supplements, Center for Food Safety and Applied Nutrition, FDA, to Richard Peterson,
Executive Director, California Prune Board (Jun. 6, 2000).
In order to provide for use of the term “corn sugar” as an alternate name for high
fructose corn syrup, the CRA is petitioning for a conforming amendment to the standard of
identity for dextrose monohydrate. 21 C.F.R. 168.111.
The standard of identity for dextrose monohydrate, defined as “purified and
crystallized D-glucose containing one molecule of water of crystallization with each molecule of
D-glucose,” provides that the name of the food is “dextrose monohydrate” or “dextrose” or
alternatively, “________ sugar monohydrate” or “________ sugar, with the blank to be filled in
with the name of the food source, for example “corn sugar monohydrate” or “corn sugar”. 21
It is appropriate to amend the standard of identity for dextrose monohydrate to
eliminate reference to the names “corn sugar” and “corn sugar monohydrate” in order to provide
the option of using “corn sugar” as an alternate common or usual name for high fructose corn
syrup. The terms “corn sugar” and “corn sugar monohydrate” have rarely been used to describe
dextrose, and these terms are not commonly associated with dextrose by consumers. Rather, as
shown in the MSR survey, consumers regard the name “corn sugar” as more accurately
describing the basic characteristics of high fructose corn syrup.
This petition is supported by an extensive label survey performed by Mintel, a
prominent market research firm, documenting that the terms “corn sugar” and “corn sugar
monohydrate” are rarely used to describe dextrose on food labels. (Appendix D). Mintel’s
database covers all new food products, including new formulations, brand extensions and new
packaging, introduced in the United States since January 1, 2004. Mintel’s survey shows that of
128,993 new food and beverage products launched in the United States from January 1, 2004 to
June 16, 2010, none used the term “corn sugar monohydrate” on the label. Of 8,840 food and
beverage products containing dextrose introduced during this timeframe, only 51 (about 0.56%)
used the term “corn sugar” on the label. By contrast, 8,789 of these products used the term
“dextrose” on the label. The Mintel survey provides strong evidence that the term “dextrose” is
widely used on food labels to describe ingredients covered by the dextrose standard of identity;
the terms “corn sugar” and “corn sugar monohydrate” are seldom used on food labels, and “corn
sugar” is not commonly associated with dextrose by consumers.
C. ENVIRONMENTAL IMPACT
This petition is subject to categorical exclusion under 21 C.F.R. 25.32(F).
D. ECONOMICAL IMPACT
Information will be provided to the extent requested by the Commissioner.
The undersigned certifies that, to the best knowledge and belief of the
undersigned, this petition includes all information and views on which the petition relies, and
that it includes representative data and information known to the petitioner which are
unfavorable to the petition.
Corn Refiners Association