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Docket Management Branch July 17,2003 Page 2 of 4

Over the years, the Sugar Association has in both formal comments and in several meetings with agency representatives, urged FDA to actively bring an end to this improper use of “and/or” labeling that is being employed by the soft drink industry to deceive consumers about the quality of their product. The attached summary documents the history of this issue as it has evolved since 1983 when the soft drink industry began using high fructose corn syrup (HFCS) instead of sugar in most products (Attachment 2)

In the six years since FDA informed the industry that it would not take enforcement action against the soft drink industry, the United States soft drink and beverage industries have not used appreciable amounts of sugar, but have instead essentially replaced sugar with HFCS.

Review of Grounds for Denial of “and/or”

Labeling

in Soft Drinks

“And/Or” Labeling Precedent Current regulations permit “and/or”

ingredient

labeling

only for fats and

oils

(when

they

are

not

the

predominant

ingredient

in

the

product)

[2 1

CFR

101.4

(b)

(14)],

for

leavening

agents [21 CFR 101.4 (b) (16)] and f or fn-ming agents [21CFR 101.4 (b) (19)]. In each instance, a compelling case was made for the flexibility that “and/or” labeling provides. Moreover, the ingredients that can be substituted and represented on the label are not perceived by consumers as possessing added value when comparing one type of ingredient to another. We emphasize that in these three instances ingredients not present

in a product may be FDA mandated this

listed only if they are sometimes used in provision to insure that consumers would

the product. We believe not be totally misled by

the

“a n d / o r ” when in label.

designation. fact it never

The is in

current label would beverages that have

suggest that sugar the “high fructose

is almost always present corn syrup and/or sugar”

When sugar is used in the manufacture of soft drinks these products are labeled correctly as sweetened only with sugar (e.g.):

l

During the eight-day period of Passover when a small number of bottlers use sugar because corn syrup is not considered Kosher. The ingredient statement lists sugar as the sole :sweetenerin these soft drinks, and for obvious reasons the “and/or’” designat ion is absent.

l

In 1996 <anumber of Louisiana bottlers started producing “Louisiana Pepsi” in recognition of the 200’ anniversary of the Louisiana cane sugar industry. “Louisiana Pepsi” was a sugar-sweetened beverage that was labeled correctly as sweetened only with sugar.

Economic Rational FDA’s primary rationale for the “and/or” exemption was to allow manufacturers to take advantage of claimed periodic price changes and fluctuations of ingredients. However,

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