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1 3.19 Resolution on remand. Although the Lollipop case was ordered to go to trial, “an order for discontinuance of the action was entered pursuant to stipulation of the parties.” PETER BARTON HUTT, RICHARD A. MERRILL, AND LEWIS A. GROSSMAN, FOOD AND DRUG LAW 109 (3d ed. 2007) (citing 5 FDA Papers, No. 3, at 42 (Apr. 1971)). Often in such cases, the company will decide to relabel the product to address FDA’s concerns. This would have gained the release of any seized product and saved the company the expense of trial. From a practical standpoint, the financial advantages of resolving the issue likely exceeded substantially any potential future value of a favorable court decision.

2 3.20 Novelty defense. How is the “novelty” nature of the lollipops relevant?

3 3.21 Curing misleading statements. Can a false or misleading statement be “cured” by other information on the label?

Misleading to Whom?

U.S. v. Manischewitz Diet Thins

377 F. Supp. 746 (E.D.N.Y 1974)

JUDD, District Judge.

Plaintiff has moved for summary judgment in this action to condemn food as misbranded….

The proceeding relates to a food product labeled “Diet‐Thins Matzo Crackers” (Diet‐Thins). Claimant B. Manischewitz Co., Inc. has manufactured Diet‐Thins under that name since about 1959.

The government initiated this action in 1972 when 423 cases of Diet‐Thins were seized in Baltimore, Maryland. The government contended that the name Diet‐Thins prominently displayed on the label’s front panel conveyed to consumers the misleading impression that the matzos were lower in caloric content than other matzos and were useful in weight control diets. Claimant asserts that the label is not misleading because Diet‐Thins have several dietary uses other than weight control….

Originally the Diet‐Thins were thinner than the regular matzos manufactured and marketed by the claimant. Sometime during the mid‐60’s, however, the thickness of the regular matzos was reduced, so that at the time of the seizure the Diet‐Thins were identical with other matzo crackers made by claimant, except that the Diet‐Thins were made with enriched flour rather than ordinary flour. The Diet‐Thins furnish the same number of calories as plain matzo crackers and have no greater value in weight control diets than claimant’s ordinary matzo crackers.

The words “Diet‐Thins” on the label of the seized article are displayed across the entire front panel in print 1 3/4′ high. In the corner of the front panel, a sunburst contains the words “enriched with vitamins and minerals, wheat germ added” in letters approximately 3/16th′ high. These legends suggest to the consumer that Diet‐Thins are useful in a balanced weight control program and are significantly lower in calories than ordinary matzos.

Although matzos contain less calories than many other crackers on the market, their caloric content is substantially the same as Melba toast, wholewheat crackers, and certain other crackers.

The side panel also states, “perfect for low salt, low sugar, no food dyes” and “No salt, no sugar, shortening, spices or artificial sweeteners added.”

There is no evidence that claimant has any intention to mislead the public.

The record contains conflicting affidavits as to the value of matzos in general and Diet‐Thins in particular for dietary uses other than weight control, an issue which the court finds it unnecessary to decide on this motion.

The present label has been in use in approximately the same form since 1963, after a controversy with the FDA concerning the property of the previous label. Claimant asserts that the label was approved in 1963, but the FDA denies ever indicating that it was acceptable.

The Statute

The Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 343, provides that

“A food shall be deemed to be misbranded—

(a) If its labeling is false or misleading in any particular.”