The FDA contended that the product was misbranded under the FD&C Act because the labeling was false or misleading because the name implied that the lollipops were flavored with real liquor, which they were not.
Freed Novelty argued that their product was not a food under the meaning of the FD&C Act, but rather a “novelty.” The company also argued that their product’s labeling—as a whole—was not false or misleading because the ingredient statement informed consumers that the lollipops contained no liquor. Freed Novelty also contended that the word “candy” on the label indicated that the lollipops contained no liquor.
The procedural posture of the case is important in understanding the opinion of the court. The court did not decide whether the lollipop labeling was misleading. This case was decided as a summary judgment. Therefore, the only ruling by the judge was whether the case could be decided solely on the pleadings submitted by the parties, or whether the case must be ordered to a full trial.
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United States v. 432 Cartons Individually Wrapped Candy Lollipops
292 F. Supp. 839 (1968)
MANSFIELD, District Judge.
This is a libel for condemnation instituted under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.A. § 334(a), on the ground that the article of food seized was misbranded when introduced into interstate commerce. The complaint for forfeiture alleges that the labeling of the article is false or misleading and that therefore the food is misbranded under 21 U.S.C.A. § 343(a)….
The article of food in question consists of about 432 cartons each containing six lollipops. On the outside the carton is labeled on top “Candy for … one with Sophisticated Taste,” on one side, “A. Freed Novelty, Inc., N.Y.C.,” and on the other side, “Ingredients: Sugar, corn syrup, citric acid, natural and artificial flavors.” The inside of the box contains the legend, “Liquor Flavored Lollypops,” and the slogan, “Take Your Pick of a Liquor Stick.” In addition the lollipops themselves are labeled, both in the box and on the cellophane in which they are individually wrapped, as “Scotch,” “Bourbon,” and “Gin.”
The Government contends that the internal labeling is false or misleading in that it implies and represents that “the article is flavored with liquor, which it is not.” In response claimant does not allege that the lollipops are flavored with liquor, but by way of affirmative defenses contends that they are not misbranded because the cartons are clearly labeled “candy” and the ingredients are distinctly set forth, and that the ordinary purchaser would not read or understand it to represent that the lollipops contain any alcohol or liquor.
In approaching the question of whether the labeling here was false and misleading within the meaning of the statute, we recognize that the statute does not provide for much flexibility in interpretation, since it requires only that the labeling be false or misleading “in any particular.” This represents a stricter substantive standard than that applied with respect to false advertising, which in order to be prohibited must be “misleading in a material respect.” Furthermore the statute says “false or misleading.” For instance, the use of the term “fruit flavored” on a pudding product has been held after a trial on the merits to be false and misleading even though the product was manufactured from grain which, while botanically a fruit, was not a fruit in common parlance.
The issue of whether a label is false or misleading may not be resolved by fragmentizing it, or isolating statements claimed to be false from the label in its entirety, since such statements may not be deemed misleading when read in the light of the label as a whole. However, even though the actual ingredients are stated on the outside of a carton, false or misleading statements inside the carton may lead to the conclusion that the labeling is misleading, since a true statement will not necessarily cure or neutralize a false one contained in the label… . Furthermore, the fact that purchasers of a product have not been misled, while admissible on the issue of whether the label is false or misleading, would not constitute a defense….
Applying these principles here, it cannot be concluded as a matter of law that no material issue exists with respect to the alleged false and misleading character of the label here before us. Although the labeling on the inside of each box of “candy,” when read alone, might be misleading, the detailed description of the contents of the box listed on the outside of the carton could convince a jury, when the labeling or literature is read as a whole, that it is not “misleading in any particular,” as that term is used in 21 U.S.C. § 343(a)….
It appears that the Government, although it has not so indicated in its papers, may be concerned with some potential abuse in the distribution of this product that has not been drawn to the attention of this Court. If this is so, it would seem appropriate for this factual aspect of the case to be developed at trial rather than to grant a judgment on the pleadings in favor of the Government on the basis of a completely rigid reading of the words of the statute and a fragmentization of the labeling under attack here. The Government’s motion for a judgment on the pleadings is therefore denied.
So ordered.
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NOTES AND QUESTIONS
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