Food Regulation. Neal D. Fortin

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СКАЧАТЬ 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.”

      Discussion

      The statute … condemn(s) every statement, design, and device which may mislead or deceive.

The same principle has been applied in this circuit United States v. An Article … Sudden Change, 409 F.2d 734, 740 (2d Cir. 1969). In the Sudden Change case, the court said that the test is not the effect of the label on a “reasonable consumer,” but upon “the ignorant, the unthinking and the credulous” consumer. Even a technically accurate description of a food or drug’s content may violate 21 U.S.C. § 343 if the description is misleading in other respects. Thus, whether or not the side panel of the Diet‐Thins label may accurately describe its virtues for certain special diets which do not appear to involve weight control, the misleading nature of the front panel still justifies condemnation of the seized articles. Moreover, claimant does not assert that the statements on the side panel apply in any different degree to Diet‐Thins than to its ordinary matzo crackers.

      Purchasers of diet products are often “pathetically eager” to obtain a more slender figure. There can be no doubt that the weight‐conscious consumer may be led to believe that Diet‐Thin Matzos are lower in calories than ordinary matzo crackers. The exchange of affidavits, and the depositions and discovery sought by the claimant have no bearing on this basic issue.

      Claimant may have a right to assert that ordinary matzo crackers have value in diet and weight control. If this were the issue, further discovery and cross‐examination of the government’s deponents might be useful. Since it is sufficient that only one label statement may be misleading in any particular, the use of the phrase “Diet‐Thins” violates the statute.

      This does not appear to be a case where the label reference to Diet‐Thins can be clarified by an explanatory phrase… . The function of the court is merely to determine whether the existing label is misleading, not to tell the Food and Drug Administration what amendments may be appropriate in order to rectify the situation.

      Claimant asserts that the government is bound or estopped by the asserted FDA approval of the label in 1963, or at any rate that the FDA should have given notice before filing a condemnation proceeding. The claimant does not assert, however, that it gave any notice to the FDA when it modified its regular matzos so as to have the same weight and caloric content as the Diet‐Thins. The change in the comparative contents of the package may render a label misleading which was truthful when it was first submitted. The asserted defense is inadequate to prevent the award of summary judgment.

      It is ordered that the government’s motion for summary judgment be granted, and that a decree of condemnation be entered, and that defendants’ motions be denied.

      * * * * *

      NOTES AND QUESTIONS

      1 3.22 The credulous consumer versus the ordinary, reasonable consumer. What type of consumer was considered in the Diet Thins case in determining what is misleading? In contrast, other courts have applied an “ordinary consumer” or “ordinary, reasonable consumer” standard. See, e.g., United States v. 88 Cases, Bireley’s Orange Beverage, 187 F.2d 967, 971 (3d Cir.) (noting that the FD&C Act § 403(f) states that “the branding must be such as is ‘likely to be read and understood by the ordinary individual under customary conditions of purchase and use’ … We think that essentially the same standard should be applied to the determination of consumer reaction under both sections.”). Also, see below, United States v. 174 Cases Delson Thin Mints, 287 F.2d 246 (1961).

      2 3.23 FDA’s policy on consumer capacity. In 2002, FDA declared that the agency would use a “reasonable consumer” standard to determine whether food labeling is misleading, explaining, “The reasonable consumer standard more accurately reflects FDA’s СКАЧАТЬ