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.
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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 belief that consumers are active partners in their own health care who behave in health promoting ways when they are given accurate health information.” 67 Fed. Reg. 78002‐78004 (Dec. 20, 2002).
3 3.24 FTC’s policy on consumer capacity. FTC has applied a similar standard by policy since 1984. See 103 FTC 100, 174 (1984) (“from the perspective of a consumer acting reasonably in the circumstances.”) Only “a significant minority of reasonable consumers” need to be deceived for the practice to be deemed misleading. Id. note 20.
4 3.25 Reasonable consumer versus not misleading “in any particular.” How can you reconcile the tension between the reasonable consumer standard and not misleading in any particular?
5 3.26 The gullible consumer as the ordinary consumer. Are there situations where a gullible consumer might be the ordinary consumer?
6 3.27 Compliance with the FD&C Act no bar to Lanham Act claims. In POM Wonderful LLC v. Coca‐Cola Co., 134 S.Ct. 2228 (2014) the court held that a statutory private right of action under the Lanham Act is not precluded by compliance with the regulatory provisions of the FD&C Act. In effect, the FD&C Act and the Lanham Act are complementary, and the FD&C Act and its regulations do not provide a ceiling on Lanham Act claims. Neither statute forbids Lanham Act claims on labeling regulated by the FD&C Act, and the statutes have coexisted for seventy years. See Chapter 19 for more of this case.
The Battles Over Labeling Substitute Foods
Plant‐based substitutes for milk and meat, such as soymilk and bean burgers, have long been available, but in recent years, the number of similar products proliferated. Beyond soymilk, we now have oat, hemp, flax, pea, almond, rice, and peanut butter milk. Beyond bean burgers, we have cell‐cultured, lab‐grown meat and burgers with plant‐based heme to simulate the blood and taste of beef.62
Soymilk
In 2000, the National Milk Producers Federation petitioned the FDA to, “make clear to manufacturers of imitation dairy products that product names permitted by federal standards of identity, including dairy terms such as ‘milk’, are to be used only on foods actually made from milk from animals like cows, goats, and sheep.”63 A number of states adopted so‐called “truth in labeling” laws to prevent plant‐based products from be called “milk.” One slogan about these laws is, “Almonds don’t lactate.”64 These battles can be distilled to three issues: (1) the government’s power to impose standardized names, (2) whether consumer confusion exists over the nature of these products, and (3) whether there are materials facts undisclosed, such as inferior nutritional composition (or what else should the label say).
FDA