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1 4.6. Fortified sugar. FDA seized cases of New Dextra Brand Fortified Cane Sugar, alleging that the labeling was misleading because it implied that the American diet was deficient in vitamins and minerals and the fortified sugar would correct this. The court found no deception or misrepresentation with the labeling. FDA also considered sugar as an inappropriate vehicle for fortification and was concerned that this might lead to increased consumption of sugar in place of other foods. The court dismissed FDA’s concern, noting, “The implementation of sound nutritional principles, and the encouragement or discouragement of the consumption of particular foods in accordance with these principles, are matters for consumer education, not for legal enforcement pursuant to the seizure provisions of the Federal Food, Drug, and Cosmetic Act… . The basic flaw in the Government's case against the product is that it is seeking, under the guise of misbranding charges, to prohibit the sale of a food in the marketplace simply because it is not in sympathy with its use. But the Government's position is clearly untenable. The provisions of the Federal Food, Drug, and Cosmetic Act did not vest in the Food and Drug Administration or any other federal agency the power to determine what foods should be included in the American diet; this is the function of the marketplace. Under Section 403 of the Act, Congress expressly limited the Government's powers of seizure to those products which are falsely or deceptively labeled.” U.S. v. 119 Cases, More or Less, New Dextra Brand Fortified Cane Sugar, 231 F.Supp. 551 (1963).

4.9 MCFAT LITIGATION

In a lawsuit that has been dubbed the “McFat” litigation, two customers sued the McDonald’s fast food chain, alleging that the restaurant’s advertising was false and deceptive. As a result of this deception, the plaintiffs alleged that their consumption of the restaurant’s unhealthy food caused their obesity and their related health problems.

As you read the Pelman case, keep in mind that at the time in question, the company provided no nutritional information for consumers (nor was any required). In addition, the lower fat and sodium options, such as salad choices, were not available. Finally, pay particular attention to the advertisements, which were key to the case. For example, ads represented the restaurant’s food as a nutritious choice and a foundation of a well‐balanced diet.

The first complaint was dismissed with leave to amend. The following case is an amended complaint, which the restaurant again moved to dismiss. The District Court held that the statute of limitations barred some of the claims. The court also found that the plaintiffs failed to draw a causal connection between false advertising and the health problems. That is, the complaint failed to allege that the McDonald’s food caused the health problems. Finally, the court found that the McDonald’s advertising was not objectively deceptive. The complaint was again dismissed without trial.

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Pelman ex rel. v. McDonald’s Corp. [McFat II]

S.D.N.Y. (Sept. 3, 2003) 105

Judge ROBERT W. SWEET

. . . .

The infant plaintiffs are consumers who have purchased and consumed the defendant’s products in New York State outlets and, as a result thereof, such consumption has been a significant or substantial factor in the development of their obesity, diabetes, coronary heart disease, high blood pressure, elevated cholesterol intake, and/or other detrimental and adverse health effects and/or diseases. . . .

McDonald’s Advertising Campaigns

In one survey of the frequency of purchases by visitors to McDonald’s restaurants, McDonald’s found that 72% of its customers were “Heavy Users,” meaning they visit McDonald’s at least once a week, and that approximately 22% of its customers are “Super Heavy Users,” or “SHUs,” meaning that they eat “at McDonald’s ten times or more a month.” Super Heavy Users make up approximately 75% of McDonald’s sales. Many of McDonald’s advertisements, therefore, are designed to increase the consumption of Heavy Users or Super Heavy Users. The plaintiffs allege that to achieve that goal, McDonald’s engaged in advertising campaigns which represented that McDonald’s foods are nutritious and can easily be part of a healthy lifestyle.

Advertising campaigns run by McDonald’s from 1987 onward claimed that it sold “Good basic nutritious food. Food that’s been the foundation of well‐balanced diets for generations. And will be for generations to come.” McDonald’s also represented that it would be “easy” to follow USDA and Health and Human Services guidelines for a healthful diet “and still enjoy your meal at McDonald’s.” McDonald’s has described its beef as “nutritious” and “leaner than you think.” And it has described its french fries as “well within the established guidelines for good nutrition.”

While making these broad claims about its nutritious value, McDonald’s has declined to make its nutrition information readily available at its restaurants. In 1987, McDonald’s entered into a settlement agreement with the New York State Attorney General in which it agreed to provide [nutritional] information in easily understood pamphlets or brochures which will be free to all customers so they could take them with them for further study [and] to place signs, including in‐store advertising to inform customers who walk in, and drive through information and notices would be placed where drive‐through customers could see them.

Despite this agreement, the plaintiffs have alleged that nutritional information was not adequately available to them for inspection upon request.

Claims

. . .The three remaining causes of action are based on deceptive acts in practices in violation of the Consumer Protection Act, New York General Business Law §§ 349 and 250. Count I alleges that McDonald’s misled the plaintiffs, through advertising campaigns and other publicity, that its food products were nutritious, of a beneficial nutritional nature or effect, and/or were easily part of a healthy lifestyle if consumed on a daily basis. Count II alleges that McDonald’s failed adequately to disclose the fact that certain of its foods were substantially less healthier, as a result of processing and ingredient additives, than represented by McDonald’s in its advertising campaigns and other publicity. Count III alleges that McDonald’s engaged in unfair and deceptive acts and practices by representing to the New York Attorney General and to New York consumers that it provides nutritional brochures and information at all of its stores when in fact such information was and is not adequately available to the plaintiffs at a significant number of McDonald’s outlets.

The plaintiffs allege that as a result of the deceptive acts and practices enumerated in all three counts, they have suffered damages including, but not limited to, an increased likelihood of the development of obesity, diabetes, coronary heart disease, high blood pressure, elevated cholesterol intake, related cancers, and/or detrimental and adverse health effects and/or diseases.

. . . .

Plaintiffs Have Successfully Stated Reliance on a Single Allegedly Deceptive Advertising Campaign

. . .The plaintiffs counter that they have alleged that their misconceptions about the healthiness of McDonald’s food resulted from “a long‐term deceptive campaign by Defendant of misrepresenting the nutritional benefits of their foods over last approximate [sic] fifteen (15) years.” Plaintiffs further argue that reliance is not an element of New York GBL § 349. . .

While plaintiffs have alleged that McDonald’s has made it difficult to obtain nutritional information about its products, they have not alleged that McDonald’s controlled all relevant information. Indeed, the complaint cites the complete ingredients of several McDonald’s products. Plaintiffs are therefore required to allege reliance in order to survive a motion to dismiss. . . .

Plaintiffs argue that it would be impracticable to require each of the tens of thousands of potential class members to state exactly when and where they observed the deceptive advertisements. Before a class has been certified, however, the number of infant plaintiffs is only two, making the task much more manageable. It is true that it would be unduly burdensome for plaintiffs, at this stage, to allege the particular time and place that they saw the advertisements which allegedly caused their injuries. It will therefore be considered sufficient for plaintiffs to allege in general terms that plaintiffs were aware of the false advertisement, and that they relied to their detriment on the advertisement.

Nowhere in the Amended Complaint Is It Explicitly Alleged That Plaintiffs Witnessed Any of the Allegedly False Advertisements Cited… .

Making all reasonable inferences in favor of the plaintiffs, the complaint implicitly alleges only one instance in which the infant plaintiffs were aware of allegedly false advertisements. The plaintiffs implicitly allege that they were aware of McDonald’s national advertising campaign announcing that it was switching to “100 percent vegetable oil” in its French fries and hash browns, and that McDonald’s fries contained zero milligrams of cholesterol, when they claim that they “would not have purchased or consumed said french fries or hash browns, or purchased and consumed in such quantities,” had McDonald’s disclosed the fact that these products “contain beef or extracts and trans fatty acids.”. . .

Plaintiffs Have Failed to Allege that Consumption of McDonald’s Food Caused Their Injuries

The most formidable hurdle for plaintiffs is to demonstrate that they “suffered injury as a result of the deceptive act.”…

The absence of a reliance requirement does not, however, dispense with the need to allege some kind of connection between the allegedly deceptive practice and the plaintiffs’ injuries. If a plaintiff had never seen a particular advertisement, she could obviously not allege that her injuries were suffered “as a result” of that advertisement. Excusing the reliance requirement only allows the plaintiff to forgo the heightened pleading burden that is necessary for common law fraud claims. It cannot, however, create a causal connection between a deceptive practice and a plaintiff’s injury where none has been alleged. Accordingly, this Court required that to state a claim under § 349 in an amended complaint, plaintiffs would “have to set forth grounds to establish. . . that they suffered some injury as a result of that particular promotion.”. . .

Plaintiffs have failed, however, to draw an adequate causal connection between their consumption of McDonald’s food and their alleged injuries. . ..

Unlike the initial complaint, the amended complaint does specify how often the plaintiffs ate at McDonald’s. For example, Jazlyn Bradley is alleged to have “consumed McDonald’s foods her entire life. . . during school lunch breaks and before and after school, approximately five times per week, ordering two meals per day.” Such frequency is sufficient to begin to raise a factual issue “as to whether McDonald’s products played a significant role in the plaintiffs’ health problems.”

What plaintiffs have not done, however, is to address the role that “a number of other factors other than diet may come to play in obesity and the health problems of which the plaintiffs complain.” This Court specifically apprised the plaintiffs that in order to allege that McDonald’s products were a significant factor in the plaintiffs’ obesity and health problems, the Complaint must address these other variables and, if possible, eliminate them or show that a McDiet is a substantial factor despite these other variables. Similarly, with regard to plaintiffs’ health problems that they claim resulted from their obesity. . ., it would be necessary to allege that such diseases were not merely hereditary or caused by environmental or other factors.

Plaintiffs have not made any attempt to isolate the particular effect of McDonald’s foods on their obesity and other injuries. The amended complaint simply states the frequency of consumption of McDonald’s foods and that each infant plaintiff

“exceeds the Body Mass Index (BMI) as established by the U.S. Surgeon General, National Institutes of Health, Centers for Disease Control, U.S. Food and Drug Administration and all acceptable scientific, medical guidelines for classification of clinical obesity.”. . .

Following this Court’s previous opinion, the plaintiffs should have included sufficient information about themselves to be able to draw a causal connection between the alleged deceptive practices and the plaintiffs’ obesity and related diseases. Information about the frequency with which the plaintiffs ate at McDonald’s is helpful, but only begins to address the issue of causation. Other pertinent but unanswered questions include: What else did the plaintiffs eat? How much did they exercise? Is there a family history of the diseases which are alleged to have been caused by McDonald’s products? Without this additional information, McDonald’s does not have sufficient information to determine if its foods are the cause of plaintiffs’ obesity, or if instead McDonald’s foods are only a contributing factor. . ..

The Advertising Campaign upon Which Plaintiffs Have Stated Reliance is Not Objectively Deceptive

Even if plaintiffs were able sufficiently to allege that their injuries were causally related to McDonald’s representations about its french fries and hash browns, that claim must still be dismissed because the plaintiffs have not alleged that those advertisements were objectively misleading. . ..

The essence of the plaintiffs’ claim of deception with regard to McDonald’s french fries and hash browns is that McDonald’s represented that its fries are cooked in “100 percent vegetable oil” and that they contain zero milligrams of cholesterol whereas in reality they “contain beef or extracts and trans fatty acids.” However, the citations in the amended complaint to McDonald’s advertisements, and the appended copies of the advertisements, do not bear out the plaintiffs’ claims of deception. The first citation is to an advertisement titled “How we’re getting a handle on cholesterol,” alleged to have commenced in 1987 and to have continued for several years thereafter. The text cited by the plaintiffs states:

… a regular order of french fries is surprising low in cholesterol and 4.6 grams of saturated fat. Well within established guidelines for good nutrition.

The text cited in the complaint, however, inexplicably drops several significant words from the text of the advertisement included in the appendix to the amended complaint. The actual advertisement states:

… a regular order of french fries is surprising low in cholesterol and saturated fat: only 9 mg of cholesterol and 4.6 grams of saturated fat. Well within established guidelines for good nutrition.

The advertisement also states that McDonald’s uses “a specially blended beef and vegetable shortening to cook our world famous french fries and hash browns.”

The plaintiffs next allege that beginning on or around July 23, 1990, McDonald’s announced that it would change its french fry recipe and cook its fries in “100 percent vegetable oil,” a change that rendered its fries cholesterol‐free. They allege that from the time of the change until May 21, 2001, McDonald’s never acknowledged “that it has continued the use of beef tallow in the french fries and hash browns cooking process.” On its website, however, McDonald’s is alleged to have “admitted the truth about its french fries and hash browns”:

A small amount of beef flavoring is added during potato processing—at the plant. After the potatoes are washed and steam peeled, they are cut, dried, par‐fried and frozen. It is during the par‐frying process at the plant that the natural flavoring is used. These fries are then shipped to our U.S. restaurants. Our french fries are cooked in vegetable oil at our restaurants.

While the plaintiffs do allege that the beef flavoring that McDonald’s acknowledges using is equivalent to beef tallow, the complaint does not allege that the beef flavoring contains cholesterol. McDonald’s maintains that its “cholesterol disclosure is regulated by the FDA and is entirely accurate and appropriate under the FDA’s regulations.”

Plaintiffs further allege that McDonald’s claims that its french fries and hash browns are cholesterol‐free is also misleading because the oils in which those foods are cooked contain “trans fatty acids responsible for raising detrimental blood cholesterol levels (LDL) in individuals, leading to coronary heart disease.” However, plaintiffs have made no allegations that McDonald’s made any representations about the effect of its french fries on blood cholesterol levels. As McDonald’s argues,

The contents of food and the effects of food are entirely different things. A person can become “fat” from eating “fat‐free” foods, and a person’s blood sugar level can increase from eating “sugar‐free” foods….

….

In light of the previous decision and the granting of leave to amend, the complaint will be dismissed with prejudice….

Because the plaintiffs have failed to allege both that McDonald’s caused the plaintiffs’ injuries or that McDonald’s representations to the public were deceptive, the motion to dismiss the complaint is granted….

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Food Regulation

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