4.8 FDA’S FORTIFICATION POLICY
FDA has written rules to established uniform set of principles for the rational addition of nutrients to foods.102 Desirable nutrient levels and quality in the food supply is an important public health objective. The uniform fortification of foods was one of the great public health achievements of the twentieth century, eliminating the nutrient deficiency diseases of pellagra, beriberi, rickets, and scurvy.
However, random fortification of foods could result in over‐ or underfortification and create nutrient imbalances in consumers’ diets. This could undermine the public health achievements through uniform fortification. It could also result in deceptive or misleading claims for certain foods.
As stated in the FDA’s fortification principles, “The Food and Drug Administration does not encourage indiscriminate addition of nutrients to foods, nor does it consider it appropriate to fortify fresh produce; meat, poultry, or fish products; sugars; or snack foods such as candies and carbonated beverages. To preserve a balance of nutrients in the diet, manufacturers who elect to fortify foods are urged to utilize these principles when adding nutrients to food… . The policy set forth in this section is based on U.S. dietary practices and nutritional needs and may not be applicable in other countries.”103
FDA finds fortification of certain listed nutrients may appropriately be added to a food appropriate under the following circumstances104:
to correct a dietary insufficiency recognized by the scientific community to exist and known to result in nutritional deficiency disease if the food is suitable vehicle for the added nutrients; or
to restore nutrient(s) to a level(s) representative of the food before storage, handling, and processing under good manufacturing practices.
The fortification rule lists a number of limits and controls, such as the food cannot be fortified in a way contrary to any other Federal regulation for a food or class of food that requires, permits, or prohibits nutrient additions (such as standards of identity), nutritional quality guidelines established in federal regulation, and common or usual name regulations. Adding a nutrient is also appropriate only when the nutrient is stable in the food under customary conditions of storage, distribution, and use; is physiologically available from the food; and the level will not result in an excessive intake of the nutrient.
NOTE
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.
* * * * *
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