• The nutrient added is stable under proper conditions of storage and use.

  • The nutrient is physiologically available from the food to which it will be added.

  • There is a reasonable assurance against intake sufficiently in excess to be toxic.

Fortification Policies and Regulations Since the 1960s

In the 1960s FDA proposed a more restrictive regulatory approach in response to increased fortification of food that it feared might lead to overfortification. These were the first major regulatory changes related to food fortification that had been proposed since 1941. In 1962 FDA proposed to limit fortification to only nutrients essential to human health and appropriate for supplementation. The agency listed 12 essential nutrients with a suitable range for their supplementation and 11 nutrients that were considered essential but not appropriate for supplementation because signs of deficiency only occurred under experimental situations (Hutt, 1980, 1984). The previous year FDA had brought legal action against New Dextra Brand Fortified Cane Sugar claiming in part that the sugar’s labeling was misleading because its 19 added nutrients inherently claimed that it was more nutritious than other sugars and that the nutrients were present in sufficient amounts to significantly improve the diet. Another element of the legal action claimed that sugar was an inappropriate vehicle for fortification. FDA’s “misbranding” approach was not upheld in the U.S. District Court, and the U.S. Court of Appeals agreed.1 The court held that FDA had no legal authority to prohibit food fortification unless it can be shown to be unsafe. The United States District Court concluded (as upheld by the United States Court of Appeals):

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….1

1  

United States v. 119 Cases … “New Dextra Brand Fortified Sugar,” 231 F. Supp. 551 (D. Fla. 1963), aff’d per curiam, 334 F 2d 238 (5th Cir. 1964).



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