People are familiar with FDA approved drugs and medical devices, but FDA does not approve food items. Except for one year when FDA approved the Thanksgiving cranberries.
At a press conference, November 9, 1959, Cabinet Secretary Arthur Flemming announced that FDA testing detected aminotriazole in the cranberry crop from Oregon and Washington State. Aminotriazole is pesticide that caused carcinogen in laboratory animals. Unfortunately a consumer could not determine on their own whether their cranberries contained the pesticide or not. So he cautioned consumers to not buy cranberries or not use those they already purchased.
Secretary Flemming’s warning traveled quickly and consumers took it to heart, which cause dramatic damage. Consumers stopped buying cranberries and businesses cancelled orders during this critical time for the cranberry business (present day, 20% of the cranberry crop is consumed during Thanksgiving). This harm ultimately lead to a compromise whereby FDA permitted cleared product to be labeled that they were FDA tested and approved.
Unfortunately, the FDA approval was too little too late.
In the end, FDA testing indicated that only 0.3 percent of the 1959 crop contained aminotriazole. Based on the levels detected, a person would need to eat every day for years 15,000 pounds of cranberries for years to consume the levels that resulted in cancer in the laboratory rats.
So what laws were at play behind the scenes.
The year before FDA began regulating “food additives” through the Food Additive Amendment of 1958. This new law gave FDA authority to have premarket approval of food additives, and it prohibited approving any “chemical additive found to induce cancer in man, or, after tests, found to induce cancer in animals.” This is known as the Delaney Clause – named after the Congressman that proposed the language.
While aminotriazole (a pesticide) was regulated as such on a raw agricultural commodity based on the Pesticide Residues Amendment of 1954, its presence in a non-raw agricultural commodity made it regulated as a “food additive” and not a “pesticide residue.” Curiously the same chemical had two different safety standards, with one subject to the Delaney Clause.
This paradox however was resolved in 1996 with the passage of Food Quality Protection Act, which excluded pesticide residues from the food additive definition.
FDA, This Week in FDA History.
American Council on Science and Health, The First Great Chemical Cancer Scare? Cranberries, Thanksgiving 1959.