Pop-Tarts and Elixirs of Death: An Examination of FDA’s Recall Authority

Abstract

In spite of all the regulations that aim to prevent unsafe products from initially entering the market, the Food and Drug Administration must often use its enforcement powers, both formal and informal, to remove hazardous products from the market. One such enforcement tool, the recall, has played a crucial role in the effective removal of products that pose a danger to public health or otherwise violate the laws FDA administers. While recall is widely employed by the FDA, it is also widely misunderstood by the public. It may come as a surprise that, in general, FDA has no authority to order a company to recall an unsafe product. Most of the recalls we see and hear about today are all voluntary recalls conducted by the company at the request of the FDA. This paper examines the development of the recall and FDA’s use of the recall in the context of its other enforcement powers. This paper begins with what can be considered the FDA’s first recall, the infamous Elixir Sulfanilamide tragedy of 1937. It continues with a description of recall and an explanation of why companies comply with voluntary recall requests. This paper then studies the specific circumstances in which FDA does have authority to order a recall—situations involving medical devices, infant formula, biological products, and human tissue intended for transplantation—and also looks at FDA’s authority to withdraw approval of a new drug application. This paper then examines the current debate regarding the granting of a general mandatory recall authority to the FDA. Finally, this paper briefly examines some of the underlying reasons for recalls.