A Statutory Look at Recalls

By Tim Ibbeson

The E. coli contamination of spinach this past September brought food-safety recalls back into our living rooms and kitchens. As Paul mentioned in his article, many farmers were forced by the FDA to “voluntarily” recall their product. What does it mean to “voluntarily” recall your product? Is there such a thing as an “involuntary” recall?

Statutes in the Code of Federal Regulations define recalls and what occurs when a company fails to issue a recall on its own. Title 21, Part 7, Subpart C, Section 7.46(a) looks at a “voluntary” recall. It states, “A firm may decide of its own volition to remove or correct a distributed product.” A firm that does so because it believes its product to be in violation of the Food, Drug and Cosmetic Act is required to immediately notify the appropriate Food and Drug Administrative office listed in Sec. 5.115 of this chapter.

The Food and Drug Administration may also “request” a recall. Section 7.45(a) states, “The Commissioner of Food and Drug or his designee may request a firm to initiate a recall when the following determinations have been made: (1) That a product that has been distributed presents a risk of illness or injury or gross consumer deception; (2) That the firm has not initiated a recall of the product; and, (3) That an agency action is necessary to protect the public health and welfare.”

The book, Food Safety Law, by Schumann, Schneid, Schumann and Fagel, 1997, p. 17, states that the FDA can initiate formal judicial proceedings, but the mere threat of action on their part (the FDA) almost always results in voluntary recalls. “Under the voluntary recall process, the FDA informs the organization that other enforcement actions may be taken if the recall is not commenced as soon as practicable.”

Enforcement mechanisms can include: (1) seizure of all available product; (2) and/or an injunction of the firm in question; and (3) criminal proceedings. Title 21 of the United States Code, Chapter 9, Subchapter III, Sections 332-335 deal with the process of enforcing an FDA requested recall when a company fails to comply.

Enforcement, however, is a rarely used tool within the FDA. While it has the authority, through the Food, Drug and Cosmetic Act, to initiate judiciary proceedings if a firm doesn’t initiate its own recall or it doesn’t comply with an FDA “requested” recall, many firms do comply. The food industry is very competitive and a company’s brand name and reputation are at stake.

It is for these reasons that you seldom hear of “involuntary” recalls. Additionally, “voluntary” recalls are the fastest and most effective way to protect the consumer. Title 21, Part 7, Subpart C, Section 7.40© of the Code of Federal Regulations reads, “Recall is generally more appropriate and affords better protection for consumers than seizure, when many lots of product have been widely distributed. Seizure, multiple seizure, or other court action is indicated when a firm refuses to undertake a recall requested by the Food and Drug Administration, or where the agency has reason to believe that a recall would not be effective, or discovers that the violation is continuing.”

To summarize, most companies “voluntarily” initiate their own recalls and the FD&C Act does not statutorily give the FDA the authority to “order” a recall. Yet, the FDA may “request” a product recall. And if the firm is not willing to initiate removal of the product from the marketplace without an FDA written request, it (the FDA) has the legal authority to remove the product from the marketplace.

This article first appeared in Volume 1-1 of L+G’s Food Safety Newsletter, in April 2007.

< Return to Articles

Categories: Recall