When the Going Gets Worse… Understanding the FDA Recall

The food business is broad and layered consisting of several consumers and business models. It consists of manufacturers, packers, distributers, and retailers, many small and large. There are several different supply chains consisting of farm to fork operations, retail chains for affordable options, and local regional markets.

The FDA plays a significant role in our society by providing regulatory efforts on various foods, drugs, biologics, medical devices, radiating products, cosmetics, veterinary products, and tobacco products. Regarding food, there are real health concerns regarding food pathogens and sickness that can affect consumers. The question begs, when and how can FDA initiate and recall food products that pose risk?

This question became of utmost importance to my family in midst of the recent Blue Bell Creameries listeria outbreak. My family owns and operates a small Ice Cream Shop in Western North Carolina where we previously sold Blue Bell products. So we asked ourselves, what exactly is a FDA recall?

Recall is a mechanism enforced and policed by the FDA to pull many products (often food products) from the market in order to protect the public from exposure or injury. The food policy “recall regulations” are found at 21 CFR Part 7. It is an effective method of removing or correcting products that are in violation of laws administered by the Food and Drug Administration. 21 C.F.R. Part 7.40.  A “recall” is defined in 21 C.F.R. 7. 3(g) as a firm’s removal or correction of a marketed product that the Food and Drug Administration considers to be in violation of the laws it administers, and against which the agency would initiate legal action, e.g., seizure. Recall does not include a market withdrawal or a stock recovery.

The recall can be voluntary; manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk or injury. 21 C.F.R. 7.40(a). The recall is an alternative to the other approaches the FDA rarely pursues. Recall alternatives are FDA-initiated court actions for removing products from the consumer market place. 21 C.F.R. 7.40(a). The recall function was created to provide assurance and to increase safety; FDA recall procedures, monitoring, and analysis achieve these goals. 21 C.F.R. 7.40(a).

The FDA can request a recall when a company does not voluntarily recall a product itself. These recalls however are reserved for urgent situations. 7 C.F.R.7.40(b). The recall is a policy-based procedure to provide more protection in more reasonable manners as opposed to other procedures. In addition to court-initiated actions, the FDA can order a seizure. Court-initiated remedies and seizures are often problematic when products are consumed and already available to consumers. However, they are needed in several situations. They are helpful when an entity refuses to follow an FDA request, a recall would not be effective, or further violations are discovered. 21 C.F.R. 7.40(c).

Health hazard evaluations and recall classifications are found at 21 C.F.R. 7.41. These regulations detail how health hazards will be evaluated by the FDA in accordance to the list of factors to be considered.  The factors considered will then enable the FDA to classify the health hazard and declare the recall as one of three different classifications. 21 C.F.R. 7.41(6)(b). If a recall is requested, the FDA has the option of detailing a recall strategy for the company.  A recall request from the FDA can only be made when the FDA has made several prerequisite determinations. These determinations can be found at 21 C.F.R. 7.45(a).

The FDA is striving to improve the recall function. Most recently, the FDA is implementing a FDA mandatory recall function. The mandatory recall authority is authorized from Section 206 of the Food Safety Modernization Act that compliments the Federal Food, Drug, and Cosmetic Act. This is highlighted in the recent draft guidance published by the FDA in finalizing their mandatory recall procedures. The draft is available for public comment for 60 days starting May 7^th, 2015 in which the FDA will consider all comments before drafting the final version.

Consumers interact daily with many products and food fibers that present risks to our health. Many of these products are regulated by the FDA and fall under the FDA’s regulatory power. Knowing the framework of the FDA “recall” can help consumers better understand our food industry and food safety.