• Product recalls are a common occurrence in the food industry. The FDA website lists about 70 Class I Recalls during a two month period. What are the legal requirements for a product recall?

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First, let’s distinguish a recall from other types of actions that a food processor or distributor might take to remove its product from distribution. A recall is the removal of a product from a company’s chain of distribution because it’s believed that the product may adversely affect the health of humans or animals. The adverse health affect may be due to adulteration, mislabeling (e.g. undisclosed allergens in the product) or possible contamination from foreign sources due to improper handling after production.

There are two other non-recall actions that a food processor or distributor might take to remove its product from distribution. One category is a “market withdrawal” which occurs when a food processor or distributor removes from distribution a product because there is a minor (i.e., non-health related) violation of FDA regulations such as an incorrect calorie listing in the Nutrition Facts or which involves no violation (e.g., product that was not properly formulated during production and therefore is unacceptable for taste or other sensory reasons). The other non-recall action is called a “stock recovery.” This occurs when the product in issue is still in the processor’s or distributor’s control such as food stored at a company or public warehouse. A stock recovery could involve product that either presents a risk to human or animal health or product that has a minor or no violation of FDA rules. In other words, a stock recovery could involve product that could be the subject of a recall or alternatively a market withdrawal had the product been in distribution.

Back to recalls. Let’s immediately clear up one misconception that is shared by members of the public and most of the media. The FDA has no legal authority to order a recall, except when the product is infant formula, but can “request” a processor to commence a recall if the processor decides not to do so on its own motion. Therefore, recalls are “voluntary.” If a processor or distributor declines to recall a product, then the FDA has to convince a U.S. Attorney to file a seizure in federal court. (However, times are a-changing. See the discussion in the Fall 2003 issue of F&MLU concerning the FDA’s new detention authority under the Bioterrorism Rules.) Nevertheless, most processors and distributors will engage in recalls whenever necessary. Also, don’t forget that plaintiffs' tort lawyers are not limited by FDA rules.

The FDA has issued guidelines concerning recalls. The guidelines divide recalls into three classes. The most serious is a Class I recall which occurs when there is a reasonable probability that consumption of a food will cause serious adverse health consequences or death to humans or animals. Undeclared allergens are Class I recalls. A Class II recall involves a food that may cause temporary or medically reversible adverse health consequences or the probability of serious adverse health consequences is remote. Finally, a Class III recall involves a food that is not likely to cause adverse health consequences. The guidelines ask that processors and distributors notify the FDA of a recall, and the agency will publish the recall in its Enforcement Report as method of providing public notice. The guidelines also ask that processors provide the FDA with status reports.

There are a number of practical considerations involved with recalls. Most importantly each processor should prepare a recall plan as a part of its standard operating procedures. It is simply too late to write a recall plan when you are in the process of doing a recall. A good recall plan should include:

•A description of the triggering events that will cause the processor to institute a recall and the identification of the person(s) who will make the call
•Line of command in recall.
•Duties for each department and employees within those departments
•Points of contact for internal and external communication.
- distributors, brokers, retailers
- public
- press
- regulators
•Up-to-date phone and fax numbers, including home numbers, for responsible individuals and alternates.
•Forms for recall communications to distributors, to public, to press.
•Forms for tracking recalled product.
•Accounting procedures

We have seen recall manuals of only a few pages including forms and manuals and others that are over 100 pages. Beyond the basic elements, the manual should be customized to a firm’s products, distribution and operating structure. Needless to say, employees should receive training about recalls prior to the occurrence of an event. This is not a situation where you want to do “on-the-job” training.

The success of a recall is basically measured by its ability to get the product off the selves and out of the chain of distribution. For those of you that have had the unfortunate experience of a recall, you know that this is much easier said than done.

Recalls involve a number of complex legal, food science, marketing, public relations, and logistical issues. When you face a potential recall issue contact Zackler & Associates. We have experience in all aspects of recall related matters. We can help you determine if a recall is necessary, what class of recall it should be, how to handle recall logistics, how to communicate internally and externally, and how to deal with regulatory agencies on your behalf. We will also work with you to develop recall policies and strategies that will leave you well prepared should your company ever need to engage in a recall.