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.
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.
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.
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.
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:
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
•Points of contact for internal and external communication.
- distributors, brokers, retailers
•Up-to-date phone and fax numbers, including home numbers,
for responsible individuals and alternates.
•Forms for recall communications to distributors, to public,
•Forms for tracking recalled product.
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.
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.
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.