FDA Recalls...Fact vs. Fiction
The recall of a defective or possibly harmful product often is
highly publicized in newspapers and on news broadcasts. Recent
headlines in major newspapers: "FDA Orders Peanut
Butter Recall", and "FDA Orders 6,500 Cases of Red-Dyed
Mints Recalled", are examples of a misunderstanding by the media
regarding the FDA' s role in product recall.
These headlines imply that the FDA can "order" a recall.
The FDA has no authority under the Federal Food, Drug and
Cosmetic Act to order a recall. The FDA does have the
authority to ask a company to recall a particular product.
The FDA has jurisdiction over food, drugs, cosmetics,
medical devices and other products and serves as a monitor
over product recalls. In most cases recalls are done
voluntarily by the manufacturer or the distributor of the
product. In some cases, a company will discover that one of
its products is defective and will recall it. In others
cases, the FDA will notify a company that one of its
products is defective and will suggest or request a recall.
Usually, the company will comply; if it does not, the FDA
can seek a court order authorizing the Federal Government
to seize the product.
The FDA has guidelines for companies to follow in recalling
defective products. These guidelines explain that the FDA
expects these firms to take full responsibility for product
recalls, including follow-up checks to assure that recalls
are successful. Under the guidelines, companies are
expected to notify the FDA when recalls are started, to
make progress reports to the FDA on recalls, and to
undertake recalls when asked to do so by the FDA.
The guidelines specify for manufacturers and distributors
to develop contingency plans for product recalls that can
be put into effect when needed. The FDA's role under these
guidelines is to monitor company recalls and assess the
adequacy of a firm's action. After a recall is completed,
the FDA makes sure that the product is destroyed or
suitably reconditioned and investigates why the product was