recall powers do the FDA and USDA have?
the exception of infant formula, technically neither
agency has the legal power to require a food distributor
or processor to recall product that is either adulterated
or mislabeled. That doesn’t mean either agency
is powerless, but the reality is a little complicated.
we need to understand what a “recall” is.
A recall means the withdrawal from the market place
by a processor or distributor of a food, drug or cosmetic.
Recalls are usually done because products either does
not or is suspected of not complying with federal law.
From time-to-time firms may remove the products from
channels of distribution that do not comply with the
firm’s own QC requirements, but are compliant
with the law. These removals are usually referred to
as “market withdrawals.”
the USDA and the FDA do have the power to seek injunctions
against firms who ship products that fail to comply
with federal law. These injunctions essentially prohibit
the firms from shipping or selling adulterated or mislabeled
product and can allow the agency to seize the product.
Unfortunately for the agencies, once a product is in
the market place, absent voluntary compliance, the agencies
must seek separate injunctions against each firm (e.g.
wholesaler, retailer) that has inventories of the subject
product. Just locating these firms could be a major
task. However, absent contempt of an order, the agencies
cannot require the firms to remove the subject product
that is already in the market place.
FDA has adopted guidelines concerning “voluntary” recalls.
The policy categorizes recalls into three categories:
Class I for products that might result in serious adverse
health consequences or death; Class II for products that
may cause non-serious, temporary adverse health effects
or have a remote possibility of adverse health consequences;
Class III for products not likely to have adverse health
consequences. The guidelines discuss in detail recall
strategies, notification of FDA, communications to facilitate
the recall, and public notification. Both the FDA and
the USDA have also created detailed documentation for
use in recalls.
why do firms engage in recalls if they don’t have
to do so? First, it's the right thing to do. No one wants
to injure consumers. Legally, if the firm does not initiate
a recall and knows or has reasons to know that a product
is adulterated or mislabeled, then it could be liable
for punitive as well as actual damages. Second, while
a recall is probably never good PR, the failure to do
a recall could be even worse PR.
you have questions or concerns about the need for a
recall, give us a call. In any case, is your recall
policy up to date? Do you know whom to contact and what
to do in the event of a recall?
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