• What recall powers do the FDA and USDA have?

    With 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.

First, 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.”

Both 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.

The 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.
So 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.


If 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?



© 2005 Zackler & Associates. All rights reserved.