There are two types of product recalls:  mandatory and voluntary.  Prior to the Food Safety Modernization Act (“FSMA”), FDA did not possess mandatory recall powers with respect to foods, excluding infant formula.  Rather, the agency was limited to requesting that a firm voluntarily initiate a recall, which it usually reserved for urgent situations.  If the firm ignored FDA’s request or failed to fully cooperate, FDA could pursue administrative detention and seizure.  It also could issue press releases explaining why an article of food is unsafe.

After FSMA, FDA can still request that a firm voluntarily initiate a recall.  See 21 U.S.C. § 350l(a) (requiring FDA to provide a firm with the opportunity to cease distribution and recall an adulterated or misbranded article of food when the use of or exposure to such article will cause serious adverse health consequences or death).   If the request is ignored or the firm does not voluntarily cease distribution or recall the article within the time and in the manner FDA prescribed, however, FDA is no longer limited to detentions, seizures, and press releases.   Under FSMA, FDA has the authority to order firms to immediately cease distribution and recall the article.  Id. at § 350l(b).  When FDA orders a recall it will specify a time table for the recall to occur and will require periodic reports describing the recall’s progress.  Id. at § 350l(d)(1).  FDA will also notify the public about the recall through press releases, alerts, and public notices.  Id. at § 350l(d)(1), (g).

Regardless of whether a recall is mandatory or voluntary, FDA will classify the recall (as either Class I, II, or III), and it will monitor the recall.  If the recall is voluntary, FDA will evaluate the recalling firm’s recall strategy concerning the type of notification, the depth of the recall, and the effectiveness check level.  If it is a requested or mandated recall, FDA will develop the recall strategy.

A recall is terminated when FDA’s monitoring district office concludes that the recalling firm has finished all recall activity, including final product disposition if the product could not be brought into compliance and monitoring.  The completion of a recall, however, does not prevent FDA from taking further regulatory action against a firm.  Thus, once a recall has been initiated, it is important for a firm to cooperate fully with FDA and ensure that its products comply with FDA’s laws.


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