21 U.S.C. § 350l — Mandatory recall authority

(a) Voluntary procedures: If the Secretary decides, based on the reportable food registry under section 350f or any other information, that a food (other than infant formula) is probably adulterated or mislabeled and that using or being exposed to it will cause serious harm or death to humans or animals, the Secretary must first give the "responsible party" (as defined in section 350f) a chance to voluntarily stop distributing and recall it. (b) Prehearing order to cease distribution and give notice: (1) If the responsible party refuses, or doesn't act within the time and manner the Secretary sets, the Secretary may order them to (A) immediately stop distributing the food, and (B) immediately notify everyone who makes, handles, or received the food to also stop distributing it. (2) If the food went to a warehouse-based third-party logistics provider without enough information for that provider to identify it, the required notice must include the information needed to identify the food. This doesn't exempt such providers from other requirements of this chapter, including sections 350l and 350c, or from being subject to the recall order themselves. (3) The Secretary may limit the recall's geographic area and affected markets if that wouldn't compromise public health. (c) Hearing on order: The responsible party gets an opportunity for an informal hearing, held as soon as possible but no later than 2 days after the order, on the required actions and on why the food shouldn't be recalled. (d) Post-hearing recall order and modification: (1) If, after the hearing, the Secretary decides the food must be removed from commerce, the Secretary must, as appropriate, (A) amend the order to require a recall or other action, (B) set a recall timetable, (C) require periodic progress reports, and (D) notify consumers who received or may have received the food. (2) If the Secretary decides after the hearing that there's no adequate basis to continue the order, or that it should change, the Secretary must vacate or modify it. (e) Rule regarding alcoholic beverages: The Secretary can't start a mandatory recall or take other action under this section for an alcoholic beverage until first giving the Alcohol and Tobacco Tax and Trade Bureau a reasonable chance to handle a voluntary cease-and-recall under its own authority. (f) Cooperation and consultation: The Secretary must work with state and local public health officials in carrying out this section, as appropriate. (g) Public notification: During a recall under this section, the Secretary must (1) ensure a press release is published, along with alerts and public notices as needed, telling consumers and retailers about the recall, including at minimum (A) the food's name, (B) the risk it poses, and (C), where practical, information about similar unaffected foods; (2) consider USDA's practice of publicly listing retailers that received products in a Class I recall, and consider doing the same; and (3) if available, post online an image of the recalled food. (h) No delegation: Only the FDA Commissioner — not any other officer or employee — may order or vacate a mandatory recall under this section. (i) Effect: This section doesn't limit the Secretary's power to request or join a voluntary recall, or to order a stop-distribution or recall under any other provision of this chapter or the Public Health Service Act. (j) Coordinated communication: (1) To help carry out this subsection, the Secretary must set up an incident command operation (or similar operation) within HHS, running no later than 24 hours after a mandatory recall starts, or after a recall begins for food whose use or exposure would cause serious harm or death. (2) This operation must use regular HHS staff and resources to (A) ensure timely, coordinated communication within HHS, including between different agencies and offices; (B) ensure timely, coordinated public communication throughout the investigation and related outbreak; (C) name a single point of contact for public inquiries about the Secretary's recall-related actions; (D) coordinate with federal, state, local, and tribal authorities as appropriate, including notifying the Secretaries of Agriculture and Education if the recalled food is used in a child nutrition program; and (E) end operations when the Secretary decides that's appropriate. (3) The Secretary may run multiple or simultaneous incident command operations if several recalls or outbreaks require it.