The Food and Drug Administration issued draft guidance on mandatory recalls in a May 7, 2015 Federal Register notice and is inviting public comment by July 6. The draft document presents the agency’s current thinking on how the food industry can implement the mandatory food recall provisions the Federal Food, Drug, and Cosmetic Act (FDCA) as amended by the Food Safety Modernization Act (FSMA).
In my experience as a former director of FDA’s Center for Food Safety and Applied Nutrition and of FDA’s Center for Veterinary Medicine, the voluntary system of recalls worked well in almost all situations. Nonetheless, the mandatory recall authority is a significant addition to the agency’s enforcement powers for those rare cases in which companies fail to comply with a request.
FDA’s mandatory food recall authority went into effect as soon as the landmark food safety law was enacted on January 4, 2011. The authority added in Section 423 of the FDCA covers all foods (other than infant formula recalls, which are covered separately under Section 412) that are manufactured, processed, packed, or held at a food facility that is required to register with FDA.
The amended FDCA gives FDA the authority to order a “responsible party” to recall food products if there is “a reasonable probability” that the food is adulterated or misbranded and “will cause serious adverse health consequences or death to humans or animals (SAHCODHA).”
The “responsible party” is the person who submits the registration for a food facility at which the food is manufactured, processed, packed, or held, FDA explains. A “person” is defined as including individuals, partnerships, corporations and associations. So the owner, operator, or agent in charge of a facility who is responsible for submitting the registration is also responsible for implementing and assuring the mandatory recall is performed, the draft guidance says.
The term “food” includes articles used for food or drink for man or other animals, chewing gum, and components of any such article. The term “food” also includes dietary supplements.
Among other topics, the draft guidance describes the process the agency will follow for a mandatory recall. Once it determines that the criteria for a mandatory recall have been met, it will first give the responsible party a chance to voluntarily stop distribution and recall the food. FDA says it will provide the request in writing using “an expeditious method.” If the responsible party won’t comply, the agency may order it to stop distributing the food and it will also give an opportunity for an informal hearing. After these steps, the agency may mandate a recall – and only the FDA Commissioner has the authority to order a recall, the guidance explains.
FDA says it will consider the following factors to assess if a recall is needed:
- Observations made during inspections of the responsible party or other parties;
- Results from sample analyses;
- Epidemiological data;
- Reportable Food Registry data; and
- Consumer and trade complaints.
The agency has the authority to collect fees from a responsible party for a domestic facility or importer who does not comply with a food recall order. The fees would cover time spent by FDA conducting the food recall activities, technical assistance, follow-up checks and public notifications. In an August 8, 2014 Federal Register notice, FDA listed its fiscal year 2015 fees for reinspections and for non-compliance with a recall order, which will remain in effect through September 30, 2015 and will be revised annually. For FY 2015, the hourly rate is $215 if domestic travel is involved and $305 if foreign travel is required.
To make consumers and retailers aware of recalls, the agency says it will “ensure that a press release is published regarding the recall,” as well as alerts and public notices, as needed. These will include, at a minimum, the name of the recalled food, a description of the risks associated with the food, and “to the extent practical, information about similar articles of food that are not affected by the recall,” the agency says.