Hold It There

Under FSMA, the FDA has increased authority to use administrative detention as an enforcement tool. For this reason, companies that manufacture, prepare, pack, or hold food should maintain strong record-keeping practices.

According to the current criteria of the Food, Drug, and Cosmetic Act, the FDA can order the detention of human or animal food where there is credible evidence or information indicating an article of food presents a threat of serious adverse health consequences or death to humans or animals.

This rule was amended under the FSMA, giving the agency greater authority to use detention as an enforcement method. The new rule changes the criteria to allow the FDA to order detention if there is reason to believe an article of food is adulterated or misbranded. Foods can be detained for 20 calendar days, with a possible 10 calendar-day extension if needed.

The goal of the administrative detention of foods is to protect public health and prevent potentially harmful products from being consumed or used. Detaining products where there is doubt concerning their safety can certainly reduce risk. The decision-making skills of those implementing administrative detention, combined with a company’s ability to create and maintain good records, will determine whether or not detention is used appropriately to protect health while avoiding unnecessary burdens, shipment delays, and added costs.

Historically, the majority of FDA administrative detention decisions appear to have been appropriate. According to information published in the Federal Register, the FDA estimated that up to 48% of detained imported foods may have been held because time was needed to determine the facts, and the product was later released as acceptable. This estimate implies that 52% of detained imported food was not released after detention. In other words, after investigation, 52% of the detentions were found to have been justified. For the public, this means that it is likely that a majority of the FDA’s administrative detentions rightfully protected public health concerns.

These estimates are based on imported product because the FDA has not used administrative detention for domestic foods. Other methods have been used, including issuing a voluntary recall, instituting a seizure action, or referring the matter to state authorities. The prior use of these other enforcement methods makes it difficult to predict how often the detention of domestic product may be used. If future FDA detentions of domestic products are based on decision-making skills similar to those used for imports, the same 48% rate of potentially unnecessary detentions may result. Industry and government should share the goal to reduce that percentage in order to ensure that the vast majority of detention actions are necessary and controls are effectively implemented.

The FDA indicates that it is more likely to use administrative detention where this is the most effective enforcement tool available and where the use of or exposure to the product may cause temporary or reversible adverse health consequences.

This would be similar to a product being potentially subject to a Class II recall. Detention decisions will be made on a case-by-case basis. The Federal Register indicates that each circumstance is “fact-specific.” Accurately recording, documenting, and ensuring a solid audit trail of the facts is essential to every entity susceptible to such a detention. The amount of time and resources spent gathering the necessary information depends on how well the required audit trail has been maintained and will determine how quickly the product can be released, saving the company the headache and costs of being forced to keep the product from the market.

A concern for companies engaged in manufacturing or holding human or animal foods is that administrative detention actions no longer need to be justified by credible evidence. Rather, a “reason to believe” could cause potentially unnecessary product loss or shipment delays of wholesome, legal products. Where facts are missing or inappropriately recorded, the FDA must act upon available information to decide whether the product is or is not safe. The old adage “when in doubt throw it out” might be changed to “when in doubt, consider the use of enforcement tools.” If sufficient doubt about a product or process exists, actions should be considered by the responsible company—before the FDA takes action.