The draft guidance describes the FDA’s policy on public warning and notification of recalled products.
The agency said it gives industry clear direction on how to work with the FDA to make sure recalls are communicated promptly.
An Office of Inspector General (OIG) report recently criticised the recall process and said it was not always ‘efficient and effective’.
One change is in the FDA’s Enforcement Report - a list of all recalls the agency monitors.
Historically, only those classified into one of three categories based on severity of the hazard have been listed. However, this classing can take weeks or months.
Douglas Stearn, FDA’s director, office of enforcement and import operations, office of regulatory affairs, said the move will alert the public sooner when a product has been recalled.
“Moving forward, FDA will include “not-yet-classified” recalls of human drugs, foods, and veterinary products in the weekly Enforcement Report, even while classification work is still ongoing.
“Posting “not-yet-classified” recalls will not affect current FDA protocols for working with companies to ensure that they quickly alert entities in the supply chain as soon as they have identified a problem with their marketed product.”
Recalling firms are expected to develop their own strategy, according to the guidance.
Comments can be made on the draft guidance until 20 March.
FDA may issue public warnings on its own initiative when the public needs immediate warning concerning a product and the firm has not made a public warning or it is deficient.
While timeframes will vary, firms should generally issue a public warning within 24 hours of FDA notifying the company that such a move is appropriate.
It should include: information to help identify the recalled product including images, codes (e.g., lot number, expiration date), packaging information or brand names; geographic areas and dates of distribution; a thorough description of the defect, health hazard and reason(s) for recall; name and contact information for the recalling firm; instructions to consumers; the number and nature of any associated illnesses/injuries/complaints and a description of common symptoms of any illness.
Phrases such as ‘an abundance of caution,’ that can be seen as trying to minimize the hazard, should not be used when illnesses or injury have resulted or when there are positive results for pathogens associated with the finished product or ingredients.
Identification of specific stores?
In some cases, it may be necessary to include the recalling firm’s supply-chain relationships to alert the public of the product being recalled.
When possible, FDA encourages firms to provide specifics about firms it sold product to so people can better identify and avoid a recalled product.
Scott Gottlieb, FDA commissioner, said it is developing a new policy on what information the FDA will make available to help the public to identify a hazardous recalled food.
“With most products that the FDA regulates, consumers can typically identify a recalled product from the information a company provides about the packaging or brand name information,” he said.
“The FDA also helps provide some geographic or retail-related information for many recalls. But in some situations, identifying additional information – such as specific stores that may have sold a potentially unsafe, recalled food – may help.
“As part of these efforts, we’re planning to announce a new approach to the release of recall information this year. In the meantime, the FDA can and will publicize this kind of information if it is necessary to effectuate a recall.”