FDA Issues Draft Guidance on Public Notification of Recalls
On January 18, 2018, the Food and Drug Administration (FDA) issued a draft guidance detailing its policy for moving forward with posting recalls in its weekly Enforcement Report. The Enforcement Report is designed to provide a public listing of products under its jurisdiction that are being recalled. Until recently, the FDA’s Enforcement Report listed only product recalls that were classified by risk level according to the FDA’s classification scheme. The classifications currently in use are as follows:
| RECALL CLASSIFICATIONS | |||
| Classification | Risk | Definition | Examples |
| Class I | Highest | Reasonable probability that use/exposure will cause serious adverse health consequences or death. | Defective pacemaker, food contaminated with salmonella, defective anesthesia products |
| Class II | Intermediate | Use/exposure may cause temporary or medically reversible adverse health consequences, remote probability of serious adverse health consequences. | Failure to declare the presence of monosodium glutamate (MSG) in a food product |
| Class III | Lowest | Use/exposure is not likely to cause adverse health consequences. | Undeclared colors on food product label, sub-potent dandruff shampoo |
Since classification of a recall into one of the three foregoing categories can take time, in order to alert the public sooner about product recalls, last year the FDA began listing recalls pending classification, or “not-yet-classified” recalls, in addition to classified recalls in its Enforcement Report. The FDA started listing not-yet-classified recalls because it recognized that the timing of recall awareness by the general public is critical to protecting the health and safety of consumers. Announcing recalls earlier can reduce the likelihood of resultant lawsuits against manufacturers, suppliers, and others in the food and drug product supply chain.
As noted in the recent draft guidance, and consistent with its current practice, in an attempt to promptly post public notifications, information on all recalls will be provided in the FDA Enforcement Report, regardless of the level of hazard. The draft guidance outlines circumstances when a company should issue a public warning about a recall, the contents of recalls, and the method by which recalls should be distributed to the public. In particular, the draft guidance states that the phrase “out of an abundance of caution” should not be used in public recall warnings in certain circumstances such as when an illness or injury has resulted or when positive results for a pathogen is involved with the product.
Individuals wishing to comment on the draft guidance should submit comments to the FDA within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.
For more information or assistance, please contact Peter Mooney (mooneyp@whiteandwilliams.com; 215.864.7164), Brian Tetro (tetrob@whiteandwilliams.com; 215.864.7070) or another member of our Food and Beverage Group.
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