The FDA has published its guidance on Voluntary Recalls (here), revising the initial draft guidance issued April 24, 2019. The Agency notes that “[I]n addition to editorial changes made to improve clarity, changes from the draft to the final guidance include the addition of the terms correction and market withdrawal to the terminology section, the addition of language encouraging the use of electronic communications for conveying voluntary recall communications about FDA-regulated products, and the deletion of Section IV (“References”).”
As a reminder, the FDA has authority for mandatory recalls of food products but not drugs (yet). They have been lobbying to obtain this authority and there have been legislative attempts to grant that authority over the years. There is a provision in the house-passed American Competes Act that will give the FDA the authority it needs to remove unsafe products from the market, but action of reconciliation of the House and Senate bill has not yet occurred. Relevant section of the of House-passed version is as follows: ”Sec. 20402. Notification, nondistribution, and recall of drugs. This section authorizes FDA to order drug manufacturers to cease distributing and recall a drug if there is a reasonable probability that the drug could cause serious adverse health consequences or death.”
The interim guidance cited above provides an outline to better understand the voluntary recall process and how to implement a recall for companies that on their own initiative or with encouragement from the FDA decide to issue a voluntarily recall for one of their products.
