In a draft guidance released last Wednesday, the FDA presented its current thinking on its authority to enact mandatory food recalls.
Under the rules of the US Food Safety Modernization Act, the FDA has the power to impose recalls on food items that are identified as adulterated, misbranded, or whose use/exposure poses a significant health risk. In Wednesday’s draft guidance, the FDA provided additional clarification into these criteria, as well the mandatory recall process. When a recall opportunity is identified, “the FDA must first provide the responsible party…with an opportunity to voluntarily cease distribution and recall the article of food.” If the organization refuses to voluntarily recall its items, the FDA can then invoke its authority and order an end to all distribution of the affected product. This is followed by an informal hearing, and depending on the outcome of that hearing, the FDA may order a full recall of the product from commerce.
To obtain a PDF copy of the draft guidance, please click here.
As a draft, the document is open to comments from individuals and organizations for 60 days starting May 7, 2015. Comments may be taken into account before the guidance is finalized. If you have reviewed the draft guidance and wish to comment, suggestions can be submitted to http://www.regulations.gov.