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New FDA Guidance Document Published – Mandatory Recall Authority

On November 5, the US Food and Drug Administration (FDA) released their final guidance regarding Mandatory Recall Authority as interpreted from the Food Safety Modernization Act (FSMA).

Simply based on title, this new guidance document gives the impression the FDA now has unlimited authority to force a recall. Careful reading of both the guidance document and FSMA clearly delineates when the FDA can force a company to have a recall – only after the company has been given the opportunity to recall voluntarily and the conditions where “the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals (SAHCODHA).”

Recalls are something no company wants to experience, yet the food industry is wrought with recalls. The same week the guidance document was released, Duncan Hines voluntarily recalled cake mix. The product was linked to an outbreak of Salmonella in which at least five humans were found to be infected after consumption of the cake product. Duncan Hines, as would any company whose food product is linked to illness, has voluntarily recalled their product.

Common sense, concern for public safety and a clear link to illness (SAHCODHA), lead to initiation of a voluntary recall; no need for the FDA to exercise its mandatory recall authority. In another case in April 2018, a kratom product was found to be contaminated with Salmonella and, again, numerous people were ill; the company refused to recall, thus the FDA exercised its authority for a mandatory recall.

What is important to know is that before the FDA can force a recall, the FDA must give the “responsible party” notice as well as an opportunity to “request a hearing to be held not later than two days after the issuance of the order.” There may be times when it is appropriate for a company to request a hearing – that must be determined on a case by case basis.

The bottom line when it comes to recalls: The FDA has finally put in writing specifics relating to changes mandated by FSMA in 2011. Each circumstance must be evaluated professionally – there is no cookie cutter approach to potential recall situations.

Have questions regarding how this guidance document could affect your business? Please contact us: support@ngpfma.org.

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