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Published: Tuesday, July 7, 2015
"AHPA supports the issuance of a guidance document to better inform industry how the new provision of the Food, Drug and Cosmetic Act that authorizes FDA to mandate a food recall will be implemented," said AHPA President Michael McGuffin. "In submitting these comments AHPA is providing several requests and suggestions to make the Draft Guidance that is the subject of these comments more useful to industry."
FDA's authority to issue a mandatory recall under certain conditions went into effect upon the enactment of FSMA on January 4, 2011. On May 7, FDA issued draft guidance titled Questions and Answers Regarding Mandatory Food Recalls to answer common questions about mandatory recall provisions and FDA's plan to implement these provisions.
Prior to the passage of FSMA in early 2011, food recalls had been voluntary initiated by the marketers of the recalled foods when the manufacturer, distributor or FDA discovered an issue like possible contamination or mislabeling. In its comments, AHPA encourages FDA to continue to rely on voluntary food recalls whenever possible and continue the practice of encouraging a voluntary recall before mandating a recall. AHPA recommends the draft guidance be amended to provide additional information to clarify FDA's approach to determining when it would encourage a voluntary recall as a preliminary action before using its mandatory recall authority.
Among other suggestions, AHPA's comments also request FDA to revise the draft guidance to:
• present examples of the sorts of adulteration that would be most relevant to FDA's use of its mandatory recall authority
• provide more specific information for industry on FDA's mandatory recall process
• state that, for FDA-mandated recall, the appropriate FDA district office will issue a written notification to the recalling firm that the recall is terminated once the office determines that the recall was effective.