Last week, the U.S. Food and Drug Administration (FDA) released draft guidance on its mandatory recall authority; in doing so, FDA elaborated on its authority to issue user fees. Food retailers and manufacturers should take note that in the event FDA determines that there is: (1) a reasonable probability that a food product is misbranded and/or adulterated and (2) there is a reasonable probability that the use of or exposure to such food would cause serious adverse health consequences or death to humans or animals, the products may not only be removed from store shelves but the firm may also find itself facing stiff penalties for non-compliance. The draft guidance explains that FDA may collect fees in not only the event that a responsible party of a domestic facility or importer fails to issue an ordered recall, but also for failing to recall the food product in the precise manner specified in the order or for failing to provide FDA with requested information.
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