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FDA Issues Draft Guidance on Voluntary Recalls

On 23 April, Food and Drug Administration Associate Commissioner for Regulatory Affairs Melinda Plaisier announced the issuance of draft guidance regarding voluntary recalls. The draft guidance will now undergo a 60-day comment period, after which a final guidance document will be released.

Prior to the passage of the Food Safety Modernisation Act of 2011, all FDA food recalls (other than for infant formula) were voluntary. FSMA granted the FDA authority to implement a mandatory food recall system and current guidance on mandatory recalls was published in November 2018. That guidance noted that while the FDA continues to rely on responsible parties to voluntarily recall violative food products, FSMA’s mandatory recall authority allows the agency – when relevant legal criteria have been met – to mandate a recall when a responsible party chooses not to conduct one voluntarily.

If the FDA has provided the responsible party with an opportunity to voluntarily recall the food product “in writing using an expeditious method of delivery” and the recall is still not issued, the FDA may proceed with a mandatory recall. If a mandatory recall is issued, the FDA will follow certain procedures before the firm can resume sales of the product. It is thus more favourable for a firm to conduct its own voluntary recall so that it can determine how to reintroduce the product into the marketplace after appropriate safety measures have been taken. The FDA notes that when a firm undertakes a voluntary recall the agency still “plays an important role in the recall process, closely overseeing FDA-regulated companies during their voluntary recalls to help ensure public health is protected.”

The new voluntary recall guidance issued on 23 April provides recommendations on the following three elements.

  • Training - Companies should identify and train appropriate personnel on their responsibilities during a recall, establish a recall communications plan, and identify what FDA reporting requirements may apply.
  • Recordkeeping - Companies should consider proper coding of their products and maintaining distribution records in order to conduct the most effective recall possible, emphasising modern methods of product tracing and even potentially using blockchain technology.
  • Procedures - Firms should consider maintaining written product recall procedures.

In addition, the FDA’s February 2019 guidance on public warning and notification of recalls applies. Public warnings apply when needed to alert the public of a serious health hazard. Examples of food-related warnings include recalls of food products (i) for which there is an active outbreak (including allergic reactions) or for which the FDA has substantiated reports of illness or injury; (ii) intended for vulnerable populations such as infants, toddlers, the elderly, pregnant women and medically-compromised individuals; (iii) where the consequences of certain manufacturing deviations could have significant health impacts (e.g., botulism); and (iv) with pathogen findings such as Listeria or Salmonella. Non-food related warnings have included recalls of (i) animal food products such as pet jerky treats contaminated with antibiotics and cat food products containing propylene glycol; (ii) home medical devices that could malfunction and lead to incorrect dosing of drugs or blood volumes; (iii) sterile injectable drug products containing particulate matter; and (iv) implantable pacemakers or defibrillators where the battery may fail suddenly.

The FDA generally gives firms an opportunity to issue public warnings during voluntary recalls and the recall strategy should address whether a public warning is needed. Firms should include any draft public warning as part of their recall strategy submission, assuming that this does not delay initiating a recall. In situations that warrant an immediate warning, firms may choose to issue public warnings without FDA review. When the FDA believes that a public warning is appropriate and the recalling firm has not included one in its initial recall strategy, the FDA may request one.

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