FDA to Strengthen Voluntary Recall Protocol


According to an April 23rd release, Melinda K. Plaisier, Associate Commissioner for Regulatory Affairs outlined the proposed procedures for voluntary recalls in a draft Guidance Document relating to 21 CFR part 7, subpart C.

Food producers will be required to prepare plans relating to voluntary recalls to ensure prompt and efficient execution. 



The key areas will be:-


  • Training – the draft guidance provides recommendations for companies manufacturing or distributing foods or products regulated by the FDA.  Specific trained personnel must be designated and their responsibilities defined.
  • Record keeping – traceability requires accurate records including digital systems with specific reference to blockchain technology.  Products must be appropriately coded with corresponding distribution records.
  • Procedures – written procedures are required to implement a recall to limit exposure of consumers to potentially hazardous products.
    During the past 18 months the FDA has refined recall procedures.  Under specific circumstances the Agency will disclose supply chain and retail distribution information relating to both human and animal foods.  There will be greater transparency relating to recalls with posting on the FDA Enforcement Report which list all events monitored by the FDA.
    The Agency points to alerts, advisories and consumer warnings issued in relation to contaminated foods, drugs and dangerous products that have averted illness, injury or death.