Consumer Products: FDA and Regulatory Issues

Nate Beaver, a partner in Foley’s Washington, D.C. office, works with manufacturers, distributors, and retailers of products regulated by the Food and Drug Administration. One of the most difficult aspects of FDA compliance is deciding whether to undertake a product recall, and Nate details the best way to go about it in this video. In particular, he discusses two key points to consider when deciding whether or not to recall a product.

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• With FDA compliance, it can be difficult deciding when and how to undertake a product recall as these decisions must be made quickly.
• In some instances, FDA can order manufacturers to conduct a recall if serious safety concerns are identified.
• Regulated industries often self-identify an issue and then decide whether to voluntarily recall the affected product.
• If the product is a food
  • Determine whether you are required to report to the reportable food registry within 24 hours.
  • Food must be reported when there is reasonable probability it will cause serious adverse health consequences or death.
  • The 24-hour clock begins after you determine the food is a reportable food.
• Not a reportable food but a recall will be needed
  • Determine whether or not to report the voluntary recall to FDA.
  • Voluntary recalls are not required to be reported, but it is often recommended to proactively report and work with FDA collaboratively on the recall plan.
  • Recalls that are not reported, may later be investigated by FDA.