FDA Issues New Draft Guidance to Aid Voluntary Recalls

FDA said the guidance builds on 18 months of improvements to its recall processes that have resulted in more timely information being available to consumers. Examples include alerts, advisories, or consumer warnings related to products such as pre-cut melon associated with an outbreak of Salmonella infections and recalled vegetables, drugs, homeopathic products, and test strips for home-use monitoring of Warfarin.

The U.S. Food and Drug Administration has issued new draft guidance that gives industry clear information on ways to prepare, plan, and work with the FDA to ensure voluntary recalls are initiated properly and promptly. The agency regards voluntary recalls as one of the most important safety tools it oversees and a vital way to protect public health; they are typically the quickest way to remove defective or potentially harmful food, medical, and consumer products from the market.

FDA said the guidance builds on 18 months of proactive and systematic improvements to its recall processes that have resulted in more timely information being available to consumers. Examples of this in the past year include alerts, advisories, or consumer warnings related to products such as pre-cut melon associated with an outbreak of Salmonella infections, recalled vegetables, romaine lettuce, drugs such as Valsartan, Losartan, and Irbesartan, homeopathic products, test strips for home-use monitoring of Warfarin, and contaminated pet food.

The draft guidance, "Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C," was published April 24. Comments on it are due by June 24. It includes recommendations in three important areas:

  • Training: The guidance provides recommendations for companies that manufacture or distribute FDA-regulated products to adopt in readying their staff for potential recall situations, training them on their responsibilities during a recall, establishing a recall communications plan, and identifying what FDA reporting requirements there may be.
  • Recordkeeping: The agency noted that thorough, organized recordkeeping is especially important as FDA continues its efforts to improve recalls through product traceability by tapping into modern approaches such as blockchain technology. The guidance advises companies on the importance of properly coding their products and maintaining distribution records in order to conduct the most effective recall possible.
  • Procedures: Written recall initiation procedures help to minimize delays created by uncertainty, according to FDA. The guidance recommends that firms consider preparing and maintaining written recall initiation procedures to swiftly ensure their recalled products are removed from the market. The procedures should clearly describe the appropriate actions to take when a decision is made to initiate a recall.
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