With new draft guidance for so-called voluntary recalls, the Food and Drug Administration is looking to be more effective in an area that’s been seen as one of its short comings.

In announcing new guidance on the subject, FDA said the agency “plays an important role in the recall process, closely overseeing FDA-regulated companies during their voluntary recalls to help ensure public health is protected.”

And it said FDA’s work does not stop there.

“When it comes to recalls and how quickly they are executed, consumers depend on the FDA to protect their health and we work quickly because it could minimize consumer exposure to a health risk and prevent consumers from being injured.

FDA says companies need to take all necessary steps before a recall is initiated. The new draft guidance is intended to prepare companies for “proper and prompt” recalls.

The agency made recommendations in the following three key areas.

Proper training of personnel is perhaps one of the most important elements to effectively executing a recall. The draft guidance provides recommendations for companies who manufacture or distribute FDA-regulated products to adopt in readying their staff for potential recall situations. Specifically, this new draft guidance advises companies on ways to best identify and train appropriate personnel on their responsibilities during a recall, establish a recall communications plan, and identify what FDA reporting requirements there may be, among other things.

Thorough and organized record-keeping is especially important as the agency continues its efforts to improve recalls through product traceability by tapping into modern approaches such as blockchain technology to further advance our mission of protecting public health. The draft guidance also advises companies on the importance of properly coding their products and maintaining distribution records in order to conduct the most effective recall possible

Written recall initiation procedures help to minimize delays created by uncertainty. For companies that initiate a recall, using initiation procedures can help reduce the amount of time a defective or potentially harmful product is on the market and that in turn reduces the potential exposure to consumers. For consignees of a company that initiates a recall, these procedures can help extend the recall quickly throughout the distribution chain. The guidance recommends that firms consider preparing and maintaining written recall initiation procedures to swiftly ensure their recalled products are removed from the market. These procedures should clearly describe the appropriate actions to take when a decision is made to initiate a recall. They should also help ensure that necessary actions are not overlooked and may minimize the disruptive effect a recall can have on a company’s operations.

Guidance accompanies new policies
The new guidance reflects the latest step in the agency’s ongoing commitment to working with companies to quickly act to protect consumers from potentially dangerous products. It builds upon 18 months of proactive and systematic improvements to the FDA’s recall processes.

Agency officials alerted companies of the situations where the FDA would disclose certain supply chain and retail distribution information during certain human and animal food recalls; provided mandatory recall guidance for human and animal foods, which answered common questions about the mandatory food recall provisions; and issued final guidance on public warnings and notifications of recalls for all FDA-regulated products outlining specific circumstances in which the agency would expect a company to issue a public warning about a voluntary recall.

The agency has also adopted new policies for moving forward with rapidly posting new recalls to the FDA’s Enforcement Report, which is a web listing of all recalls monitored by the FDA.

More timely information for consumers is one of the goals FDA has for the new guidance.

FDA cited Kellogg’s Honey Smacks, recalled vegetables, romaine lettuce, angiotensin II receptor blocker (ARB) drugs like Valsartan, Losartan and Irbesartan, King Bio homeopathic products, test strips for home-use monitoring of Warfarin, and contaminated pet food as recent examples of where strengthen recalls have worked.

During the view period, the agency also issued the first mandatory recall order for Kratom products, and released detailed retail distribution information during a recall of pre-cut melon associated with an outbreak of Salmonella infections, so consumers could better identify where the recalled food may have been purchased or distributed.

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