The USDA forced Westland/Hallmark Beef to recall 143 million pounds of beef in 2008, which equaled two years' worth of processing and production. The largest food recall ever happened without any illness complaints. The USDA was pressured to act after the Humane Society released an undercover video revealing horrid practices at one of the company’s meat processing plants. Westland/Hallmark blatantly failed to pull sick cows from the processing line, and they didn’t tell inspectors about the sick cows. The company agreed to a nearly $500 million settlement, which was paid out to government agencies and animal welfare groups. (1)
No company wants to find itself in the position of a product recall. A recall could involve logistics, high costs, and potential harm to the brand's reputation. Mandatory steps are enacted to remove or correct the product in the marketplace. Recall preparedness is essential for any company, which provides less pressure when a situation necessitates action. To clarify what preparations companies should take to more seamlessly manage a recall, on March 2, 2022, FDA published its Final Guidance Document on Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C.
This Guidance Document details the recalling company's responsibilities, preparations, and communications. The Guidance applies to voluntary recalls of any food (tea is included under this heading) or drug intended for human and animal use, any cosmetic, biological, and tobacco product intended for human use, and any item subject to a quarantine regulation under 21 CFR part 1240.
What is a recall?
The guidance defines a recall as a business's removal or correction of a marketed product that the FDA considers violating its laws.
The FDA mentions that the same principles could apply to a company’s action even if it does not rise to the level of a recall, like in the example of market withdrawals. Almost all recalls are conducted voluntarily by the manufacturer. FDA maintains a database for recalls of FDA-regulated products based on information gathered from press releases and other public notices.
FDA recommends companies in a product distribution chain stand "recall ready."
How can you be "recall ready"?
The Guidance Document provides practical guidelines for both companies and direct accounts. For example, companies should identify and train appropriate personnel with recall-related responsibilities and establish a recall communications plan.
FDA recommends using electronic communications, as noted here, to inform the public about recalls. The Guidance highlights that the business should identify specific points of contact for internal communications, communications with the FDA, and communications to direct accounts or the public ahead of time and maintain draft templates for prompt communication. FDA has model recall communication templates available here.
Companies should identify any reporting requirements for distributed products and know whether their product is associated with any legal or regulatory requirements to make a report to the FDA. Businesses must also maintain distribution records to identify the direct accounts that received the recalled product by name, delivery address, and contact information.
The recalling company should maintain distribution records to locate the products being recalled. Distribution records should be retained for a period that exceeds the product's shelf life or expected life and at least the length of time specified in applicable record retention regulations. Product coding (a UPC code) is helpful for the identification of recalled products, but it may also help a recalling firm accurately limit the scope of the recall.
The Guidance also provides recommended procedures for initiating a recall and performing actions related to initiating a recall. Preparing, maintaining, and documenting the procedures list for initiating a recall and performing actions related to initiating a recall is an excellent preparatory effort. This effort could help minimize delays created by uncertainty about what actions to take when a firm decides to initiate a recall, thereby reducing the amount of time a violative product is on the market. An effective written procedure should carefully note:
the plans of ceasing distribution, shipment, and sales of the affected product
a recall strategy
communication strategies to notify direct accounts about the product being recalled, including what should be done concerning the recalled product
a communication plan to notify the public about a product that presents any health hazard
What do you do if there's a problem?
If there is an indication of a problem with a distributed product, FDA recommends that all businesses should implement procedures to:
identify indicators that there may be a problem with a distributed product
investigate the problem
make decisions and take action
consult with FDA about the problem
Of note, FDA emphasizes that the recalling company does not need to wait for the completion of an investigation before it initiates a voluntary recall. In addition, if a company identifies any problem with a distributed product, it should not delay the initiation of a voluntary recall pending the FDA’s review of its recall strategy or recall communications.
The recalling company should promptly issue a press release or other public notice. The details of the procedural guidance regarding press releases and written recall notification letters can be found here.
Finally, the Guidance notes that the FDA’s recall coordinators can work cooperatively with a recalling company to facilitate the orderly and prompt removal of, or correction, a violative product in the marketplace. If a recalling company is located in the United States, it can contact a Division Recall Coordinator within the FDA Office of Regulatory Affairs (ORA). For recalls of CBER-regulated products, firms should contact the CBER’s Direct Recall Classification (DRC) Program. (Note: for tea, you would contact your local ORA.) If a recalling business is located outside the United States and is recalling a product exported to the United States, then the recalling business should contact ORA Headquarters.
Most FDA-regulated entities have an established SOP governing the evaluation, decision, notification, and process for a recall. Although the guidance does not impose new requirements, it provides detail on what these SOPs should address and encourages companies to begin the recall process even if FDA has not agreed with the recall plan.
What now?
The best preparation is to be "recall ready"! When the FDA inspects a food facility, the agent checks for compliance with current good manufacturing practices and other applicable food safety regulations(e.g. FSMA, IA, etc.). Failure to comply can result in warning letters, citations, or detentions.
If you feel unprepared for an FDA Inspection or do not feel "recall ready," you'll need an expert on your team - and we can help! Hula Consulting can help with your questions and documents, assist in a mock-inspection (gap audit) visit to your facility and give you a detailed report on what is necessary to correct to pass an FDA inspection.
Contact us today at 561.600.7025 or scott@hulaconsulting.com. We look forward to helping you with your business!
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