A recall is a potential source of anxiety for any food manufacturer, but, if conducted effectively, recalls can be an invaluable tool for protecting a company’s reputation, brand image and sales. However, a recent government study has identified deficiencies in the food recall processes of the Food and Drug Administration (FDA), which has prompted the agency to propose new policies for improving the oversight, communication and implementation of its recall process.  

Food recalls are a vital method for alerting consumers to food safety issues and maintaining public trust in the safety of the U.S. food supply. But a recent study by the Center for Food Integrity revealed only 33% of the survey respondents “strongly agreed” with a statement indicating confidence in food safety, which suggests a “trust deficit” exists between consumers, food companies and federal regulators. Under a new  FDA draft guidance, the public will learn about food recalls sooner, which may help increase consumer confidence in food safety.

The FDA’s Oversight of Recalls

The FDA is responsible for ensuring the safety of 75% of the U.S. food supply, which includes the oversight of approximately 150,000 domestic and foreign food facilities. To safeguard public health, the agency monitors hundreds of food recall events that occur annually due to various reasons such as microbial hazards, allergens, labeling and manufacturing errors.

A recall is expected when a product is determined to be in violation of the Federal Food, Drug and Cosmetic Act (FD&C Act). Food product recalls are typically voluntary actions implemented by food manufacturers in response to the discovery of a safety, quality or regulatory violation. For every recall of an FDA-regulated product, the agency completes a health hazard evaluation and classifies the recall as Class I, II or III, depending on the level of risk to the public.

Since the implementation of the Food Allergen Labeling and Consumer Protection Act (FALPCA) in 2006, undeclared allergens have triggered more FDA recalls of food products annually than any other reason, including microbial hazards such as Listeria monocytogenes or Salmonella.

During calendar year 2017, nearly 700 food recall events were classified with the FDA Enforcement Report. Undeclared allergens and microbial hazards accounted for 40% and 35%, respectively, of FDA food recalls.

Deficiencies in FDA’s Recall Processes

A recent study by the Department of Health and Human Services’ inspector general has concluded the FDA lacks “an efficient and effective food-recall process” for ensuring the safety of the U.S. food supply.  The inspector general issued a report in December that criticizes the FDA’s oversight of food recalls, monitoring of firm-initiated recalls and maintenance of food recall data.

The federal investigation reviewed 30 voluntary food recalls selected from 1,557 food recalls reported to the FDA between October 1, 2012 and May 4, 2015. In brief, the inspector general concluded the FDA failed to evaluate food hazards in a timely manner and inconsistently monitored the effectiveness of recalls implemented by firms. For the recalls studied, food companies took an average of 57 days to pull a food product after the FDA became aware of the potential health hazards.

In response to the report, the FDA emphasized that the 30 recalls evaluated by the inspector general constituted only 0.2% of all recalls during the 30-month period covered by the investigation. In fact, the agency monitored more than 7,300 recalls, including more than 1,500 food recalls, during the period covered by the report.

Since the FDA relies on voluntary recalls, the timing of recalls is dependent on a company’s willingness to take action. Within the report, the timing risk factors were identified as: “how long it took to complete the recall, when the firm began notifying its distribution chain of the recall, when the firm issued a press release, how long it took to classify the recall, how long it took to complete the recall, how long it took to terminate the recall.”

The FDA Unveils New Policies

In the wake of the recent assessment of the FDA’s recall effectiveness, the agency issued a draft guidance to advise the industry of circumstances mandating a public warning and notification of a recall, the timeline for issuing a warning and situations that would provoke FDA actions.

The draft guidance is focused on public warnings, which are expected when a recalled product poses a serious and immediate health hazard. A public warning is typically reserved for recalls classified as Class I recalls. Companies should issue a warning within 24-hours of notification from the FDA that a public warning is appropriate.

In order to accelerate public notifications of recalls, the FDA has unveiled a new approach for notifying consumers of public health hazards associated with specific food products. The FDA plans to post recalls within the weekly FDA Enforcement Report prior to classification and regardless of the hazard level.

Currently, the FDA does not disclose the names and locations of retailers that have sold recalled food items, however, according to a recent statement by FDA Commissioner Scott Gottlieb, the agency plans to revise this policy later this year.

Preparation is Key

All food companies are vulnerable to manufacturing deviations, labeling errors and contaminants that could trigger a food recall. So in order to prepare for a potential recall and minimize damage to their brand, manufacturers must be aware of the latest guidance and regulations.  

The FDA expects food companies to comply with the current regulations for recalls (21 CFR 7), addressing all issues related to recalls of FDA regulated products, including health hazard evaluation, recall classification, recall strategy and public communication.

In support of the food industry, the FDA has previously issued the guidance, ‘Product Recalls, Including Removals and Corrections’ as well as model press releases for announcing recalls due to Allergens (Allergy Alert), Listeria monocytogenes and Salmonella (all serotypes).

Under the Food Safety Modernization Act (FSMA), the FDA was authorized to increase food facility inspections and to implement mandatory recalls when needed. Moreover, the FSMA rule for preventive controls requires firms to identify hazards requiring a preventive control, assess hazards that would need to be addressed in a recall plan and establish procedures to ensure the effectiveness of a recall. In the age of FSMA, food manufacturers must be prepared for the intensified FDA inspections and the elevated risk of a product recall.

One key way to prevent product recalls due to microbial hazards and ensure compliance with FDA regulations is to implement a preventive environmental monitoring program at your facilities. EnviroMap®, Mérieux NutriSciences’ cloud-based environmental monitoring solution, allows food companies to easily schedule, map and track their sampling procedures. Additionally, customizable dashboards give manufacturers the ability to view and analyze their data over time to recognize trends. Pure Pacific Organics has used EnviroMap to improve their environmental monitoring system and better align themselves with FDA Listeria requirements. Learn more about it by reading our latest case study.

 

Meet the Author

Patrick Kennedy
Information Services Manager, Mérieux NutriSciences

Patrick Kennedy is the Information Services Manager for Mérieux NutriSciences. He has over 15 years of food industry experience and has written extensively covering a wide range of food safety and regulatory subjects. He holds a MS degree in information science from the University of Illinois, and is a member of several industry organizations including AOAC, IFT and IAFP.

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