As many will remember 2009 and 2010 showed a fairly dramatic increase in recalls compared with the two years prior to that. Of note 2009/10 was marked by a few very large recalls due to Salmonella contaminated peanut products and Salmonella in hydrolysed vegetable protein.
Now that the data are in for 2011 we have compared the trends in 2011 with that of the previous year (Figure 1). This is particularly relevant given that FDA has recently released their current thinking on how to categorize a domestic facility as “high risk.” Class I recalls are a prime data source that informs the “known safety risks of the food”, which is a key factor in determing whether a facility is considered “high risk” or not which drives the frequency of inspection.
The first thing to note with regard to 2011 recalls is that the total number were about the same as in 2010 (Figure 1) so the trend of increased recalls since 2009 has been maintained into 2011. What is different however between 2010 and 2011 are the agents that triggered recalls.
The single biggest factor leading to a recall in 2010 was Salmonella, accounting for 43 percent of the recalls, with allergens coming in second with 31 percent and Listeria third with 12 percent. In contrast, in 2011 there were about half as many recalls due to Salmonella (21 percent) but more recalls due to allergens (43 percent) and a slight increase in recalls due to Listeria (18 percent). Yet overall these three groups still accounted for the vast majority of recalls, accounting for 86 percent of the recalls in 2010 and 82 percent of the recalls in 2011.
Some would look at the high level of recalls and question if it means that food safety systems are failing? My view is that recalls actually indicate that important parts of the system are working. Recalls are never good but on the other hand illness linked to product that is not recalled is even worse. As programs like the Reportable Food Registry continue to gain traction we are likely to continue to see high numbers of recalls. Similarily as epidemiologists continue to get better at linking food with illness that too will drive recalls. Finally, as the data above indicate, controlling Salmonella, Listeria and allergens are critical parts of avoiding recalls. While some situations leading to recalls are clearly processing failures we are seeing more and more instances where the problem has not be a processing failure but a failure to control the environment, once again emphasizing the importance of environmental sanitation and monitoring.
Like recalls the trend in recent years has been for FDA to issue more warning letters and as can be seen from Figure 2 this trend has continued to rise into 2011. The FDA uses a Warning Letter when it “finds that a manufacturer has significantly violated FDA regulations” as a way to inform the recipient. There is a request from the FDA for the company to plan corrective actions that the FDA will monitor to ensure the problem is resolved. Many times Warning Letters are the result of findings from an FDA inspection.
Compared to 2010, there was a 52 percent increase in food related warning letters in 2011. There was a 155 percent increase in Warning Letters overall (including food and all other FDA regulated products) from the FDA in 2011 from the prior year. As FDA increases their inspections of high-risk facilities, and as the expectations with respect to food safety increase, we can expect that FDA will continue to use warning letters to send “strong messages” to regulated firms.
If one looks at which types of industry are getting the most warning letters it clearly falls on the seafood industry who get the most, with that sector receiving about one third of the warning letters in 2011. Seafood HACCP Warning Letters were the most frequently issued by FDA, with almost twice as many issued in 2011 compared with 2010. Concerns around Current Good Manufacturing Process (CGMP) for manufacturing, packing, or holding human food resulted in the second most commonly used warning letter by the FDA, making up about a quarter of the total food related warnings. Illegal drug residues was another major focus for warning letters.
Warning letters are activley publicized by FDA and will continue to be used as an enforcement tool. As FDA starts to focus on risk based inspection strategies, and the collecting of reinspection fees, food companies are going to want to do all in their power to avoid warning letters as well as 483s, which will likely herald closer FDA scrutiny as well as potential financial consequences. Paying close attention to preventive control systems is the best way to meet this goal.
This information and more can be found at the links below:
David Acheson, MD, is a former U.S. Food and Drug Administration Associate Commissioner for Foods and is now Managing Director for Foods and Import Safety at the Leavitt Partners consulting firm. “Recalls and Warning Letters Still High in 2011” was originally posted March 23, 2012 on the Leavitt Partners bog. Reposted with permission.