Comments to FDA: “Modernizing the Recall Process”

October 26, 2023

Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993-0002

Submitted electronically via https://www.regulations.gov

RE: “Modernizing the Recall Process” Docket (FDA-2023-N-2393) 

We at U.S. Public Interest Research Group Education Fund are writing regarding the Food and Drug Administration’s recent discussions on modernizing the recall process and request for comments. As PIRG Education Fund’s Consumer Watchdog who has worked for years on issues including food safety, I am hopeful that the FDA will launch new efforts among stakeholders to dramatically improve the food recall process.

Just this week, on Oct. 23, 2023, the FDA announced a recall of Gills Onions because of possible Salmonella contamination. So far, 73 illnesses and 15 hospitalizations have been reported in 22 states. Unfortunately, it is almost guaranteed that more illnesses will occur (even though the use-by dates were in August) because many consumers will have those recalled onions in their freezers and will not have heard about the recall.

This is awful. Our food recall system in this country is broken.

As we highlighted in our 2022 report “Food for Thought: Are Your Groceries Safe,” we had a different, huge Salmonella outbreak announced in 2021, also, coincidentally traced to onions. Ultimately, more than 1,000 people got sick. One-fourth of them were hospitalized. The recalls involving two suppliers were announced in October 2021. 

The CDC said the last illness onset was Jan. 1, 2022 – more than two months after the last recall. The incubation period for salmonellosis is generally 12 to 72 hours. Clearly, some victims ate contaminated onions because they didn’t know about the recalls.

How many of those illnesses and hospitalizations could have been prevented through a more efficient food recall system that notifies consumers more quickly? As Dr. Ben Chapman, a professor and food safety specialist in the Department of Agricultural and Human Sciences at North Carolina State University, said in an interview with U.S. PIRG Education Fund: “We have an inconsistent, fragmented system. No one really owns recalls.”

When we have hundreds and sometimes thousands of people getting sick every year from a particular contaminated food item, we should consider what else can be done to prevent it. Clearly, a goal of our food production and distribution system must be reducing the need for recalls in the first place. That’s the difficult part. 

But when problems with food occur, we need to stop contaminated food from being sold, identify it more quickly when something does slip through and warn consumers when contaminated food makes it to market. 

The easiest part of this should be warning consumers of what we know. 

The CDC acknowledges that many illnesses occur long after recalls have been announced – sometimes weeks or months later – because people eat previously recalled food. There’s no single method of reaching everyone who may have purchased a particular product. Multiple methods of outreach would be better.

It often takes too long for companies and regulators to notify grocers, consumers, restaurants and food packagers, particularly regarding Class I recalls with a “reasonable probability” that exposure or use of the product could cause “serious adverse health consequences or death.”

And once grocers find out, they aren’t required to contact customers who may have already purchased contaminated products. While many stores do quickly notify customers one way or another, the practices aren’t uniform and aren’t always timely. Meanwhile, people continue to get sick.

The ​​CDC estimates that one in six Americans become ill every year from foodborne diseases. Among those, 128,000 wind up in the hospital and 3,000 die.

We see about 300 food and beverage recalls every year from the Food and Drug Administration and U.S. Department of Agriculture Food Safety and Inspection Service.

Under the FDA, only two notifications of a recall are currently required: One, a posting on the FDA’s recall website. Two, a news release from the company that’s actually initiating the recall. No one has to contact grocery stores. No one has to notify consumers.

Here are some steps that would help:

• The FDA and USDA should develop or support a way for consumers and businesses to receive direct email, text or phone alerts of all Class I recalls and any allergens of concern.
  
  The FDA and USDA combined post an average of a half-dozen recalls a week. Many aren’t a huge risk to most people. Products with undeclared allergens such as peanuts or milk make up more than 40% of recalls, but only an estimated 6% of the population has some kind of food allergy and would care significantly about those recalls.
  
  Yes, you can sign up for email alerts – for every food recall. If someone were to get email or text alerts about every single recall – one almost every day on average – they’d suffer from what experts call “recall fatigue.” Many consumers would become numb and stop noticing or would get annoyed by all of the alerts and stop reading them.Push notifications from an app such as Food Recalls & Alerts by SmartAddress, Inc. are a great starting point.Whether through phone notifications or email or text alerts, consumers should still be able to customize notifications a bit so consumers aren’t getting every alert if they don’t want them all. Food Recalls & Alerts offers two ways to limit alerts to only those stemming from microbes such as Salmonella, Listeria or E-Coli, or alerts just for pet food. That’s a start. Since only 6% of Americans suffer from any type of allergy, it would be helpful if a consumer could choose not to get alerts for the 40% of recalls that are for undeclared allergens.Another app, The Foodkeeper, provides a lot of good information but its recall notification alert system isn’t consumer-friendly. Food Recalls & Alerts is the best option we’ve seen and it should be supported by public dollars.
• Industry leaders in the past have recommended that the FDA and USDA revamp their email alert processes so people could opt to be notified about specific categories of recalls and alerts, instead of all of them. Maybe someone wants to be alerted only to foods recalled because of undisclosed nuts or wheat. Maybe someone wants to be notified only about issues with pet food. If companies such as eBay can notify us only about products from saved searches, surely the government can too.
• A separate idea that we probably will see at some point in the future: Food producers could leverage technology so consumers can easily learn whether an item in their home has been recalled.
  
  Currently, consumers can use an app to scan the barcodes for many food items and find out their nutritional value. What if every food product contained a QR code, for example, so you could scan it with your phone and find out about any recalls in real time.
  
  This would also help address the issue of recalled foods at food pantries and soup kitchens. They don’t have the computer systems a grocery store has, so volunteers have to go through products by hand to find recalled items.
• Companies need to do more. Currently, government regulators require only two notifications when there’s a food recall: a posting on the FDA’s recall website, and a news release issued by the company that’s conducting the recall. This is woefully inadequate.
  
  Companies conducting a recall should be required to try to reach out to consumers directly. Many food manufacturers sure spend a lot of money to market their products to us. How about if they spend the same amount that was spent to sell us the product to inform us that it’s been recalled?
• In addition, retailers should offer shoppers a way to be contacted by phone, text or email in case of recalls involving items they bought, whether that’s through a loyalty card or some other system. Retailers are inconsistent here.
  
  In a survey we conducted last year, we found that only half of the 50 largest U.S. grocery and convenience chains we talked with offered a way for customers to be contacted directly about recalls. Some retailers post recall notices in their stores. Perhaps in the section where the item was sold. Maybe at the customer service counter. For big recalls, some post a notice at the front entrance.But those don’t help people who aren’t regular shoppers, or don’t visit that section of the store the next time they shop, or order their groceries online and pick them up curbside or get them delivered. Grocers should ask themselves whether posting notices of Class I recalls would reach some people who otherwise wouldn’t find out.A multi-layered approach to communication can help: traditional media, social media, websites, loyalty cards, automated phone calls, emails and/or in-store notifications.
• The FDA needs to implement the part of the Food Safety Modernization Act that requires retailers to post recall notices in a consistent manner.
• Consumers should do more to be informed, particularly if their home includes people with severe food allergies, or young children, senior citizens, pregnant women or others who are medically more vulnerable to foodborne illness. Consumers should be proactive to make sure they have multiple ways to find out about recalls through their grocers, free apps, government alerts and news alerts.