Phyllis DeGioia with lamb

Photo by Dr. Linda Sullivan

After 20 years with the Veterinary Information Network, Phyllis DeGioia is retiring from full-time work in early 2022 so she can spend more time doing fun things like cuddling a lamb.

American consumers tend to be woefully ignorant about the true nature of food recalls overseen by the U.S. Food and Drug Administration. We're ignorant not because we don't listen to the news; most of us just haven't looked deeply into the topic. We presume that if a food has not been recalled, it is safe for us or our pets, and that if it has been recalled, we'll hear about it.

That thought process — if we ever have one about recalls — is far from correct.

About a decade ago, the Veterinary Information Network, an online community for the profession, established a Drug and Food Recall Center, which I've maintained from the start. But until recently, I didn't understand how the FDA's recall system works. They send out notices, and I post them. We list recalls on pet food and treats, medicines used in veterinary practice, and pertinent medical devices or support products such as IV fluids. Recently, I became curious about the inner workings of pet food recalls and began asking around. What I understand now is far more than I understood a few months ago, and that embarrasses me.

The biggest misconception I had, and that I suspect others share, is that if anything whatsoever is wrong with a pet food, it will be recalled, and you'll hear about it in the news and thus know not to give it to your pet. In reality, the FDA has three classifications of recalls. When it comes to pet foods and treats, the public usually hears about only the most serious of them.

A recall happens when a product is removed from sale, or something about the item is corrected. Here are the recall classifications used by the FDA, in order of seriousness:

Class I recall is a situation in which there is a strong likelihood that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.

These are the ones that make the news. They tend to involve things like Salmonella, E. Coli, Listeria or aflatoxin contamination, or excessive vitamin D. They are so serious that if the companies responsible do not initiate a recall voluntarily, regulators could consider taking legal action, including seizing the affected products or suspending a facility's registration. I think of these recalls as The Big Guns.

Class II recall is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

You don't hear about these much. They are generally for something that's wrong but not necessarily life-threatening. It might be a touch of mold that can be scraped off, or a foreign object that's relatively benign, like a bit of rubber. I consider these The Young Guns.

Class III recall is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.

You also don't hear about these. They are for issues that aren't a big deal, such as harmless inaccuracies on a label or text that's illegible. Let's call these The BB Guns.

The only way you are likely to hear about The Young Guns or The BB Guns (Class II or Class III recalls) is if you virtually wander the halls of the FDA website on enforcement reports. 

But wait. There's more.

There is one type of action that is even more obscure than a Class III recall: withdrawal. Withdrawal is not an FDA classification but may be a company move to get ahead of or sidestep a recall. A withdrawal is not listed anywhere unless the company engaging in a withdrawal decides to say something about it; they are not obligated to tell the FDA. Call them The Squirt Guns.

Understandably, the FDA focuses most on The Big Guns. Let's say too much vitamin D was found in canned food that's been shipped. The manufacturer involved should notify retailers and consumers so the product can be removed from store shelves or, if already purchased, returned or discarded. It writes a recall notice, which it must distribute through a news wire service and which the FDA lists on its website. Eventually, the consumer hears about it. Unfortunately, this might be after many pets are sickened, possibly fatally.

While the FDA prioritizes Class I recalls because of their higher risk, it does investigate Class II and III recalls to make sure they're in the right category. Sometimes after the FDA learns more, a product's status changes. We'll hear about a product that has been moved into Class I because that's egregious. But a withdrawal becoming a Class III or Class II recall? Or a Class III moving to Class II? Those tend to stay under the radar, even though the problem has been deemed to be worse than originally thought. The FDA has a chat with the manufacturer, and the recall classification changes quietly.

Hang on. If the FDA doesn't handle or get notified about withdrawals, how can a product that's been withdrawn move up the classification ladder?

"If we get adverse event reports," Anne Norris, a health communications specialist for the FDA, explained to me. Consumer complaints to regulators get their attention. Norris noted that pet food complaints made directly to a company, however, are not necessarily shared with the FDA. In contrast, drug companies are required to notify the government when they receive adverse event reports from consumers. There's a difference for you.

Note that while the FDA has the power to order a company to remove a dangerous product from the market, so far it has done so only once. In April 2018, the FDA issued a mandatory recall order for products containing powdered kratom from Triangle Pharmanaturals LLC after samples were found to contain Salmonella. Powdered kratom is an herbal extract marketed as an energy booster, mood enhancer, pain reliever and antidote for opioid withdrawal.

I imagine that the public relations fallout that comes from a mandatory recall is considerable, as the public can interpret it to mean, "We don't care if our product kills you." Triangle Pharmanaturals was dissolved in Nevada on April 11, 2018, five days before the FDA mandated their recall. I suspect a cause and effect scenario because even though the dissolution preceded the recall, Triangle presumably knew it was coming. That mandate makes me cheer for my government.

In two other instances, the FDA almost initiated recalls when the companies involved were reluctant. One of the cases involved pet treats made by Kasel's found to be contaminated with Salmonella. The companies eventually pulled their heads out of the sand and chose to do "voluntary" recalls. Thankfully, the FDA is not above pressuring people into doing the right thing. That totally works for me.

Transparency and obfuscation

Some companies do a wonderful job of getting the word out about a recall. On Oct. 1, Fromm Family Foods recalled some canned dog food for potentially elevated levels of vitamin D. At the time, there were no reports of illness. In their recall notice, Fromm said consumers should stop giving the specific products listed. They provided geographic distribution (nationwide), the size of the cans, the product barcode number, the "best by" date range, potential signs of illness and the direct phone number for a specific contact person. The recall notice was front and center on the company's website.

Fromm stated: "The recall was initiated after we discovered, through our own analysis, that these products may contain elevated levels of vitamin D. We have identified and isolated the error, and in addition to our existing safety process, we have put corrective actions into place to prevent this from happening again."

Fromm did everything voluntarily that they were supposed to do. They took responsibility and indicated they would take actions to avoid a repeat. I have enormous respect for them.

Contrast that with a situation that developed in mid-February, when customers of the pet treat brand Zuke's, owned by Nestlé Purina, complained on Facebook that they found mold in some newly purchased bags of Mini Naturals training treats. Some dogs became sick. Consumers on social media asked for a recall. Zuke's withdrew the treats. I thought it should be recalled and was angry that it was not.

On March 9, the company responded to a consumer's Facebook comment — rather than originating a post that would be seen more widely — "Thanks for reaching out to us. Please know we are not having a recall. We proactively and voluntarily removed our Zuke's Mini Naturals product from shelves due to a quality issue." In April, they tweeted that they had voluntarily removed the affected line from store shelves. In mid-May, they posted on their home page: "As you might have heard, we are voluntarily removing Zuke's Mini Naturals (all recipes) from sale due to a quality issue." The notice goes on to say the reason is "not a food safety issue."

It turns out that my suspicion that the problem justified a recall was right. In June, after the FDA looked into the issue, the situation was categorized as a Class II recall and listed in FDA enforcement reports. The treats were back on the market by September. I don't have much respect for the approach Zuke's took because unlike Fromm, they weren't upfront about the problem.

A similar situation occurred with J.M. Smucker's Pup-Peroni treats: Consumers complained on social media that dogs given Pup-Peroni were having diarrhea or vomiting because the treats were moldy. Pup-Peroni eventually withdrew a couple of flavors and placed a link on the brand's home page with the misleadingly innocuous title "Product Notice." I looked all over the website trying to find the key word "withdrawal" but came up empty. Even if a consumer was aware of the withdrawal, as I was, the information was not easy to find. The notice did not appear on Pup-Peroni's Facebook page.

On June 4, in response to a consumer's complaint on their Facebook page about her dog's vomiting and diarrhea, Pup-Peroni said, "We sincerely appreciate you making us aware of the first experience your dogs have had with our treats. ... Please know that a sudden change in diet can cause a change in stool consistency, gassiness, and even regurgitation/vomiting as not every treat will be right for every pet. So we can learn more about your experience and best help, would you be willing to private message us the bar code, Best When Used By Date and surrounding numbers from the bag?"

Really, Pup-Peroni? Blame a sudden change in diet when you know your product is moldy?

When I asked why there was no information about the withdrawal on parent J.M. Smucker's website or Facebook page, Frank Cirillo, senior manager in corporate communications, responded by email that "We communicate product notices, as appropriate, through the relevant brand web sites to reach consumers most effectively."

Of course they didn't — someone in the family might find out about it!

Eventually, the Pup-Peroni treats problem was elevated to a Class III recall but, remember, Smuckers was not legally required to notify the public. In all fairness, not many companies would but I felt that Pup-Peroni was particularly evasive, more so than Zuke's. A "sudden change in diet" is a ridiculous response to a problem with treats. I now have less than zero respect for Pup-Peroni, and I don't care if that is not mathematically possible.

Everybody makes mistakes. Vendors unknowingly provide less-than-perfect ingredients to manufacturers. Sometimes the production facilities have a problem — something was measured incorrectly, or the recipe was tweaked. I've made mistakes at work, and I dare anyone to say they have not. The difference in how a consumer feels about a problem has much to do with how the manufacturer responds: Do they stand up and own it, or not?

You can let a company know how you feel about their actions by purchasing or not purchasing their products, but first you have to know there was a problem. My opinion is that all classes of recalls should be publicized, but the FDA doesn't have the staffing to enforce that and never will. Hopefully, manufacturers will learn that being upfront about a problem is better for their business in the long run.

About the author: In addition to maintaining the VIN Drug and Food Recall Center, Phyllis DeGioia writes for and edits the VIN client education websites, Veterinary Partner and VetzInsight, and is a proofreader and copyeditor for the VIN News Service. She writes for a living because she passes out at the sight of needles approaching skin, much less bones sticking outside a body where they absolutely are not supposed to be. Since 2002, she has been writing for VIN from her home in Madison, Wisconsin. Phyllis lives with a feisty Pomeranian mix, a sweet collie and her scary smart boyfriend.