FDA "Screams": The Real Reason Your Snack Is At Risk

Undeclared allergens remain the #1 cause of food recalls in the U.S., yet many brands still treat labeling as a "marketing" task rather than a "legal" one. In this episode of KLF Deep Dive, Darshan Kulkarni breaks down the regulatory horror stories of major brands—from Nugo to Frito-Lay—and explains why the FDA doesn't care if your co-manufacturer messed up. If your name is on the bag, you own the risk.

Learn how to transition from "marketing font arguments" to FSMA-compliant allergen controls that survive federal scrutiny.

Transcript

Darshan 0:00

If you care about what's keeping a food brand out of the recalled news cycle, this is your episode. If you don't care, respect the chaos. This may still save you a few million dollars. So hit subscribe anyways. So today's question What if one missing allergen disclosure turns your healthy snack into an adulterated product? Short answer, it can and it happens all the time. Undeclared allergens are one of the leading causes of food recalls in the United States. This includes milk, eggs, fish, crustacean shellfish, creanuts, peanuts, wheat, soybeans, and sesame. If an allergen is undeclared, it can result in recalls and a big chunk of serious risk allocations that involve undeclared allergens in packaged foods. What happens in those cases and what you can do with your healthy snack so that it doesn't become a regulatory horror story? Let's start from the beginning. How does a quote-unquote healthy snack become adulterated or misbranded? From a regulator's perspective, the logic is simple. If your label leaves off a major allergen like milk, peanuts, eggs, wheat, soy, tree nuts, fish, or shellfish, and consumers could be harmed because they could not see the allergen on the label, they now have a misbranded food. And because the food may cause harm, an adultre won as well. Recent recalls make this very clear. There was Nugo Dark Chocolate Chip, the nutrition bar company, and they made pretzel bars because they contained undeclared milk that recalled. The announcement explicitly warned that people with milk allergy could face serious or life-threatening conditions. Onovegan blueberry muffin protein overnight oats with a certain lock number had to recall the product after discovering that the muffins contained undeclared milk. Again, the risk was severe reactions on people who actually trusted the label. Then you had select bags of lace potato chips. They were recalled and classified the highest risk because of undeclared milk. Again, a third one. This was the class one recall, which means that there was a reasonable probability of serious health consequences or death for allergic consumers. Now, none of these products looked dangerous, they looked normal, they were shelf stable, there was pretty packaging, there was great branding, the only problem was the label. For the FDA, that is enough. Recall's got all the headlines, but your operations team should also be thinking about the warning letters and the FSMA implications that come with undeclared allergens. Take the case of Negarbaka 365 Inc. It's a bakery and snack manufacturer that had a recall for undeclared allergens. They failed to respond adequately. The FDA actually issued a warning letter that specifically called out the undeclared major food allergens and noticed that the firm did not address root cause or corrective actions. Similarly, the MENA Food Group had its hazard analysis reviewed by the FDA. They had considered undeclared allergens as a hazard, but it decided that this was really the customers' and consumers' responsibility and not theirs. The FDA saw it differently. Under the preventative controls rule, you are responsible for evaluating and controlling this hazard in your facility. You don't get to outsource that to the shopper in the grocery aisle. FSM may changed that game. Allergen control is no longer a nice to have, it's a required preventative control. Undeclared allergens have been the number one cause of food recalls for years. There's a guidance in their webinars, and they keep repeating the same message. Number one, undeclared allergens are the leading cause of recalls. Number two, they regularly show up on 483s and warning letters as control failures. Number three, the FDA has issued detailed guidance multiple times on allergen preventative controls under FSMA. That's not vague. That is the FDA screaming polite regulatory language. You are seeing the picture emerging, labeling errors, packaging mix-ups, shared lines with poor changeover, inadequate cleaning, bad assumptions that our co-manufacturer has this handle. Which brings us to that next point. Co-manufacturers. It's their problem, right? If you're using a co-manufacturer or a private label partner, it's very simple to say, it's very tempting to say they handle production, we handle branding. The FDA does not agree with you. If it's your brand name in the package, you own the risk. From the regulator's perspective, from the consumer's perspective, both the firm making the product and the firm whose name appears on the label have responsibilities. We've already seen the FDA call out firms that try to offload allergen responsibility to their customers. Message from the Minan Group warning letter is simple. The hazard analysis needs to treat undeclared allergens as your hazard. This means you qualify co-manufacturers, you confirm their allergen cleaning procedures, you verify their changeover practices on shared lines, you review their labels and packaging controls, you check how they handle rework and relabeling.

SPEAKER_00 5:01

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Darshan 5:09

If your co-manufacturer messes up packaging and a peanut product goes into a peanut-free pouch, your customer is not going after co manufacturers. They might, but they will for sure go after you. FSMA expects to have supply chain controls that are more than we like this vendor's energy. For allergens, this means ingredient specifications that spell out potential allergens, supply approval programs, certificates of analysis when appropriate, verification that the allergen-containing ingredients are what you think they are, controls on how ingredients are received, stored, and handled. Regulators look at you whether you identified undeclared allergens as a reasonably foreseeable hazard, whether you determined that hazard requires a preventative control, you verify that these controls are working, you implemented allergen preventative controls like labeling checks, like packaging controls, like cleaning. If any of these steps is sort of not really being done, you are inviting a recall or worse. Now I've never met a QA or a food safety person who went, you know what I want for this year? An undeclared allergen recall. Just to spice things up. Somehow every year it happens: a bag, a bar, a muffin, a chip, a vegan product that quietly contains milk. Somewhere there's a marketing team that's arguing over font size. Meanwhile, they're allergens that are cross-contaminating over two rooms. Somewhere else, a regulator is downloading your recall announcement for their files. So here's what you want to do. This is what we do at the Coal Carney Law Firm, so stay tuned on this. But essentially you want to treat allergen control as a top-tier risk, not as a side project. You want to map your allergen flow, know where they're coming in when they move out, when they might cross-contaminate. You want to tighten your label and package controls. You want to have double checks, barcode verification, physical separation of packaging, and there's no we'll fix it on third shift. You want to audit your co-manufacturing suppliers. This is a continuing problem. Do not accept that we have a system as proof. Want to see SOPs, you want to see logs, you want to see training, you want to see corrective actions, you want to document the allergian preventive controls. This means you want hazard analysis, preventive controls, you want verification logs, you want corrective actions that can defend unit inspection. You want to rehearse recall guidelines. Something goes wrong. You want to be fast, transparent, and credible. Follow our page on LinkedIn. And this is where KLF comes in. We help food brands and CPG companies. We help you build FSMA compliant allergen control programs. We help you review and strengthen the hazard analysis. We help you design supply chain and co-manufacture qualification systems. We prepare and respond to FDA inspection and warning letters. We draft and refine recall playbooks. We integrate legal regulatory operations and compliance all into one plan. If you're looking at your healthy snack labels and thinking, I'm not sure we'd survive a close read, that's a good reason to bring us in early rather than late. You can learn more, reach out to us at the Kolkani Law Firm. Now, legal advice is one thing, execution is another. SARIS, we help you store and share your hazard analysis. We help you store and share your SOP securely. We track supplier approvals, certificates, audits, we keep version control over labels, specifications, and artworks. Document exactly who approved what and when. Build an audit trail for every key compliance document. When the FDA asks, show me your hazard analysis, show me your provider control verification record. You don't want to be hunting through like a bunch of random folders or old email threads. You want to be able to pull it up calmly and in one place, and that's what CERES is for. Here's the core lesson. You can't control everything, but you can build systems. These systems dramatically reduce the odds. You want tight algin control, you want verified systems, you want qualified control manufacturers, you want clean documentation, and most of all, you want a legal team that understands the rules. And then you want something like Ceres to bow things up. Find this useful, please hit subscribe so you don't miss future KLF Deep Dive episodes. If you want help applying this to your own business, visit Kilakarnelawfirm.com. Call, click, click or email.