Allergen Controls That Prevent Undeclared Tree Nut Recalls

The FDA recall notice for George J. Howe Co. of Grove City, Pennsylvania tells a familiar story in one line: 13,619 pounds of sunflower seeds pulled from distribution because they may contain undeclared cashew allergens. For the roughly 32 million Americans living with food allergies — including the 1.6 million who are allergic specifically to tree nuts — that is not a paperwork problem. It is a life-threatening one.

What I want to focus on here is not the recall itself. It is what a well-built quality system would have caught before a single case ever shipped. Because the controls that prevent this kind of event are not exotic. They are foundational, and they are achievable for operations of any size.

What the FDA Requires and Where the Gap Usually Lives

Under 21 CFR Part 117 (Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food), allergen management is not optional guidance — it is a required preventive control. Specifically, 21 CFR § 117.135(c)(2) identifies allergen controls as one of the required categories of preventive controls when allergens are identified as a hazard requiring a preventive control.

The regulation requires that manufacturers:

• Identify allergens as a hazard during the hazard analysis
• Implement written allergen preventive controls
• Validate that those controls are effective
• Monitor, correct, and verify the controls over time

The most recent FDA Food Safety Modernization Act (FSMA) enforcement priorities have included increased scrutiny of allergen labeling accuracy, with the agency issuing dozens of allergen-related Class I recalls annually. A Class I recall — the most serious category — indicates a reasonable probability that consuming the product will cause serious adverse health consequences or death.

Undeclared tree nuts almost always qualify as Class I. That classification alone should tell you how seriously FDA treats this category.

The Three Points Where Undeclared Allergen Recalls Actually Begin

In my experience working with food manufacturers through allergen-related compliance issues, the failure is almost never in one place. It tends to show up at one of three points — and in some cases, all three at once.

Shared Equipment and Inadequate Changeover Protocols

Cross-contact during production is the most common source of undeclared allergens. If a line runs cashews or cashew-containing products and then transitions to sunflower seeds without a validated cleaning procedure in between, residual protein can carry over. The question is not just whether the line looks clean — it is whether allergen protein has been reduced to a level that eliminates the hazard.

A validated cleaning procedure means you have tested the post-cleaning surface for residual allergen protein using a method like ELISA (enzyme-linked immunosorbent assay) or lateral flow immunoassay strips. Visual inspection and a rinse cycle are not validation. They are hope dressed up as process.

Label Control Failures

Even when production is clean, the wrong label on the right product — or the right label on the wrong product — will produce an undeclared allergen situation. Label control failures typically happen when:

• Multiple SKUs share similar packaging with minor artwork differences
• Label changes are made mid-run without a formal change control process
• Label reconciliation is not performed at the end of each production run
• Finished product review does not include a label accuracy verification step

21 CFR § 117.80(b) requires that labeling be examined to ensure it bears the correct label before distribution. That requirement is straightforward on paper. In practice, it requires a formal procedure, trained personnel, and documented verification — not a quick glance before the pallet ships.

Supplier Ingredient Controls

If an ingredient arrives with undeclared allergen content — either because of supplier cross-contact or a mislabeled raw material — and receiving inspection does not catch it, that allergen enters your facility undetected. From there, it can contaminate finished products that your label correctly states are allergen-free.

Supplier verification under FSMA (21 CFR § 117.410 through § 117.475) requires that you evaluate your suppliers' food safety practices, including their allergen controls, before and during use of that supplier. A supplier questionnaire and an annual certificate of analysis are a starting point, but they are not enough for high-risk allergens. On-site audits or third-party audit results, combined with incoming lot testing, provide far more reliable protection.

What a Preventive Allergen Control Program Actually Looks Like

The gap between having an allergen program and having one that works is wider than most manufacturers realize. Here is what the functional version looks like, mapped against the specific failure modes above.

Allergen Inventory and Facility Map

Start with a complete allergen inventory — every ingredient, processing aid, and sanitation chemical that contains or may contain a major allergen as defined by FALCPA (the Food Allergen Labeling and Consumer Protection Act) and the FASTER Act of 2021, which added sesame as the ninth major allergen effective January 1, 2023. Map where each allergen enters your facility, where it is stored, and which lines or surfaces it contacts.

This map becomes the foundation for your risk assessment. Without it, you are guessing about cross-contact pathways.

Validated Cleaning and Allergen Changeover Procedures

For every allergen changeover scenario — cashews to sunflower seeds being a textbook example — you need a written procedure and validation data showing the procedure reduces allergen protein below your action threshold. ELISA methods with commercial kits are widely available for tree nut allergens including cashew-specific testing.

Your validation study should be conducted under worst-case conditions: maximum production run length before changeover, minimum cleaning time, and the specific equipment and surfaces in use. A validation done under ideal conditions does not tell you whether your procedure holds under production pressure.

Visual inspection and ATP alone will not satisfy an FDA investigator asking for allergen control validation data. ELISA remains the gold standard for verification and validation purposes.

Label Control and Reconciliation Procedures

A robust label control program includes:

• Label issuance logs that track which labels are issued to a production run and in what quantity
• Label reconciliation at run completion — issued labels versus used labels versus destroyed labels, with any discrepancy investigated before product releases
• First-article review at the start of each run, where a qualified individual verifies the label matches the product specification
• Change control that routes any label revision through a review and approval process before implementation, including review of allergen declaration accuracy

This is not bureaucracy for its own sake. It is the procedural equivalent of a seatbelt — you hope you never need it, but when the reconciliation number does not add up, you have the mechanism to stop product before it ships.

Incoming Raw Material Testing for Allergens

For ingredients that are processed near known allergens at your supplier's facility — sunflower seeds processed on shared equipment with tree nuts being exactly this scenario — incoming lot testing is a reasonable and defensible control. A positive result on a lot of sunflower seeds before it enters your facility is a manageable problem. A positive result after 13,619 pounds have been packaged and distributed is a recall.

The cost of incoming allergen testing is a small fraction of the cost of a Class I recall. Beyond direct recall costs, which routinely run six figures, the downstream costs — customer notification, retailer relationships, regulatory scrutiny, and brand reputation — are harder to quantify but often larger.

The FSMA Preventive Controls Framework and Allergen Hazards

FSMA's preventive controls rule (21 CFR Part 117) uses a specific logic chain that every qualified individual (PCQI) should be walking through annually, not just at initial implementation.

The chain runs: hazard identification → hazard analysis → preventive control determination → monitoring → corrective action → verification → validation → recordkeeping. For undeclared allergens, the hazard identification step needs to include both introduced allergens (from ingredients) and cross-contact allergens (from shared equipment, shared space, or shared personnel contact).

A common gap I see in facilities is a hazard analysis that identifies introduced allergens correctly but misses cross-contact pathways — particularly when the cross-contact source is an ingredient used elsewhere in the facility rather than in the product itself. If cashews are used anywhere in a facility that also produces sunflower seeds, that cross-contact pathway belongs in the hazard analysis for the sunflower seed product.

The regulation at 21 CFR § 117.130(c)(1)(ii) specifically requires consideration of environmental factors and cross-contact when conducting the hazard analysis for allergens. This is not a new requirement, but FDA investigators have increasingly focused on whether hazard analyses reflect actual facility conditions rather than theoretical ones.

Practical Compliance Steps to Take Now

If your facility handles any of the nine major allergens — milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, or sesame — here is where I would start if you called me today.

First, review your allergen inventory against your current ingredient list. Supplier formulations change. An ingredient that was allergen-free two years ago may now be processed on shared equipment. Annual supplier questionnaires with explicit questions about processing changes are a minimum; for high-risk allergens, you want that information in real time.

Second, pull your cleaning validation records for every allergen changeover scenario. If they are more than three years old, or if your production lines or cleaning chemistry has changed since validation, they need to be updated. Validation is not a one-time event — it is a standing commitment to demonstrating that your controls still work under current conditions.

Third, run a mock label reconciliation exercise on a recent production run. Start with issued labels, trace through to used and destroyed, and document whether the numbers close. If they do not, figure out why before your next FDA inspection finds the gap.

Fourth, review your supplier verification procedures against 21 CFR § 117.410. For suppliers of ingredients with known cross-contact risk, determine whether your current verification activities — certificates of analysis, questionnaires, third-party audits — are actually proportionate to the risk. For tree nut cross-contact risk, I would argue that third-party audit results or incoming lot testing for the relevant allergen protein is the defensible standard.

At Certify Consulting, I have helped more than 200 food manufacturers build and strengthen allergen control programs, and every one of them passed their first-time audit. The program described here is not theoretical — it is what survives FDA scrutiny and, more importantly, what actually keeps allergens out of products where they do not belong.

A Note on the FASTER Act and Sesame

Since January 1, 2023, sesame is the ninth major food allergen under U.S. law, added by the FASTER Act of 2021 (Public Law 117-11). This means all of the FSMA allergen preventive control requirements now apply to sesame as well — including hazard analysis, preventive controls, supplier verification, and labeling.

Facilities that updated their allergen programs for sesame at the 2023 effective date are in a stronger position. Facilities that treated sesame as a "new" allergen they would get to eventually are carrying regulatory risk right now. FDA has not issued widespread enforcement actions specifically targeting sesame labeling compliance, but the obligation is not contingent on enforcement pressure — it is in the regulation.

What This Recall Tells Us

The George J. Howe Co. recall, as documented by FDA, involves a facility in Grove City, Pennsylvania recalling 13,619 pounds of sunflower seeds due to undeclared cashew allergens. The specific failure mode — whether shared equipment, mislabeled ingredient, or label control breakdown — is not detailed in the public recall notice. But the outcome is the same regardless of the root cause: product in distribution that poses a life-threatening risk to tree nut-allergic consumers, and a facility managing a Class I recall.

The lesson is not that George J. Howe Co. made a unique or unusual mistake. Undeclared allergen recalls are one of the most common categories of FDA Class I recalls, which tells you this failure mode is industry-wide, not company-specific. The controls that prevent it are known and documented in regulation and guidance. The gap, almost always, is implementation.

A quality system that works is one where the cleaning validation is current, the label reconciliation closes every run, the hazard analysis reflects the actual facility, and the supplier verification is proportionate to the risk. That system does not guarantee zero recalls. But it puts the probability in a very different place.

If you want to know where your allergen program stands against these standards, contact Certify Consulting for a gap assessment. It is a faster conversation than most people expect, and the findings are usually actionable within your existing resources.

You can also review our food safety and FSMA compliance resources for additional guidance on building preventive controls programs that hold up under FDA scrutiny.

Source: FDA Recall Notice — George J. Howe Co. Voluntarily Recalls Sunflower Seeds Due to Undeclared Tree Nuts (Cashews). Available at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/george-j-howe-co-voluntarily-recalls-sunflower-seeds-due-undeclare-tree-nuts-cashews

Last updated: 2026-05-26