Undeclared Allergens: What Food Manufacturers Must Know

Citation Hook: Undeclared allergen violations are the single leading cause of FDA-initiated food recalls in the United States, accounting for more than 40% of all Class I recall events annually — the most serious classification, reserved for products that pose a reasonable probability of serious adverse health consequences or death.

When Schreiber Foods, Inc. of Green Bay, Wisconsin voluntarily recalled 144 cases of Honey Almond Cream Cheese Spread due to undeclared almonds, most observers saw a single product issue. What I see — after 8+ years of food safety and certification consulting across more than 200 clients — is a blueprint of exactly how and why preventable labeling failures reach consumers, and what every food manufacturer can do right now to ensure it never happens to them.

The FDA's official allergy alert, published at fda.gov, confirms that people with an allergy or severe sensitivity to almonds run the risk of serious or life-threatening allergic reaction if they consume this product without adequate warning. No illnesses had been reported at the time of announcement — but the risk was real, the regulatory obligation was clear, and the recall was entirely avoidable.

Let's unpack the compliance lesson.

What Happened: The Schreiber Foods Recall at a Glance

Schreiber Foods voluntarily recalled 144 cases of Honey Almond Cream Cheese Spread because the product labeling failed to declare almonds — a major food allergen under U.S. law. The product is a cream cheese spread containing almonds as an ingredient, yet the label did not disclose this to consumers.

This is a textbook undeclared allergen event. It is not a contamination issue. It is not a foreign object issue. It is a labeling and label verification failure — one of the most controllable quality system breakdowns in food manufacturing.

The Regulation Behind This Recall: FALCPA and FASTER

To understand why this recall is a compliance matter — not just a quality matter — you need to understand the two laws at play.

The Food Allergen Labeling and Consumer Protection Act (FALCPA) — 21 U.S.C. § 343(w)

Enacted in 2004 and effective January 1, 2006, FALCPA established the legal requirement that the eight major food allergens must be declared on food labels in plain language. Those eight allergens are:

1. Milk
2. Eggs
3. Fish
4. Crustacean shellfish
5. Tree nuts (including almonds)
6. Wheat
7. Peanuts
8. Soybeans

Under FALCPA, manufacturers must declare tree nuts by their specific type (e.g., "almonds," not just "tree nuts"). This specificity requirement is critical — and it is precisely what appears to have been absent from the Schreiber Foods product label.

Failure to comply with FALCPA labeling requirements renders a product misbranded under the Federal Food, Drug, and Cosmetic Act (FD&C Act), making it subject to regulatory action, including mandatory or voluntary recall, import alerts, and potential enforcement proceedings.

The FASTER Act of 2021 — Effective January 1, 2023

The Food Allergy Safety, Treatment, Education, and Research (FASTER) Act, signed into law April 23, 2021, added sesame as the ninth major food allergen, with mandatory labeling compliance required by January 1, 2023.

Citation Hook: With the FASTER Act's addition of sesame as the ninth major allergen, food manufacturers who had not already revised their label review procedures by January 1, 2023 were immediately out of compliance — and any existing product formulations referencing sesame as a "spice" or "natural flavoring" became misbranded by operation of law.

The FASTER Act did not change the obligations for tree nuts like almonds — those have been firmly in place since 2006. What it signals, however, is that allergen labeling law continues to evolve, and static label management processes are a recipe for recurring compliance failures.

Why Undeclared Allergen Recalls Keep Happening

If the law has been clear since 2006, why do undeclared allergen recalls remain the #1 driver of food product recalls? After working with food manufacturers ranging from small regional producers to multinational operations, I've identified five recurring root causes:

1. Label Change Management Failures

A product reformulation — even a minor one — triggers a cascade of label update requirements. When Honey Almond Cream Cheese Spread was developed or reformulated to include almonds, a formal label change management process should have flagged the allergen declaration requirement. If that process was absent or bypassed, the label shipped without the required disclosure.

2. Supplier-Driven Ingredient Changes

Ingredient substitutions by suppliers — even "equivalent" substitutions — can introduce new allergens into a product without the manufacturer's immediate awareness. Without a robust Supplier Qualification Program that requires ingredient change notifications, manufacturers may unknowingly produce misbranded product.

3. Inadequate Allergen Control Plans

FDA's Preventive Controls for Human Food rule (21 CFR Part 117), which became fully effective for most manufacturers by September 2016, explicitly requires allergen preventive controls as part of a written Food Safety Plan. Clause 117.135 mandates that allergen controls address cross-contact and labeling. Many operations focus on cross-contact but underinvest in label verification controls.

4. Artwork Approval Process Gaps

Label artwork often travels through marketing, operations, and regulatory affairs before approval — but without a structured, checklist-driven allergen review at each gate, allergen declarations can be inadvertently omitted, especially during label redesigns or brand refreshes.

5. No Pre-Release Label Verification Step

Perhaps the most preventable gap: the absence of a finished product label verification step before commercial release. A simple physical comparison of the final printed label against the product formulation's allergen profile — completed by a trained reviewer before the product ships — would catch the vast majority of undeclared allergen events.

The Regulatory Framework: What FDA Expects Right Now

If your operation produces food products subject to FDA oversight, here is the current compliance landscape you must operate within:

Citation Hook: Under 21 CFR § 117.135(c)(2), allergen preventive controls must specifically address the presence of an undeclared major food allergen caused by — among other things — the failure to declare a major food allergen on a label, making label verification a legally required preventive control step, not an optional quality practice.

Practical Compliance Guidance: A Six-Step Allergen Labeling Control Framework

Whether you are proactively building your allergen management program or responding to a near-miss in your own operation, the following six-step framework addresses the documented root causes of undeclared allergen events.

Step 1 — Build a Complete Allergen Inventory

Map every allergen present in every ingredient across your entire product portfolio. This includes processing aids, rework, and shared equipment. Your allergen inventory is the foundation of every downstream control.

Step 2 — Implement Formulation-to-Label Traceability

Every product formulation must have a documented, version-controlled allergen profile. Every label must have a verified, traceable link back to that formulation. When either the formulation or the label changes, a formal change control record must be opened and closed before commercial release.

Step 3 — Institute a Gated Label Approval Process

Create a multi-stage gate review for all label changes, new labels, and periodic label audits. Each gate must include an explicit allergen declaration check, signed off by a qualified individual (as defined under 21 CFR § 117.3 — someone with the education, training, or experience to manufacture, process, pack, or hold food safely).

Step 4 — Verify Labels Against Finished Product Before Release

Establish a pre-release label verification procedure. Before any new or revised product ships, a trained reviewer must physically confirm that the printed label's allergen declarations match the product's allergen profile. Document this verification with a record that includes the product lot, label version, reviewer identity, and date.

Step 5 — Qualify and Monitor Your Suppliers for Ingredient Changes

Your Supplier Qualification Program must require suppliers to notify you of any ingredient or formulation changes — including processing changes that could introduce allergen cross-contact — before shipment. Make this a contractual obligation in your supplier agreements, and verify compliance through periodic supplier questionnaires or audits.

Step 6 — Train All Relevant Personnel Annually

FDA's Preventive Controls rule requires that individuals responsible for allergen controls be qualified through training. Under 21 CFR § 117.4, training must be documented and reflect the specific hazards and controls relevant to your operation. Annual refresher training for production, quality, and regulatory staff is a best practice and increasingly an auditor expectation.

What a Recall Really Costs: The Business Case for Prevention

The Schreiber Foods recall involved 144 cases — a relatively contained volume. But the cost of any recall extends far beyond the retrieved product. Industry data consistently shows that the average direct cost of a food recall exceeds $10 million, when accounting for:

• Product retrieval, destruction, and replacement
• Customer notifications and retail partner communications
• Regulatory correspondence and audit readiness
• Legal exposure and potential litigation
• Brand damage and lost shelf placement

For smaller and mid-sized manufacturers, a recall of even a few hundred cases can be existential. The investment required to build a robust allergen labeling control program — when viewed against this cost exposure — is not a compliance burden. It is risk management.

At Certify Consulting, I have helped food manufacturers across the United States build allergen control programs that satisfy FDA's Preventive Controls requirements, pass SQF, BRC, and FSSC 22000 third-party audits, and — critically — prevent the kind of undeclared allergen event that triggers an FDA recall notice. Our 100% first-time audit pass rate across 200+ clients is built on exactly this kind of practical, regulation-grounded compliance work.

If You Produce or Distribute a Product That May Be Affected

If you are a retailer, foodservice operator, or distributor who may have received Schreiber Foods Honey Almond Cream Cheese Spread, take the following immediate steps:

1. Remove the product from sale or service immediately. Do not wait for consumer complaints.
2. Check your inventory against lot codes identified in the FDA recall notice at fda.gov.
3. Contact Schreiber Foods directly for return and credit instructions.
4. Notify any customers who may have purchased or consumed the product, particularly those with known tree nut allergies.
5. Document your response actions for your own regulatory and quality records.

If any individual has consumed the product and is experiencing symptoms of an allergic reaction — including hives, swelling, difficulty breathing, or anaphylaxis — they should seek emergency medical attention immediately and contact FDA's MedWatch program at 1-800-FDA-1088.

The Broader Signal: Allergen Compliance Is Not Static

Schreiber Foods' voluntary recall is a responsible action — they identified the issue and acted to protect consumers. But the compliance lesson is this: the best recall is the one that never happens.

The regulatory framework governing allergen labeling has been in place for nearly two decades. The science of allergen management is well understood. The controls required by FDA's Preventive Controls rule are specific and achievable. What separates manufacturers who experience undeclared allergen events from those who don't is, in virtually every case, the rigor and consistency of their internal systems.

If you are not certain that your allergen labeling controls would withstand an FDA inspection or a third-party audit today, that uncertainty is itself a compliance risk signal — and it is one worth addressing before an allergy alert, not after.

How Certify Consulting Can Help

At Certify Consulting, we specialize in building and auditing the food safety and quality management systems that prevent exactly these kinds of events. From full Food Safety Plan development under 21 CFR Part 117 to allergen control program design, supplier qualification frameworks, and label verification procedure writing, we bring practical, regulation-grounded expertise to every engagement.

With 8+ years of experience, credentials spanning JD, MBA, PMP, CMQ-OE, CQA, CPGP, and RAC, and a track record of 100% first-time audit pass rates across more than 200 client engagements, I built Certify Consulting specifically to give food manufacturers the compliance confidence they need to operate — and grow — without regulatory surprises.

Contact us today at certify.consulting to schedule a complimentary consultation on your allergen labeling compliance posture.

Last updated: 2026-04-10

Source: FDA Safety Alerts — Schreiber Foods, Inc. Issues Allergy Alert on Undeclared Tree Nuts (Almonds) in Product