Thiamine Controls That Prevent Freeze-Dried Pet Food Recalls

When GO Raw LLC expanded its voluntary recall on June 8, 2026, to include an additional lot of Steve's Real Food Freeze-Dried Chicken Recipe — citing potentially low thiamine (Vitamin B1) levels — it wasn't just a product problem. It was evidence of a gap in nutrient verification protocols that shows up in raw and freeze-dried pet food manufacturing more often than most people realize. And because this expansion follows an original recall from February 17, 2026, for the same root cause, the pattern itself is worth examining.

Thiamine is fragile. It degrades under heat, moisture, and certain processing conditions, and freeze-drying does not preserve nutrients automatically just because temperatures are lower than conventional cooking. If your quality system isn't specifically designed to verify thiamine retention at the finished product stage, you may be shipping a product that doesn't match its label claim. That's a recall waiting to happen.

The lesson the GO Raw situation hands us is this: nutrient label claims require nutrient verification, and verification requires a testing protocol that goes beyond the batch sheet.

Why Thiamine Is a Recurring Problem in Raw and Freeze-Dried Pet Food

Thiamine (Vitamin B1) is an essential water-soluble vitamin required for carbohydrate metabolism and neurological function in animals. Thiamine deficiency in cats can cause severe neurological symptoms — loss of muscle coordination, seizures, and in serious cases, death. The FDA has issued multiple alerts over the years specifically about thiamine deficiency in commercial cat foods, which tells you this isn't a new problem in the category.

Three things make thiamine uniquely difficult to manage in raw and minimally processed pet food:

Raw ingredients carry variable levels. Chicken muscle tissue contains thiamine, but actual levels depend on the bird's diet, the cut used, the freshness of the raw material, and storage conditions prior to processing. If you're sourcing chicken from multiple suppliers or buying on the spot market, raw material thiamine content isn't consistent from lot to lot.

Processing depletes it. Studies on freeze-drying's effect on thiamine retention show losses ranging from 5% to 30% depending on moisture content, pre-treatment, and cycle parameters. If you haven't validated your specific freeze-dry process for thiamine retention, you don't know your actual loss rate — and you can't demonstrate you're hitting the label claim.

Shelf life depletes it further. Thiamine degrades over time in stored products, especially in the presence of oxygen and moisture. A product that passes a nutrient check at production may fall below minimum levels before its stated best-by date if packaging and water activity controls are inadequate.

The Regulatory Framework That Applies

The rules for this situation sit primarily in 21 CFR Part 507 — Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals. This regulation took effect for most manufacturers on September 17, 2017, and it established a preventive controls framework specifically designed to catch the kinds of issues that cause nutrient deficiency recalls.

Under 21 CFR § 507.34, manufacturers are required to implement supply chain programs when the hazard analysis identifies a hazard requiring supply chain-applied controls. Low nutrient levels in incoming raw materials is exactly this kind of hazard. The GO Raw situation raises a real question about whether thiamine was analyzed as a known hazard in raw animal protein ingredients — and whether appropriate supplier verification activities were in place.

Under 21 CFR § 507.36 and § 507.38, a facility must verify that preventive controls are consistently implemented and effective. For a nutrient like thiamine that can be depleted by processing, this means process validation — demonstrating that your freeze-dry cycle actually retains the nutrients you're claiming on the label.

AAFCO (Association of American Feed Control Officials) sets the minimum nutritional requirements that most commercial pet foods use as their formulation standard. For adult maintenance cat food, the AAFCO 2026 minimum for thiamine is 5.0 mg/kg on a dry matter basis. If your finished product doesn't meet this threshold, your AAFCO nutritional adequacy claim is false — and the FDA treats that as an adulterated product under 21 U.S.C. § 342 of the Federal Food, Drug, and Cosmetic Act.

Control Points That Were Likely Missing

In my experience working with raw and minimally processed pet food manufacturers, the control point failures in a thiamine-related recall almost always trace back to one or more of the following:

Incoming raw material testing was absent or insufficient. Many small and mid-size raw pet food manufacturers rely exclusively on supplier certificates of analysis rather than independent verification. The problem is that a COA tells you what the supplier measured — not what arrived at your facility, and not what the thiamine level will be after your process. If your receiving procedure doesn't include periodic in-house or third-party testing for key nutrients, you're operating on trust rather than verification.

Process validation for the freeze-dry cycle was never completed. Freeze-drying is not a set-it-and-forget-it process for nutrient retention. Your specific combination of product thickness, pre-freezing temperature, primary drying time, secondary drying time, and condenser temperature all affect how much thiamine survives the cycle. Without validation studies comparing pre-process and post-process thiamine levels, you don't know your retention factor — and you can't claim you're consistently hitting the label.

Finished product testing was not part of the lot release criteria. In a well-designed quality system, a product does not ship until it meets its specifications. For a nutritionally complete pet food, that means nutrient verification before release. In my view, any manufacturer making an AAFCO nutritional adequacy claim for a minimally processed product should have finished product nutrient testing built into lot release criteria — not just into an annual formulation review.

Shelf-life studies didn't include thiamine stability. If you ran a shelf-life study for texture and appearance but didn't include a nutrient retention component, you may have a label claim that holds at day one but fails at month eighteen. That's a real compliance gap, and the FDA's 21 CFR § 507.40 verification requirements contemplate exactly this kind of ongoing review.

The Quality System Design That Prevents This

A properly designed quality system for a freeze-dried raw pet food manufacturer includes controls at four stages:

The "≥120% of minimum" figure in the incoming control row is not arbitrary. For fragile water-soluble vitamins like thiamine that lose 10–30% during freeze-drying and additional potency over shelf life, formulating to exactly the AAFCO minimum creates no margin for process variation. You need to start higher to finish compliant.

This is a straightforward principle that some manufacturers skip in order to reduce ingredient costs. That's a defensible choice only if your process has been tightly validated. Without that validation, it's a recall waiting to happen.

What Your HARPC Plan Should Say About Thiamine

Under 21 CFR Part 507, your Hazard Analysis and Risk-Based Preventive Controls (HARPC) plan needs to identify thiamine deficiency as a known or reasonably foreseeable hazard for minimally processed animal protein-based pet foods. The FDA's guidance on preventive controls for animal food explicitly places nutrient content under the "chemical hazards" category — naturally occurring chemical hazards include vitamin imbalances caused by processing loss or raw material variability.

Your HARPC plan should address five elements for this hazard:

1. Hazard identification: Thiamine is a water-soluble vitamin susceptible to processing loss in freeze-dried products. Identified as a chemical hazard under 21 CFR § 507.24.
2. Preventive control: Formulation with adequate processing buffer + finished product nutrient verification + supplier qualification program.
3. Monitoring: Nutrient testing protocol, frequency, testing laboratory, and minimum acceptable level — with the action level set above the AAFCO floor to allow for corrective action before a shipment decision.
4. Corrective action: Specific steps when a finished product lot tests below the action level — hold, retest, root cause investigation, and disposition (rework or destroy).
5. Verification: Annual review of finished product nutrient data against label claims, including trending for any drift over time.

If your HARPC plan doesn't specifically address thiamine as a hazard for a thiamine-sensitive formula, the FDA will view that as an incomplete hazard analysis — and they'll be right.

The Supplier Qualification Problem

When a recall expands rather than closes, it usually means one of two things: the original investigation wasn't thorough enough to identify all affected lots, or the root cause fix wasn't implemented quickly enough to prevent the same problem from appearing in subsequent production. Either way, it points to a systemic gap rather than a one-time anomaly.

Effective supplier qualification for raw animal proteins in a thiamine-sensitive formula requires more than an approved vendor list. It requires:

• Baseline nutrient profiling for each supplier's product, established before the supplier is approved
• Periodic requalification testing — not just annual review, but triggered whenever a new lot or new growing region is introduced
• A defined acceptable range for thiamine in incoming lots, with documented acceptance and rejection criteria
• Escalation procedures when a supplier's result falls outside the accepted range

Most small raw pet food manufacturers have a list of approved suppliers, maybe a few COAs on file, and a fair amount of trust. That's not a quality system. It's a gap you discover on the day an FDA inspector walks in or a consumer calls about a sick animal.

What the Recall Tells You About the HARPC Plan

There's a useful diagnostic here. When a nutrient deficiency recall happens, work backward through the quality system to find where the gap was. The failure is almost always traceable to a specific missing element in the HARPC plan.

For the GO Raw situation, the right question is: was thiamine retention identified as a known hazard in the HARPC plan for the Steve's Real Food Freeze-Dried Chicken formula, and if so, what preventive controls were documented and monitored? If the answer is "we relied on the formulation" without finished product verification, that's the gap. If the answer is "we did testing," then the question becomes whether the sampling plan covered all lots or only a representative subset that missed a low-performing lot.

In my experience, most nutrient deficiency recalls in minimally processed pet food come down to the same three-word explanation: insufficient finished product testing. Not no testing — insufficient testing. A quarterly nutrient panel on a running product line will catch a chronic formulation problem. It won't catch a batch-level production failure unless you're testing every lot, or have a statistically validated sampling plan that accounts for expected batch-to-batch variability.

Practical Steps If You Manufacture Freeze-Dried or Raw Pet Food

If you're manufacturing freeze-dried or raw pet food and this recall is prompting a self-assessment, here's where I'd start:

1. Pull your current HARPC plan and check whether thiamine appears as an identified hazard. For any formula that relies on animal protein as a primary thiamine source, the answer should be yes. If it's not there, your hazard analysis is incomplete under 21 CFR § 507.24.

2. Review your finished product specifications. Do they include thiamine levels with both a target and a minimum? Is the minimum set above the AAFCO floor to account for shelf-life depletion?

3. Check your lot release criteria. Does the product ship on batch record review alone, or is nutrient testing part of the release gate?

4. Review your supplier qualification records. When was the last time you ran independent nutrient testing on incoming raw material — not just reviewed a COA from the supplier?

5. Check whether you have a documented process validation study showing thiamine retention through your specific freeze-dry cycle parameters.

If any of those five questions produces an uncomfortable answer, the time to address it is before a recall, not after. The FDA isn't the only audience for your quality system. Your customers are feeding this food to animals they love, and they're entitled to trust that the label is accurate.

For manufacturers who want an independent gap assessment before their next FDA inspection or HARPC review cycle, Certify Consulting has helped more than 200 food and dietary supplement manufacturers build quality systems that pass the first time. Our FDA compliance consulting services are available for a no-obligation initial conversation about where your system stands.

Frequently Asked Questions

Does FDA require nutrient testing for every lot of pet food?

There's no regulation that prescribes a specific testing frequency — 21 CFR Part 507 requires that your monitoring procedures be adequate to ensure your preventive controls are working. What "adequate" means for a fragile nutrient like thiamine in a minimally processed formula is more than annual formulation review. Most FDA compliance professionals recommend lot-level testing or a statistically valid sampling plan with documented justification for any product making an AAFCO nutritional adequacy claim.

Can we rely on formulation software to ensure we hit AAFCO minimums?

Formulation software calculates what you designed. It doesn't measure what you made. Process losses, raw material variability, and shelf-life depletion are all outside the scope of formulation software. Hitting the AAFCO minimum on paper doesn't mean your finished product meets the AAFCO floor — and the FDA bases enforcement on the finished product, not the recipe.

What's the difference between a preventive control and a standard quality check?

Under 21 CFR Part 507, a preventive control is a specific documented element of your HARPC plan — identified hazard, specific control measure, monitoring procedure, corrective action, and verification activity. A standard quality check might catch a problem before shipment, but it doesn't constitute a preventive control unless it's integrated into a HARPC plan with all five elements documented and accessible during an inspection.

How long does thiamine testing take, and does it affect production scheduling?

Standard AOAC Method 986.27 for thiamine in pet food takes approximately 3–5 business days at most commercial laboratories. Many manufacturers address this with a conditional release hold — the product is packaged and held pending test results, then released once results are confirmed. This adds time to your lead cycle but eliminates the risk of shipping a non-conforming lot that triggers a recall.

What should we do if a finished product lot tests below the AAFCO minimum?

Your HARPC plan should have a documented corrective action for exactly this scenario: place the lot on hold, notify your HARPC team, investigate root cause (raw material issue vs. process issue vs. testing error), and make a disposition decision — rework if nutrient supplementation is technically feasible and documented, or destroy. If the product has already been distributed, you are likely looking at a voluntary recall. Notify your FDA district office promptly; early and transparent communication generally produces better outcomes than delayed disclosure.

The GO Raw LLC recall expansion is a reminder that "minimally processed" doesn't mean "minimally regulated." If anything, raw and freeze-dried pet food manufacturers face harder quality demands than conventional pet food makers, because their processing methods offer fewer opportunities to correct a nutrient problem once it's been introduced. The quality system has to do the work the process doesn't.

Last updated: 2026-06-21