Salmonella Testing Controls That Prevent Powder Recalls

Powder Is Not a Safe Harbor From Salmonella

Lexunder Inc., doing business as Food To Live of Brooklyn, NY, recalled its Food To Live brand green powder products in August 2026 over possible Salmonella contamination (FDA recall announcement). This article isn't about that recall. It's about the testing and monitoring controls that catch contaminated powder before it reaches a scoop, a smoothie, or a capsule — controls that exist in the regulations whether or not a given facility has built them out.

Manufacturers of dried greens blends, botanical powders, and superfood mixes have long treated low-moisture products as inherently low-risk. Bacteria need water to grow, the reasoning goes, and a powder with water activity well below what supports growth shouldn't be dangerous. That reasoning confuses growth with survival. Salmonella doesn't need to grow in a dry powder to make someone sick; it only needs to survive. A food is generally considered stable against bacterial growth below 0.85 water activity — the threshold FDA's Food Code uses to define a Time/Temperature Control for Safety food — and typical green powder blends test well below that, often between 0.2 and 0.4 aw. Drying reduces water activity. It does not reliably kill Salmonella already present on the leaf, root, or grass before it was dried. That single fact is why spices, cocoa, dry pet food, and powdered infant formula have all produced documented Salmonella outbreaks despite low moisture content, and it's why a testing program built on the assumption that dry equals safe has a structural gap before it ever gets to paper.

Why Green Powders Sit in a Regulatory Gray Zone

Green powder blends — wheatgrass, moringa, spirulina, chlorella, barley grass, and the dozens of ingredients that go into a typical blend — are grown in fields, harvested from soil-adjacent environments, and processed through drying and milling steps that concentrate whatever contamination was present before the material is ever standardized or encapsulated. Depending on labeling and intended use, the identical raw material might be regulated as a conventional food ingredient under 21 CFR Part 117 (the FSMA Preventive Controls for Human Food rule) or as a dietary supplement under 21 CFR Part 111 (Current Good Manufacturing Practice for dietary supplements). Some companies sell the same powder through both channels under different labels, and a hazard analysis built for one framework doesn't automatically satisfy the other. Companies that haven't clearly classified a given SKU sometimes end up with neither program fully built out — a compliance gap that has nothing to do with the biology of the hazard and everything to do with which binder the paperwork lives in.

Unlike a cooked or pasteurized food, most green powders have no validated kill step anywhere in the process. That means every meaningful control has to happen either before the material enters the facility, or on the environment the material moves through once it's there.

The Regulatory Framework: What Applies and When

FDA finalized the Preventive Controls for Human Food rule under the Food Safety Modernization Act on September 17, 2015. Compliance dates were staggered by business size: larger businesses had to comply by September 2016, small businesses (fewer than 500 full-time-equivalent employees) by September 2017, and very small businesses by September 2018. Any facility manufacturing, processing, packing, or holding green powder as a conventional food is well past those deadlines today and should have a written food safety plan that reflects current suppliers and formulations, not one drafted years ago and never revisited.

Three sections of Part 117 carry most of the weight for a powder facility:

• 21 CFR 117.130 — Hazard analysis. The plan must identify known or reasonably foreseeable biological hazards. Salmonella in a raw agricultural powder is about as reasonably foreseeable as a hazard gets.
• 21 CFR 117.135 — Preventive controls. This requires controls, including sanitation controls, at points where a hazard needs to be significantly minimized or prevented. For a dry-processing facility, that usually means a documented dry-cleaning versus wet-cleaning protocol, since introducing water to sanitize equipment can create the moisture pocket a dormant Salmonella cell needs to persist.
• 21 CFR 117.165 — Verification. This section contemplates environmental monitoring and product testing as verification tools when appropriate to the hazard.

If the same product is sold as a dietary supplement, 21 CFR Part 111 governs instead. 21 CFR 111.75(a) requires component testing or a documented basis for relying on a supplier's data, and 21 CFR 111.75(c) requires verification that a finished batch meets its specifications before release. A company that tests finished capsules or tablets only for label-claim potency, without a microbiological specification for a raw powder ingredient known to carry environmental risk, has a gap that a potency audit alone will never surface.

Where Powder Programs Actually Fail

The pattern across every row is the same: a program can look complete in an SOP binder and still fail in practice, because the gap is between what's written and what's actually sampled on the specific lot moving through the facility that week. The next four sections go deeper on each row — what to test for, how, and at what threshold.

Incoming Material Testing: Setting a Verifiable Specification

A Certificate of Analysis tells you what the supplier's lab found in a sample the supplier selected. It does not tell you what's in the specific lot sitting on your dock, and under a documented supply-chain program built to 21 CFR 117.405 — or component testing obligations under 21 CFR 111.75(a) — the receiving facility needs either a documented basis for relying on that COA or independent verification testing of its own.

The specification needs a number, not a general reference. USP General Chapter <2023>, "Microbiological Attributes of Nonsterile Nutritional and Dietary Supplements," is the reference many contract labs use to set that number for botanical ingredients, commonly expressed as absence of Salmonella in a defined test portion (frequently a 10-gram or 25-gram sample, depending on the chapter's category assignment for the ingredient). "Meets USP microbial limits" with no chapter or test-portion size attached is not a specification a lab can act on. The reference test method matters too: ISO 6579-1:2017, "Microbiology of the food chain — Horizontal method for the detection, enumeration and serotyping of Salmonella — Part 1: Detection of Salmonella spp.," and FDA's Bacteriological Analytical Manual (BAM) Chapter 5 for Salmonella are the two methods most contract labs run, and both are presence/absence assays, not colony counts. There is no numeric CFU threshold below which Salmonella is acceptable — a detectable organism in the test portion is a fail, full stop, because any detectable amount can render a food adulterated under the standard discussed below.

Environmental Monitoring: Where to Swab and What Triggers a Hold

Facilities that process wet or high-moisture food have generally internalized environmental monitoring as standard practice. Dry-powder facilities sometimes haven't, because the intuition that dry equals safe is strong even when it's incomplete. FDA's draft guidance on Listeria environmental monitoring, issued in January 2017, describes a zone framework — zone 1 (direct food contact), zone 2 (near food contact, e.g., equipment housings), zone 3 (further from the line, e.g., walls and floors near the line), zone 4 (general facility, e.g., break rooms and hallways) — that dry-processing facilities increasingly apply to Salmonella monitoring as well, since the logic of harborage points is the same regardless of which pathogen is the concern.

For a powder facility, that means routine swabbing of the food-contact surfaces on mills, sifters, blenders, and packaging equipment — not just the floors and drains around them — along with dust collection systems, which trap fine particulate and create a persistent reservoir if not cleaned on a defined schedule. A practical program swabs zone 1 and zone 2 surfaces at a fixed interval (commonly weekly to monthly depending on production frequency) and increases frequency after any positive result, equipment modification, or new supplier onboarding. There is no CFU action level for a pathogen swab; the action level is presence itself. A positive result on a food-contact surface requires a documented corrective action under 21 CFR 117.150(a)(2), which includes evaluating whether any affected product needs to be held, retested, or kept from distribution while the root cause is identified. A positive environmental swab is not a program failure. It's the program working as designed, catching a harborage point before it reaches a production lot — the failure is not testing the surface at all.

Finished Batch Release Testing: Testing the Lot, Not the History

Whether governed by 21 CFR 111.75(c) or 21 CFR 117.165(a), release testing has to answer one question: does this batch, the one about to ship, meet the pathogen specification? A strong track record on prior lots doesn't answer that question for the lot in front of you, and a hold-and-release SOP should require the passing result to exist in the batch record before shipping paperwork is generated, not after.

A workable release program pulls a composite sample from multiple points across the batch — not a single grab sample from the top of a drum — and sends it to a lab running BAM Chapter 5 or ISO 6579-1:2017 against the specification set in the material's spec sheet. Turnaround time matters operationally: most contract labs report a presumptive Salmonella result within 24 to 48 hours and a confirmed result within 3 to 5 days, and a facility that ships before the confirmed result is in hand has effectively made the test optional. If a batch has already shipped by the time a positive result comes back, the recall decision is no longer a testing question — it's a legal one under the standard below.

Hazard Analysis Specificity: Naming the Organism, Not the Category

FDA's expectation under 21 CFR 117.130 is a hazard analysis specific enough to drive a specific preventive control. "Microbiological contamination is a potential hazard, controlled by good manufacturing practices" tells a reviewer nothing about why. "Salmonella is a reasonably foreseeable hazard in [ingredient], based on its documented association with soil-grown leafy and grass-based botanicals, controlled by supplier verification testing per the supply-chain program and environmental monitoring of zone 1/2 surfaces per the sanitation SOP" tells a reviewer — and an auditor, and eventually FDA — exactly what was decided and why. The difference between those two sentences is usually the difference between a hazard analysis written to satisfy a checklist and one written to actually manage risk, and it is the cheapest fix on this list because it costs nothing but a rewrite.

The Legal Standard Behind the Recall

Section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act deems a food adulterated if it bears or contains a poisonous or deleterious substance that may render it injurious to health. That's the statutory basis FDA cites in Salmonella-related recall announcements, and it's a strict standard: the presence of the organism, not an illness report, is what triggers it. A company whose internal testing data already reflects that standard — meaning a passing result exists for the lot before it ships — isn't surprised when a recall becomes necessary somewhere in its supply chain. The company with no internal data is the one that finds out from a regulator or a customer complaint instead of its own lab.

Auditing Your Own Program This Week

If this recall has prompted a look at your own powder or botanical ingredient program, these are five concrete tasks, not a restatement of the sections above:

1. Pull twelve months of environmental monitoring records and calculate the positive rate by zone. A cluster of zone 1 positives on the same mill or sifter over time is a trend that needs a root-cause investigation, not a series of isolated incidents each closed out independently.
2. Ask your contract lab, in writing, which method they run and what their limit of detection and turnaround time commitments are. If the answer is vague, or if the invoice just says "microbial panel" with no method named, you don't actually know what you're paying for.
3. Check whether your raw material and finished product specifications state a number. "Absence in 10 g" or "absence in 25 g" is a specification a lab can test against. "Meets USP standards" with no chapter cited is not.
4. Trace one random lot from last quarter through the hold-and-release SOP. Confirm the passing lab result was in the batch record before the shipping paperwork was generated — not filed afterward to complete the file.
5. Check the revision date on your hazard analysis against your supplier list and formulation history. If you've changed a supplier or added an ingredient since the last revision, the hazard analysis is out of date regardless of what it says on paper.

Frequently Asked Questions

Does a positive environmental swab automatically trigger a recall? No. A positive swab on a food-contact surface requires a documented corrective action under 21 CFR 117.150(a)(2), which includes evaluating whether product made on that line needs to be held or retested. A recall is a separate legal event tied to product that has already been distributed and found, or reasonably believed, to be adulterated under Section 402(a)(1) of the FD&C Act.

Is there a numeric CFU limit for Salmonella in a finished powder? No. Salmonella testing under BAM Chapter 5 or ISO 6579-1:2017 is a presence/absence assay, not a colony count. Any detectable Salmonella in the tested portion is a fail against the specification, because the organism's presence, not a quantity threshold, is what can render the food adulterated.

How quickly does FDA require a corrective action after a positive result? 21 CFR 117.150(a)(2) requires a facility to take action to identify and correct, or to prevent, the problem, but the regulation does not specify a fixed number of hours or days. A defensible program documents corrective action promptly and ties the timeline to the batch records of any product that could have been affected while the surface or lot was contaminated.

Why would the same ingredient be tested differently depending on how it's sold? A raw powder sold as a conventional food ingredient falls under 21 CFR Part 117, while the identical material sold as a dietary supplement falls under 21 CFR Part 111. The specification-setting and testing obligations differ in structure between the two parts, which is why a company selling the same botanical powder through both a food-labeled SKU and a supplement-labeled SKU needs two hazard analyses or specification files, not one applied loosely to both.

What's the fastest way to tell if a hazard analysis is inadequate? Read the sentence describing the biological hazard for a given ingredient. If it names a category ("microbiological contamination") rather than a specific organism tied to that ingredient's documented risk and a specific control measure, the hazard analysis was likely written to close an audit checklist rather than to manage the actual risk.

Companies working through a broader dietary supplement quality system build-out can go deeper with our Salmonella prevention guidance for dietary supplement manufacturing and our supplier and vendor qualification procedures, which detail the documented verification basis these regulations require.

Last updated: 2026-08-14