Case Study · Sports Nutrition & Proprietary-Blend Adulteration

The label said “banned-substance tested.” Two of them were in the blend.

PROTOCOL™ Sport cleared every gate a careful brand is supposed to run — premarket review, supplier qualification, identity testing, batch release, and a banned-substance program. Every gate checked the paperwork or the declared label. Not one of them looked at what was actually inside the proprietary blend.

A constructed teaching case · built from real regulatory patterns, not a real company

PROTOCOL Sport pre-workout — bottles and single-serve pouches on a gym counter — The product at the center of the file — a pre-workout sold direct to athletes on a “banned-substance tested” claim.

Why we built this one

It is a pattern worth recognizing early. Most brands running it are sure they have already done the work. Not this company — its name, its people, its lot numbers are invented — but the shape it takes: a proprietary blend, a stack of supplier COAs, a “tested” mark on the label, and a brand certain it had done the work.

The two ingredients that made the product unlawful were printed right on the panel, inside the blend — and every check the company ran was built to read the label, never the molecule.

So we built the case, because the lesson is worth more than the recall it usually ends in.

— Regulatory Options

Read this if it sounds like your operation

You sell a proprietary blend and release on a single marker assay (often caffeine).
Your ingredient supplier is a broker or trading company, and you’ve never identified the plant that actually makes the material.
You carry a “banned-substance tested” or sport claim built on an in-house program, not a held third-party certification.
You blend a flagship and a hotter formula on the same shared equipment.

If two or more are true, this case is describing your operation, not an invented one.

The file, as it arrived

Every record behind the case — each one signed, formatted, and internally consistent. Each one, read on its own, looks like a company doing its job.

A product like this fails between documents, never inside one. Open the file and read what you’d catch — then see what we found, just below.

Open the full case file

What the records showed, together

No single page is alarming — read apart, each record looks like compliance. Read together, the same evidence resolves into four threads, all turning on one decision: to check the declared label, never the molecule.

Two unlawful ingredients, declared in plain sight.

The proprietary blend contains DMHA (octodrine) and higenamine — neither a lawful dietary ingredient. The eligibility file waved both through; the specs and release were built to confirm the label, not to find what shouldn’t be there.

DMHA cleared as a grandfathered “walnut-bark (Juglans regia) extract” constituent. FDA does not recognize that botanical basis — the product is adulterated. · FD&C §201(ff) · §402(f)

Higenamine cleared by “GRAS self-affirmation.” GRAS is a food-additive concept; it does not establish dietary-ingredient eligibility, and higenamine was never the subject of an accepted NDI notification. · FD&C §201(ff)

Blend identity established by organoleptic examination only. An adulterant passes “identity” on look, smell, and taste. · 21 CFR 111.75(a)(1)

Release assay tracks the caffeine marker. Seven other actives, DMHA and higenamine among them, are never assayed. · 21 CFR 111.75(c)

The finished-product banned-substance screen never tests for the actual adulterants — despite the “tested” claim on the label. · §403(a) · 21 CFR 111.75

Every gate checked the paperwork, never the producer.

Supplier approval, foreign-supplier verification, and the quality agreement all ran on documents about the blend — never on the establishment that made it, or the molecules inside it.

The qualified supplier is a broker; the manufacturer of record is “not disclosed,” its FDA establishment identifier (FEI) blank. Qualification attaches to an office, not a plant. · 21 CFR 111.75(a)(2)

COA reliance adopted without confirmatory testing — three lots accepted with assay “not performed.” · 21 CFR 111.75(a)(2)

The quality agreement assigns identity testing to the manufacturer but leaves adulterant testing of the blend to no one. · 21 CFR 111.75(a)(1)(i)

Foreign-supplier verification aimed at a trading company, not the producer. Under modified FSVP for supplements, verification still has to reach the establishment that actually makes the material. · 21 CFR 1.511 · 1.500

Whole-blend NIR (near-infrared) can’t resolve constituents below ~3%. The low-dose actives are never confirmed on receipt. · 21 CFR 111.75(a)(1)(i)

A sport claim the product could never earn.

The brand’s “Banned-Substance Tested” mark rested on an in-house program and a self-selected lab. The screen read trade names off the panel; the lab panel was built to miss exactly what was in the blend.

The eligibility screen matches declared ingredient names against an internal list. The blend clears as one line; DMHA and higenamine are never screened as substances. · WADA S3/S6 · full-formula disclosure

The lot panel includes DMAA but omits its analog DMHA — the substance actually present. · WADA S6

The beta-2 panel omits higenamine, a WADA-listed beta-2 agonist (class S3, prohibited at all times) in the blend. · WADA S3

The product is structurally ineligible for the certification it implies, yet carries the “tested” mark anyway. · NSF Certified for Sport · FTC substantiation

Then they ran a steroid down the same line.

A hormonal “ANDRO” extension (DHEA + “1-Andro”) was added to the same shared blender that makes legitimately sport-certified products for other brands. The assessment treated a certification-ending event as a routine carryover question.

“1-Andro” is a Schedule III anabolic steroid, mis-classed as an exempt “DHEA-class dietary ingredient.” · DASCA 2014 · 21 U.S.C. 802(41)

Housing the actives puts the site’s Certified for Sport registration at risk — and with it every other brand’s certification on that line. · NSF Certified for Sport

The only carryover check uses the caffeine marker, which isn’t in the steroid product — an anabolic-steroid residue would be invisible. · 21 CFR 111.27(d)

Read apart, every record was defensible. Read together, they describe a product that was unlawful at the first gate and stayed that way through every one after — because each gate was built to confirm the label, the contract, or a convenient marker, never the molecule. The batch record shows DMHA dispensed ~16% over target and an 84%-yield lot released with no investigation; a revision to the blend spec was waved through as a “Minor” change. The product shipped “banned-substance tested” while being adulterated from the start.

None of it needed a new test to see. It needed one check built to look at what was actually in the blend — the thing every other check agreed to skip.

What was at stake

What actually happened

A recall and a Form FDA 483

An unlawful stimulant stack shipped to athletes on a “tested” claim; a steroid added to the line put every other brand’s certification on that site at risk. The 483 (an FDA inspection’s written list of observations) and the recall followed the same paperwork that had passed.

What catches it first

One check reads the molecule

A real ingredient-eligibility review stops the launch at the first gate; an identity method that resolves the actives — not the marker — names what’s in the blend before a single bottle ships.

If this is your operation

You don’t need us to find out whether your program has the same blind spot. Most of it you can check yourself, this week, with records you already have.

Does anything you run test the actual ingredients inside a proprietary blend— or only the declared label and one marker?
Is your supplier the broker, or the plant that makes the material?Who is your manufacturer of record — and could you name the establishment today?
Does your sport or “banned-substance” claim rest on a held third-party certification— or on your own program and a lab you chose?
On shared equipment, does your cleaning check look for the hardest-to-clean active— or whichever residue is easiest to detect?

Where this case connects across the rest of the site — start with the opinion on a single ingredient, or go wider.

Understand the process · Technology Powder blending How a multi-ingredient blend is built and made uniform — and why a whole-blend marker can’t see the low-dose actives inside it. See the reference Check one decision · Service Classification & Viability Opinion Not sure an ingredient is a lawful dietary ingredient? One ingredient, one question, answered as an opinion before it reaches a label. See the service

Implement the system · Program The 21 CFR 111 dietary-supplement cGMP program Identity, supplier qualification, release testing, and change control built to the rule — a buy-and-go document system you run at your own pace. Coming soon

Grade your readiness · Assessment Dietary Supplement cGMP (21 CFR 111) Readiness Assessment A rubric-graded review of your held records against what 21 CFR 111 requires — identity, supplier, and release controls, before an inspector grades them for you. Coming soon

Learn the concept · Training Why a proprietary blend can hide what a panel can’t The idea this case turns on — that a name-match screen and a single marker can’t see the molecules that matter — is what our supplement-quality course teaches. Coming soon

A “tested” seal was never the same thing as a clean formula.