Product Labels

Your label, reviewed or built from scratch.

Two ways in. Have a label? Get an independent written opinion on whether it holds up, at the depth you choose. Need one? Send your product basics and we build the regulated label content from scratch.

The trendWhere the label meets enforcement

Across FDA’s warning letters to supplement companies, the same three patterns recur: manufacturing-practice gaps, illegal or undeclared ingredients, and claims the records can’t support. Two of those three live on the label.

FDA warning-letter record, dietary-supplement sector

What this is

Whether your label holds up, against the rules and against the product behind it.

A label carries every claim and declaration your product makes to a regulator, a retailer, and a buyer. We judge the one you hold, or build the one you’re missing. Either way we work on the regulated content, not the artwork, read against the labeling and claims rules and against your own records.

Label Opinion Letter

An independent regulatory opinion on a label you already have: does it hold up, against the rules and against the product behind it? Start at the base, and add a record to take the opinion deeper.

What this covers

Label compliance (21 CFR 101)
Supplement / Nutrition Facts panel
Allergen declaration (FALCPA)
Claim review (structure-function, health, nutrient-content)
Marketing-claim labeling (Non-GMO, organic, GF, vegan)
Prop 65 warning
Banned-substance screen
Certification-claim labeling

What you get back

You get a straight answer on whether the label holds up: each requirement read against the rule, with a clear conclusion and what it would take to address it. It comes as a signed opinion you can file in your quality system, hand to a retailer or an auditor, or use to close a finding before an inspection instead of after. Not a label check that stops at the artwork, and not a by-the-hour engagement with a quote you can’t see up front. The base reads the label on its face; add the records and the read reaches the claim the substantiation doesn’t support, the panel that doesn’t match the spec, and the quantity that was never made as printed.

What a review catches

A worked label, and what the base review alone surfaces.

This is the $1,150 base: the label read on its face, before a single other record. Hover or tap a marker to read the finding. The deeper reviews add the records that catch what a label alone can’t.

Constructed teaching example. An invented company, a real failure pattern; the full story lives on the case.

See the full PROTOCOL™ Sport case

Vanguard Performance Labs

PROTOCOL^™

SPORT

Elite Performance & Recovery Complex

✓

CERTIFIED

FOR SPORT

Banned-Substance Tested · Trusted by Athletes

90 CapsulesDIETARY SUPPLEMENT

Supplement Facts

Serving Size: 3 Capsules

Servings Per Container: 30

% Daily Value

Vitamin B6 (as P-5-P) 10 mg588%

Zinc (as bisglycinate) 25 mg227%4

Protocol Sport Proprietary Blend 2,400 mg†3

Caffeine Anhydrous, Beta-Alanine, L-Citrulline, Ashwagandha, DMHA (Octodrine), Higenamine HCl, Tribulus Terrestris, Theacrine2

† Daily Value not established.

✓ BANNED-SUBSTANCE TESTED — SCREENED FOR 200+ SUBSTANCES

1A sport seal the product could never hold

On the label · a “Certified for Sport” seal, “Banned-Substance Tested · Trusted by Athletes,” and “screened for 200+ substances.”

The blend carries ingredients a sport program screens for and prohibits, so the product can’t hold the certification it implies, yet the mark and the athlete-trust claim sit on the pack. A retailer or the certifier reads this first.

Standard · base§403(a) · FTC cert-mark

2Two ingredients that put the product’s status in question

On the label · the blend lists DMHA (Octodrine) and Higenamine HCl.

FDA treats DMHA as not a lawful dietary ingredient and takes the same position on higenamine, which puts the product’s legal status in serious question. That is the most consequential thing this review surfaces, and it is sitting in plain sight in the ingredient line.

Standard · base§201(ff)/§402(f) · 21 CFR 190.6

3A blend that hides its own doses

On the label · “Proprietary Blend 2,400 mg” with eight actives and no individual amounts.

The format is permitted, but it conceals the dose of each stimulant, caffeine, DMHA, higenamine and theacrine stacked, so neither a consumer nor an athlete can see what they are taking.

Standard · base21 CFR 101.36(c)

4The %DV math doesn’t reconcile

On the label · “Vitamin B6 10 mg = 588%” and “Zinc 25 mg = 227%.”

Those percentages only reconcile if calculated on the salt weight rather than the elemental amount, so the Daily Values are overstated. A facts-panel math check catches it on the face of the label.

Standard · base21 CFR 101.36

What the deeper reviews add

+Does the label match the product as made?

Reconciling the blend, the count, and the declarations against the finished-product specification needs that record. The consistency check.

Standard · + product specification

+Is “banned-substance tested” actually backed?

The substantiation file is what proves or breaks it. In the case there was no banned-substance screen behind the seal at all, so the assurance had nothing under it.

Exceeding · + substantiation file

+Was the lot screened and made as labeled?

The batch record answers it. In the case DMHA was dispensed about 16% over target and an out-of-yield lot was released with no investigation.

Exceeding · + batch production record

Build your opinion

Standardthe baseline the field expects

Included

Label compliance, on its face$1,150

Judges the label against the labeling and claims rules as written: mandatory statements, the Facts panel, declarations, and claim format. Whether it reads correctly and is complete and defensible on its face.

You send: Product LabelThe label as it appears on the product: front panel, Supplement/Nutrition Facts, ingredient and allergen declarations, claims, and net quantity.Also called: label artwork, pack copy, front/back panel, label proofFull details on the Records page

Optional add-on · tap to add

Matches the product as specified+ $450

A label can be perfectly compliant and still be wrong for your product. We reconcile it against the finished-product specification (panel, declarations, quantities) so the label matches the product you actually specified, not just the rules.

You also send: Product SpecificationThe finished product’s defining record: identity, ingredients and quantities, and the declarations the label has to match.Also called: product spec, finished-product specification, formula sheetFull details on the Records page

Exceeding Standardschecked against the spec, the evidence, and the batch

Optional add-on · tap to add

Claims are supported+ $700

A claim you can’t back is a claim that draws a letter. We check whether the label’s claims and assurances are supported by your substantiation records: the structure-function, health, and marketing claims that read fine on the artwork and fail when someone asks for the evidence.

You also send: Safety Substantiation FileThe evidence behind the label’s claims and assurances: the substantiation that a structure/function, health, or marketing claim (or a “tested” seal) can actually be backed.Also called: claim substantiation, evidence file, banned-substance / testing recordsFull details on the Records page

Optional add-on · tap to add

Made as labeled+ $800

The label says what is in the product; the batch record says what you actually made. We check whether the executed record and release testing confirm the labeled quantities were really dispensed and verified, the gap between what the label promises and what the line produced.

You also send: Batch Production Record (BPR)The executed record of the lot as actually made: what was dispensed, and the in-process and release results, used to confirm the product was made as labeled.Also called: BPR, executed batch record, production / manufacturing recordFull details on the Records page

Optional add-on · tap to add

Additional artwork, same product+ $300

A carton, an insert, or a secondary label for the same product reviewed alongside the primary label. A different product is its own order.

You also send: The additional artworkA carton, insert, or secondary label for the same product, reviewed alongside the primary label.Also called: secondary artwork, carton / insert copy, outer packagingFull details on the Records page

If your label can’t be given a clean opinion on what you send, you get a straight report on what’s missing instead, at the same fee.

Your review$1,150base only

Label Development

No label yet? Send your product basics and we build the full regulated label content from scratch: one flat fee, one product, content only.

What this covers

Label compliance (21 CFR 101)
Supplement / Nutrition Facts panel
Allergen declaration (FALCPA)
Claim wording (structure-function, health, nutrient-content)
Marketing-claim labeling (Non-GMO, organic, GF, vegan)
Prop 65 warning
Statement of identity & net quantity
Mandatory warnings & directions

What you get back

You get the regulated label content, ready to hand your designer or printer. That’s the statement of identity, net quantity, name and place of business, the ingredient and allergen declarations, the Supplement or Nutrition Facts panel built from your formula, and the claim wording with its required disclaimers in place. It’s built true to the actual formulation and the claims you can stand behind. We build content, not artwork: no design, die-lines, or print-ready files. And if your formula can’t carry a clean label as it stands, we tell you that plainly and give you the path to fix it, at the same fee.

What you send

The specific records we build from: your formulation (the formula or master manufacturing record), the claims you intend to put on the pack, and the package (container, count, and how it ships).

What this builds

The same product, sent with no label. The calls we made, and why.

Nothing to catch on a build: you send raw inputs, and the reasoning is the work. Here is the same constructed PROTOCOL™ Sport, its formulation, claims, and package, brought to us to build from scratch, and the call we made on each line.

Constructed teaching example, disclosed as constructed.

See the full PROTOCOL™ Sport case

01The panel was built on the elemental amount, not the salt weight.

B6 came in as P-5-P and zinc as bisglycinate. We declared the elemental B6 and zinc and ran the %DV off those, so the panel reconciles, instead of the overstated “588%” and “227%” you get when the salt weight slips through.

21 CFR 101.36

02The performance line was rewritten as a structure/function claim, with its disclaimer.

The recovery wording on the brief implied more than a supplement may claim. We rebuilt it to what the product does for normal function and attached the required “not intended to diagnose, treat, cure, or prevent” disclaimer, the claim kept, written so it holds.

21 CFR 101.93 · §403(r)

03The sport-certification mark came off, nothing was behind it.

The “Certified for Sport / banned-substance tested” claim on the brief had no qualifying program and no lot screen under it. On this formula that mark is a claim the product can’t support, so the pack was built without it.

§403(a) · FTC cert-mark

!And the honest fork, up front: two ingredients put a lawful label in question.

This formula’s blend carries DMHA (octodrine) and higenamine. FDA treats neither as a lawful dietary ingredient, which puts the product’s status in serious question. So the build didn’t paper over it: the call, that the blend changes or the label can’t be made clean, came back up front, at the same fee, not from a retailer or an inspector.

§201(ff) / §402(f) · 21 CFR 190.6

Built label content$2,750one product · flat fee

Common questions

Straight answers.

Isn’t this the same as a cheaper label review?

Only at the base, and even there you get a defensible written opinion, not a redline. The difference is depth you control: a cheaper review reads the artwork against the rules and stops. Ours starts there, then lets you add the records that reconcile the label against the product as specified and as actually made.

Why does it cost more than a $300–600 review?

Most reviews at that price check the artwork only and explicitly disclaim your formula. You are buying an independent written opinion you can put in front of a retailer or an auditor, and you choose how deep it goes, from face compliance to claim substantiation and batch execution. You pay for the opinion and the depth, not a proofread.

Do you check my formula, or only the artwork?

As deep as you want. The base opinion reads the label on its face. Add the product specification and we reconcile the label to the product as specified; add the substantiation file and the batch record and we check whether the claims are supported and whether the lot was actually made as labeled.

What if the product can’t be labeled clean?

You get told that plainly, at the same fee: on the review as a finding, on the build as the honest path to fix it. We lay out the options and you decide what to do; we don’t bury a problem in a panel that looks finished, and we don’t make the call for you.

Is this legal advice?

No. It is an independent regulatory opinion, not legal counsel, and it creates no attorney-client relationship. If your exposure is litigation, that is a lawyer’s job. If your question is whether the label holds up against the regulation and the product behind it, that is ours.

Do you design the artwork too?

No. The build gives you the regulated content: the panel, declarations, identity, and claim wording, ready to hand your designer or printer. The layout, die-lines, and print-ready files are their job, not ours.

Where to go from here.

Once you know whether your label holds, here’s where it goes next.

Implement the system · Program The document system for your category The label is one document in a compliance system. The complete document set for your standard is already built, for supplements, cosmetics, food, or OTC. You buy it and put it in place. Browse the programs Train your team · Training Labeling and the claims behind it Self-paced courses that take your team from the baseline to auditing and system design: labeling, claim substantiation, and the QMS they live in. See the courses Run the mock audit · Assessment Readiness assessment for your certification A mock audit that maps your labels, claims, and procedures against the standard you’re pursuing, from 21 CFR 111 to cosmetic or OTC GMP, with the gaps and fixes before your auditor finds them. See the assessments

Regulatory work product, not legal advice. A deliverable is prepared from the records you submit and is not legal counsel, not a guarantee of any regulatory or retailer outcome, and forms no attorney-client relationship. It is prepared for your own use; any reliance by a retailer, an auditor, or another third party is at their own risk and creates no duty to them absent a separate written agreement. The review is a document review, not a GMP audit or analytical test, and not the disposition or release decision. The build produces the regulated label content only; it is not the artwork, and not the FDA notification, registration, or filing the product may still require, and does not itself make the product lawful to market. Where the records provided can’t support a defensible result, we deliver a findings report on what’s missing instead. PROTOCOL™ Sport is a constructed teaching case; no real company or product is depicted.