COMPLIANCE & TESTING

The paperwork is part of the product.

Third-party batch testing, full documentation, and MoCRA obligations handled for you. Putting your name on a jar makes you responsible to the FDA — we make sure that's covered before you sell a single unit.

WHAT MOCRA MEANS FOR YOUR PRACTICE

The label says your name. So does the FDA file.

Most practices don't realize that private-labeling makes them a regulated party, not just a reseller.

Under the Modernization of Cosmetics Regulation Act, every cosmetic product has a "responsible person" — the entity whose name appears on the label. If that's your practice, the obligations are yours: safety substantiation on file, adverse event records, and specific label requirements including a contact for reporting.

There's a small business exemption, and most practices launching a line qualify for it. If your average annual cosmetic sales sit under roughly one million dollars across the previous three years, you're exempt from facility registration and product listing. We'll tell you that plainly rather than selling you a filing you don't need.

What the exemption doesn't cover is the part that matters. Safety substantiation on file, adverse event records, and specific label requirements — including a domestic contact for reporting — apply to every responsible person regardless of size. Those are the three most practices have no system for.

Enforcement is light right now, and most people know it. The file isn't for an inspection that probably isn't coming — it's for the retailer who asks for documentation before they'll stock you, the one customer who has a reaction, and the insurer who wants to know what testing you ran. Those all arrive without warning.

So we build them. A safety substantiation file assembled from real batch test data, label review before print, the record keeping structure you'd need if the FDA ever asked, and full registration and product listing the moment you cross the threshold. You get a compliance file, not a verbal assurance.

We also tell you when a claim crosses a line. "Reduces the appearance of fine lines" is cosmetic. "Stimulates collagen production" is a drug claim, and it changes what you're legally selling. We flag it at the label stage, while it's still cheap to fix.

Your name appears in our facility registration, as the law requires — but FDA does not release facility brand names under public records requests. Competing brands can't look up who else we manufacture for.

Compliance scope
Small business exemption guidanceFacility registrationProduct listingSafety substantiationLabel & claim reviewINCI verificationAdverse event record keepingLot traceability
THIRD-PARTY BATCH TESTING

Every batch tested outside this building.

We use Vertex Analytical, an independent lab. Our own equipment doesn't grade our own homework — and an outside COA is what a retailer or insurer will actually accept.

Microbial testing
Total aerobic count, yeast and mold, and screening for specified organisms on every production batch.
Preservative challenge
Deliberate inoculation to confirm the preservative system holds across the product's shelf life.
Stability testing
Accelerated and real-time holds to verify the formula doesn't separate, discolor or drift on pH.
pH and viscosity
In-process and finished-product checks against a written specification, batch to batch.
Packaging compatibility
Confirms the formula and the container don't degrade each other over time.
Certificate of Analysis
Issued per batch and retained. Yours on request, always.
Active facility registration
Your product listing is only valid if our facility registration is current. We keep it active and renewed — your filing depends on it.

Panels are selected per formula — an anhydrous balm and a water-based serum don't carry the same risk profile, and we don't bill you for tests your product doesn't need.

WHAT YOU RECEIVE

The file that proves it.

Retailers, insurers and marketplace listings all ask for some version of this. It's assembled as we go, not reconstructed afterward.

Batch records
Full manufacturing record for every lot produced.
Certificates of Analysis
Third-party results, per batch, from Vertex Analytical.
Raw material documentation
Supplier specs and COAs for every input.
Safety substantiation file
Assembled to satisfy the responsible person requirement.
INCI and label copy
Reviewed for accuracy and claim compliance before print.
Product listing confirmation
FDA listing submitted and confirmed on your behalf.
Facility registration
Our Henderson facility is registered with FDA and renewed every two years, with your brand listed among the products we process.
Product listing & annual updates
Your product listing is filed under your name as the responsible person, and updated annually. We track the date so nothing lapses.
Facility identification for your listing
When you file a product listing, it has to name the facility that manufactured your product and carry our FDA registration number. We give you ours. If you're buying relabeled stock through a middleman, that number is often the thing nobody can tell you.

Regulatory requirements change and thresholds are inflation-adjusted. Nothing here is legal advice — we'll tell you what we see and recommend you confirm scope with your own counsel.

Send us your label before it goes to print.

Free review. We'll tell you what needs changing and what your MoCRA obligations actually are — whether or not you manufacture with us.

Get a label review