Premarket Safety Filing

The premarket submission your route requires — built from your records.

An NDI notification, a GRAS determination, a food-additive petition, or an EU novel-food application. Send your records and we build the filing the route needs, grounded in what you actually have — not a template. If the records can’t carry it yet, you get the ordered path to a filing that will, at the same fee.

Why this matters nowThe pathway is closing

Many ingredients reach market on a self-affirmed GRAS conclusion the maker never files with FDA. In March 2025 HHS directed FDA to explore a rule to end self-affirmation, and a bill in Congress would make GRAS notice mandatory. Filing the notice ahead of the rule is how a route stays open.

HHS directive to FDA, Mar 10 2025 · FDA GRAS rulemaking on the Unified Agenda · S. 3122 (2025), mandatory-notification bill

What this is

The filing your market route requires, built to hold.

Some routes to market need a premarket submission before you can sell — an NDI notification, a GRAS determination, a food-additive petition, or an EU novel-food application. We build that submission from your real records, and we work it the way a reviewer will read it, so you learn whether it holds before you spend. Where the records can’t carry it yet, you get the specific work, data, and corrections the route needs — the honest path to a filing that stands, not one built to bounce.

Premarket Safety Filing

The route needs a submission and you don’t have one? Send your records and we build the filing the route requires — one flat fee, grounded in your actual records, not a template.

What this covers

NDI notification — 21 CFR 190.6
GRAS dossier / determination
Food-additive petition
EU novel-food application

What you get back

The built submission ready to file — an NDI notification, a GRAS determination, a food-additive petition, or an EU novel-food application — with a record of how it was built and what it rests on. We work it the way a reviewer will, so before you spend, you learn whether your records can carry a defensible filing. Where they can’t yet, you get the ordered path to get there at the same price: the specific work, data, and corrections the route needs, not a filing built to bounce. A submission that doesn’t hold is worse than none — it draws questions, delays the launch, and puts the market position in doubt.

What you send

The basis we build from — many records can fill each, and the guided intake asks for the exact documents after you buy:

What the substance isWhat the ingredient or product actually is — its identity and composition. How it’s made and specifiedHow it’s manufactured and the specification it’s held to. How it’s used and at what exposureHow it will be used, in what products, and how much a person takes in. The safety evidenceThe studies, history of use, and safety data behind it.

What this builds

The same ingredient, with a filing that has to hold — the calls we’d make, and why.

Nothing to catch on a build — you send the substance, the process, the exposure, and the safety evidence, and the reasoning is the work. Here is a constructed functional-mushroom ingredient brought to us to build a defensible GRAS submission from scratch, and the call we’d make at each step.

See the full True Fruit™ / Cascadia Fungi case

01We define the substance as the material you actually sell.

We’d fix the identity first: the submission has to characterize what’s in the drum — fruiting body and mycelium-on-grain accounted for, the grain substrate quantified or removed — not an idealized “fruiting-body extract” that the batch record doesn’t make.

Substance identity basis

02We build the spec on a method that measures the analyte.

We’d set the β-glucan specification on an enzymatic α-/β-resolving assay and add an α-glucan (starch) determination — so the number means β-glucan, the grain shows where it is, and the safety case rests on a value that proves what it claims.

Specification & method basis

03We estimate exposure across the whole line, at concentration.

We’d build a cumulative dietary-exposure estimate — every product the ingredient goes into, at the 10:1 concentration factor, not a single serving — so the safety margin underneath the conclusion is real.

Intended-use & exposure basis

!And the honest fork, up front: file the notice, or hear why the route won’t carry yet.

We’d build it as a GRAS notice ready to file with FDA ahead of the rule that ends self-affirmation — and if the safety evidence can’t carry the concentrated, grain-grown extract as it stands, we say so before you spend, with the ordered path to a filing your records can defend.

Notification basis · honest path

Built premarket filing$10,000fixed price

Common questions

Straight answers.

Not sure you even need a filing?

Then start with the Classification & Viability Opinion. It tells you which route your product’s category allows and whether a premarket submission is required at all, before you commission a build. See the opinion

Do you file the submission with FDA for me?

No. We build the submission or the roadmap to one; you file it. We don’t run the lab studies, convene the expert panel, or act as your agent with the agency, which keeps the work independent of the filing decision.

How do you set a flat price on a build you haven’t seen?

One fixed fee for the filing, the same for everyone. If your records can’t carry a defensible submission yet, you don’t get a filing built to bounce, you get the ordered path to one at the same fee.

What if my records can’t support a filing yet?

You get that plainly, at the same fee, with the ordered path to get there: the specific work, data, and corrections the route needs. Sometimes the honest answer is “not yet, and here’s why,” and that saves you the five figures and months a dead filing costs.

My ingredient is “self-affirmed GRAS” already. Do I need this?

Self-affirmation means you concluded it yourself and never filed with FDA, the route FDA has moved to eliminate. Filing a GRAS notice ahead of the rule is how the route stays open, and a notice is only as good as the identity, exposure, and evidence under it. We build the one that would hold.

Is this legal advice?

No. It is a built regulatory work product, not legal counsel, and it creates no attorney-client relationship. We build the submission your route requires; the legal judgment on your situation stays with your counsel.

Where to go from here

The filing is one part of the route.

Whether you still need to confirm the route or you’re ready to stand up the system behind it, here’s where it goes next — whichever fits where you are.

Confirm the route · Service Classification & Viability Opinion Not certain a filing is even the right route? Get the written call on what your product is and whether its route is open — go or no-go — before you commission a build. See the opinion Implement the system · Program The compliance system for your category Once the filing is handled, the complete document system for your standard is already built — supplement, cosmetic, food, or OTC. You buy it and put it in place, at your own pace. Browse the programs

Regulatory work product, not legal advice. A built submission is prepared from the records you submit and is not legal counsel, not a guarantee of any regulatory or market outcome, and forms no attorney-client relationship. We build the submission or the ordered roadmap to one — not the agency filing made on your behalf, the lab studies, or the expert panel. Where the records provided can’t support a defensible filing, we deliver the roadmap to one instead. True Fruit™ / Cascadia Fungi Labs is a constructed teaching case; no real company or product is depicted.