How much does an FDA label review cost?
Most law firms will not answer this question on their website. You call, you get "it depends," and you get a retainer agreement with an hourly rate attached. For a company trying to decide whether to launch in Q3, that is not a useful answer.
So here is ours, in numbers.
Our flat fees
| Service | Fee | What you get |
|---|---|---|
| Basic Label Review | $749 | Full FDA compliance review of one label plus a written report with action points |
| Expert Label Review | $1,099 | Everything in Basic, plus ingredient review, detailed Nutrition or Supplement Facts review, and suggested label revisions |
| Multi-Flavor Product | $1,299 | Everything in Expert, for one product line of up to three flavors |
The fee is fixed before we start. It does not change because the review took longer than expected.
What a Basic Review actually covers
A Basic Label Review checks your label against the requirements in 21 CFR Part 101 and reports back on each of the following:
Statement of identity — the common or usual name of the food, on the principal display panel
Net quantity of contents — correct placement in the lower portion of the principal display panel, correct units
Ingredient list — complete, correctly ordered by weight, correct nomenclature
Manufacturer, packer or distributor information
Country of origin
Allergen declaration — covering all nine major allergens, including sesame, which became the ninth on January 1, 2023
Nutrition Facts or Supplement Facts — whether the panel is present, and whether it is required
You get a written report identifying each problem and what to do about it.
What the Expert review adds
The Expert review does everything above and then goes further into the two areas where products most often get into trouble after launch.
The first is ingredients. We look at the legal status of what is actually in your product — whether each ingredient is permitted for its intended use, whether anything triggers a food additive or new dietary ingredient issue, and whether the nomenclature on your label matches what the ingredient legally is.
The second is the Nutrition Facts or Supplement Facts panel itself. Format, rounding, serving size, and the required nutrients under the current rule, including added sugars, vitamin D, calcium, iron and potassium. This is detailed work and it is where a lot of otherwise clean labels fail.
The Expert review also comes back with suggested revisions, not just a list of problems.
What is not included
Claims review is a separate service. If your label says "supports immune health," "high in protein," "clean," "natural," or anything else that characterizes what the product is or does, that is a claims question and it is priced separately.
We separate it deliberately, because claims review is a different analysis with different risk. A label can be perfectly compliant on structure and still generate a class action over one word on the front panel. If you are making claims, tell us up front and we will quote the combined work.
Why flat fee instead of hourly
Two reasons, and only one of them is about you.
The one about you: you can budget. A founder deciding whether to spend on legal review before a production run needs a number, not a range. An hourly quote of "probably eight to fifteen hours" is not a number.
The one about us: we have done this hundreds of times. The work is scoped and repeatable. Charging by the hour for repeatable work rewards inefficiency, and we would rather be paid for knowing the answer than for the time it takes to find it.
When you need a label review
You should get one before you print. Not after.
The single most expensive version of this problem is a founder who has 40,000 units of printed film sitting in a warehouse and a label that names the product incorrectly. Reprinting is the cheap outcome. Relabeling by hand is worse. A recall is worse still.
The specific moments that should trigger a review:
Before your first production run of any new product
Before you change a formulation, even slightly — a new ingredient can change the ingredient list, the allergen statement, and the Nutrition Facts panel at once
Before you import into the U.S., where labeling violations are a leading cause of import refusals
Before you list on Amazon or a major retailer, since both will pull non-compliant products
When you change co-packers, because the manufacturer information on your label changes
A thing people get wrong
FDA does not approve your label before you sell. There is no pre-market clearance for a conventional food or a dietary supplement label. Nobody at FDA looks at your artwork and stamps it.
That sounds like good news and it is not. It means the first time anyone at the agency evaluates your label may be when your shipment is stopped at a port, or when a Warning Letter arrives, or when a plaintiff's firm reads it. You are responsible for getting it right on your own, in advance.
Ready to start
If you want a label reviewed, the Flat Fee Label Review page has the details and the intake form.
If you are not sure which tier you need, send us the label. We will tell you which one fits, and if the answer is the cheaper one, we will say so.