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Getting started

What it costs to start

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The physical cost of this craft is trivial and the compliance cost is not, which is the reverse of how most people budget it.

The cheap half

  • Raw botanicals or ingredients, bought in modest quantity.
  • Alcohol, glycerin or whatever the carrier is.
  • Small glass bottles and dropper assemblies.
  • Basic equipment: scales, vessels, a press or strainer, filters.

The expensive half

Identity testing of incoming ingredients, which cGMP requires and which means a lab. Written procedures and batch records, which means somebody’s time. Label review, because the cost of getting a claim wrong is far higher than the cost of having somebody read it first.

Identity testing is the line people argue with

The requirement exists because botanical material is routinely misidentified or substituted upstream, and a supplier’s certificate is not the same as your verification. It is a real recurring cost per ingredient lot and it is not optional for a manufacturer.

Label artwork is more expensive here

A Supplement Facts panel has formatting rules about type size, bars and alignment that a designer unfamiliar with the category will get wrong. Budget for a designer who has done one, or for the revisions.

Co-packing is a real option

Using a contract manufacturer already operating under cGMP moves the manufacturing burden to somebody set up for it, at the price of a minimum order and less control. For a first product it is often the cheaper route once the documentation cost is counted honestly.

Price it with all of that in

A tincture costs pennies to make and the business costs considerably more to run correctly. Pricing from the materials is how a maker ends up unable to afford the testing the rules require.

Start with one product, properly

Every additional product multiplies the testing, the records, the panel work and the claims review. A single product made correctly is a business; four made loosely is a liability, and the costs above are the reason.

Whichever route you take, decide it before buying bottles. Switching to a co-packer later usually means their minimums and their formats rather than yours.

References

21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. law.cornell.edu
21 CFR 101.36, Nutrition labeling of dietary supplements, which requires the “Supplement Facts” heading set larger than all other print, a serving size expressed in a term suited to the form, servings per container, and other dietary ingredients by common name. law.cornell.edu
Written from federal regulation, not from a laboratory and not from a lawyer. The claims rules here are specific and strictly enforced, and the difference between a permitted statement and a drug claim is narrower than it looks. Treat anything here as a starting point for advice on your own label rather than as clearance for it.