How to start a supplement company, from formula to first import

What the law puts on you, not the factory

Dietary supplements are regulated under the "umbrella" of foods^[2], not as drugs. There is no approval to apply for: FDA does not have the authority to approve dietary supplements before they are marketed^[2]. The firms that make and sell supplements are instead responsible for evaluating the safety and labeling of their products before marketing^[3].

If your company name is on the bottle, that includes you, even when a contract factory mixes, encapsulates and packs every unit. Starting a supplement company is mostly the work of being able to show, at any time, why your product is what the label says it is.

The steps

1. Choose a formula you can stand behind. The fast route is private label: pick a formula from the existing range of one of the private label manufacturers on your shortlist and put your brand on it. A custom formula means development and stability work before the first order, and it can be yours: get the formula and its specification assigned to you in writing before development starts. Either way, check every ingredient against FDA's new dietary ingredient rules first: if one qualifies, you must notify FDA at least 75 days before^[4] the ingredient goes into interstate commerce, with the basis for concluding it is safe, unless every dietary ingredient in the supplement has been present in the food supply as an article used for food in a form in which the food has not been chemically altered^[5].
2. Decide whose name goes on the label, and set up for it. Under the adverse event law, the responsible person is the manufacturer, packer or distributor whose name appears on the label^[6]. For a private label brand that is normally you. The label must carry a domestic address or domestic phone number for reporting serious adverse events^[2], you must pass each serious adverse event report to FDA no later than 15 business days^[6] after you receive it, and you keep adverse event records for 6 years^[6]. Have the phone line, the inbox and a log running before the first unit sells.
3. Write the specification before you ask for quotes. A distributor that has a supplement made and sells it under its own label has an obligation to know what and how manufacturing activities are performed^[1], so it can decide whether each batch meets specification and can be released. The CGMP rule requires specifications for the identity, purity, strength, and composition^[7] of each finished batch, plus limits on contaminants, and the maker must run at least one appropriate test or examination to verify the identity^[7] of each dietary ingredient it uses. Put your targets in one document: ingredients and amounts per serving, capsule or powder format, count per bottle, the tests you want on each batch and the pass limits. If the goods travel by sea, add the shelf life you need and the packing that protects it, because gummies, softgels and probiotics can suffer in a hot container.
4. Shortlist factories, overseas and at home. The CGMP rule is not only for US plants: it applies to supplements imported or offered for import^[1] into the United States. Facilities that manufacture, pack or hold supplements for US consumption must register with FDA^[2] before they start. Before you order, see each candidate's FDA food facility registration number, its most recent CGMP audit report, the MOQ per formula and a certificate of analysis for a recent batch of a similar product. If you contract a factory yourself, ask it for these directly. If you buy from us, ask us for a summary of the factory's registration, latest CGMP audit and a recent certificate of analysis instead. A factory audit by someone you choose tells you more than any document the factory sends.
5. Plan the import before the first order. If you are the importer, FDA's Foreign Supplier Verification Program rule for importers of supplements applies to you. The supplier verification activities it accepts include onsite audits, sampling and testing, and review of the foreign supplier's relevant food safety records^[8], and you may not rely on the foreign supplier or employees of the foreign supplier to perform supplier verification activities, except with respect to sampling and testing^[8]. So the verification is yours, not the factory's: you, or a qualified person you pick, review its food safety records, audit it or test its product, and document what you found. An independent lab test you commission is the simplest check to budget for. A very small importer, meaning one averaging less than $1 million per year, adjusted for inflation, in sales of human food combined with the U.S. market value of human food imported^[9], may instead obtain written assurance, before importing the food and at least every 2 years thereafter^[10], from the supplier that it makes the food to US safety requirements; a first brand importing a few thousand bottles may well qualify. The law also requires that FDA receive prior notification of food^[11] imported into the country, which covers supplements, so your customs broker files prior notice for each shipment.
6. Write claims you can prove. A structure or function claim, one that describes how an ingredient supports the body, must carry the disclaimer "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."^[12], and you notify FDA of the claim no later than 30 days after first marketing^[12] the product with it. Advertising is the FTC's side: health claims need competent and reliable scientific evidence^[13], which for health benefits generally means randomized, controlled human clinical testing^[13]. That standard applies to your product pages and ads, not only the bottle.
7. Approve samples, then release the first batch. Test the pre-production samples at an independent lab against your specification before you sign off. After production, the maker holds reserve samples of at least twice the quantity necessary for all tests or examinations^[1], and CGMP records are kept for 1 year past the shelf life date, if shelf life dating is used, or 2 years beyond the date of distribution of the last batch^[7]. Ask for the batch record summary and the certificate of analysis with every shipment, and keep them where you can find them by lot number.

Stock formula or custom formula

One way in is to launch on a stock formula, learn what sells, then move the best seller to a custom formula you own. If you plan to do that, keep your label claims to what both versions can support.

What your first order costs, landed

The unit price is only the first line. Freight, duty, broker fees, testing and the last trucking leg all land on the same bottle, and they change which factory is cheaper.

Line	Amount
Factory price, 5,000 bottles of 60 capsules at $2.40, FOB the origin port	$12,000
Ocean freight and cargo insurance to the US port	$900
Duty at 5% (assumed) of the factory price	$600
Customs broker, entry fees and prior notice filing	$450
Independent lab test of the first batch	$600
Trucking from the port to your warehouse	$500
Landed cost	$15,050
Landed cost per bottle	$3.01

Illustrative figures, not a quote. Real prices depend on the spec, quantity and factory.

Add the costs that are not per unit on top: label design, product liability insurance, the samples you rejected and the stock you give away. Run every quote through the same table before choosing: a lower unit price from one country can still land higher than another country's quote once freight and testing are counted.

Getting quotes

We source supplement manufacturing overseas-first and sell the finished product to you. The price per unit we quote includes our margin, and each quote states its shipping terms, so you know which costs are already inside it.