Do I need a lawyer to import dietary supplements?

Honest answer: not always. Plenty of importers handle this themselves, and if you are importing a simple product from a supplier who already sells into the U.S. and knows the requirements, you may be fine.

But there are specific situations where doing it yourself reliably goes wrong, and it is worth knowing which side of the line you are on before your first container ships.

What you are legally responsible for as the importer

The core misunderstanding we see is this: importers think of themselves as buyers. FDA thinks of them as the responsible party.

You are on the hook for four separate things, and they are genuinely separate — satisfying one does not satisfy another.

FDA facility registration. The facility that manufactures your product must be registered. If it is a foreign facility, it must also designate a U.S. Agent who is physically in the United States and reachable by FDA around the clock.

Foreign Supplier Verification Program. You, the importer, must have an FSVP verifying your foreign supplier is meeting U.S. food safety standards. This is your obligation, not your supplier's. FDA has cited the absence of an FSVP as one of its most common findings against registered facilities, and the agency can ask to see your plan on demand.

Prior Notice. FDA must be notified before each shipment arrives — at least 2 hours ahead by road, 4 hours by rail or air, 8 hours by water.

Compliant labeling. Your product must meet U.S. labeling requirements before it arrives, not after.

What actually goes wrong

Labeling. Consistently, overwhelmingly, labeling.

Labeling violations are among the leading reasons supplement and food products are refused entry to the United States. And the failure mode is worse than a single rejected shipment: once FDA identifies a labeling problem with a company's products, that company's future shipments are more likely to be examined. One mistake creates ongoing friction at the border.

The second most common failure is an FSVP that does not exist, or exists as a document nobody actually followed. FDA has issued Warning Letters and Import Alerts to importers on exactly this basis.

When you probably do not need a lawyer

  • You are importing a product your supplier already sells into the U.S. successfully, with U.S.-compliant labels they have used before

  • The product makes no claims beyond the required panels

  • Every ingredient is unambiguously permitted and has a long history of use in U.S. food

  • Your supplier is registered, you have Prior Notice handled through your broker, and you have a real FSVP

If that describes you, get a label review and move on.

When you should get help

Your product contains an ingredient you are not certain about. If anything in the formula might be a new dietary ingredient — not marketed in the U.S. before October 15, 1994 and not present in the food supply as an article used for food — you need a premarket safety notification submitted to FDA at least 75 days before you introduce it into interstate commerce. Discovering this at the port is a disaster. Discovering it at formulation is a scheduling problem.

You are making claims. Structure/function claims require notification to FDA within 30 days of first marketing, and the DSHEA disclaimer on the label, linked to each claim. Health and disease claims are a different and much more dangerous category. If your product's marketing rests on what it does for people, get the claims reviewed.

You are selling on Amazon. Amazon enforces FDA compliance independently and will remove listings. The economics here are brutal — a delisting during a launch window can cost more than years of legal fees.

Your product has already been detained or refused. At that point you are responding to the agency, not preventing a problem, and the process has its own rules.

You are the U.S. arm of a foreign brand. Then you are almost certainly the responsible party for all four obligations above, and often the party the foreign manufacturer assumes is handling it.

The honest cost comparison

A label review with us is $749 to $1,099. FDA facility registration including U.S. Agent service is $799. If your manufacturer holds the registration and you need their written permission to register, that letter is $199.

Compare that to one refused container. Add demurrage, the cost of the goods, the reprint, and a launch date you miss. The math is not close, and it is why we price these flat — the decision should be easy.

What we do

We handle FDA facility registration and serve as U.S. Agent. We review labels for import compliance. We help importers build FSVP plans. And when a shipment has already been stopped, we work on getting it released.

If you are not sure which of the four obligations above you are missing, that is a reasonable thing to ask us. It is usually a short conversation.