By Tam Nguyen | CEO, GOL Solution | 24+ years in international trade & cross-border logistics
Last Updated: August 2026

13 min 18 sec · Tam Nguyen, CEO, G.O.L Solution · Published 23 June 2025

Dietary supplements do not go through FDA approval before they reach the U.S. market. That single fact surprises most first-time brands, and it cuts both ways: there is no pre-market review to pass, but there is no FDA stamp confirming safety either. The responsibility for compliance sits entirely with the manufacturer and importer, across facility registration, labeling, claims, and ingredient safety.

This guide covers what dietary supplement companies actually need to do to bring a product into the U.S. compliantly, including the requirements most first-time brands miss entirely.

What Are Dietary Supplements?

Dietary supplements are products intended to augment the diet, sold in forms such as tablets, capsules, powders, gummies, and liquids. They differ from conventional food and from drugs: a product intended to diagnose, treat, cure, or prevent a disease is regulated as a drug, regardless of how it’s marketed or labeled.

Typical supplement categories include:

• Vitamins and minerals (multivitamins, vitamin D, calcium, iron)
• Botanicals and herbs (echinacea, ginger, curcumin)
• Amino acids (tryptophan, glutamine)
• Live microbials, commonly marketed as probiotics

The FDA regulates dietary supplements as a category of food, not as drugs. That classification is exactly why there’s no pre-market approval process, and exactly why the compliance burden falls on the company rather than the agency.

Do Dietary Supplements Need FDA Approval?

No. Under the Dietary Supplement Health and Education Act (DSHEA) of 1994, the FDA does not pre-approve dietary supplements for safety, efficacy, or labeling before they reach the market. This is a deliberate structural choice that distinguishes supplements from drugs, and it means the company selling the product, not the FDA, is legally responsible for ensuring it complies with every applicable requirement before the first unit ships.

Not needing approval does not mean not needing compliance. The requirements below apply regardless of the absence of a pre-market review.

FDA Requirements for Bringing a Dietary Supplement to the U.S. Market

Facility Registration

Facilities that manufacture, process, pack, or hold dietary supplements for the U.S. market must register with the FDA, the same requirement that applies to other FDA-regulated food facilities. Registration must be renewed every two years, and foreign facilities need a U.S. agent on file.

FSVP for Supplement Importers

Dietary supplements imported into the U.S. fall under the Foreign Supplier Verification Program (FSVP). The importer of record needs a supplier verification program, evidence of supplier audits, and a Letter of Consent in place before the shipment arrives. FDA product registration and FSVP compliance are separate obligations. Having one does not satisfy the other.

The Supplement Facts Label

Labels must carry a Supplement Facts panel listing serving size, servings per container, and the full list of dietary ingredients with quantity per serving. The product must also be identified on the front label as a “dietary supplement” or an equivalent term.

Structure/Function Claim Notification (the 30-Day Requirement)

If a supplement label makes a structure/function claim, a general well-being claim, or a classical nutrient deficiency claim, the company must notify the FDA in writing within 30 days of first marketing the product with that claim, under 21 CFR 101.93(a). This is one of the most commonly missed requirements we see. Brands assume that because there’s no pre-approval, there’s no filing obligation at all, but the 30-day notification is mandatory and separate from labeling itself.

Any product making this type of claim must also carry the standard disclaimer, in boldface: “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.”

New Dietary Ingredient (NDI) Notification

If a product contains a dietary ingredient that was not marketed in the U.S. before October 15, 1994, the manufacturer or distributor must submit a New Dietary Ingredient notification to the FDA at least 75 days before introducing the product into interstate commerce. Introducing an NDI-containing product without a timely notification makes the product adulterated under the FD&C Act.

Where Claims Cross Into OTC Drug Territory

A supplement’s classification depends heavily on what the label claims, not just what’s in the bottle. Claims that treat, cure, prevent, or alleviate a disease push a product out of the supplement category and into OTC drug or unapproved new drug territory, which carries a far more demanding regulatory path. This is one of the most frequent issues we see during R&D and label review, and it’s avoidable with a claims check before formulation is finalized.

GOL Insight

Most supplement brands that come to us are not aware that the structure/function claim filing is mandatory within 30 days of first distributing a product in the U.S. market. We handle the full registration scope for clients: facility registration, label review, function claim filing, and FSVP compliance, so nothing sits unfiled after launch.

We also support brands earlier, during R&D, by reviewing ingredients and proposed claims against FDA requirements before formulation is locked. A recurring issue we catch is claims language drifting into OTC drug territory. When that happens, we revise the label claims to keep the product classified and compliant as a dietary supplement rather than triggering a drug review pathway.

Should Your Brand Use a Label Review Service?

Label review is not a mandatory FDA filing on its own, so brands can technically skip it. We recommend it strongly for regular clients, and we require it for any client using our FSVP service, because the two are directly connected: an FSVP importer of record carries legal responsibility for the products they bring in, and a label error discovered at the border becomes their problem, not just the brand’s.

Client Experience

We’ve worked with brands that decided to skip label review because they had already reviewed the label internally. In one case, the brand shipped their first Amazon FBA shipment without our review, and FDA rejected it on arrival. The shipment, worth roughly $10,000, was destroyed.

The rejection traced back to two issues: the Supplement Facts panel was in the wrong format, and the declared value on the shipment did not match the value determined during FDA’s review of the product. Either issue alone can be enough to trigger a rejection.

This risk has grown, not shrunk, for online and DTC brands. Effective July 9, 2025, CBP and the FDA removed the Section 321 de minimis exemption for FDA-regulated products, which previously let many low-value e-commerce shipments (informally, under $800) move with minimal FDA review. That workaround is gone. Every FDA-regulated shipment, regardless of value, is now subject to full review, which makes label accuracy non-negotiable for brands planning to sell on Amazon or direct-to-consumer in the U.S. long term.

FDA’s Ongoing Role After Market Entry

Because supplements enter the market without FDA notification, the agency’s regulatory role is almost entirely post-market. The FDA inspects manufacturing facilities for compliance with labeling and manufacturing standards, reviews product labels and marketing claims (including online), and monitors adverse event reports from companies, healthcare providers, and consumers.

If a product is found unsafe or non-compliant, the FDA can work with the company to correct the issue, request a voluntary recall, or take direct action to remove the product from the market.

Benefits and Risks: What Brands Should Know

Dietary supplements can help address nutrient gaps and are commonly used to support cardiovascular, bone, and immune health.

But not every ingredient or claim is risk-free. Some supplements interact with medications, affect lab test results, or carry risk during surgical procedures. Consumers should be cautious of products that combine multiple active ingredients, exceed labeled dosages, or make claims that sound too strong to be backed by the underlying research.

For brands, this translates directly into labeling discipline: dosage instructions, interaction warnings where relevant, and claims that stay within what the evidence and the regulatory category actually support.

When This Guidance Does Not Apply

This guide covers standard dietary supplement compliance under DSHEA. It does not cover:

• Products making disease treatment or prevention claims, which are regulated as drugs regardless of how they’re marketed
• Infant formula and medical foods, which follow separate FDA frameworks
• Products already the subject of an FDA warning letter or Import Alert, which require a different remediation path. See our FDA import detentions guide for that process.
• Exporting an already-compliant US supplement to other countries. Once your product is FDA compliant for the US, shipping it internationally brings a separate set of country-by-country rules, documentation, and cold-chain requirements. See our guide to shipping supplements internationally for that process.

Getting the Import Setup Right: Importer of Record and Bonds

Before anything else, you need to settle who is the Importer of Record (IOR) for your shipments. If your supplier ships under DDP terms, they typically act as importer of record end to end. If you want your own entity to hold that role, you need to complete the importer license application and bond requirements yourself.

If you’re the importer of record, you’ll need:

• A DUNS number — a unique identifier tied to your bond and importer information, free to register directly with D&B
• A US Customs bond, either a single-entry bond covering one shipment, or a continuous bond valid for a year up to a set shipment-value threshold (for example, a $50,000 bond covers up to $50,000 in shipment value across the year — buy additional bond value if you need more headroom)
• An ISF bond, if you’re bringing product in by ocean freight

Making the Product Itself FDA Compliant

Work with a manufacturer that is GMP-certified and registered on the FDA facility database. Beyond the facility itself, your product labels and advertising materials need to independently meet FDA supplement labeling and advertising rules — a compliant manufacturer doesn’t automatically mean a compliant label. Many brands assume the manufacturer has this covered; in practice, it’s worth confirming whether they’ve actually used an FDA-focused label reviewer, and engaging a third-party label review consultant if they haven’t.

One specific, common mistake: never use the term “FDA approved” on a supplement. That language applies to medical devices and drugs, categories the FDA does pre-approve. Supplements aren’t pre-approved by the FDA at all, so the claim is simply inaccurate. “FDA registered facility” is the accurate term to use instead.

Advertising and Influencer Compliance

Your website, ads, video content, and influencer content all fall under the same FDA advertising rules as your label — and platforms like Meta and TikTok enforce these rules directly, restricting ad accounts over non-compliant claims. The practical fix is to build an influencer guide before you start spending on influencer marketing: clear do’s and don’ts, with real examples of accurate supplement advertising claims, so a smaller influencer with no experience in the category isn’t guessing at what’s compliant.

FSVP: A Separate Importer Role

Being the importer of record doesn’t automatically make you FSVP-compliant — these can be two entirely separate roles, and conflating them is a common first-time mistake. More than half of US importers reportedly fail FDA inspection specifically on FSVP.

Two scenarios: if your supplier is handling everything end to end as importer of record, confirm directly whether they already have an FSVP plan in place for your specific product — don’t assume it. If you’re the importer of record yourself, you need your own FSVP plan, either built through FSVP training courses yourself, or handled end to end by an FDA compliance agency. Missing FSVP paperwork is one of the more common reasons supplement shipments get held at port, since supplements are among the more heavily regulated categories entering the US.

Check Your 3PL Is a Registered Facility

If you’re shipping to a fulfillment center handling Shopify, Amazon FBA, or FBM orders, confirm that 3PL is itself an FDA-registered facility with its own DUNS number. Smaller or newer fulfillment operations sometimes aren’t properly registered, which can hold your product at port even when everything else about your compliance is in order — a gap that’s especially easy to miss if you’re new to working with 3PLs.

Made in USA vs. Manufacturing Overseas

Manufacturing in the US still requires importing raw materials, so if those come from multiple countries you need to factor each country’s tariff rate into your cost, on top of generally higher US manufacturing costs, which usually means positioning as a premium brand to absorb that.

Manufacturing overseas remains a viable alternative to China specifically — South Korea, Malaysia, Thailand, and Vietnam all have experienced supplement manufacturing bases, strong access to natural ingredients, and meaningfully lower tariff exposure than China. To find suppliers outside China, regional trade shows (search “supplement,” “food,” or “cosmetic trade show” plus the country and year, since supplements typically exhibit alongside food or cosmetics) are worth the trip — seeing and handling samples in person before committing to a manufacturer is hard to replace. Vitafoods Asia and SupplySide are two shows worth checking, since manufacturers from well beyond the host country tend to exhibit there.

Frequently Asked Questions

Read the full video transcript

If you want to start a supplement company, what are the things you need to prepare legally to bring the product into the market? This video walks through the comprehensive requirements to start a supplement brand in the US.

The first thing you need, if you’re bringing products in from overseas, whether that’s raw materials or finished packaged product, is an Importer of Record. This is something to clarify directly with your supplier: if the shipping terms they’re offering are DDP, they’ll typically handle everything through final delivery and act as importer of record themselves. If you’d rather have your own entity hold that role, you’ll need to complete the importer license application and bond requirements yourself. Either way, the first step is defining who is the importer of record, since that party carries the paperwork obligations that follow.

If you decide to be the importer of record: first, you need a DUNS number, a unique identifier used across your bond and importer information, issued free by D&B and registrable directly on their website. Second, you need a US Customs bond, and an ISF bond if you’re bringing product in by ocean freight. There are two bond types to consider: a single-entry bond covering one shipment, or a continuous bond valid for a year, covering shipments up to a value threshold. A $50,000 bond, for example, covers up to $50,000 in shipment value across that year. If you need more headroom, you simply purchase additional bond value for the same importer of record setup, which satisfies CBP’s requirements for bringing product in from overseas.

The second major piece, specific to supplements, is FDA compliance for the product itself. That means working with a manufacturer that’s GMP-certified and registered on the FDA database. Just as important, and something most brands miss, is making sure your product labels and advertising materials independently comply with FDA supplement labeling and advertising rules. Getting this wrong risks your product being classified as misbranded or misleading, which can mean returns, destruction, or detention at import. Manufacturers will often say they’ll handle compliant labeling for you, but in my experience, it’s worth asking directly whether they’ve actually used an FDA-focused agency for label design. If they haven’t, I’d recommend engaging a third-party label review consultant, since DIY label design frequently misses the full rule set.

One specific and important point: never use the term “FDA approved” on your product. That term applies to medical devices and drugs, categories that go through FDA pre-market approval. Supplements are not pre-approved or reviewed by the FDA before market entry, so the claim is inaccurate. “FDA registered facility” is the correct, accurate term to describe your facility and product instead.

Equally important is making sure your advertising materials, meaning your website, ads, video content, and influencer content, are compliant with FDA advertising rules. These are heavily enforced by platforms like Meta and TikTok directly, and a violation can mean losing the ability to run ads on that content entirely. Rather than spending on influencers and then discovering the content can’t be used, my suggestion is to build an influencer guide up front, with clear do’s and don’ts and real examples of accurate supplement advertising claims. This is especially useful with smaller influencers who don’t have experience promoting regulated products.

The last compliance piece is FSVP: as importer of record, you also need an FSVP importer on record, and these can be two separate entities, which is where things get confusing for first-time importers. FSVP compliance matters because more than half of US importers actually fail FDA inspection specifically on FSVP. There are two scenarios: if your supplier is the importer of record handling everything end to end, ask them directly whether they know what FSVP is and whether they have a plan in place for your specific product. If you are the importer of record, you need to develop your own FSVP plan, either by taking FSVP training and building it yourself, or by authorizing an FDA compliance agency to handle it end to end. Supplements are one of the more heavily regulated product categories entering the US, and missing FSVP paperwork is a common reason shipments get held at port.

One more thing to check: if you’re shipping to a fulfillment center handling your orders, whether Shopify, Amazon FBA, or fulfillment by merchant, confirm that 3PL is itself a registered facility. I’ve seen cases where a fulfillment center was small enough to essentially be someone’s garage, with no registered facility and no DUNS number to verify, and the product got held at port as a result. If you’re new to working with a particular 3PL, or based overseas without prior US fulfillment experience, this is easy to overlook. Ask for the 3PL’s DUNS number directly to verify.

A common question when starting a supplement brand is whether to manufacture in the USA or overseas. Made-in-USA still means importing raw materials, and if those come from multiple countries, you need to factor each country’s tariff rate into your cost. US manufacturing cost also tends to run higher, which usually means positioning as a premium brand to support that. Manufacturing overseas remains a strong option outside of China specifically: South Korea, Malaysia, Thailand, and Vietnam all have experienced manufacturers, strong natural ingredient sourcing, and meaningfully lower tariffs than Chinese-made product.

To find suppliers outside China, I’d recommend booking travel to a relevant trade show, searching for supplement, food, or cosmetic trade shows in the countries you’re considering, since supplements often exhibit alongside food or cosmetics. These schedules are typically set about a year ahead, so you can plan travel around them. There’s real value in seeing, touching, and sampling products in person before committing to a manufacturer. Vitafoods Asia and SupplySide are two shows worth checking specifically, since manufacturers from well beyond the host country tend to exhibit at both.

We help brands navigate all of this as a one-stop compliance provider, since bringing a product into the US legally usually means satisfying more than one agency, depending on how the product is made. We’ve helped more than 500 businesses navigate this so they can focus on marketing and sales rather than compliance. If you’d rather not think about compliance day to day, we can start with a one-on-one consultation on the compliance roadmap for your specific product. Thanks for watching.