Home / Knowledge / Guides / FDA compliance
Pillar guide
What the FDA actually requires before your product can legally be sold in America — registration, labeling, claims, and imports — and the mistakes that most often cost a brand its first year.
Almost every brand we meet has the same misconception: that FDA compliance is paperwork you complete after the commercial decisions are made. It isn’t. It determines what you can put on the label, which determines how the product is positioned, which determines which buyer will take the meeting.
The cost of discovering this late is measured in production runs. A brand that manufactures 100,000 units against a label that can’t be sold in the United States has bought a warehouse full of packaging waste and lost a selling season. We have watched it happen to well-funded companies with good products and competent teams, because nobody told them the order of operations.
There is a second cost that is harder to see. Compliance work done late is done under time pressure, which means it is done narrowly — fix the panel, ship the container, move on. Compliance done early is a chance to make commercial decisions you cannot make later: whether to reformulate while it is still cheap, whether a claim you rely on at home can be replaced with one that survives here, whether the pack has room for what the United States requires.
This guide covers what the requirements are, the order to close them in, and where international brands most often get caught. It is not legal advice and it does not replace regulatory counsel. It is meant to make you a well-informed client of that counsel rather than a passenger.
The single most useful thing to understand early: FDA does not approve dietary supplements before they go to market. Under the Dietary Supplement Health and Education Act of 1994, responsibility for safety and labeling accuracy sits with the company placing the product on the market — not with a regulator who reviews it in advance.
This surprises brands from jurisdictions with pre-market approval regimes, and it cuts both ways. Entry is faster than they expect. It is also less forgiving, because nobody is going to tell you your label is wrong until there is a problem — and the party holding that problem is you, your importer, and increasingly your retailer.
What FDA does do is enforce afterwards. Warning letters, import alerts, detention without physical examination, seizure and injunction are all available, and the practical trigger is usually a complaint, an inspection, or a claim somebody noticed. Enforcement is not the only risk either: the Federal Trade Commission regulates advertising substantiation, and class-action plaintiffs in the United States read labels closely.
“FDA compliance” is shorthand for at least four different regimes, and which one applies is determined by what your product is rather than what you call it.
Products near a boundary — a functional beverage with supplement positioning, a topical with an active ingredient, a food with a therapeutic claim — are the ones that cost the most to get wrong, because classification determines every requirement downstream.
The order matters more than any individual item.
Steps one and two are the ones brands skip, and they are the two that cannot be fixed with money once product exists.
Where do you actually stand?
Most brands can answer three or four of these confidently and guess at the rest. The Retail Readiness Assessment tells you which ones are actually closed, in about five minutes, and names your three biggest gaps.
Take the assessmentIf one section of this guide is worth reading twice, it is this one. Labels can be redesigned in weeks. An ingredient problem can cost a year, or the product.
A dietary ingredient not marketed in the United States before October 1994 is a new dietary ingredient, and marketing it generally requires a notification submitted to FDA in advance of the product going on sale — conventionally understood as at least 75 days before marketing. The notification has to include the evidence on which you base a reasonable expectation of safety. Assembling that evidence is the slow part, not the filing.
Three patterns cause the most trouble for international brands:
Certain ingredients also carry a specific complication: substances that have been approved as drugs or subjected to substantial clinical investigation before being marketed as supplements can be excluded from the supplement category entirely. That is a formulation decision, not a labeling one, which is why it belongs before the recipe is fixed.
The practical advice is simple. Send your full formulation — every ingredient, every level, every form and extract specification, not the marketing version of the ingredient list — for review before you commit to a production run. It is the cheapest week you will spend on this project.
A compliant U.S. label is not a translated version of your domestic one. The required elements differ, the panel formats are prescribed, and the units are not the ones most of the world uses.
Serving sizes and daily values follow U.S. conventions. A panel that is accurate at home can be non-compliant here without a single ingredient changing, because the reference values and the rounding rules are different.
Panel format is prescribed, not stylistic. Type size, line weights, indentation and ordering are specified. A beautifully redrawn panel that departs from the format is a non-compliant panel.
There may not be physical room. Artwork that works at home often cannot accommodate the U.S. panel, the allergen statement, the domestic address and the disclaimer. This is a design problem discovered at the worst possible moment — after tooling, after photography, after everyone signed off.
Ingredient nomenclature differs. The name you use at home may not be the name FDA expects, and botanical ingredients generally require the plant part and Latin binomial.
Bilingual and imported-stock shortcuts fail. Overlabelling with stickers is occasionally viable for a limited element and never a strategy. Stickered product looks provisional on shelf, and buyers notice.
This is where most of the real risk sits, because claims are where marketing and regulation collide.
Statements describing how an ingredient affects normal structure or function of the body are permitted for supplements, subject to the required disclaimer and a notification to FDA within a defined window after first marketing — conventionally 30 days. They must be truthful, not misleading, and substantiated before you make them, not after somebody asks.
Statements that a product diagnoses, treats, cures, mitigates or prevents a disease turn it into an unapproved drug. This is the line brands cross most often, usually without meaning to, and often in marketing copy rather than on the label itself.
It is worth being concrete about how close the line runs:
Context creates disease claims too. A product name, an image of an affected body part, a citation to a clinical trial about a disease, or a customer testimonial describing a cure can all establish an implied disease claim even where the label text is careful. Reposting a customer’s “this cured my eczema” review is a claim you have adopted.
Claims linking a substance to a disease or health-related condition require authorization or must fall within a qualified claim framework. You cannot invent one.
FDA is not the only regulator reading your marketing. The Federal Trade Commission requires advertising claims to be substantiated, and for health-related claims the expected level of support is high. “Competent and reliable scientific evidence” means studies on the product or the ingredient at the level used, not a mechanism paper and an inference.
The practical implication for a commercial team: your website, your Amazon listing, your influencer briefs and your social media are labeling. Enforcement does not stop at the physical package, and retailers increasingly review off-pack claims before they list a brand.
Compliance is not only what the label says. It is whether you can demonstrate that what is in the bottle matches it.
Dietary supplements manufactured for the U.S. market are subject to current good manufacturing practice requirements under 21 CFR Part 111, which cover identity testing of incoming ingredients, process controls, specifications, batch records and complaint handling. Food facilities carry preventive controls obligations under FSMA: a hazard analysis, a written food safety plan, a preventive controls qualified individual, and supply chain controls.
An international manufacturer working to a domestic or EU standard is often close to this and rarely identical to it. The gaps that surface most often are documentation rather than practice — the process is sound but the records do not demonstrate it in the form an inspector or a retailer’s auditor expects.
Three things worth having before you need them:
Compliance and importation are separate problems and brands routinely solve only the first.
Food and supplement shipments generally require prior notice to FDA before arrival. Entries are screened, and shipments can be detained on labeling grounds alone — a detention that costs demurrage, storage, and often the delivery window that the purchase order depended on.
Where a U.S. entity is the importer of record, foreign supplier verification obligations apply, which means documented verification of the foreign supplier rather than a signed assurance.
There is also the possibility of appearing on an import alert, which allows detention without physical examination — every subsequent shipment held by default until you demonstrate compliance. Getting off one is slower than getting on.
Add to that customs bonds, correct tariff classification, product liability coverage that retailers will require before they list you, and freight that has to arrive against a retailer’s delivery window. None of this is conceptually difficult. All of it takes longer than brands plan for.
If your product is a low-acid or acidified canned food — and many ready-to-drink beverages are — additional registration and process-filing requirements apply, and a qualified process authority must establish the scheduled process. Brands treating an RTD beverage as though it were a supplement discover this late and it is expensive.
The classification question bites hardest here. A beverage presented as a beverage is a conventional food and carries a Nutrition Facts panel; ingredients that are acceptable in a supplement are not automatically acceptable in a food, because the standard is different.
The regulatory position changed materially with the Modernization of Cosmetics Regulation Act, which introduced facility registration, product listing, a responsible person, safety substantiation and adverse event reporting. Brands working from pre-2023 guidance are working from the wrong map.
The boundary to watch is the one with drugs. Sunscreen, anti-dandruff, acne treatment, antiperspirant and similar products are regulated as over-the-counter drugs in the United States regardless of how they are positioned elsewhere, and a cosmetic making a therapeutic claim becomes an unapproved drug.
The boundary between a conventional food with a functional benefit and a dietary supplement is determined by composition, form and representation. Getting this classification wrong changes every downstream requirement.
Animal products sit under a different framework again, with state-level feed control officials and their own ingredient definitions playing a substantial role alongside FDA. Human-supplement assumptions do not transfer.
Federal compliance is not the whole picture, and this is the part international brands are least prepared for: the United States is fifty jurisdictions with their own rules layered on top of the federal ones.
California’s Proposition 65 catches the most brands. It requires a warning where a product can expose a consumer to listed substances above defined thresholds, and it applies to things international manufacturers do not always test for — heavy metals in botanicals and marine ingredients in particular. A warning requirement discovered after a print run is the same expensive problem as a non-compliant panel, and enforcement is largely driven by private litigation rather than a regulator.
Beyond that, states differ on age restrictions for certain supplement categories, on bottle deposit and recycling labelling, on extended producer responsibility for packaging, and on ingredients some states have restricted independently of FDA. None of these is fatal. All of them are easier to design for than to retrofit.
Closing your FDA obligations does not make you sellable. Retailer vendor requirements are a separate set, they are enforced more immediately than FDA’s, and a gap here stops a purchase order regardless of how compliant the product is.
Assemble this pack once, keep it current, and the vendor onboarding conversation takes days instead of months.
Classify the product before anything else, because classification drives every other requirement. Check ingredient status before the formulation is locked, because that is the one problem money cannot solve quickly. Register the facility and appoint a reachable U.S. agent. Build the label before the print run. Confirm the manufacturing standard and have the certificates that demonstrate it. Then build the import pathway — prior notice, customs, supplier verification, insurance — and close the retailer vendor requirements, which are a separate set that will block a purchase order just as effectively.
Do it in that order and compliance is a project. Do it in any other order and it is a year.
This guide is educational and reflects our operating experience bringing brands into U.S. retail. It is general information, not legal or regulatory advice, and requirements change. Timeframes and thresholds described here are conventional understandings and should be verified against current requirements for your specific product. Confirm your obligations with qualified regulatory counsel before acting. Last reviewed August 2026.
Next in this path
U.S. Market Assessment
We'll come back with the specific FDA, labeling and import work your product needs — alongside category fit and a realistic first-year door target.
