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US market entry

US marketing compliance for foreign brands: what you can claim and sell.

A product that sells legally at home can still stall at the US border, get pulled from Amazon, or draw regulator attention because of one sentence on the box.

US rules are split across several agencies: the FTC polices advertising claims, endorsements and Made in USA; the FDA covers food, cosmetics, supplements and medical devices; the FCC authorizes most electronics; the CPSC covers consumer and children's products; CBP enforces country of origin marking; and California adds Prop 65. On top sit Amazon, Google and Meta policies that often go further than the law. Theory Road plans the marketing around these rules and builds claims review into the launch, working alongside your attorney, regulatory consultant and customs broker, who own the legal calls.

Questions this page answers

  • Which US agencies regulate my product and my marketing claims
  • Do foreign food companies need FDA registration
  • Does my electronic product need FCC certification
  • What CPSC requires from importers of consumer products
  • Do I need a Prop 65 warning to sell online
  • How country of origin labeling works for imports
  • Can I call my product Made in USA

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US marketing compliance

What the US market asks of you.

The US regulates marketing mostly through claims, not through a single product approval. The FTC expects advertisers to hold a reasonable basis for objective claims before they run, and health claims generally need competent and reliable scientific evidence. Your product category decides the rest: the FDA for food, cosmetics, supplements and devices, the FCC for most electronics, the CPSC for consumer and children's products. Imported goods generally need their country of origin marked for CBP. The words on packaging, listings, ads and creator posts all count as claims, so compliance is a marketing workstream as much as a legal one.

Most trouble starts with copy that was fine at home. A translated supplement description slips into a disease claim, which US regulators treat as a drug claim. A skincare line promising to repair skin can drift toward drug territory. A Bluetooth speaker ships without FCC authorization and the listing is suppressed. A toy arrives without a Children's Product Certificate based on accepted lab testing. Creators post without clear disclosure, or the launch leans on incentivized reviews. Then retailers ask for a Prop 65 position and liability insurance nobody planned for, and the launch date slips while everyone waits on documents.

We start with a claims inventory: every statement across packaging, listings, the website, ads, emails and creator briefs, sorted by the rule it touches and the evidence behind it. Your attorney or regulatory consultant decides what is allowed; we turn their decisions into an approved claim library, a banned words list and platform-ready copy. We check Amazon, Google and Meta category rules before creative is made, collect the certificates retailers and marketplaces ask for, and route every new claim through the same review before it runs. The launch does not have to be rewritten after the first takedown.

The launch, phase by phase
  1. Weeks 1 to 2Claims and category inventoryEvery claim listed with its source, category rules mapped by agency, and open questions flagged for your attorney and broker.
  2. Weeks 2 to 4Counsel review and evidence fileYour attorney or regulatory consultant rules on claims while we gather substantiation, certificates and test reports in one place.
  3. Weeks 4 to 6Approved copy and platform checksClaim library, banned words list and channel versions for Amazon, Google, Meta and your own site.
  4. Weeks 6 to 8Creator, review and retail packsDisclosure rules in creator briefs, review requests that follow FTC and Amazon policy, and document packs for retail buyers.
  5. OngoingReview gate for new claimsNew ads, listings and emails pass the same documented review before they run, with changes logged.
US marketing compliance

Where US launches stall.

  • Translated claims that change meaning

    Copy approved at home often turns into a disease, drug or performance claim once translated. US regulators read a claim the way a consumer would, so phrasing that sounded modest in the original can need evidence or removal.

  • More than one agency per product

    One product can sit under the FDA, FCC and CPSC at once, for example a heated massager with Bluetooth. Teams often discover the second or third set of rules only when a marketplace asks for documents.

  • Reviews and creator content

    The FTC's Endorsement Guides and its 2024 rule on fake reviews and testimonials cover incentivized reviews, undisclosed creator posts and review suppression. Launch playbooks built on seeded reviews abroad often need rethinking for the US.

  • Platforms that go further than the law

    Amazon, Google and Meta restrict some categories, claims and imagery beyond what federal law requires, and enforce through suppression or suspension. A claim your attorney accepts can still fail platform review, so both need checking.

Theory Road

What we run for you.

Talk to us about your US launch
  • Claims inventory and library

    We catalog every claim across packaging, listings, the website, ads and creator content, then maintain an approved claim library that your team and every agency partner write from.

  • Counsel coordination

    We prepare the questions, evidence and draft copy for your attorney or regulatory consultant, so their time goes to decisions, and we turn those decisions into usable marketing language.

  • Marketplace and ad platform readiness

    We check Amazon category approvals and document requests, Google and Meta ad policies, and store content against the approved claims before anything goes live.

  • Creator and review program

    Creator briefs with clear disclosure requirements, review request flows that follow FTC rules and Amazon policy, and monitoring of what creators actually post.

  • Packaging copy handoff

    We draft consumer-facing packaging and listing copy from the approved library and hand it to your regulatory team, who own required label elements, warnings and origin marking.

  • Ongoing review gate

    Every new ad, listing change and email passes a documented check before launch, so compliance holds as the marketing scales and more people write copy.

United States

How US demand gets built.

Amazon USStrictest document checks; category approvals, test reports and listing claims reviewed firstBefore listings go live
Shopify or your own storeApproved claim library applied to product pages, FAQs, warnings and policiesBefore store launch
Google Ads and ShoppingHealthcare, supplement and restricted category policies checked against copy and feedsBefore campaigns launch
Meta adsCopy and imagery checked for health, before and after, and personal attribute rulesBefore the first creative test
Creators and influencersBriefs with disclosure rules, posts monitored after publishingFrom first product seeding
Retail and distributionBuyer document packs: certificates, insurance, Prop 65 positionBefore buyer meetings
Email and SMSClaims match the library; SMS consent language set with counselAt list launch
Compliance

US rules to plan for.

  • FTC advertising and endorsements.

    Objective claims need evidence before they run, endorsements need clear disclosure, and fake reviews can bring penalties. Unqualified Made in USA claims require all or virtually all US content. Your attorney owns the legal read.

  • FDA registration and product claims.

    Food facilities register and renew in even-numbered years, and foreign facilities need a US agent. Importers carry FSVP duties, cosmetics fall under MoCRA, supplements follow DSHEA. Your regulatory consultant owns these filings.

  • FCC and CPSC product rules.

    Most electronics need FCC equipment authorization before marketing. Many consumer products need certificates of conformity, and children's products need testing by a CPSC-accepted lab. Your compliance team and testing lab own this.

  • Prop 65 and origin marking.

    California's Prop 65 can require warnings for listed chemicals, including on online listings. CBP generally requires imports to be marked with country of origin. Your attorney and customs broker own these decisions.

A good fit

  • Supplement, food, beauty, pet or electronics brands whose category draws regulator or marketplace scrutiny in the US.
  • Brands with strong claims at home that need to be tested against US substantiation rules before launch.
  • Teams that have, or will hire, a US attorney or regulatory consultant and want marketing to work from their decisions.

Probably not a fit

  • Companies looking for a legal opinion, FDA filing service or customs brokerage; those belong with licensed professionals we coordinate with.
  • Brands that want to keep aggressive claims and deal with problems only after a platform or regulator complains.
Perspectives

Reading before a US launch.

FAQ

Questions from founders abroad.

Q01
Does Theory Road provide legal or regulatory advice?
No. We are a growth firm, not a law firm, regulatory consultancy or customs broker. We map where your marketing touches US rules, prepare the questions and evidence, and turn your attorney's or consultant's decisions into approved copy and platform-ready listings. If you do not have US counsel yet, we can describe the kind of specialist to look for, but the legal calls stay with them.
Q02
Do foreign food companies need FDA registration
In general, yes. Facilities that manufacture, process, pack or hold food for US consumption register with the FDA, renew in every even-numbered year between October and December, and foreign facilities must name a US agent. US importers also have Foreign Supplier Verification Program duties, and food shipments need prior notice. Confirm what applies to your products with a regulatory consultant or attorney at the time of launch.
Q03
Does my product need FCC certification?
Most electronics that emit radio frequency energy need FCC equipment authorization before they are marketed in the US. Devices with radio transmitters, such as Wi-Fi or Bluetooth, usually need certification through an accredited certification body, while some other devices can use a Supplier's Declaration of Conformity. Your testing lab or compliance consultant decides the route; we make sure listings and packaging reflect it.
Q04
Can a foreign brand say Made in USA if it assembles here?
Only with care. The FTC standard for an unqualified Made in USA claim is that all or virtually all of the product is made in the US, and its labeling rule allows civil penalties. A qualified claim, such as assembled in USA from imported parts, may work in some cases if it is accurate. Customs origin rules differ from FTC rules, so your attorney and customs broker should review both.
Q05
What does Prop 65 mean for brands selling online?
If a product can expose California consumers to a chemical on the Prop 65 list, a clear warning may be required, and for online sales the warning generally has to be shown before purchase. Retailers often ask suppliers for a written position. Your attorney decides whether a warning applies to your products; we place the approved warning language everywhere the product is sold.
Q06
How do Amazon, Google and Meta policies differ from the law?
They are private rules and are often stricter. Amazon can require category approval, test reports or certificates before listing, and may suppress listings with certain claims. Google and Meta restrict health, supplement and weight loss claims and some imagery in ads. We check these policies at the time of launch and build them into the claim library alongside your counsel's decisions.
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