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Selling consumer products in the US

In the US, the product decides the regulator. The FDA covers food, formula, pet food, cosmetics and food contact materials; TTB alcohol labels; the CPSC toys and other consumer products; the FTC textile and energy labels; the EPA disinfectants; the FCC radio devices. Most labels need no prior approval, and states can add rules.

Updated · Each section links to the official source it comes from

Food, formula, pet food, cosmetics, food contact
The FDA
Alcohol labels
TTB, with a certificate of label approval
Toys and other consumer products
The Consumer Product Safety Commission
Textile and energy labels
The Federal Trade Commission
Disinfectants
The EPA, as pesticides under FIFRA
Radio and digital devices
The FCC
Food label approval
None: the FDA does not pre-approve labels
States
Can add their own rules, such as Proposition 65

By product

What each kind of product has to meet in the US.

Before a product goes on sale

The questions to answer, in the order they usually come up.

  1. 1Which agency regulates the product? Read more
  2. 2Does the facility register, or the label need approval? Read more
  3. 3Does the product need testing, a certificate or an authorisation before sale? Read more
  4. 4Does it come in from outside the US? Read more
  5. 5Which states will it be sold in? Read more

The rules, by area

What each area covers, the texts that set it, and what the official pages say.

Who regulates what

The agency, and what it asks before a product is sold.

  • Food and supplement facilities register with the FDA and renew every other year; the FDA does not pre-approve food labels.
  • Cosmetic facilities register with the FDA every two years, and each cosmetic product is listed with its ingredients under MoCRA.
  • Distilled spirits bottled in the US need a TTB certificate of label approval before bottling.
  • Consumer products subject to a CPSC rule are certified to it in a certificate of compliance.

How we help: Compliant Always works out which of these apply to your product and keeps the documents behind each one ready. Ask about this

What happens before sale

Registrations, notifications, certificates and authorisations by product class.

  • A new infant formula is registered with the FDA and notified at least 90 days before marketing; the FDA does not approve formulas.
  • Children's products, toys among them, are tested by a CPSC-accepted third party laboratory and certified in a Children's Product Certificate; toys meet ASTM F963-23.
  • Radio frequency devices are authorised before marketing, by FCC certification or a Supplier's Declaration of Conformity.
  • Disinfectants and other pesticides are registered with the EPA under FIFRA, with certain exceptions.
  • Textile products carry fibre content, country of origin and identity labels under FTC rules, and clothing carries a care label.
  • Pet food and food contact materials have no product approval, but ingredients and substances must be permitted for their use.

How we help: Compliant Always works out which pre-sale steps apply to your product and keeps the registration, certificate or test report behind each, dated. Ask about this

Recalls and safety reporting

What a business tells a regulator when something goes wrong.

  • Firms report to the CPSC within 24 hours of obtaining information that reasonably supports the conclusion that a consumer product fails a CPSC rule, has a defect that could create a substantial product hazard, or creates an unreasonable risk of serious injury or death.
  • Infant formula recalls are reported to the FDA by telephone within 24 hours of the decision, with written reports at least every 14 days.
  • Cosmetic serious adverse events are reported to the FDA within 15 business days under MoCRA.

How we help: Compliant Always ties each document to the product and lot it covers, so the facts behind a report are in one place. Ask about this

Import

What importers owe for products made outside the US.

  • Food importers give prior notice of shipments and follow a Foreign Supplier Verification Program for each food and foreign supplier.
  • Importers of consumer products that must be certified eFile the certificate data with US Customs and Border Protection at entry.
  • Radio frequency devices may be imported only with a valid FCC authorisation, where none is needed, or under limited exceptions.
  • Importers of pesticides, disinfectants included, submit a Notice of Arrival to the EPA before the shipment arrives.

How we help: Compliant Always reads your foreign suppliers' documents as they arrive and keeps them by product and supplier. Ask about this

Who answers for what

WhoWhat they answer forHow we help
BrandThe label and claims of what it sells, and often the responsible person's duties.The rules that apply, with the paperwork behind each, in one place.
ManufacturerFacility registration, manufacturing practice and certificates.Specifications, test reports and certificates ready for each customer's form.
ImporterSupplier verification, prior notice, certificate eFiling and, for children's products, the CPC; Notice of Arrival for pesticides.Foreign suppliers' documents read and dated before the goods ship.
Registrant or granteeAn EPA pesticide registration or an FCC grant, and the label or device it covers.Registrations and grants kept with each product and label version.

Federal and state

Federal agencies set the national rules. States can add their own: California's Proposition 65, for example, can call for a warning on a product sold there.

Retailers and marketplaces often ask for more than the law does, such as test reports by lot or third party certificates.

Questions businesses ask

Which US agency regulates my product?
The FDA: food, supplements, drinks, infant formula, pet food, cosmetics and food contact materials. TTB: alcohol labels. CPSC: toys and other consumer products. FTC: textile and energy labels. EPA: disinfectants. FCC: radio frequency devices.
Does the FDA approve labels before sale?
Not for food: the FDA does not pre-approve food labels, and the business is responsible for getting them right. Distilled spirits bottled in the US need TTB label approval.
Which businesses register with the FDA?
Facilities that make, process, pack or hold food, supplements included, renewed every other year, and facilities that manufacture or process cosmetics, renewed every two years.
What do importers into the US owe?
For food, prior notice and a Foreign Supplier Verification Program; for consumer products that must be certified, the certificate data eFiled with Customs at entry.
Do toys need third party testing in the US?
Yes. Toys are children's products: they are tested by a laboratory whose accreditation the CPSC has accepted, and certified in a Children's Product Certificate.
Is a disinfectant regulated as a cleaning product or a pesticide?
As a pesticide. The EPA states that disinfectants are pesticides, registered under FIFRA; non-pesticide household cleaners fall under the CPSC's hazardous substances rules.
Does an electronic product need FCC authorisation?
If it emits radio frequency energy, usually: transmitters are certified, and most digital devices use a Supplier's Declaration of Conformity or certification, before marketing.
When must a product defect be reported to the CPSC?
Within 24 hours of obtaining information that reasonably supports the conclusion that a product fails a CPSC rule, has a substantial product hazard, or creates an unreasonable risk of serious injury or death.
Do states have their own product rules?
Yes. California's Proposition 65, for example, can call for a warning, and states set their own rules on alcohol sales and often on pet food labels.
How does Compliant Always help with selling in the US?
Our team reads the rules for the markets you sell in. Compliant Always shows which apply to your product, keeps the documents behind each one ready, and watches federal sources for changes. It shows what the requirements say and what your documents show; you decide.

Sources

Compliant Always is a product of Lettuce Labs LLC. It shows what requirements say and what your documents show. It is not legal advice, and you decide.

Tell us what you make, and we will show you the rules for it.

Name the product and the markets you sell in. We will come back to you with what applies in the US and what your paperwork needs to show.

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