Compliant Always
Get in touch

Selling soft drinks, juices and bottled water in the US

In the US, non-alcoholic drinks are food under FDA rules: the general labelling rules in 21 CFR Part 101 apply, and the FDA does not pre-approve labels. A drink that appears to contain juice declares its juice percentage, juice is processed under a HACCP rule, and bottled water meets its own standard of identity.

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

Labelling
21 CFR Part 101
Juice drinks
A percentage juice declaration (21 CFR 101.30)
Juice processing
HACCP under 21 CFR Part 120
Bottled water
A standard of identity (21 CFR 165.110)
Facilities
Registered with the FDA, renewed every other year

Before a product goes on sale

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

  1. 1What has to be on the label? Read more
  2. 2Does it contain juice, or appear to? Read more
  3. 3Is it sold as bottled water? Read more
  4. 4Is the facility registered, with a food safety plan where needed? Read more

The rules, by area

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

Labelling

The general food label, applied to drinks.

  • The FDA does not pre-approve labels.
  • Labels carry a statement of identity, the net quantity, the ingredients, the name and place of business, and nutrition labelling.
  • The nine major food allergens are declared.

How we help: Compliant Always sets what the label has to show beside what yours shows, with the regulation for each. Ask about this

Juice

Declaring juice content, and processing juice safely.

  • A food that purports to be a beverage containing fruit or vegetable juice, by name, label or advertising, declares its percentage of juice (21 CFR 101.30).
  • Juice sold as such, or used as an ingredient in beverages, is processed under the juice HACCP rule in 21 CFR Part 120.

How we help: Compliant Always keeps the juice percentage, the HACCP records and the supplier documents with each drink. Ask about this

Bottled water

The standard bottled water meets.

  • Bottled water is water for human consumption sealed in bottles or other containers with no added ingredients, except optional safe and suitable antimicrobial agents and fluoride within set limits.

How we help: Compliant Always keeps the source and test records for each bottled water with the product. Ask about this

Facilities and food safety plans

Registration and preventive controls.

  • Facilities that make, process, pack or hold food for consumption in the US register with the FDA, and renew every other year.
  • Covered facilities keep a written food safety plan with a hazard analysis and risk-based preventive controls.

How we help: Compliant Always keeps your registration numbers and your co-packers' certificates dated. Ask about this

Who answers for what

WhoWhat they answer forHow we help
BrandThe label, the juice declaration and the claims.The label checked against the regulations, and the paperwork behind it.
Bottler or co-packerRegistration, the food safety plan and, for juice, HACCP.HACCP and batch records kept together, ready for a customer's form.
ImporterPrior notice and supplier verification for drinks made abroad.Foreign suppliers' documents read and dated.

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

Does the FDA approve drink labels?
No. The FDA does not pre-approve labels for food products, drinks included. The business is responsible for a label that meets the requirements.
When does a drink have to declare its juice percentage?
When it purports to be a beverage containing fruit or vegetable juice, through its name, label, advertising or any other representation (21 CFR 101.30).
Does juice processing have its own rules?
Yes. Juice sold as such, or used as an ingredient in beverages, is processed under the juice HACCP rule in 21 CFR Part 120.
What counts as bottled water in the US?
Water for human consumption, sealed in bottles or other containers with no added ingredients, except optional antimicrobial agents and fluoride within set limits (21 CFR 165.110).
Does a drinks facility register with the FDA?
Facilities that make, process, pack or hold food for consumption in the US register with the FDA, and renew every other year.
Which allergens must a drink label declare?
The nine major food allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame.
Do states add their own rules for drinks?
They can, through warnings such as California's Proposition 65, and retailers often ask for more than the law requires.
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.

Get in touch

No card, no account, and no call to book. Tell us what you make and where you sell it, and we will come back to you.

Get in touch