A Grupo Nativot Company Est. 2012

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Beverages and juices ready for the U.S.

Juices, nectars, ready-to-drink and shelf-stable beverages follow the FDA food rules plus a few of their own. We identify which apply to your drink and help you meet them.

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Unlabeled glass carafes of green, orange and red juice with pineapple, grapes, carrots, citrus and berries on a glossy table.

Beverage categories we support

Choose the closest category to start an assessment with it already selected.

Stainless steel processing tanks and sanitary piping in an industrial plant.

How we can help

A beverage is a food for FDA. These are the requirements we review first.

  • Facility registration and U.S. Agent

    The facility that makes or packs the beverage must register, and foreign facilities need a U.S. Agent.

  • Juice HACCP

    Juice processors need a HACCP plan under 21 CFR 120, including the required pathogen reduction.

  • Labeling

    Nutrition Facts, ingredients, allergens and the percentage juice declaration.

  • Canned and acidified beverages

    Support with FCE registration and process filing when the product is low-acid canned or acidified.

  • GMP and preventive controls

    Readiness for 21 CFR 117 in the bottling or packing facility.

  • Prior Notice

    Required for each imported shipment, like any other food.

A beverage with added vitamins or botanicals may be a conventional food or a dietary supplement depending on how it is labeled and represented. We assess the classification before the label.

Key FDA regulations for beverages

Key FDA regulations for beverages
Reference Topic Why it matters
21 CFR 120 Juice HACCP Hazard analysis and the 5-log pathogen reduction for juice.
21 CFR 101 Food labeling Nutrition Facts, ingredients, allergens and percentage juice declaration (101.30).
21 CFR 117 cGMP and preventive controls How the bottling or packing facility must operate.
21 CFR 108, 113, 114 Low-acid canned and acidified foods Applies to canned or acidified beverages.
21 CFR 1, Subparts H & I Registration and Prior Notice Facility registration, U.S. Agent and shipment notices.

Our process

  1. Regulatory assessment

    Product, formula, process and packaging.

  2. Gap analysis

    What is missing for the U.S., in order.

  3. Compliance implementation

    Registration, HACCP support, labels and documents.

  4. U.S. market readiness

    Prior Notice and importer requirements.

  5. Ongoing support

    Renewals, updates and questions within your scope.

Beverage export FAQs

Does my juice need a HACCP plan?

Yes. Juice processors must operate under a HACCP plan according to 21 CFR 120, which includes a process that achieves a 5-log reduction of the pertinent pathogen.

Is my functional drink a beverage or a supplement?

It depends on how it is labeled, marketed and consumed. FDA has guidance to distinguish liquid dietary supplements from beverages; we review it before you print labels.

Do beverages need Prior Notice?

Yes. Beverages are food for FDA, so each imported shipment needs Prior Notice.

Does FDA approve my beverage before export?

No. FDA does not approve conventional beverages before they are sold. The facility must be registered and the product must comply with the applicable rules.

Tell us about your beverage

Call or WhatsApp us with the type of drink and how it is packed. We will tell you which rules apply.

Ready to export your beverages?

Start with an assessment of your product and process.