Global Import Agent
Food & Beverage

Food & Beverage FDA Labelling Compliance

Food sold in the United States must carry a label that meets FDA's rules in 21 CFR Part 101: a statement of identity, net quantity of contents, ingredient list, Nutrition Facts, and the name and place of business of the manufacturer, packer or distributor, plus a major food allergen declaration. Global Import Agent reviews your labels against these rules before you print.

· By the Global Import Agent team
Overview

What must a US food label include?

Core FDA food-label elements include the following.

We can also train your team to apply these requirements consistently.

  • A statement of identity.
  • The net quantity of contents.
  • An ingredient list and Nutrition Facts.
  • The name and place of business of the manufacturer, packer or distributor.
  • A major food allergen declaration.
Cargo containers moving through an international port

Full FDA Label Compliance Review

We review your product labels against FDA regulations before your products enter the US market.

  • Verification of all required label elements (e.g., product name, net weight)
  • Review of nutrition facts or supplement facts panels for proper formatting
  • Compliance check for allergen labelling and warning statements

Nutrition Facts & Supplement Facts Panel Review

Food and supplement labels must carry an FDA-compliant Nutrition Facts or Supplement Facts panel, and we check its formatting and content.

  • Compliance with FDA's 2020 Nutrition Labeling Final Rule
  • Verification of serving sizes, daily values, and nutrient calculations
  • Ingredient and additive compliance checks
Product documentation being reviewed for compliance
Food & Beverage

Food & Beverage FDA Labelling Compliance

Allergen Labelling Compliance

Under FALCPA, products containing major food allergens must declare them correctly, and we check your labels against FDA allergen declaration rules.

  • Verification of proper allergen labelling for the top 9 allergens
  • Correct placement of allergen statements
  • Review of cross-contact warnings for manufacturing facilities

Ingredient List & Additive Compliance Review

The FDA regulates food additives, preservatives and dietary supplement ingredients, and we check that every component of your ingredient list is permitted in the US.

  • Verification of GRAS (Generally Recognized as Safe) for additives
  • Identification of unapproved or restricted ingredients
  • Label formatting to meet FDA ingredient declaration rules

Health & Nutrient Content Claims Compliance

Claims such as "low fat", "high in fiber" or "supports heart health" must meet FDA criteria, and we review yours to avoid misleading statements.

  • Review of structure-function, nutrient content, and health claims
  • Verification of claim substantiation with scientific evidence
  • Review of organic, non-GMO, and gluten-free labelling compliance

Country of Origin & Import Labelling Compliance

Imported products must show accurate country of origin labelling under FDA, USDA and CBP rules, and we check your labels against these requirements.

  • Verification of mandatory country of origin labelling
  • Correct formatting and placement of country declarations
  • Compliance with USDA regulations for meat, dairy, and produce

Ongoing compliance support

  • Time-Saving

    One full label review covers every mandatory element, so you aren't chasing issues after shipping.

  • Regulatory Assurance

    Nutrition Facts, allergen and claims checks aligned with current FDA labelling rules.

  • Peace of Mind

    Catch labelling errors before they cause import delays, detentions or misbranding issues.

What you'll need

Send us the full label artwork plus the product facts behind it.

  • Complete label artworkEvery panel, including product name and net weight.
  • Nutrition or Supplement FactsThe panel as it will appear, with serving sizes.
  • Allergen informationWhich of the top 9 allergens are present or cross-contact risks.
  • Claims you plan to makeHealth, nutrient content, organic or gluten-free wording.
  • Country of originHow and where origin is declared on pack.
Free tool

Official sources

Related services: FDA labelling training

Client feedback

Trusted support, in our clients’ own words.

“Global Import Agent have successfully worked with me to land product in the U.S and remain compliant for FDA regulations. I'm really happy with their response times, and easy to use tech platform that facilitates the process.”
Jane MckayAstute Beverages
Frequently asked questions

Food & Beverage FDA Labelling Compliance

Requirements vary by product and destination. These answers outline the starting point for the questions we receive most often.

Ask our team

What products need FDA-compliant labeling?

All food, beverage, dietary supplement, cosmetic, and OTC drug products require FDA-compliant labels before being sold in the U.S.

What are the mandatory label elements for FDA compliance?

Labels must include:

  • Product name (Statement of Identity)
  • Net quantity of contents (weight or volume)
  • Ingredient list in descending order
  • Nutrition Facts or Supplement Facts panel
  • Allergen declarations (if applicable)
  • Manufacturer or distributor name and address

Can I make health or nutrient claims on my product label?

Yes, but all health-related claims must meet FDA guidelines. Claims such as:

  • “Supports immune health” (structure-function claim)
  • “Low in cholesterol” (nutrient content claim)
  • “Reduces risk of heart disease” (health claim)

Must be scientifically substantiated and formatted within FDA rules to avoid misbranding violations.

What happens if my labels do not comply with FDA regulations?

  • The FDA can detain or refuse entry of your products at U.S. ports.
  • You may face fines, recalls, or legal penalties for misbranded products.
  • Non-compliant labels may result in increased FDA scrutiny for future shipments.

How can I ensure my labels are FDA-compliant before shipping?

  • Conduct a pre-import label compliance review.
  • Verify nutrition facts, ingredient lists, and allergen declarations.
  • Ensure claims are backed by FDA-accepted evidence.
  • Work with an FDA compliance expert for label compliance review before printing.

Can you help with FDA labeling compliance?

Yes, we offer comprehensive labeling compliance services, including reviewing your product labels to ensure they meet FDA requirements for nutrition facts, allergen statements, claims (e.g., "organic"), and more.

Read more

Further reading

Discuss your requirements

Talk through your product and target market with our team.

Talk to an expert Get started

Consultation

Tell us what you need to import.

Share your product, target market and compliance question. A member of our team will respond promptly.

Scope your product and target market
Identify the applicable regulatory route
Receive a clear proposal and next steps