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FDA Labeling Compliance Services

Ensure Your Product Labels Meet FDA Requirements & Avoid Costly Import Delays

Food, dietary supplements, cosmetics, and medical devices imported into the U.S. must comply with strict FDA labeling regulations. Non-compliant labels can result in import refusals, detentions, recalls, or enforcement actions. Our FDA Labeling Compliance services ensure your product labels meet all regulatory requirements, preventing costly mistakes and ensuring smooth market entry.

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Why is FDA Labeling Compliance Important?

The FDA enforces strict labeling regulations to ensure product transparency, consumer safety, and regulatory compliance.

Common reasons for FDA labeling violations include:

  • Missing or incorrect mandatory label elements – Product name, net quantity and ingredient lists
  • Non-compliant nutrition facts panels – Incorrect formatting, serving sizes, or misrepresentation of nutrients
  • Improper allergen declarations – Missing warnings for major food allergens under FALCPA regulations
  • Misleading health claims – Unauthorized use of nutrient claims, structure-function claims, or health statements
  • Incorrect or missing supplement facts panel – Non-compliance with dietary supplement labeling rules
  • Failure to meet country of origin labeling requirements

Our FDA Labeling Compliance services help prevent regulatory violations, reduce legal risks, and streamline FDA approvals.

Labeling Services

Our FDA Labeling Compliance Services

All of the below is included in our FDA labeling compliance package

Full FDA Label Compliance Review

We will help you by conducting a comprehensive review of your product labels to ensure compliance with all FDA regulations before your products enters the U.S. 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 labeling and warning statements

Nutrition Facts & Supplement Facts Panel Review

Food and supplement labels must contain an FDA-compliant Nutrition Facts or Supplement Facts panel. We ensure that all information is formatted correctly and follows FDA standards.

  • Compliance with FDA’s 2020 Nutrition Labeling Final Rule
  • Verification of serving sizes, daily values, and nutrient calculations
  • Ingredient and additive compliance checks

Allergen Labeling Compliance

Under the Food Allergen Labeling and Consumer Protection Act (FALCPA), products containing major allergens must include proper allergen warnings. We ensure your labels meet FDA allergen declaration rules.

  • Verification of proper allergen labeling 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. We assess your ingredient list to ensure all components are approved for use in the U.S.

  • 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

Marketing claims such as “low fat,” “high in fiber,” “supports heart health” must meet FDA approval criteria. We review and validate your claims to avoid misleading statements and regulatory penalties.

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

Country of Origin & Import Labeling Compliance

Ensure your imported products must display accurate country of origin labeling (COOL) in compliance with FDA, USDA, and CBP regulations. We ensure your labels meet U.S. requirements.

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

Benefits of Our FDA Labeling Compliance Service

Expert FDA Labeling Specialists

We specialize in food, beverage, dietary supplement, and cosmetic labeling compliance.

Avoid Costly Labeling Mistakes

We help prevent import refusals, recalls, and penalties due to non-compliant labels.

Detailed Compliance Reports

Get a full compliance review with recommended corrections.

Pre-Market Approval Assistance

We help new brands and foreign manufacturers enter the U.S. market smoothly.

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 Mckay
Jane MckayAstute Beverages
I had hit a brick wall trying to get my FDA number for export of my rum to the USA. Ryan and James knew all the right contacts to sort this out for me. I could not have done it without Global Import Agent. They even sorted out my prior notification paperwork for me. I can highly recommend them.
James Singlehurst
James SinglehurstRevival Rum
Ryan, Chris and their team were exceptional in getting our food supplement product FSVP compliant. Pretty good experience with Global Import Agent overall.
Kelvin Yeo
Kelvin YeoAdvagen
Great level of service in the 3 months we have been working with Global Import Agent to date. From the first call with Fabrizzio to the comms with Ryan, James & Carlos, all has been good and the progress we are making is fantastic!
Jeff Webster
Jeff WebsterHunter & Gather
I recently had the pleasure of working with Ryan and his team for a label review of a dietary supplement, which was intended for commercialization in the United States. My experience was overwhelmingly positive, as they provided exceptional and professional support throughout the process.
Renato Di Lorenzi
Renato Di LorenziLoli Pharma
We use Global Import Agent as our FSVP agent for importing dietary supplements into the US from the EU. They've provided us with professional high-quality service thus far. Recommend!
Keiu Kadarik
Keiu KadarikEcosh Life
We were a start up working on our first import, and Global Import Agent was superb in taking care of our documentation and import process. Highly recommend.
Hee Joong Kim
Hee Joong KimMuom Life
Ryan is very helpful from the beginning to end. He responds super fast and he is on point to the issue / objectives.
Wonsik Woo
Wonsik WooLifeLab
James, Ryan and Carlos have been really helpful all along our FSVP. Great service.
Anahi Cabrera Herrera
Anahi Cabrera HerreraScience In Sport
Flexible and helpful FSVP agent. After comparing a couple of agents, this one is the one we picked. No regrets!
Andreas Edström
Andreas EdströmSwedish Signature AB
they are fast, efficient, and always open to help. They have been a great support for me and my company
Alba Rodríguez
Alba RodríguezGricha
Great to deal with, cost efficient and professional, highly recommended
Stephen Goument
Stephen GoumentGolden Turmeric
​What our clients say

Client Feedback

Read what our clients have to say about our services and how we have helped them export product.

Q. 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.

Q. 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

Q. 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.

Q. 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.

Q. 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 approval before printing.

Q. 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.

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We are always ready to answer your questions

Our team is friendly, responsive and we love to talk to people interested in what we do. Feel free to get in touch and one of our team will always get back to you. Guaranteed!

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Incorrect labeling can result in costly FDA detentions, recalls, or import refusals. Our experts ensure your labels meet all U.S. regulatory requirements, helping you avoid compliance risks and market disruptions.

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