Labelling
FDA label reviews for dietary supplements, from Supplement Facts panels to claims and ingredient lists.
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Dietary Supplements
FDA compliance for dietary supplement imports, covering labelling, ingredients, GMP, FSMA and FSVP.
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Specialist support for your route to market.
NDI & GRAS
NDI and GRAS reviews to confirm your supplement ingredients meet FDA requirements.
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GMP audits, documentation and training for dietary supplement manufacturers under 21 CFR Part 111.
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FSVP Agent services and supplier verification for dietary supplement importers.
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FSMA compliance support for dietary supplement importers and manufacturers.
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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.”
Frequently asked questions
Dietary Supplements
Requirements vary by product and destination. These answers outline the starting point for the questions we receive most often.
Ask our teamDo I need to register my dietary supplement facility with the FDA?
Yes. All U.S. and foreign dietary supplement manufacturing, packing, or holding facilities must register with the FDA and renew their registration every two years.
What are the FDA labeling requirements for dietary supplements?
Labels must include a Supplement Facts panel, ingredient list, allergen declarations, manufacturer/distributor details, and comply with health claim regulations. We can review your labels for compliance.
What happens if my supplement contains a new ingredient not previously sold in the U.S.?
You may need to submit a New Dietary Ingredient (NDI) Notification to the FDA before marketing the product. We assess your ingredients and assist with regulatory submissions.
What is the role of an FSVP Agent for supplement importers?
If you import dietary supplements from foreign suppliers, you must verify that they comply with FDA regulations under the FSVP rule. As your FSVP Agent, we handle supplier verification and FDA compliance.
What are common reasons for FDA detentions of dietary supplements?
Supplements can be detained for:
- Non-compliant labeling or missing supplement facts panel
- Unauthorized health claims on packaging or marketing materials
- Unapproved ingredients or improper NDI notifications
- GMP violations or supplier non-compliance
How can I avoid customs delays when importing dietary supplements?
Ensure all required FDA registrations, prior notices, and customs documentation are correctly submitted. We assist with compliance reviews and customs documentation preparation.
Discuss your requirements
Talk to us Talk through your product and target market with our team.
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