FDA Compliance Solutions for Dietary Supplements
B2B TradeCenter provides full support for companies in the dietary supplement sector that want to sell in the U.S. market. Our team includes technical specialists, attorneys, and former FDA staff, ensuring full compliance with applicable regulations.
FDA Registration
U.S. Agent Services
Product Review
Product Compliance
FDA Registration made Simple
FDA registration for dietary supplement facilities can be a complex process, but we make it simple and stress-free. Our team of specialists will guide you through each step to ensure your facility is properly registered with the FDA.
Here’s how our process works:
1
Fill out our comprehensive intake form Submit your company details and our team will guide you in completing the form and providing the required documentation.
2
Obtain your FFR registration with the FDA! We handle the submission of all necessary information and documents to the FDA, addressing any potential issues along the way.
3
Receive the official registration certificate and proof of registration. We provide all account data, along with the official confirmation required by the FDA.
Get registered now!U.S. Agent Services for FDA Communication
The FDA requires foreign companies to appoint a U.S. Agent. We serve as your reliable point of contact, offering much more than standard representation.
Speak with a U.S. Agent
Accurate reports on your facility identifiers (DUNS, UDI, FEI)
Ongoing updates to your FDA registration
Forwarding of FDA notifications with response support
Review of Dietary Supplement Labels
Avoid detentions and rejections due to incorrect labeling. Our expert team reviews and adapts your label to meet all FDA compliance requirements.
Translation with suggested changes
Review of claims, mandatory sections, and formatting rules
Detailed report with corrective actions
Optional print-ready label design service
Supplement Facts Panel & Ingredient Compliance
Compliance with the Supplement Facts panel and ingredient list is essential. We technically review both to ensure everything complies with current regulations.
Supplement Facts Panel:
Serving sizes and applicable exemptions
Rounding rules and % Daily Value
Layout recommendations based on label size
Ingredient List:
Compliance review for GRAS, food additives, and colorant
Ingredient names and functions according to FDA records
Published safety reports as supporting documentation
FSVP Compliance (Foreign Supplier Verification Program)
U.S. importers are required to ensure their foreign suppliers meet FDA standards. We offer complete FSVP solutions, from plan creation to execution.
FSVP plan development and review
Acting as FSVP Agent for foreign exporters
Ensuring compliance at the point of entry when no U.S. buyer exists
Still have questions about our services?
Read the most common questions
from
B2B TradeCenter
clients
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What is the FDA?
The FDA (Food & Drug Administration) is the U.S. federal agency responsible for regulating food, beverages, dietary supplements, and other products to ensure safety and public health in the United States. To sell dietary supplements to the U.S., you must comply with FDA regulations.
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What is FDA Registration?
FDA registration is required for facilities that manufacture, pack, or hold dietary supplements intended for the U.S. market. It allows the FDA to monitor and inspect foreign operations.
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Do I need a U.S. Agent?
If you are a foreign company, then you must designate a U.S. Agent when registering with the FDA. The agent serves as the official contact for the FDA and assists with urgent communications and compliance issues.
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What is considered a dietary supplement by the FDA?
The FDA defines a dietary supplement as a product intended to supplement the diet and contain one or more dietary ingredients, such as vitamins, minerals, herbs, amino acids, or other substances.
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Do you help with labeling and ingredient review?
Yes. We review your product’s label and ingredient list to ensure compliance with FDA requirements, including Supplement Facts formatting, allowed claims, allergen declarations, and permissible ingredients.
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Do you offer FSVP services?
Yes. The Foreign Supplier Verification Program (FSVP) is an FDA requirement that holds U.S. importers responsible for verifying and documenting that imported supplements meet FDA food safety standards. We serve as FSVP Agents, prepare verification plans, evaluate supplier histories, and maintain FDA-required records.
