Selling dietary supplements in the U.S., whether vitamins, mineral blends, herbal formulas, collagen products or similar wellness items, is a high-demand and closely regulated field. For brands that want to compete in this segment, a quality product alone is not enough; technical requirements such as facility registration, laboratory verification and labeling now need to be met in full. We cover the topic in more detail in our article What Is an Export Service?
Oversight carried out by the FDA under FSVP is now built directly into online marketplaces, Amazon in particular. Manufacturers shipping to the U.S. therefore need to manage both production and documentation in line with these regulations.
Within this framework, we manage U.S.-focused compliance, registration and Amazon listing work end to end, helping manufacturers enter the market on solid ground.
Legal and Technical Framework for Positioning Dietary Supplements in the U.S.
Vitamin, mineral, collagen, amino acid and herbal formulas fall under DSHEA in the U.S. Legally they are classified as dietary supplements, but the oversight criteria are applied with a rigor close to that of drug categories.
Any company planning to ship products in this category to the U.S. faces a set of mandatory notifications and quality verifications.
Core Requirements for Manufacturers and Suppliers
- FDA Food Facility Registration: officially registering the production facility
- COA (Certificate of Analysis): providing results for ingredient content, microbiological parameters and heavy metals
- GMP certificate: certification that the facility operates under Good Manufacturing Practices
- FDA labeling standards: preparing the Supplement Facts panel, ingredient statement, serving information and manufacturer details in the correct format
- FSVP agent designation: identifying the party responsible for the FSVP process in the U.S.
These requirements are the core compliance items requested both at U.S. customs and in the review processes of online marketplaces.
Amazon’s Policies for Wellness Products
Because Amazon builds U.S. regulations into its own platform standards, sellers who want to list in the wellness category go through a thorough verification process before selling. Lab documents, manufacturing standards and label compliance sit at the center of that process.
COA (Certificate of Analysis) Requirement
Amazon requires a current certificate of analysis from an accredited laboratory for each product. The report technically confirms that the product contains what the label declares.
Without a COA, listing and selling steps generally cannot be completed. We coordinate testing with laboratories that meet accreditation requirements, helping manufacturers meet the documentation requirement in full.
Demonstrating GMP Compliance
A GMP certificate showing that the facility follows Good Manufacturing Practices is one of the main documents Amazon requests. The certificate should clearly show the manufacturer name, address and the accredited body that issued it.
Our team helps facilities meet the compliance requirements and complete a GMP certification process that Amazon accepts.
Label Layout and FDA Compliance
Label design is one of the most sensitive regulatory points for wellness products shipped to the U.S. The Supplement Facts panel must use the correct format, and the serving size declaration, ingredient list and manufacturer information must all be complete.
In addition, the label cannot carry health claims or promises of medical benefit. Our team works to bring labels in line with FDA rules.
Letter of Guarantee (LoG)
For some products, Amazon asks the manufacturer for an additional letter of commitment. This document states that the product is manufactured correctly, that the ingredients are genuine and that the label information is accurate.
Why Label Compliance Reviews Matter
Dietary Supplement Sales Service for the U.S. – U.S. authorities review the wording used on labels closely. Misleading or unverifiable claims may lead to the product being removed from Amazon and refused at customs inspection.
For this reason, bringing labels in line with regulations is one of the most important steps of the whole process. We offer a professional label compliance service to help brands pass these checks smoothly.
FSVP (Foreign Supplier Verification Program) and Agent Designation
Companies shipping wellness products to the U.S. need a U.S.-based party under the FSVP framework. If the company has no U.S. entity, a representative registered in the FDA system is designated so that customs procedures can run smoothly.
This representative:
- Handles all correspondence with the FDA
- Provides the required technical documents during inspections
- Acts as the official point of contact when products enter the U.S.
Together with our partners in the U.S., we manage FSVP representation directly on behalf of manufacturers.
Compliance Steps for Amazon
Offering products in Amazon's wellness category means more than creating a listing. The following steps need to be carried out systematically:
- Facility registration
- FSVP agent designation
- Verification of analysis reports
- GMP certificate review
- Label compliance and revisions
- Seller Central listing and category service
We coordinate this process end to end, drawing on our U.S.-focused experience.
Strategic Recommendations for Sellers
Long-term success in the U.S. market depends not only on sales volume but also on consistent, well-managed compliance.
- Review your labels and documents again with every new batch or formula update
- Keep your documents up to date so you are prepared for inspection requests
- Manage communication with your official representative professionally so customs clearance goes smoothly
- Plan ahead to avoid delays during Amazon's periodic document checks
At this stage, we help manufacturers meet both FDA and Amazon requirements accurately and on time.
Our Role
For manufacturers who want to work in the U.S. wellness category, we manage the technical and regulatory processes under the following headings:
- Facility registration
- FSVP representation
- Label and formula compliance review
- COA and GMP document coordination
- Amazon category and listing service
All our services are carried out together with authorized partners for the U.S. market.
Frequently Asked Technical Questions
Is facility registration mandatory?
Yes. Facilities shipping wellness products to the U.S. need to be registered in the FDA system.
Why is an FSVP agent needed?
When there is no U.S. party to take on import responsibility, the FDA requires an official representative to be designated.
Does the FDA pre-approve products?
No. The FDA does not approve these products before they go on the market; it verifies facilities, documents and processes.
Why does Amazon ask for an analysis report?
Because the COA serves as evidence of product quality, Amazon accepts only current reports from accredited laboratories.
Why is label layout so important?
Incorrect declarations may lead to suspension of the Amazon account and refusal at customs.
Entering the U.S. Market Safely
For brands that want a place in the U.S. wellness category, managing compliance professionally is a basic condition for commercial success.
Once facility registration, analysis documents, GMP standards and FSVP representation are complete, products are ready for long-term, well-grounded sales in the U.S. market.
For our dietary supplement sales service for the U.S., Contact Us
Last updated: October 6, 2026
