SOLVING YOUR FDA NEEDS
Compliance Solutions for Importers and Exporters of Food, Beverages and Dietary Supplements
OUR MOST POPULAR SERVICES
US Imports makes registering your facility with FDA quick and easy. We can serve as the U.S. Agent for food facilities located outside the United States.
All U.S. and foreign facilities that manufacture, process, pack or store food, beverage or dietary supplements to be consumed in the United States must register with U.S. Food and Drug Administration (FDA). Facilities not located in the United States must appoint a U.S. Agent physically located in the United States to communicate with FDA. Upon registration you will receive a certificate confirming your FDA facility registration number.
What’s included:
FDA Food Facility Registration submission
U.S. Agent designation for foreign facilities
Official FDA-issued registration number
Certificate confirming registration
Ongoing U.S. Agent representation for FDA communications
Who it’s for:
Manufacturers, processors, packers, or storage facilities — U.S. or foreign — that handle food, beverages, or dietary supplements intended for U.S. consumption.
FAQ:
Do I need a U.S. Agent? Only if your facility is outside the United States. Domestic facilities register directly.
How long does registration take? Typically 1–2 business days after we receive your facility information.
Does FDA registration expire? Yes. Renewal is required every even-numbered year (Oct–Dec window).
This is an annual subscription. Your card will be charged $689 today and automatically renewed every 12 months at the same price unless you cancel. You can cancel anytime from your account at usimports.us/account. We'll email you a reminder 7 days before each renewal.
The Foreign Supplier Verification Program (FSVP) rule requires every U.S. food and dietary supplement importer to develop, maintain, and follow an FSVP Plan. Products without an adequate FSVP Plan can be refused entry at U.S. ports. We build your plan from the ground up, customized to your products and suppliers.
What's Included:
Custom-built FSVP Plan tailored to your product and supplier(s)
Foreign supplier hazard analysis and risk evaluation
Supplier verification activity recommendations (on-site audit, sampling, records review — whichever matches your risk profile)
Corrective-action procedures documented per FSMA requirements
Records retention guidance for FDA inspection readiness
One round of revisions included after your review
Who It's For:
U.S. importers of human food, beverage, or dietary supplements sourcing from foreign suppliers. FSVP applies regardless of company size. If you import food into the U.S. for resale, you almost certainly need a plan.
FAQs:
Q: How is FSVP Plan different from FSVP Agent?
A: The Plan is the written program. The Agent is the qualified individual responsible for performing the FSVP activities in the U.S. — many importers without a U.S. presence buy both. The Plan is the document; the Agent is the human implementation.
Q: How long does it take to build a plan?
A: Typically 2–3 weeks from intake to final deliverable, depending on how many suppliers and product categories are involved.
Q: Does FDA approve my FSVP Plan?
A: No. FDA doesn't pre-approve plans. You must develop, maintain, and follow your plan; FDA inspects it on demand.
The Foreign Supplier Verification Program (FSVP) rule requires importers to perform risk-based activities to verify that food brought into the U.S. meets U.S. food safety standards. Foreign importers with no U.S. employees must designate a qualified individual physically located in the United States to carry out those FSVP responsibilities. US Imports serves as that qualified FSVP Agent.
What's Included:
Qualified-individual FSVP Agent service per product (select 1, 2, or 3 products on this page)
Direct point of contact with FDA on your behalf
All FSVP records maintained in the U.S. per 21 CFR 1.510
Annual review of supplier verification activities
Email and phone support for FDA inquiries during the coverage year
Discount pricing for larger product counts — email info@usimports.us for 4+ products
Who It's For:
Foreign importers (no U.S. employees or U.S. office) who must designate a qualified individual physically located in the U.S. to perform FSVP activities. Also a fit for U.S. importers without a qualified individual on staff who'd rather outsource the role than train internally.
FAQs:
Q: What does the variant (1 / 2 / 3 Products) mean?
A: Each "Product" is a distinct food item or product line that requires its own FSVP determination. If you import three different products from the same supplier, that's 3 Products. Pricing scales because the verification work scales with product count.
Q: Can I add more products later?
A: Yes. Email info@usimports.us and we'll quote the incremental addition mid-cycle.
Q: How does this renew?
A: Annual subscription. Same card auto-charged on the anniversary date unless you cancel. Cancel anytime from your account. If you cancel, you must designate a replacement FSVP Agent before service ends — we'll remind you of this when you cancel.
This is an annual subscription. Your card will be charged either $1500/$2495/$3490 (depending of the selected option) today and automatically renewed every 12 months at the same price unless you cancel. You can cancel anytime from your account at usimports.us/account. We'll email you a reminder 7 days before each renewal.
Labeling mistakes are a top reason for detention at U.S. ports. Our specialists review your label for FDA compliance and provide a detailed markup with action points. Includes one re-review.All imported foods and dietary supplement labels must be in English and comply with FDA labeling requirements. Our food labeling specialists review your label for FDA compliance and provide you a detailed list of suggested changes along with a complete markup of your label. We also include one additional review of your label as part of our labeling review service.
What’s included:
A comprehensive review of the label for FDA compliance and a detailed report with action points covering:
Statement of Identity
Net Quantity Statement
Ingredient List
Manufacturer / Importer Information
Country of Origin
Allergen Statement
Nutrition or Supplemental Facts (present or not)
Who it’s for:
Food, beverage, and dietary supplement importers preparing labels for the U.S. market.
FAQ:
Basic vs. Expert review — which do I need? Basic confirms required FDA label elements are present and correct. Expert adds ingredient review, detailed nutrition/supplemental facts review, and suggested revisions. Choose Expert if you want us to rewrite, not just check.
Do I get a marked-up label back? Yes. You receive a detailed report with action points plus a complete markup of your label.
Multi-label discount? Yes — 2 labels $1,098, 3 labels $1,647 (roughly 15% off when bundled).
A deeper FDA label review with written rationale for every suggested revision, expert-level nutrition/supplement facts analysis, and a detailed action-point report. The Expert tier is for clients who want a defensible compliance record.
What's Included:
Everything in FDA Label Review — Basic, plus:
Detailed action-point report with prioritized fixes
Deeper ingredient review
Expert-level nutrition or supplement facts panel analysis (including rounding rules, daily value calculations, allergen disclosure)
Written rationale for each suggested revision
Additional review with revisions within 30 days of purchase
Choose 1, 2, or 3 labels of similar product on this page
Who It's For:
Any brand where labeling errors carry higher stakes . Also a fit for importers or retail buyers who require an expert review on file.
FAQs:
Q: How is Expert different from Basic?
A: Basic confirms your label meets FDA's mandatory elements and flags obvious compliance issues. Expert adds CFR-cited written rationale for each revision, deeper ingredient/claim analysis, and a prioritized action-point report.
Q: What does "1 / 2 / 3 Labels" mean?
A: Each label is one distinct product label. Variations of one product (e.g., different sizes of the same flavor with same ingredient panel) count as one label. Different flavors, varieties, or formulations are separate labels.
Q: Do I need a separate Claims Review?
A: Expert Label Review does not covers claims that are part of the label being reviewed. If you make claims on your label or have standalone claims, marketing materials, or website language to review, the FDA Claims Review service is the right fit.
Labeling claims must comply with FDA regulations or your product will be considered misbranded and denied entry. Our specialists review your claims and offer alternative wording to maintain FDA compliance — nutrient content, organic, health, and other regulated claims. Food and dietary supplement importers should ensure they thoroughly understand FDA regulations before making claims on product labels. Claims not complying with U.S. law result in a product being considered misbranded — subject to FDA enforcement and private-party false advertising lawsuits. A claim is any representation made about a product on the label, website, flyer, or even social media.
What’s included:
Our specialists can review your claims and offer alternative suggestions to maintain FDA compliance, including:
Nutrient content claims
Organic claims
Health claims
Other regulated claims (natural, fresh, non-GMO, gluten-free, etc.)
And more
Some claims are pre-approved by FDA regulations; others are permissible so long as they are truthful and not misleading. Knowing which rules apply before making claims can help you avoid costly mistakes before shipping to the U.S.
Who it’s for:
Food and dietary supplement brands making marketing claims on packaging, websites, or advertising.
FAQ:
What counts as a “claim”? Any representation about the product — on label, website, flyer, social media, or advertising.
What happens if my claim isn’t compliant? The product is considered misbranded. FDA can detain or refuse entry, and you may face false-advertising lawsuits.
Will you rewrite my claim? Yes — we offer alternative wording that achieves your marketing goal while staying FDA-compliant.
WHY US IMPORTS
WHY TRUST US
US Imports has spent over two decades helping importers and exporters navigate FDA regulations for food, beverages, and dietary supplements. Every service is delivered by experienced consultants — never templated, never outsourced. From a single label review to a full FSVP plan, we handle the regulatory complexity so your product clears U.S. ports on schedule.