United StatesTaevas Global helps food and dietary supplement manufacturers navigate FDA import requirements, prior notice obligations, and supply chain complexities to bring products to market in the United States with speed and confidence. From facility registration
Our six interconnected pillars give food and dietary supplement importers a complete operational and regulatory picture of the United States market so every shipment arrives compliant, on time, and commercially ready.
We decode the full spectrum of FDA requirements that apply to imported food and dietary supplements, including FSMA Foreign Supplier Verification Program rules, Prior Notice obligations, and facility registration under Bioterrorism Act Section 305. Our team tracks regulatory updates from CFSAN and translates them into actionable compliance checklists for your product category. This pillar ensures your team understands exactly what is required before the first shipment departs origin.
Our structured four-step engagement transforms your import ambition into a fully documented, compliance-ready market entry plan for the United States food and dietary supplements market.
We begin with a structured intake session to understand your product portfolio, origin countries, target United States channels, and existing compliance documentation. Our team reviews any prior FDA correspondence, existing facility registrations, and label assets to establish a precise scope. This baseline prevents duplicated effort and ensures every subsequent workstream is calibrated to your specific situation.
The discovery session covers product category classification, ingredient inventory review, intended use and claims strategy, supply chain origin points, and a gap assessment against known FDA import requirements. Deliverable at this stage is a signed scope-of-work document with defined milestones and a dedicated project manager assigned.
The United States is the world's largest dietary supplement market, accounting for roughly one-third of global supplement sales. Consumer demand is driven by aging demographics, preventive health trends, and a well-established retail infrastructure spanning natural specialty stores, mass market chains, and a rapidly growing direct-to-consumer e-commerce channel. Foreign manufacturers face intense domestic competition but also significant volume opportunity.
The Food Safety Modernization Act fundamentally shifted the United States import framework from reactive to preventive, placing legal responsibility on importers to verify that foreign suppliers produce food and supplements in compliance with FDA standards. The Foreign Supplier Verification Program requires importers to conduct hazard analysis, supplier audits, and ongoing monitoring, creating substantial documentation burdens for first-time United States importers. Non-compliance can result in Import Alert listing and automatic detention of all future shipments.
FDA and FTC have intensified joint enforcement actions targeting unsubstantiated structure-function claims and disease claims on dietary supplement labels and in digital advertising. Warning letters to supplement importers have increased year over year, with particular scrutiny on immune support, weight management, and cognitive health claims. Importers must ensure claims are substantiated, properly disclaimed, and consistent across all labeling and marketing assets before market entry.
Online sales now account for over 35 percent of United States dietary supplement revenue, with Amazon, direct-brand websites, and subscription models driving growth. This shift creates new import and fulfillment considerations, including Amazon FBA compliance requirements, third-party seller product listing standards, and state-level sales tax obligations. Foreign manufacturers entering through e-commerce channels must align their import and logistics architecture with platform-specific requirements in addition to FDA rules.
Every Taevas Global import intelligence engagement for the United States food and dietary supplements market delivers eight structured deliverables designed to move your team from uncertainty to action.
A product-by-product mapping of all applicable FDA requirements including FSMA, FSVP, labeling rules under 21 CFR Part 101 and 111, and Prior Notice obligations. Each requirement is tied to its CFR citation and current FDA guidance document.
A line-by-line review of your existing labels against FDA Supplement Facts panel requirements, allergen declarations, net quantity statements, and claim substantiation standards, with annotated markup and specific revision recommendations.
A screening of your foreign supplier facilities against the FDA OASIS Import Alert database, with a risk-scored register identifying any active alerts, prior detention history, and recommended remediation steps before shipment.
A defensible Harmonized Tariff Schedule classification for each product SKU, with applicable duty rates, Section 301 tariff exposure, anti-dumping order screening, and USMCA or other FTA preferential treatment eligibility.
A comparative analysis of recommended United States ports of entry based on FDA district workload, transit time, cold chain capability, and cost, with a preferred routing recommendation and contingency options.
Ready-to-use Foreign Supplier Verification Program procedure templates including hazard analysis worksheets, supplier audit checklists, corrective action records, and importer-of-record attestation forms formatted for your QMS.
A snapshot of the competitive landscape for your product category in the United States, covering key domestic and imported brands, retail price benchmarking, channel distribution patterns, and white-space opportunity identification.
A curated list of qualified United States natural products distributors, food brokers, and e-commerce fulfillment partners relevant to your category, with contact information, channel focus, and minimum volume requirements.
You produce food or dietary supplements outside the United States and are preparing your first commercial shipment to American buyers or retailers. FDA's layered import framework, including FSMA, Prior Notice, and facility registration, is unfamiliar territory and the cost of a shipment refusal or Import Alert listing would be significant. You need a clear, sequenced compliance roadmap before your first container departs.
Taevas Global combines deep FDA regulatory expertise with practical import logistics intelligence to help food and dietary supplement manufacturers enter the United States market compliantly and commercially. Contact us today to discuss your import program and receive a tailored proposal.