United StatesTaevas Global provides dedicated legal representation to help Food & Dietary Supplements manufacturers meet FDA requirements and confidently enter the United States market. From regulatory filings to ongoing compliance, we are your trusted partner every s
Our six interconnected pillars give Food & Dietary Supplements companies the regulatory clarity, legal protection, and market intelligence needed to operate successfully in the United States.
We map every applicable FDA requirement for your product category, including DSHEA compliance for dietary supplements and FSMA obligations for food manufacturers. Our team ensures your labeling, structure-function claims, and manufacturing processes align with current Good Manufacturing Practices. We proactively monitor FDA guidance updates so your compliance posture is always current.
Our four-step engagement process moves Food & Dietary Supplements companies from initial assessment through full U.S. legal representation in a structured, transparent timeline.
We begin with a structured intake session to understand your product portfolio, target market segments, and existing compliance documentation. Our regulatory specialists map your products against applicable FDA frameworks including DSHEA, FSMA, and 21 CFR Part 111. This assessment produces a clear picture of compliance gaps and the legal representation scope required.
The discovery phase includes a detailed product questionnaire, review of existing labels, ingredient lists, and any prior FDA correspondence. We identify whether your products require New Dietary Ingredient notifications, facility registration, or Foreign Supplier Verification Program documentation. The output is a written regulatory gap analysis delivered within three business days.
The FDA regulates dietary supplements under the Dietary Supplement Health and Education Act of 1994 and food products under the Food Safety Modernization Act of 2011, creating a dual regulatory environment that foreign manufacturers often underestimate. FDA has significantly increased enforcement activity, issuing over 100 warning letters to supplement companies in recent years. Companies without proper U.S. legal representation face heightened risk of import alerts and product detention.
U.S. supplement and food labeling requirements are among the most prescriptive globally, covering mandatory Supplement Facts or Nutrition Facts panels, specific font size rules, allergen declarations under FALCPA, and strict limits on disease claims. FDA's updated Nutrition Facts label rules, fully implemented since 2021, added new requirements for added sugars and revised serving size calculations. Non-compliant labels are one of the most common triggers for FDA warning letters.
The U.S. dietary supplement market is driven by aging demographics, growing consumer interest in preventive health, and rising demand for sports nutrition, immune support, and personalized nutrition products. E-commerce now accounts for a significant and growing share of supplement sales, attracting increased FTC scrutiny of online marketing claims alongside FDA label requirements. Companies that align their product positioning with substantiated claims are better positioned for long-term market success.
Foreign-manufactured food and dietary supplement products entering the United States are subject to FDA Prior Notice requirements, Foreign Supplier Verification Program obligations, and potential physical examination at ports of entry. Products from facilities not registered with the FDA or associated with prior violations can be placed on automatic detention, blocking market access entirely. Proactive legal representation significantly reduces the risk of costly import delays.
Every Legal Representation engagement for Food & Dietary Supplements in the United States includes these eight core deliverables, designed to give you complete regulatory coverage from day one.
A written assessment mapping your current product and operations status against all applicable FDA requirements, with prioritized remediation recommendations.
Complete preparation and submission of your FDA facility registration under 21 CFR Part 1, including biennial renewal management.
Line-by-line review of all product labels for compliance with FDA Supplement Facts or Nutrition Facts panel rules, allergen declarations, and permissible claim language.
Formal appointment of Taevas Global as your designated U.S. Agent for FDA purposes, ensuring all regulatory correspondence is handled promptly and professionally.
Documentation and guidance covering FDA Prior Notice requirements and Foreign Supplier Verification Program obligations to support smooth U.S. customs clearance.
A board-ready written strategy document outlining your recommended U.S. market entry pathway, risk mitigation steps, and compliance timeline.
Ongoing handling of all inbound and outbound FDA communications, including responses to deficiency notices, warning letters, and inspection-related inquiries.
A personalized compliance calendar tracking all FDA filing deadlines, registration renewals, and adverse event reporting obligations, with proactive alerts.
You manufacture food or dietary supplement products outside the United States and are ready to export to U.S. retailers, e-commerce platforms, or distributors. You need FDA facility registration, a U.S. Agent, and compliant labeling before your first shipment clears customs. Without proper legal representation, your products risk detention at the port of entry.
Connect with Taevas Global today to get dedicated Legal Representation for your Food & Dietary Supplements business in the United States and enter the market with full regulatory confidence.