Specialised U.S. Market Support
FDA Dietary Supplement Consulting
Entering the U.S. dietary supplement market requires more than a basic GMP review. FDA requirements under DSHEA, 21 CFR Part 111, labeling, claims, ingredient status, New Dietary Ingredient considerations, registration, import requirements, and inspection readiness all need to work together. For European manufacturers, this can be especially challenging because U.S. requirements differ significantly from EU regulatory frameworks.
Choosing the lowest-cost consultant may save money initially, but gaps in regulatory strategy can lead to delayed market entry, import problems, claim violations, costly corrections, or FDA enforcement.
CIRG provides specialized FDA dietary supplement consulting tailored to European manufacturers preparing to enter or expand in the U.S. market. Our approach focuses on practical, risk-based compliance—from product and labeling review to GMP readiness and FDA inspection preparation—so your U.S. market strategy is built correctly from the start, not repaired after problems arise.
Why Our Review Is Different
Our FDA Dietary Supplement Consulting is led by a former FDA Compliance Officer with direct experience reviewing dietary supplement labelling, promotional claims, and regulatory compliance. This background matters because the Agency does not evaluate only the product label. Websites, brochures, books, advertisements, and other promotional materials can also affect how a product is regulated. Our review looks at the complete marketing picture, not isolated wording. We assess claims from the same regulatory perspective used during Agency compliance and enforcement review. This includes identifying disease claims, drug claims, misleading statements, and other wording that may create unnecessary regulatory risk. We also understand how individual statements can change meaning when viewed together with surrounding content. That practical Agency experience allows us to identify issues that a general marketing or labelling review may miss.
Key Steps to U.S. Dietary Supplement Compliance
Before focusing on GMP inspection readiness, the first priority is to establish a sound regulatory foundation for U.S. market entry. This begins by confirming dietary supplement eligibility, reviewing all labelling and promotional claims, and completing any required DSHEA or NDI notifications. These first three steps determine whether the product can be marketed lawfully and whether its claims create additional Agency requirements. Once these issues are addressed successfully, attention can shift to facility registration, manufacturing compliance, and inspection readiness. Our FDA Dietary Supplement Consulting follows this sequence so that companies do not invest heavily in GMP preparation before resolving fundamental product or labelling concerns. From there, we help strengthen manufacturing controls, prepare for Agency inspection and establish the post-market systems needed to maintain compliance after commercial distribution begins.
U.S. Dietary Supplement Eligibility
Before entering the U.S. market, a foreign company should first confirm that its product qualifies as a dietary supplement. Our FDA Dietary Supplement Consulting starts by reviewing the product’s formulation, ingredients, intended use, dosage form and proposed claims. Each dietary ingredient must fit a category recognised under U.S. law. We assess whether any ingredient may be a new dietary ingredient, or NDI. An NDI generally covers a dietary ingredient with no U.S. dietary supplement marketing before 15 October 1994. In certain cases, the Agency requires an NDI notification at least 75 days before marketing. Claims also matter. Disease claims can cause the Agency to regulate the product as a drug instead. FDA Dietary Supplement Consulting helps identify these issues early, before you invest in registration, labelling, manufacturing or U.S. distribution. This review establishes the foundation for successful U.S. market entry.
Labelling and Claims Compliance
Before we begin the documentation process, we review your labelling and promotional materials for U.S. compliance. Our FDA Dietary Supplement Consulting covers product labels, websites, brochures, books, publications, and other marketing content. We examine claims carefully to identify wording that may create drug or disease claims. The Agency distinguishes permitted structure/function claims from claims to diagnose, mitigate, treat, cure, or prevent disease. Disease claims can cause a dietary supplement to be regulated as a drug. We also review required disclaimers and whether claims need supporting evidence or Agency notification. Complex labelling can require a detailed review, especially when many products or marketing channels are involved. FDA Dietary Supplement Consulting helps correct these issues before filings and other compliance documentation begin. This step reduces regulatory risk and helps ensure that your U.S. market materials support the product’s lawful dietary supplement status.
DSHEA Claim and NDI Notifications
Once your labelling and claims are brought into U.S. compliance, we prepare the required Agency notifications. Under DSHEA, certain structure/function, general well-being, and nutrient deficiency claims require notification within 30 days after first marketing. Our FDA Dietary Supplement Consulting prepares the submission, confirms the claim wording, and ensures the required information is complete. If your product contains a new dietary ingredient, we also assess whether an NDI notification is required. When required, the manufacturer or distributor must submit the NDI notification at least 75 days before introducing the product into interstate commerce. The submission must explain the basis for concluding that the ingredient can reasonably be expected to be safe under the proposed conditions of use. We coordinate these regulatory steps carefully so your documentation follows the correct sequence and your U.S. market entry proceeds on a sound compliance foundation.
FDA Registration and U.S. Market Requirements
After completing the required claim and NDI notifications, we address facility registration and other U.S. market requirements. FDA Dietary Supplement Consulting helps foreign manufacturers determine whether their facility must register with the Agency. A foreign food facility that must register also needs a designated U.S. Agent and an acceptable unique facility identifier. Registration must remain current and generally requires renewal during each even-numbered year. We also review import requirements, including Prior Notice and the applicable Foreign Supplier Verification Program responsibilities. Dietary supplement manufacturers must follow current good manufacturing practice requirements under 21 CFR Part 111. Our FDA Dietary Supplement Consulting also helps confirm the responsibilities of the manufacturer, U.S. importer, distributor, and U.S. Agent before commercial shipments begin. Completing these requirements properly helps prevent avoidable entry delays, registration problems, and compliance issues when your dietary supplements reach the U.S. market.
FDA GMP Inspection Readiness
Before exporting dietary supplements to the U.S., your manufacturing operation should be ready for an Agency inspection. Our FDA Dietary Supplement Consulting evaluates compliance with 21 CFR Part 111 and applicable Part 117 requirements. We review quality control responsibilities, specifications, master manufacturing records, batch production records, testing, supplier controls, sanitation, complaints and recordkeeping. We also assess whether written procedures match actual practices on the manufacturing floor. During inspection readiness, we identify gaps that could lead to observations, product adulteration findings or enforcement action. Corrective actions are prioritised according to regulatory risk and operational impact. We can then conduct a mock Agency inspection to test staff readiness, document retrieval and management responses under realistic conditions. The objective is simple: your facility should be able to demonstrate compliance through both its documentation and its day-to-day manufacturing practices before an Agency investigator arrives.
Post-Market Compliance and Adverse Event Reporting
Once your product enters the U.S. market, compliance responsibilities continue. Our FDA Dietary Supplement Consulting supports post-market monitoring, complaint handling and adverse event reporting requirements. Companies should maintain procedures for receiving, evaluating and documenting complaints and safety information. Serious adverse events associated with dietary supplements must be reported to the Agency within 15 business days by the responsible person. Follow-up information may also require submission when it becomes available. Relevant records must be maintained for six years and made available during an Agency inspection. We also review recurring complaints, emerging safety signals, labelling changes and marketing claims that could create regulatory risk. Post-market oversight should remain active throughout the product lifecycle. FDA Dietary Supplement Consulting helps manufacturers and distributors maintain compliant systems, respond appropriately to safety issues and stay prepared for Agency questions, inspections and enforcement concerns after distribution begins.
Ready for the U.S. Market?
Entering the U.S. dietary supplement market requires more than completing a registration or filing a notification. Our CIRG FDA Dietary Supplement Consulting brings the entire process together, from product eligibility and labelling review to DSHEA notifications, facility registration, GMP readiness, and post-market compliance. We identify regulatory risks early, correct problems before they reach the Agency, and help you build a practical compliance pathway for U.S. distribution. Our experience allows us to evaluate both documentation and real-world operations, including claims, manufacturing controls, complaints, and inspection readiness. Whether you are entering the U.S. market for the first time or strengthening an existing programme, we provide focused regulatory support at each stage. The goal is simple: help you enter the market properly, remain compliant, prepare through a realistic mock FDA inspection, and stay ready for Agency scrutiny as your business grows in the United States, with confidence and fewer avoidable delays.