Regulatory Support for Food Supplement Registration in USA

The United States is one of the most rigorous and dynamic markets for food products and dietary supplements.Under the oversight of the U.S.Food & Drug Administration(FDA) and regulated frameworks such as the Food Safety Modernization Act(FSMA) and the Dietary Supplement Health and Education Act(DSHEA), U.S.FDA Food Facility Registration, product compliance and import readiness are critical for successful market access.At DDReg, we provide full - spectrum food regulatory consulting in USA and food product registration services USA, supporting global brands with regulatory strategy, submission execution and lifetime compliance.

• Facilities including domestic and non-U.S. operations that manufacture, process, pack, or hold food or dietary supplements for U.S. consumption must register with the FDA.
• Food Registration must be renewed biennially in even-numbered years between October 1 and December 31.
• Dietary supplements in the U.S. fall under DSHEA as a subset of foods and require compliance with labeling, ingredient status (e.g., New Dietary Ingredient notifications), manufacturing controls, and import readiness, rather than routine pre-market approval.
• The FDA’s registration database is a foundational element of traceability, import inspection readiness, and regulatory oversight under FSMA.

• + Regulatory Pathway & Market Entry Strategy
  • Assess your product portfolio (food vs supplement) and map applicable FDA regulatory services path.
  • Evaluate facility structure, supply-chain alignment and identify registration obligations (domestic or foreign).
  • Develop regulatory roadmap aligned to your launch timeline, documentation needs, U.S. import strategy and post-market maintenance.
• + Food Facility Registration & U.S. Agent Support
  • Manage or guide the US FDA food registration of your facility(s) via the FDA’s Food Facility Registration system.
  • For foreign facilities, provide support in appointing a U.S. Agent, coordinating communications and ensuring ongoing account maintenance.
  • Ensure biennial renewals, database accuracy, and operational visibility for U.S. import readiness.
• + Food & Supplement Product Compliance
  • Review dietary supplement labeling requirements (Supplement Facts panel, identity statement, other ingredients, domestic address/phone) as per FDA guidance.
  • For foods and supplements, assess ingredient status (GRAS, NDI, allowed ingredients), claims, and manufacturing controls under cGMP/FSMA frameworks.
  • Prepare documentation to support safety assertions, traceability and quality control aligned with FDA expectations.
• + Post-Market Surveillance & Regulatory Intelligence
  • Establish mechanisms for adverse event monitoring, product complaint management and regulatory audit readiness. (Especially relevant for dietary supplements.)
  • Monitor changes in FDA regulations, guidance documents and enforcement trends relevant to food and supplement sectors.
  • Provide ongoing updates, customized compliance alerts and strategic guidance to maintain U.S. compliance continuity.

DDReg is positioned as a regulatory affairs services partner that brings strategic perspective and technical depth to U.S.food and supplement compliance.Unlike generic service providers, we emphasise:

• Translating regulatory change into business-enabling compliance architectures, not just reactive fixes.
• Precision in submission data, registration accuracy, and operational readiness for importers and manufacturers.
• Ongoing regulatory intelligence that anticipates U.S. FDA and FSMA shifts supporting your brand’s sustainable U.S. presence.

Whether you are launching a new dietary supplement or expanding your U.S. food product reach, DDReg provides FDA food registration support with the regulatory clarity and operational reliability to support your journey.