HUMAN FOOD, BEVERAGE & DIETARY SUPPLEMENTS
Human food and supplement requirements can change with a single ingredient, claim, process, or distribution decision. ProConXol helps teams evaluate those details early, build compliant operations, and keep products aligned with U.S. and selected international requirements.
Discuss Your ProductA PRACTICAL STARTING POINT
We support companies of all sizes—from start-ups to global manufacturers—with practical, industry-focused food and dietary supplement regulatory and compliance solutions. Our experience covers a wide range of products, including ingredients, processed foods and beverages, packaging, and ready-to-eat (RTE) products. We work with manufacturers, brand owners, importers, distributors, and ingredient suppliers, tailoring our approach based on each product’s category, intended use, and business needs.
HOW WE CAN HELP
Clarify whether a product and its ingredients fit the intended category, identify the rules that apply, assess key risks, and create a workable plan for formulation, labeling, manufacturing, and market entry.
Assess food and dietary supplement ingredients and formulations for regulatory compliance, including ingredient status, intended use, specifications, documentation, GRAS status, food additive requirements, DSHEA compliance, NDI notification needs, and potential regulatory risks.
Review labels, Supplement Facts or Nutrition Facts panels, ingredient statements, allergen declarations, warnings, structure/function claims, health-related claims, websites, and advertising for consistency with applicable FDA and FTC expectations or global market regulations.
Develop, implement, and enhance comprehensive food safety and quality systems through gap assessments, regulatory recommendations, execution planning, and program implementation. Services include HACCP, FSMA Preventive Controls, GMP, GFSI certification programs (BRCGS, SQF, FSSC 22000), food safety plan development, process flow design and system verification, certification readiness, and continuous improvement.
Provide comprehensive audit and assessment support to evaluate food safety and quality system performance. Services include gap assessment audits, pre-assessment audits, supplier and second-party audits, internal audits, executive audit reports, corrective action planning, and guidance for implementing audit recommendations. Support also includes audit mentoring, coaching, and readiness preparation.
Support FDA food-facility registration and applicable state or local licensing, renewal calendars, updates, and documentation needed to keep operations current.
Support global registration and market access through regulatory assessment, product classification, label review and adaptation, dossier preparation and submission, and communication with regulatory authorities to address market-specific requirements across international regions.
Strengthen complaint handling, serious-adverse-event processes where applicable, investigation records, trend review, recall readiness, and responses to regulatory questions or enforcement activity.
Support readiness for third-party certifications, including Halal, Kosher, USDA Organic, Vegan/Vegetarian, Non-GMO, NSF, and USP verification through documentation review, gap assessment, coordination, and corrective action support. Certification decisions remain with the relevant certifying organization.
Support compliant global trade of food and dietary supplements through FDA and USDA import requirements, documentation review, import/export compliance guidance, detention resolution, and preparation of export certificates (FSC, CoE, CFG) and regulatory documentation.
Access experienced regulatory professionals through flexible remote staffing solutions tailored to your project needs and business requirements. We provide contract-based hourly, fixed-rate, part-time, and full-time regulatory personnel, significantly reducing the cost and commitment of traditional hiring.
Our qualified trainers provide industry-focused public, onsite, and virtual training programs tailored to the needs of manufacturers of all sizes. Training programs include GMP, HACCP, FSMA Preventive Controls (FSP), SQF, BRCGS, and FSSC 22000 requirements.
WHY IT MATTERS
A product name, serving size, ingredient form, dosage instruction, claim, or manufacturing step can affect how a product is regulated. A structured review helps find those issues before artwork, production, or launch decisions become expensive to change.
COMMON QUESTIONS
Generally, FDA does not approve dietary supplements for safety and effectiveness before marketing. Companies remain responsible for meeting applicable safety, manufacturing, labeling, notification, and post-market requirements.
Yes. Reviewing the label, website, social content, and sales materials as one claims system helps reduce inconsistencies and unsupported messages.
No. Some requirements overlap, but product categories, ingredients, claims, manufacturing rules, and notifications can differ. We start by confirming what the product is and how it will be marketed.
Yes, for selected markets. We confirm jurisdiction-specific expertise and local partner needs before defining the scope.
LET’S MOVE FORWARD
Send us the product category, ingredient list, draft label, target market, and planned claims. We will help you identify the right review and the questions that need answers.
