U.S. Food Industry Regulation Compliance Consultation Service
According to the U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture – Food Safety and Inspection Service (USDA-FSIS), and the Centers for Disease Control and Prevention (CDC), an estimated 48 million people in the United States, that is, 1 in 6 Americans, get sick from foodborne illnesses each year. Of these, approximately 128,000 are hospitalized and 3,000 lose their lives, often due to preventable causes.
These figures highlight the serious public health risks posed by inadequate food safety and quality practices, especially within small and medium-sized food enterprises (SMEs). At Fresh Group, we help food businesses address these challenges by providing expert guidance to ensure compliance with U.S. food safety regulations and protect both consumers and brands.
Key Benefits
Market Access
Product Safety
Enhanced Brand Reputation
Regulatory Compliance
Our FDA and USDA-FSIS Compliance and Consultation Services:
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The Food Safety Modernization Act (FSMA), enacted in 2011 under the authority of the U.S. Food and Drug Administration (FDA), represents the most significant modernization of U.S. food safety law in decades. FSMA shifts the regulatory approach from responding to contamination events to preventing food safety hazards before they occur, strengthening protections for consumers and the global food supply.
FSMA regulations apply to food businesses operating both within the United States and internationally, including companies that manufacture, process, pack, hold, or export food products to the U.S. market. Major FSMA rules include the Preventive Controls for Human Food Rule, Preventive Controls for Animal Food Rule, Produce Safety Rule, and the Foreign Supplier Verification Programs (FSVP) Rule. Compliance with these regulations is essential for meeting FDA food safety requirements and maintaining market access in the United States.
Our team of experienced food safety and regulatory compliance consultants provides comprehensive support for FSMA compliance, FDA regulatory requirements, and USDA-FSIS food safety mandates. We assist food businesses in interpreting complex regulatory requirements and implementing practical systems that meet federal food safety standards.
Our consulting services include:
- Development and implementation of FSMA-compliant Food Safety Plans,
- Preventive Controls program design and hazard analysis (HARPC),
- Foreign Supplier Verification Programs (FSVP) compliance support,
- FDA and USDA-FSIS regulatory compliance assessments,
- Food labeling and regulatory labeling compliance,
- Food defense program development and vulnerability assessments,
- Food processing operations and regulatory process validation,
- Product formulation and ingredient regulatory review,
- Packaging compliance and regulatory risk assessment,
- Food safety training and internal compliance audits.
We work with food manufacturers, food importers, exporters, ingredient suppliers, and international food businesses seeking to meet U.S. regulatory requirements. Whether you are a small food company entering the U.S. market or a large food manufacturer managing complex regulatory obligations, our consultants provide tailored guidance to help you achieve and maintain compliance.
Our services are designed to align with the rigorous requirements of the FDA Food Safety Modernization Act (FSMA) as well as the U.S. Department of Agriculture Food Safety and Inspection Service (USDA-FSIS)regulations governing meat, poultry, and egg products. By identifying compliance gaps and mitigating regulatory risks, we help protect your operations, maintain regulatory approval, and safeguard your brand reputation in the U.S. marketplace.
At Fresh Group, we offer comprehensive support to help food businesses comply with the FDA and USDA-FSIS.
Our services include:
Regulatory Guidance
We provide expert, up-to-date guidance on FDA and USDA-FSIS regulations, helping you understand and apply the specific requirements relevant to your food products and operations.
Labeling Compliance
Our experts review your product labels to ensure full compliance with FDA standards, including nutritional information, health claims, allergen declarations, and other mandatory elements.
Facility Inspection Preparation
We assist you in preparing for and responding to FDA and USDA-FSIS inspections, ensuring your facility meets current Good Manufacturing Practices (cGMP) and all applicable regulatory requirements.
FDA and USDA-FSIS Submission Support
We provide expert assistance in preparing and submitting key documentation such as GRAS (Generally Recognized as Safe) notifications, food facility registrations, and New Dietary Ingredient Notifications (NDINs).
Risk Assessment
We help you identify, assess, and mitigate potential food safety risks, therefore ensuring that your products meet safety standards and remain in full compliance with FDA and USDA-FSIS expectations.
Benefits of Our FDA and USDA-FSIS Compliance & Consultation Services:
Regulatory Compliance
Our services are designed to assist your food business in meeting FDA and USDA-FSIS regulatory requirements; therefore, minimising the risk of legal penalties, costly fines, and potential business shutdowns due to non-compliance.
Product Safety
Compliance with FDA and USDA-FSIS regulations is fundamental to ensuring product safety and protecting the health and well-being of consumers across the United States.
Market Access
Compliance with FDA and USDA-FSIS requirements enables your food business to enter and compete in the U.S. market, unlocking access to a broader customer base and driving revenue growth.
Enhanced Brand Reputation
Demonstrating a strong commitment to FDA and/or USDA-FSIS compliance builds trust with both consumers and regulators; thereby, enhancing your brand’s reputation, supporting market success, and ultimately driving increased sales and revenue for your food business.
Get In Touch
At Fresh Group, we are committed to helping food businesses successfully navigate the complexities of FDA and USDA-FSIS regulations. Our regulatory experts work closely with clients to ensure food products meet the highest standards of food safety, quality, and regulatory compliance required for the U.S. market.
Contact us today to learn how our FDA and USDA-FSIS compliance consulting services can be tailored to your organization’s specific needs. Whether you require support with FSMA compliance, food safety plans, regulatory labeling, FSVP programs, or USDA-FSIS requirements, our team provides the expertise and practical guidance needed to help your products succeed in the U.S. food marketplace.