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—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 Compliance and Consultation Services:
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In 2011, the Food Safety Modernization Act (FSMA) was signed into law, under FDA jurisdiction, with the primary goal of proactively preventing foodborne illnesses to protect public health. FSMA regulations apply to food businesses, both domestically and abroad. These rules include Preventive Controls for Human and Animal Food, the Produce Safety Rule, and the Foreign Supplier Verification Programs (FSVP) rule.
Our dedicated team of industry consultants specializes in comprehensive FDA compliance, quality systems, and GMP matters (Good Manufacturing Practice Regulations). We work closely with your management team, ensuring that every step, from the initial gap analysis to quality control system enhancement and implementation, is executed flawlessly.
As a provider of regulatory compliance solutions, we cater to food enterprises regulated by the U.S. FDA and USDA. Our seasoned consultants offer expert guidance to meet your specific regulatory needs. Whether you’re a small-scale food business or a large food manufacturer, we provide support across a spectrum of food safety compliance challenges.
We extend our assistance to food manufacturers in crucial areas such as food safety, food defense, food labeling, food process operations, food formulations, and packaging programs. Our services are designed to align with the rigorous requirements of the U.S. FDA and USDA, while meticulously assessing and mitigating regulatory noncompliance risks.
At Fresh Group, we offer comprehensive support to help food businesses comply with U.S. regulatory requirements enforced by the Food and Drug Administration (FDA) and the U.S. Department of Agriculture – Food Safety and Inspection Service (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 specialists 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—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 meet FDA and USDA-FSIS regulatory requirements; therefore, minimizing 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; therefore, 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 you navigate the complexities of FDA and USDA-FSIS regulations—ensuring your food products meet the highest standards of safety, quality, and compliance.
Contact us today to learn how our FDA and USDA-FSIS compliance and consultation services can be tailored to your specific needs and provide the expertise you need to succeed in the U.S. food market.