What Food and Beverage Producers Must Know About FDA Regulations

If you’re in the food and beverage industry—whether you’re a manufacturer, private label brand, co-packer, or importer—compliance with FDA regulations is non-negotiable. The U.S. Food and Drug Administration (FDA) plays a central role in regulating, inspecting, and enforcing food safety laws that directly affect your ability to stay on shelves and in supply chains.

This guide will walk you through the key FDA regulations that govern food and beverage operations in the U.S., and how to prepare your business for compliance at every stage—from labeling and ingredient sourcing to facility inspections and product recalls.

How the FDA Regulates the Food and Beverage Industry

The FDA regulates approximately 80% of the U.S. food supply. This includes packaged food, beverages, dietary products, imported goods, and food sold in interstate commerce. (Note: The USDA regulates meat, poultry, and certain egg products.)

Your responsibilities include:

• Complying with the Food Safety Modernization Act (FSMA)
• Following Current Good Manufacturing Practices (cGMPs)
• Ensuring proper labeling and allergen disclosure
• Being ready for unannounced inspections
• Maintaining robust recordkeeping systems

FSMA: The New Standard in Food Safety

The Food Safety Modernization Act (FSMA) represents the most sweeping reform of food safety laws in over 70 years. Unlike older laws focused on reacting to contamination, FSMA is designed to prevent it.

Under FSMA, food companies must:

• Develop and implement a Food Safety Plan (FSP)
• Conduct a Hazard Analysis and Risk-Based Preventive Controls (HARPC)
• Monitor supplier verification programs
• Keep detailed traceability and batch records
• Be prepared for FDA inspections and enforcement

Not complying with FSMA can result in shutdowns, import refusals, or legal penalties.

Labeling: A Top Reason for Recalls and Enforcement

Incorrect or misleading food and beverage labels are a major source of FDA action, particularly related to:

• Allergen mislabeling (e.g., undeclared peanuts, soy, dairy)
• Nutritional panel errors
• Misleading health claims or organic claims
• Serving size discrepancies

Your labels must include:

• Product identity (what it is)
• Net weight or volume
• Ingredient statement
• Nutrition Facts panel
• Allergen disclosure (if applicable)
• Business name and contact information
• Country of origin (for imported foods)

If your product makes any functional or health-related claims, those must be substantiated and follow strict FDA/FTC rules.

Manufacturing Compliance: What FDA Looks For

Whether you run your own facility or partner with a co-manufacturer, the FDA holds you responsible for ensuring:

• cGMP compliance (21 CFR Part 117)
• Pest control and environmental monitoring
• Sanitation SOPs and allergen controls
• Employee hygiene and food safety training
• Process validation and batch records

Facilities are subject to unannounced FDA inspections, and manufacturers must be FSVP (Foreign Supplier Verification Program) compliant if sourcing ingredients internationally.

Key Compliance Challenges for Food & Beverage Companies

eCommerce, DTC, and International Risks

If you’re selling food and beverage products via Amazon, Shopify, or exporting overseas, you face additional risks:

• Amazon and retailers may require FSMA documentation, Certificates of Analysis, and proof of registration
• Imported goods must be filed via the Prior Notice system and meet all FSVP requirements
• Products labeled “organic,” “non-GMO,” or “natural” must adhere to USDA, FDA, and FTC rules

Be Proactive: Compliance is a Growth Enabler

Treating regulatory compliance as a “check-the-box” activity is risky. Forward-thinking companies use compliance as a strategic advantage:

• Faster approvals from retailers and distributors
• Lower risk of costly recalls
• Greater consumer trust and brand loyalty
• Easier expansion into international markets

How PSC Software Can Help

PSC Software provides cloud-based solutions tailored to regulated food and beverage manufacturers and suppliers, including:

• Digital Document Management Systems (DMS)
• Inspection readiness tools
• eQMS platforms for batch record control and deviation tracking
• Compliance workflows to meet FSMA, FSVP, and cGMP standards

We help food and beverage companies manage quality processes efficiently—without the paper trail.