14.1 Overview of food laws and regulations

Federal Agencies

The U.S. food safety system is split between two main federal agencies, each covering different categories of food. Understanding which agency has jurisdiction over what is a common exam topic, so pay attention to the dividing line.

Food and Drug Administration (FDA)

The FDA oversees the safety and labeling of most food products sold in the United States. The big exception: meat, poultry, and certain egg products fall under the USDA instead.

• Regulates food additives, dietary supplements, and food contact substances
• Enforces food safety regulations and conducts inspections of food processing facilities
• Oversees recalls of contaminated or mislabeled food products
• Collaborates with state and local agencies to investigate foodborne illness outbreaks

United States Department of Agriculture (USDA)

The USDA handles the safety and labeling of meat, poultry, and certain egg products (think shell eggs at processing plants, liquid eggs, etc.).

• Conducts inspections of slaughterhouses, processing plants, and import facilities
• Enforces legislation specific to its jurisdiction, including the Federal Meat Inspection Act and the Poultry Products Inspection Act
• Oversees grading and certification programs for agricultural products (beef grades, egg grades)
• Promotes and supports the U.S. agricultural industry through various programs

Key Legislation

Federal Food, Drug, and Cosmetic Act (FD&C Act)

Passed in 1938, this act is the foundation of modern food safety regulation in the U.S. It replaced earlier, weaker legislation and gave the FDA real enforcement power.

• Grants the FDA authority to oversee the safety of food, drugs, and cosmetics
• Prohibits the sale of adulterated or misbranded food products. "Adulterated" means the food is unsafe or produced under unsanitary conditions. "Misbranded" means the label is false or misleading.
• Requires food manufacturers to list ingredients on product labels
• Establishes standards for food additives and sets tolerance levels for pesticide residues

Food Safety Modernization Act (FSMA)

Signed into law in 2011, FSMA is the most significant overhaul of U.S. food safety laws in over 70 years. The core shift: moving from a reactive approach (responding after people get sick) to a preventive approach (stopping contamination before it happens).

• Requires food facilities to implement preventive controls and develop written food safety plans
• Enhances the FDA's ability to oversee imported foods, which matter more as the global food supply chain grows
• Gives the FDA mandatory recall authority for the first time. Before FSMA, the FDA could only request voluntary recalls.
• Increases the frequency of inspections, especially for high-risk facilities

Food Safety Regulations

Good Manufacturing Practices (GMPs)

GMPs are a set of baseline requirements for food safety and quality during manufacturing, processing, and packaging. Think of them as the minimum standards every food facility must meet.

They cover areas like:

• Sanitation of facilities and equipment
• Equipment maintenance and design
• Employee hygiene and training (handwashing, protective clothing)
• Record-keeping and documentation

GMPs serve as the foundation for more advanced food safety systems like HACCP (Hazard Analysis and Critical Control Points). Both the FDA and USDA enforce GMPs through inspections and audits. Failing to comply can lead to legal action, product recalls, and serious reputational damage.

Food Additives Regulations

These regulations govern substances added to food for purposes like preservation, flavor enhancement, or nutritional fortification.

• Food additives must be approved by the FDA before they can be used in food products. The manufacturer bears the burden of proving safety.
• The FDA establishes safe usage levels and conditions for each approved additive.
• An important exception: substances that are Generally Recognized as Safe (GRAS) by qualified experts don't need formal FDA approval. Common examples include vinegar, salt, and baking soda.
• All additives used must be disclosed on the product label.

Pesticide Residue Limits

Pesticide regulation involves three agencies working together. The Environmental Protection Agency (EPA) sets the maximum residue limits (called tolerances) based on scientific risk assessments. The FDA and USDA then enforce those limits through testing and monitoring programs.

• Tolerances apply to both raw agricultural commodities and processed foods
• Designed to protect consumers from health risks associated with long-term pesticide exposure
• Violations can result in product seizures, fines, and legal action

Allergen Labeling Laws

The Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004 requires food manufacturers to clearly disclose major food allergens on product labels.

The nine major food allergens recognized under U.S. law are:

1. Milk
2. Eggs
3. Fish
4. Crustacean shellfish
5. Tree nuts
6. Peanuts
7. Wheat
8. Soybeans
9. Sesame (added in 2023 under the FASTER Act)

Allergens must be listed in plain language, either within the ingredient list (e.g., "casein (milk)") or in a separate "Contains" statement (e.g., "Contains: milk, wheat"). These requirements exist because allergic reactions can be severe or even fatal. Failure to properly label allergens is one of the most common reasons for food product recalls.