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Food For Thought: Understanding Federal Food Processing, Distribution and Labeling Laws
Practical Law Legal Update w-000-7179 (Approx. 6 pages)
Food For Thought: Understanding Federal Food Processing, Distribution and Labeling Laws
by Practical Law Commercial Transactions
| Law stated as of 10 Nov 2015 • USA (National/Federal) |
This Legal Update highlights various Practical Law resources that discuss food producers and distributors' obligations under federal law, including the Food, Drug and Cosmetic Act and the Federal Trade Commission Act. Businesses that violate these federal laws can face an extensive range of risks and liabilities from the federal government, consumers and competitors.
The US market for food products is one of the largest in the world and can serve as a vast source of revenue and sales, especially during this holiday season. This market is also heavily regulated by state and federal agencies, including the Food and Drug Administration (FDA), the US Department of Agriculture (USDA) and the Federal Trade Commission (FTC).
Under laws such as the Food, Drug and Cosmetic Act (FDCA) and the Federal Trade Commission Act (FTC ACT), these agencies regulate, among other things:
- When businesses that produce or sell food products must register with the FDA (see Registering with the FDA).
- The kind of records food businesses must keep about their products and role in the food supply (see Establishing and Maintaining Records).
- Good manufacturing practice requirements for producing food products (see Mandatory Current Good Manufacturing Practices).
- How manufacturers and distributors must label food products (see Labeling Food Products).
- Food safety and preventive controls, including inspections (see Food Safety and Preventive Controls).
The federal government has established an infrastructure that both protects consumers and creates a complex set of obligations and prohibitions for parties that produce and sell food products. This Legal Update highlights various Practical Law Commercial Transactions resources that describe federal laws governing the production and supply of food products.
For more general information on US consumer protection laws, see Practice Notes, Consumer Protection: Overview and FTC Consumer Protection Investigations and Enforcement.
Registering with the FDA
The FDA tracks the origin and distribution of food products to respond to threats to the food supply. It does this through strict registration requirements for domestic and foreign food facilities that manufacture, process, pack, hold, or import food for human consumption in the US.
These food facilities must:
- Register with the FDA before beginning their operations.
- Provide the agency with specific information about their business and food products.
- Renew their registrations every other year.
For more information on the FDA's registration requirements, see Practice Note, FDA Food and Dietary Supplement Regulations: Food Facility Registration Requirements.
Establishing and Maintaining Records
The FDA requires businesses to establish and maintain certain records related to their role in the food supply chain and where the food products have traveled or will travel. These detailed recordkeeping requirements help the agency to effectively track a food's:
- Previous sources.
- Subsequent recipients.
Domestic or foreign parties that manufacture, process, pack, transport, distribute, receive, hold, or import food in the US must comply with the FDA's recordkeeping requirements and allow the agency to access certain records upon request.
For more information about the FDA's recordkeeping requirements, see Practice Note, FDA Food and Dietary Supplement Regulations:Recordkeeping Requirements for Transporters and Nontransporters of Food.
Mandatory Current Good Manufacturing Practices
Under the FDA's Current Good Manufacturing Practice regulations (CGMPs), food that is offered for sale or introduced into interstate commerce must be produced under safe and sanitary conditions. The CGMPs outline the FDA's manufacturing recommendations and requirements for producing processed food, including the:
- Requirements for the maintenance, layout, and sanitary operations of food processing buildings and facilities.
- Standards for the design, construction, and maintenance of equipment and utensils.
- General sanitation production and process controls for ensuring that food is safe for human consumption.
- General requirements for warehousing and distribution.
The CGMPs requirements are described generally, which gives manufacturers some flexibility in how they implement them.
Labeling Food Products
Food products that move in interstate or foreign commerce must have proper labeling. Under the FDCA and the Fair Packaging and Labeling Act (FPLA), food manufacturers and distributors:
- Must include certain information about a product on its label and principal display panel, including specific nutritional information and a list of ingredients.
- Are prohibited from misbranding food and making certain claims on labels.
- Must meet certain conditions before making specialty claims about their products, such as by labeling a product as organic or gluten-free.
The FDA does not pre-approve food labels subject to its regulations. Instead, it relies on enforcement actions, warning letters, and other measures to correct misbranded products.
For specific information about federal labeling requirements for food (and agriculture) products, see Practice Notes, FDA Food Labeling: Overview and Producing and Labeling Organic Agricultural Goods and Product Labeling Checklist: Food.
For more general information about federal advertising and labeling laws, see Practice Note, Advertising: Overview: The Federal Trade Commission Act and Article, Watch that Label: An Introduction to Product Labeling and Advertising.
Food Safety and Preventive Controls
The Food Safety Modernization Act (FSMA) amended the FDCA and gave the FDA more authority to strengthen the US food safety system. Among other things, the FSMA and FDCA:
- Require food facilities to establish comprehensive, prevention-based controls across the food supply to prevent food safety issues (see Practice Note, FDA Food and Dietary Supplement Regulations: Preventive Controls).
- Expand the FDA's authority to inspect food facilities and respond to food safety issues (see Practice Notes, FDA Food and Dietary Supplement Regulations: FDA Access to Records and Product Recalls: Food).
Violating US Food Laws
Businesses that participate in the US food supply must be aware of and comply with the various state and federal rules that govern the production and sale of food products. Violating these laws can result in a range of risks and liabilities, including:
- Government warning letters, enforcement actions, and fines (see, for example, FDA: Warning Letters and Legal Update, DC Circuit: POM Wonderful's Health Claims Were Deceptive).
- Lawsuits from consumers or competitors alleging misleading advertising or labeling (see, for example, Legal Update, Supreme Court: Lanham Act False Advertising Claims Not Precluded by Food Labeling Rules).
Additionally, if the government concludes that a party has violated federal food laws, it can seize their food products or even prohibit them from distributing or selling the products in the US.