The food and beverage industry operates worldwide and keeps growing as new ingredients and products reach the market. In the U.S., every step from handling a single ingredient to processing a finished food carries legal obligations, and keeping track of them gets harder as the workforce and supply chains expand. This article explains the main food and beverage regulations and the agency that enforces them.
What is the FDA?
The Food and Drug Administration (FDA) is the federal agency that sets and enforces most of the rules for food and beverages sold in the U.S. Because the industry employs so many people and handles so many products, companies need to check their practices against FDA policy on a regular basis.
FDA policies also cover dietary supplements, including whether a drug may be used as an ingredient in a supplement and whether a supplement’s claims are valid.
What role does the FDA play in the food and beverage industry?
The FDA’s reach runs from bottled water to whole foods and their derivatives, such as milk and dairy products, food additives and infant formula. It works alongside the U.S. Department of Agriculture, which oversees meat and poultry products.
Within the FDA, food oversight used to sit with the Center for Food Safety and Applied Nutrition (CFSAN). On October 1, 2024, the FDA reorganized that work into a unified Human Foods Program. The goal is unchanged: a national food supply that is safe, sanitary, wholesome and honestly labeled.
Food labeling rules
Labeling is one of the areas the FDA watches most closely. Inaccurate labels can mislead people about nutrition, create health risks and spread false information. Under the updated Nutrition Facts label rules, manufacturers with $10 million or more in annual food sales had to comply by January 1, 2020, and smaller manufacturers by January 1, 2021.
Which FDA laws govern the food and beverage industry?
The Federal Food, Drug, and Cosmetic Act, passed in 1938, is the foundation. It contains most of the rules on food safety and the food supply.
The Food Safety Modernization Act (FSMA), signed into law in 2011, amended that act. FSMA shifts the focus from reacting to food-borne illness to preventing it, and it strengthens safety controls across the food supply, including imported food. Water matters here too: the FDA regulates bottled water, and preventive controls cover how water used in food production is kept clean.
How does 21 CFR Part 11 apply to food companies?
21 CFR Part 11 is one of the best-known FDA rules for companies that keep records electronically. It sets requirements so that electronic records and electronic signatures are trustworthy, reliable and equivalent to paper records and handwritten signatures. This helps protect the food supply chain from errors and tampering.
The rule drew criticism for being costly and hard to put into practice. In response, the FDA narrowed how it interprets Part 11 and uses enforcement discretion for some of its requirements, such as validation and audit trails, while other controls still apply. Companies may still keep paper records where the underlying FDA rules allow it.
Key takeaways
- The FDA enforces most U.S. food and beverage rules, with the Department of Agriculture covering meat and poultry.
- The FD&C Act is the core law, and FSMA added a prevention-based approach to food safety.
- Labels must give accurate nutrition information under the updated Nutrition Facts rules.
- Electronic records that FDA rules require must meet 21 CFR Part 11.
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