Understanding the distinct roles of the FDA and the USDA is pivotal for professionals in the food industry.
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Understanding the distinct roles of the FDA and the USDA is pivotal for professionals in the food industry.
These government agencies have specific roles in food regulation. But they've evolved significantly since their inception, shaped by public health needs and technological advancements.
The FDA, established in 1906, primarily ensures the safety and efficacy of food, drugs, and cosmetics, while the USDA, founded in 1862, focuses on the quality and standardization of food, agriculture, and related products.
Five benefits of having these regulatory bodies in place are enhanced public health, consumer confidence, market stability, innovation and improvement, and international trade compliance.
WHAT WE'LL COVER:
The jurisdictions of the FDA and USDA are distinct across different food categories. Each agency has responsibilities which focus on specific products. Below is a detailed table that clarifies which agency oversees which types of food, complete with examples for better understanding:
|
Food category |
FDA regulated |
USDA regulated |
|---|---|---|
|
Meat |
Game meats (e.g., venison, bison) |
Domestic meats (e.g., beef, pork) |
|
Poultry |
Processed poultry products (e.g., nuggets) |
Poultry (e.g., chicken, turkey) |
|
Seafood |
Most seafood (e.g., fish, shellfish) |
Catfish |
|
Eggs |
Egg products (e.g., liquid eggs, pasteurized egg products) |
Shell eggs |
|
Dairy |
Milk, cheese, butter |
N/A |
|
Produce |
Fruits, vegetables |
N/A |
|
Mixed products |
Foods with <2% cooked meat or poultry by weight (e.g., soups, pizzas) |
Foods with >2% meat or poultry by weight (e.g., frozen meals with meat) |
This table highlights that while the FDA covers a broad spectrum of foods including seafood and produce, the USDA is specifically tasked with the regulation of meat and poultry, ensuring comprehensive oversight from farm to fork.
Each entry in the table provides typical examples of the foods regulated by each agency, which helps identify the responsible authority for food industry professionals.
There's also a formal agreement between the FDA and USDA with respect to the oversight of human food that "describes the parties' intended roles and responsibilities for oversight of such food." While this is a positive relationship, it also highlights the complex, overlapping reality that can result in food safety incidents and slow-moving progress.
The FDA conducts inspections based on risk assessments and follows a tiered approach to ensure food safety. For example, a food processing facility that manufactures ready-to-eat foods might be inspected more frequently than one producing less-risk-prone items like canned goods.
During inspections, FDA inspectors check for general sanitary conditions, proper storage, labeling accuracy, and adherence to Good Manufacturing Practices (GMPs). A notable example includes the FDA’s rigorous scrutiny of facilities handling high-risk foods like peanut butter to prevent Salmonella contamination.
The USDA conducts daily inspections in facilities that process meat, poultry, and egg products. Inspectors perform many checks, including animal welfare assessments before slaughter, post-mortem inspections to detect diseases or contamination, and continuous monitoring during processing.
An example is the USDA’s requirement for carcass-by-carcass inspection in beef plants, aiming to detect and prevent spreading diseases such as Bovine Spongiform Encephalopathy (mad cow disease).
The FDA mandates comprehensive labeling that includes nutritional information, ingredient lists, allergen declarations, and serving sizes. A prime example of FDA labeling is found on a jar of peanut butter, which must list calories, fat content, carbohydrates, proteins, and potential allergens like peanuts.
Food labels must also include the manufacturer's name and address, ensuring traceability.
The USDA requires that meat and poultry products have a USDA inspection seal and an establishment number where the product was processed. Additionally, these products must bear country of origin labels, safe handling instructions, and detailed ingredient lists especially when multiple ingredients are included.
For instance, all chicken breast food packaging must display a USDA seal and include a label stating whether the chicken was raised in the U.S. or imported, along with cooking instructions to ensure consumer safety.
The FDA (U.S. Food and Drug Administration) is the agency responsible for protecting public health by regulating and supervising food safety (except for most meats and poultry), dietary supplements, drugs (both prescription and over-the-counter), cosmetics, medical devices, and tobacco products.
The USDA (United States Department of Agriculture) oversees agriculture, forestry, and food. It is especially known for its oversight of meat, poultry, and certain egg products, ensuring that they are safe, wholesome, and correctly labeled and packaged.
However, it's important to note that the FDA can exercise its jurisdiction over meat and poultry products primarily regulated by USDA, when appropriate.
Ultimately, in the context of human food safety, these agencies aim to protect humans and the food supply from contamination, intentional adulteration and more, by way of food defense.
The USDA's Food Safety and Inspection Service (FSIS) is primarily responsible for the food safety regulation of domestic livestock animals such as cattle, sheep, swine, and goats (i.e., beef, pork, and lamb). This includes oversight from slaughter through raw meat processing, ensuring all meat products are safe, properly labeled, and free of harmful pathogens.
The FDA, on the other hand, regulates game meats focusing on food safety standards similar to those for other types of meat it oversees. In general, these game meats include but are not limited to:
The USDA rigorously inspects all poultry products, including domesticated birds such as:
This ensures compliance with safety standards, from the farm to the processing facility and includes a daily presence in facilities to monitor slaughter and processing operations.
The FDA oversees certain processed poultry products, especially those that are minimally processed or include other ingredients also under FDA regulation. Similar to meats, the FDA primarily regulates:
While the FDA is responsible for regulating most seafood, including fish and shellfish, the USDA uniquely regulates catfish.
The FDA's regulation involves monitoring for contaminants, enforcing proper handling and processing practices under HACCP guidelines, and ensuring that seafood is safe and properly labeled.
For example, as with fish and fishery products, if temperature controls are necessary to ensure the safety of a refrigerated non-fish raw material, FDA will expect the necessary critical control points for those raw materials or ingredients to be identified and included in the seafood HACCP plan. Seafood processors may need to refer to additional guidances for appropriate preventive controls when conducting their hazard analyses to identify the hazards associated with non-seafood raw materials or ingredients and recommended controls.
The USDA's focus on channel and blue catfish involves similar safety and labeling oversight. To serve catfish, restaurants must source it from farms that the USDA FSIS has approved and prove that it has a protein content of at least 30%.
Shell eggs are under USDA regulation, which includes inspections for quality and safety at the point of production.
The FDA oversees egg products, such as those used in liquid, frozen, or dried form. This includes ensuring that these products are processed safely, properly pasteurized, and free from pathogens.
The FDA regulates all aspects of dairy production, including milk, cheese, and butter. This includes ensuring compliance with the Pasteurized Milk Ordinance, which sets standards for milk safety.
The FDA also oversees labeling standards, including label claims about the nutritional content and health benefits of dairy products.
The FDA has jurisdiction over fresh fruits and vegetables, ensuring they are free from harmful pesticides and contaminants.
The agency’s Produce Safety Rule, part of FSMA, focuses on preventive measures to minimize the risk of microbial contamination during the growing, harvesting, packing, and holding of produce.
Products that contain more than 2% cooked meat or poultry fall under USDA regulation. These include many ready-to-eat and frozen meals.
The USDA ensures that these products meet safety standards, are correctly labeled, and include a USDA inspection stamp. Products with less than 2% meat or poultry are regulated by the FDA, which ensures that these products meet food safety standards and are properly labeled.
Here's a summarized breakdown of the different types of businesses the FDA and USDA regulate:
| Agency | Regulated Businesses | Details |
|---|---|---|
| USDA | Meat and Poultry Processing Plants | Regulates slaughtering and processing, ensuring compliance with safety and labeling standards. |
| Egg Processing Facilities | Oversees processing of egg products, ensuring safety and proper labeling. | |
| Dairy Farms (Indirectly) | Influences dairy through marketing orders and grading services. | |
| Agricultural Businesses | Supports and regulates crop production, though products mainly regulated by FDA post-market. | |
| Organic Farms | Regulates all labeled organic products, including non-food items. | |
| Importers and Exporters of Food | Ensures compliance with U.S. safety standards for meat, poultry, and egg products. | |
| FDA | Food Processors and Manufacturers | Regulates facilities processing non-USDA regulated foods, including seafood, dairy, and dietary supplements. |
| Restaurants and Retail Food Establishments | Must adhere to FDA food codes and guidelines for handling and storage. | |
| Food Importers | Regulates imported food products, requiring compliance with FSVP to ensure safety. | |
| Cosmetics Companies | Ensures cosmetic products are safe and properly labeled. | |
| Pharmaceutical and Biotechnology Firms | Regulates development, manufacturing, and sale of drugs and biological products. | |
| Medical Device Manufacturers | Oversees safety and effectiveness of medical devices. | |
| Tobacco Product Manufacturers | Regulates manufacturing, marketing, and distribution under the Tobacco Control Act. |
We go into more detail below, specifically for food businesses:
The United States Department of Agriculture (USDA) primarily regulates businesses that are directly involved in food production and processing that include meat, poultry, and processed egg products. Here's a more detailed look at the types of businesses typically regulated by the USDA:
The Food and Drug Administration (FDA) regulates a much broader spectrum of businesses across various sectors, primarily focusing on consumer safety in food, pharmaceuticals, medical devices, and more. In terms of food-related businesses, here’s who falls under the FDA's regulatory scope:
The regulations enforced by the USDA and FDA are vital for ensuring the safety and integrity of the commercial supply of food in the United States. These benefits include:
The foundation of the FDA’s regulatory authority is the Federal Food, Drug, and Cosmetic Act (FD&C Act), enacted in 1938. This act provides the FDA with the authority to oversee the safety of food, drugs, and cosmetics.
The FDA is also governed by subsequent amendments and related laws, such as the Nutrition Labeling and Education Act of 1990, which mandates nutritional labeling for most foods, and the Food Safety Modernization Act (FSMA) of 2011, which focuses on preventing foodborne illnesses before they occur.
FSMA and more specifically the Food Traceability Rule represents the most significant expansion of FDA's authority in over 70 years, shifting the focus from responding to contamination to preventing it.
The USDA’s regulatory authority primarily stems from the Federal Meat Inspection Act (FMIA) of 1906 and the Poultry Products Inspection Act (PPIA) of 1957. These acts require federal inspection of all meat and poultry sold in interstate commerce and set strict standards for slaughter and processing facilities.
Additionally, the Egg Products Inspection Act (EPIA) of 1970 mandates the inspection of egg products to ensure their safety, quality, and wholesomeness. These laws ensure that meat, poultry, and egg products are safe, accurately labeled, and packaged in a sanitary environment.
The FDA’s regulations have significantly reduced the prevalence of foodborne illnesses linked to non-meat products. By enforcing GMPs and the Hazard Analysis Critical Control Point (HACCP) principles, particularly in seafood and juice processing, the FDA has effectively minimized risks associated with pathogens like Listeria and E. coli.
An example is the sharp decline in Salmonella infections following the FDA's stricter processing standards for shell eggs introduced in the late 1990s.
USDA regulations have a profound impact on reducing instances of contamination in meat and poultry products. Daily USDA inspections and mandatory HACCP systems in all meat and poultry plants have led to reductions in Salmonella and Campylobacter incidences.
The agency's stringent control measures during the Bovine Spongiform Encephalopathy outbreak in 2003, including banning certain cattle products in human food, showcased how proactive regulatory measures could protect public health.
A POLITICO report uncovered fundamental structural issues that significantly impede effectiveness. The FDA operates under the Department of Health and Human Services, positioning its commissioner, though confirmed by the Senate, outside of the Cabinet.
Typically, FDA commissioners have backgrounds primarily in medicine, with very little familiarity with food-related concerns. This lack of alignment often leads to substantial policy decisions becoming entangled in multiple layers of approval beneath them.
There’s a long-running joke among FDA officials that the “F” in FDA is silent. Commissioners have also been known to slip up and accidentally call it the Federal Drug Administration. Aside from a relative lack of interest in food issues, there’s also just been a straight-up lack of leadership at FDA: The agency has had five commissioners in three years, three of whom have been acting.
Now layer on the fact that, compared to the USDA, the FDA is regulates 80% of the food supply with disproportionate budget allocation...
It's near-impossible to envision how this inequitable funding will allow the FDA to achieve its "mission to protect and promote the health and wellness of all people through science-based approaches to prevent foodborne illness, reduce diet-related chronic disease, and ensure chemicals in food are safe."
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When setting up your personalized monitoring system, you can choose whether to create:
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The traceability system also allows you to:
Whether it's compliance with the U.S. Food and Drug Administration or the Department of Agriculture, FoodDocs will support your food safety efforts.
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