7 Things Business Owners Need to Know About Food Regulations

Are you thinking about finally starting a business in food manufacturing or distributing?

Whether it’s as small as selling homemade pickles at your local farmers market or as big as running your own catering company, you need to be aware of the food regulations and laws.

Failing to do so could lead to a fine or worse a lawsuit. We got you covered with these top seven things future food business owners (like yourself) need to know about food regulations.

Keep on reading to learn more!

How Food Regulations Are Created

In the United States, the Congress declares food safety regulations. State and local regulatory agencies handle the retail food and other food safety issues through local town ordinances and bylaws.

The state and local agencies can adopt or modify any federal standards. The USDA and FDA regulate food safety with the Code of Federal Regulations.

Why Were Food Safety Regulations Created?

Regulations are created through scientific-based studies and data. The history of modern food safety regulations dates back to the Pure Food and Drug Act and Meat Inspection Act. These acts were both passed in 1906 by Theodore Roosevelt.

The U.S. food regulation was the government’s response to Upton Sinclair’s 1906 publication of The Jungle. This novel described the horrific conditions and practices of the meat packing industry.

Even though this novel was published as fiction, Roosevelt’s investigative team uncovered that the conditions noted were sadly accurate. This alarmed Roosevelt so much that he considered turning to vegetarianism. He later signed the acts which became the first modern regulations for food safety.

To this day, food is regulated and even tested through microbiology test to ensure it’s safe for human consumption.

1. Determine if Your Business Needs to Follow Food Regulations

The kind of food business you’re starting will determine what kind of food regulations you’ll need to follow.

The Food & Drug Administration, or FDA, regulates all foods and ingredients offered for sale. However, the U.S. Department of Agriculture (USDA) is responsible for regulating meat, poultry, and certain processed egg products.

There’s also the Center for Food Safety and Applied Nutrition (CFAN) that works with the FDA. Its responsibility is to make sure the food the FDA regulates is safe, sanitary, wholesome and correctly labeled.

There are certain food businesses that are not regulated by the FDA and instead regulated by the state and local governments. These businesses include retail food establishments like grocery stores, restaurants, cafeterias, food trucks and farmer’s markets.

2. Register Your Food Facility

If your facility manufactures, processes, packs or stores food for human or animal consumption in the United States, it must be registered with the FDA before it does any of these activities, unless for some reason your facility is exempt.

An exempt facility is one that manufactures, processes, packs or holds only food that is a contact substance or pesticide.

3. Understand Food Imports

In the United States, food imports need to meet the same laws and regulations as if they were produced in the United States. These regulations mean they must be safe and contain no prohibited ingredients. Also, all packaging and labeling must be informative, truthful and in English or if in Puerto Rico, in Spanish.

4. Be Aware of Prior Notice

Since December 12, 2003, the FDA needs to be notified in of any shipments of food for humans or animals. This is also known as Prior Notice.

Prior Notice of imported food shipments gives the FDA an opportunity to, review and evaluate information before a food product arrives in the states. This also allows for the FDA to inspect and intercept any contaminated foods or products.

5. Have Good Recordkeeping

If you are a food manufacturer, processor, packer, transporter, distributor, receiver, holder or importer, you are required to establish, maintain and make certain records available to the FDA. These records will allow the agency to identify all products handled by the facility.

So, if your business needs to register under the Bioterrorism Act, because you make potato chips that are baked and packaged by another facility, your records should include the names and addresses of the facilities where you send your chips to be baked and packaged. This process is also known as “one up, one down” in the distribution chain.

Depending on what type of food business you run, your business may have to keep records available to the FDA in addition to the ones needed under the Bioterrorism Act.

Look into Titel 21 of the Code of Federal Regulations to find out which records are needed for your specific type of facility and operation. Know that requirements can vary depending on your business.

6. Maintain Good Manufacturing Practice Requirements

Know that the current Good Manufacturing Practice (cGMP) regulations require that the food you’re selling are produced under safe and sanitary conditions.

Certain food commodities have additional requirements because of hazards, attributes, or specific manufacturing processes.

Take egg producers for example. Because of the spread of Salmonella Enteritidis, that comes from raw or spoiled eggs, they need to follow the Egg Safety Final Rule to reduce the spread of Salmonella.

7. Keep Labeling & Reporting

If you’re manufacturing food, you are responsible for properly labeling said food. These labels include nutritional information that meets legal food labeling requirements. All FDA regulated food products must be truthful and not misleading.

Proper labeling includes nutritional labeling and also pointing out the major food allergens in the product. Like if the product could contain traces of soy or tree nuts.


Registered facilities must also report if there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health problems or death to humans or animals.

For more information on how to report these issues, check out the FDA’s Reportable Food Registry. The FDA enforces reporting of serious adverse events involving dietary supplements.

Preventive Controls

On January 2011, The FDA Food Safety Modernization Act (FSMA) was signed. This allows the FDA to focus more on preventing food safety problems instead of relying on reacting to problems after they occur.

Regulate Your Food

Now that you know about the seven most important things new food businesses need to know about food regulations, it’s time to open that business.

Be aware of the history, and when it comes to regulating your food, or if you’re unsure about something, always check with the FDA.

For more tips and articles on starting your new business, check out our blog.

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