How to Keep Your Food Company FDA-Compliant

Preplanning

The first thing to do is to talk about the particular facility and product with local and state regulatory agencies having jurisdiction and the FDA District Office. This will help identify the local and state regulations that need to be met to operate a food company. Knowing what the FDA regulates types of companies and which ones will not help you get started and help simplify the process.

Registration & Prior Notification

The next step is to register the food company with the FDA before getting it up and running. Certain facilities like farms and restaurants are exempt from this requirement. As interstate commerce, imported food items must meet the same requirements as those locally produced. They must be safe for consumption, contain no outlawed ingredients, and be labeled truthfully in the local or national language. Except in the case of exemptions, the FDA must have prior notice of imported food shipments. This allows the FDA to intercept and inspect food items that may be contaminated or otherwise unsafe for consumption.

Recordkeeping

All food companies must keep detailed and accurate records available at any given time to the FDA so that it can identify all food items the facility has handled or come into contact with. This process includes any facility with which the leading company has interacted in any way. For example, if another company does any part of the process, its information must be included in the records.

cGMP Compliance

A food company must adhere to Current Good Manufacturing Practice or cGMP regulations and be produced safely and sanitary before being released into interstate commerce. Particular food items such as eggs may also have their requirements due to inherent attributes, known pathogens, or production processing risks in their handling. A solid silicone sheet is a great tool to seal packaging and minimize contamination or regulation violation risk tightly.

Labeling

A food company must provide labels for its food items that accurately detail their contents and other considerations such as potential allergens and nutritional value. These labels must be in the local or state language to ensure they are widely understood. Should any food item carry a risk of causing adverse health effects to anyone who might consume it, the food company must report this properly to the FDA's Reportable Food Registry.

Prevention

When it comes to problems with food items, the FDA takes the initiative by focusing more on prevention rather than reaction. As such, it evaluates hazards and risks, implements preventative measures to minimize risk, provides proof of the food not being tampered with or mislabeled in any way, monitor control performance regularly and keep detailed records thereof.

Inspection

The FDA's Office of Regulatory Affairs (ORA) investigators must inspect food companies periodically to ensure that they are up to standard. Their schedule may vary based on product risk level, company compliance history, and the amount of time elapsed since the last inspection. For example, facilities that manufacture or handle baby formula have annual reviews.

Making sure one's food company, be it a large corporation or a local or home-run business, can be daunting, as there are many risks involved and regulations to be adhered to. However, given that others consume the products involved, this is not surprising. Making sure a company is FDA-compliant will give it a much better chance of success, let alone allow it to be functional at all. 

Though the laws and regulations may seem confusing and inaccessible at first, particularly for those without the technological savvy or legal understanding or experience, all the necessary information is freely available online and elsewhere. A person can be consulted who can explain the concepts and help you follow them correctly.