FDA Regulations for Food Packaging: Penalties and Ramifications for Failing to Meet Them

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Over the years, the Food and Drug Administration (FDA) has been consistently putting forth restrictions and guidelines on food packaging to protect consumers and to ensure that brands are being forthright in their labels. 

As new ingredients are continuously integrated into foods (think of the rise of CBD-infused products), it’s important that for the safety of consumers that the FDA keeps a watchful eye on all food packaging and products.

And, in order to deter companies from making false claims or from including ingredients in their food that are not safe, the penalties for failing to meet FDA regulations can be quite steep. 

Today, we’ll discuss the potential ramifications of being found guilty of not adhering to FDA food packaging guidelines. 

First, here are some of the key areas in which the FDA regulates food packaging and ingredients. 

FDA Regulations on Packaging and Ingredients

Here is a high-level look at some of the ways in which the FDA oversees food packaging and ingredients. 


The FDA regulates packaging to ensure that false claims are not made, as well as to ensure that the packaging is secure and safe enough to keep food fresh. 

Food Contact Substances

The FDA also regulates contact with food products from other substances while it is made and packaged. You may have seen food packaging with advisory statements such as “may contain [allergen]” or “produced in a facility that also uses [allergen].” However, according to the FDA, these statements should not be used as a substitute for “adhering to current good manufacturing practices.” The FDA is currently considering the best way to manage these types of statements to better inform consumers. 

Irradiation of Packaging and Food

Irradiation is typically used to increase shelf-life and reduce harmful bacteria in meat, poultry, vegetables, and other foods and is a major part of what the FDA oversees. The FDA requires that irradiated food packaging contains the international symbol for irradiation, as well as a statement that reads “treated with radiation” or “treated by irradiation.”

Types of FDA Penalties For Failing to Comply With Regulations

Warning Letters — Of all the actions the FDA may take against a company for failure to meet their regulations, a warning letter is by far the most lenient. If a violation is found on your packaging, the FDA will send a letter to the company outlining the specific error or grievance. If a business does receive one of these letters, they must respond with a plan for remedying the violation, complete with each step that will be taken to fix the issue. 

In November of 2019, the FDA issued a warning letter to a CBD product company that was making false claims that their products could be used as dietary supplements. In reality, the CBD company’s products did not meet the definition of a dietary supplement under the FDA. 

Seizure — Having products removed from commerce completely can be extremely costly for any company. If there is a significant violation of an FDA regulation that warrants more than a warning letter, the FDA may decide to simply seize the product from both physical and eCommerce shelves. The FDA website defines cases in which a seizure is necessary as instances in which the packaging is “adulterated and/or misbranded.”

An example of an instance in which a seizure may be necessary is if a food manufacturer labeled their product as being “100% sugar-free,” but that actually wasn’t true. 

Injunction — In an effort to completely stop or prevent a violation, the FDA may issue an injunction against a company. An injunction is a civil judicial process that will halt the flow of products in interstate commerce that are in violation until the correction can be made in regard to the conditions that initially caused a violation. 

An injunction may occur in similar situations as a seizure, where the main goal is to stop consumers from purchasing the product until the packaging is fixed. 

Criminal Prosecution — For some cases of infringement regarding FDA regulations, criminal prosecution may be recommended. Misdemeanor convictions, which do not require proof of intent to violate the Act, can result in fines and/or imprisonment for up to one year. Felony convictions, which involves the intent to defraud or mislead, can result in fines and/or imprisonment for up to three years.

How Esko Can Help You Remain FDA Compliant 

Esko is the premier packaging software partner for companies that want to streamline their label and artwork process while remaining compliant with FDA regulations. 

Esko assists Consumer Packaged Goods (CPG) companies with their FDA compliance in the following ways:

  • Create nutritional templates and have the capability to merge new nutritional data into packaging artwork.
  • Offering workflows that automatically route new nutritional information and tables for transparent and speedy approvals.
  • Support from subject matter experts who can advise on the best way to tackle current regulations and future ones as well. 
  • Working with manufacturers and the GS1 organization to ensure that existing standards take into account these changes and can be used to exchange nutritional data between systems.

To learn more about Esko’s packaging software and how it can help keep your brand FDA compliant while still maximizing your output, reach out to Esko today!

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