Perishables, the Cold Chain, and the FDA

Published by: Vanesia Adkins, Chief Executive Officer, 02/16/2021

In the previous two articles, we discussed various regulations regarding the FDA and pharmaceuticals and the CDC and vaccines within the cold chain. In this series, we want to return to the FDA and cover the regulations and guidance in transportation and storage of perishables. Not only do these requirements keep your customers safe, but they also protect your business and products.

The Importance of Adherence to FDA Regulations for Perishables

From milk to vegetables to eggs, perishables (or TCS foods) require special attention at all stages, including manufacturing, transportation, storage, and, of course, after the consumer’s purchase. Failure to comply with the FDA’s requirements could cause problems for your business, your products, and your customers. It’s essential to follow all regulations to ensure you keep product waste to a minimum and don’t get your customers sick.

In the event of violations, the FDA may take several different actions depending on the severity of the breach. Companies and individuals can be subjected to

            • Warning letters

            • Seizure

            • Injunction

            • Criminal prosecution

            • And fines

FDA Regulations to Note for TCS Foods

Title 21 Food and Drugs covers several regulations regarding food and drug storage, manufacturing, and transportation. Chapter 1 covers the various rules and guidelines for TCS foods, including milk, cream, cheese, desserts, bakery items, fruit, fish, etc. There are a few specific requirements you should note regarding the transportation of these products.


Whether you’re in charge of the manufacturing or transportation of the TCS foods, recordkeeping is a must. All those involved in the supply chain have to maintain specific records to ensure safety. In the event of a problem, the FDA may request these records from your organization.

Some records you will have to maintain are

            • Names and addresses of facilities where you send your products

            • Where you received your products or ingredients from

            • Dates of shipments including received and shipped

            • Description of freight

            • Names of signers

            • Transfer point details

            • Vehicle details

            • Written agreements

            • Written procedures

            • Training documentation

Records need to be kept for an extended period, from 6 months to 2 years, depending on the history and company.


Foods, including perishables, all have to meet legal food labeling requirements. Labels should be honest, not misleading, identify significant food allergens, and be in English if sold in the United States. Your shipping packages should also be labeled appropriately for those involved in the transportation of the goods. Proper labeling will ensure consumers are storing their products safely and lowering your risk of waste during the cold chain.

Preventive Controls

The FDA Food Safety Modernization Act, or FSMA, helps companies be more proactive when it comes to food safety issues rather than reactive. The FSMA requires those involved in the manufacturing, transportation, and handling of perishables and foods to

            • Identify hazards

            • Minimize or prevent the hazards from occurring

            • Monitor labeling and branding

            • Maintain records of monitoring and performance


Companies involved in the cold chain are required to report in the event of mishandling or other problems regarding food. If an individual or company notices an issue that will cause health consequences or death to humans or animals, they can report it to the FDA Reportable Food Registry.


All vehicles used in the transportation of perishables must be “designed, maintained, and equipped as necessary to provide adequate temperature control.” Companies involved in the transport of these goods should also take precautions to ensure the segregation of foods in the same shipment, monitor temperature, and other controls, and provide adequate training for employees that focus on food safety problems, sanitary practices, responsibilities, and more.

Proper storage, handling, and transportation of TCS foods will help lower your risk of FDA fines, reduce waste, and keep your customers safe. Different food items have separate guidance regarding production, storage, and transportation. It’s essential to be familiar with Title 21 Food and Drugs in addition to all other guidance published by the FDA.

We can assist you with a plan for the transportation of your perishables and TCS foods that adheres to FDA regulations and guidance. If you’re curious to see how we can help, please visit our website For inquiries and questions, contact us at [email protected].