FDA Updates General Food Labeling Requirements Compliance Program

June 24, 2025

The U.S. Food and Drug Administration has updated Compliance Program 7321.005, now titled General Food Labeling Requirements and Labeling-Related Sample Analysis – Domestic and Import. This update replaces the previous 2010 version of the program and reflects current labeling regulations, operational guidance, and enforcement priorities.

FDA’s Compliance Program (CP) outlines the guidelines and procedures for FDA inspectors when conducting inspections of food facilities, both within the United States and in foreign countries. The purpose of the CP is to help ensure that food facilities comply with FDA regulations, and to protect public health by identifying and addressing food safety issues.

These updates support FDA’s ongoing efforts to help ensure that food labeling is truthful, not misleading, and compliant with federal regulations. The updated program will enhance oversight of domestic and imported foods, guide enforcement activities, and improve data consistency across FDA operations.

Key changes to the program include the incorporation of sesame as the ninth major food allergen in accordance with the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act of 2021, and includes guidance on gluten-free labeling requirements. The program also aligns with the 2016 updates to the Nutrition Facts label, including formatting and nutrient declaration changes.

More information about FDA’s labeling requirements and compliance efforts can be found at:
https://www.fda.gov/food/food-labeling-nutrition.

Request a Consultation

★★★★★

Working with Shelly on various new product launches over the last couple of years has been seamless. Quick and clear guidance is always what we get.

R.G. Client

I've been working with Shelly and her team at Garg law for a little while now and they are fantastic! Very responsive, professional and they certainly get things done. Extremely satisfied with their service and highly recommend.

Mike H. Client

Ms Garg helped my company navigate an FDA import issue. She achieved an excellent result, was very responsive and professional, and managed to keep the project within budget. She is a stellar attorney.

Dr. Sastry Client

I have been using Shelly Garg as FDA Counsel for 10+ years, since she was at another international law firm. While we continued to use the previous firm she was at (mainly due to the process required to change firms), we realized the quality of counsel was not the same. We have since been using Garg Law and the ease of use and trust in the knowledge was back instantly. Shelly has the skills to help me understand the regulations (by translating into layman's terms) and risks in a manner that is specific to my business. She is also extremely timely in her responses which is critical when we have a deadline mandated by the FDA. Many other attorneys cite the regulations which l've already read, but need further counsel. In my opinion, this demonstrates Shelly's in-depth knowledge of the regulations, how they pertain to the law, and how they are applicable IRL. Shelly's personable approach and pleasant manner in communication makes it very easy to have been work with her and have productive discussions on the best next steps. She truly has a passion iternational for all things FDA and I've learned so much from her.

Claire P. Client