Contact us

Thank you for your interest in Garg Law PLLC.

Our commitment to understanding your regulatory questions and business goals, and helping you achieve results starts here.

If you are looking for representation on a new matter, please fill out the form below to request a free consultation. The form enables us to conduct a preliminary check for potential conflicts of interest and to determine if we can proceed with the free consultation.

FDA Finalizes Guidance for Ready-to-Eat Fresh-Cut Produce Operations under Preventive Controls for Human Food Rule

Today, the FDA released final guidance to help manufacturers and processors of fresh-cut produce comply with the FSMA Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls (PCHF) rule.

Fresh-cut produce can be particularly susceptible to contamination, which can be introduced in the environment where it’s grown, during transport, during manufacturing, when it’s commingled with other products or at retail, and the opportunity for contamination can be amplified through each of these steps as it makes its way to consumers. Fresh-cut produce does not receive a kill step to eliminate pathogens that may be introduced during these processes and most are sold ready-to-eat. The guidance provides recommendations and examples of how the PCHF requirements can be implemented to protect fresh-cut ready-to-eat produce from contamination with biological hazards.

Fresh-cut produce includes any fruit or vegetable that has been physically altered from its whole state (e.g., by chopping, dicing, peeling, shredding) without additional processing (such as freezing or cooking) and distributed in fresh form. Examples of fresh-cut produce include chopped lettuce, cut cantaloupe, diced onions, and shredded carrots.

The final guidance reflects public comments received on the October 2018 draft guidance and replaces the 2008 FDA fresh-cut produce guidance. This guidance represents the agency’s current thinking on the issues related to preventing contamination in fresh cut produce. The agency encourages the industry to continue advancing and improving food safety practices, including through the development and implementation of Best Practice documents tailored to their specific commodities and processes.

Additional Information

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

News & Insights

Get the latest news on FDA regulatory delivered straight to your inbox.