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.

Food Traceability: FDA Issues Draft Enforcement Discretion Policy for Certain Small Retailers and Restaurants and Announces Public Meeting

To fulfill a directive from Congress, the FDA is taking steps to identify and offer stakeholders additional flexibilities, as appropriate, for complying with the Food Traceability Rule.

In response to feedback from stakeholders, and after determining there would be minimal public health impact, the FDA is issuing draft guidance that will, if finalized, provide enforcement discretion from the requirements of the Food Traceability Rule for certain smaller retail food establishments (RFEs) and restaurants that were not previously captured as part of the full exemption for small RFEs and restaurants offered as part of the rule. We believe this additional flexibility will maintain the intended public health benefits of the rule as it would only impact a small percentage of total food sales while also providing relief to numerous smaller RFEs and restaurants.

Under the draft policy, the FDA does not intend to enforce any of the requirements of the Food Traceability Rule for RFEs and restaurants whose average monetary value of food sold or provided during the previous three-year period is greater than $250,000 but not more than $1million, adjusted for inflation using 2020 as the baseline year for calculating the adjustment.

FDA plans to offer additional flexibilities for complying with the Food Traceability Rule, beyond this draft enforcement policy for small RFEs and restaurants. Towards that end, the FDA will hold a public meeting on November 6, 2026, as part of a series of engagements being held in accordance with the Congressional directive under the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 (P.L. 119-37).

The Federal Register notice announcing the public meeting includes a high-level summary of feedback received on the discussion paper released on May 27 and discussed at the June 15 public meeting. The goal of this upcoming public meeting is to hear additional stakeholder perspectives on lot-level food traceability efforts and implementation challenges. Specifically, the FDA is interested in feedback on the potential flexibilities outlined in the discussion paper and on the feedback received on the discussion paper in the docket.

The public meeting is free and open to the public, but registration is necessary to attend. More information about registration and how to request to speak during the public comment period are available on our meeting page. General registration will remain open until November 5, 2026, but individuals who want to speak during the public comment period must register by October 26, 2026.

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.