Tag: FDA News
Documentation Alone Is Not Enough
The FDA continues to aggressively enforce the Foreign Supplier Verification Program (FSVP) , and its most recent Warning Letters reveal a common theme: importers are being cited not simply for lacking paperwork, but for failing to demonstrate meaningful oversight of their foreign suppliers. Recent Warning Letters issued to Datil Fresh Produce LLC, Moda Food LLC, […]
Registration Is Only the Beginning
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) significantly expanded FDA’s authority over cosmetics and created new obligations for many cosmetic companies. For businesses that entered the market after MoCRA’s enactment, one of the most common misconceptions is that facility registration and product listing equal FDA approval. They do not. FDA recently reiterated that […]
FDA’s Annual and Biennial Registration Season Is Here
As the leaves turn, pumpkin spice takes over, and inboxes become increasingly terrifying, FDA-regulated companies have another seasonal tradition to add to the calendar: registration renewals . Between October 1 and December 31, FDA’s registration systems become the regulatory equivalent of an annual physical. Some industries get called in every year. Others only every other […]
What Recent Enforcement Trends Are Really Telling Us
There are few phrases that ruin an importer’s morning as efficiently as: “FDA has refused admission.” One minute your shipment is crossing oceans, clearing customs, and heading toward your warehouse. The next, it is sitting at the port accumulating storage charges while everyone on the supply chain starts asking uncomfortable questions. FDA import refusals are […]
The End of the Self-GRAS Era?
For decades, the GRAS process has operated a bit like the honor system at a highway fruit stand: companies could determine that an ingredient was Generally Recognized as Safe (GRAS) and, if they chose, tell FDA about it. Many did. Some did not. FDA now wants everyone to show their work. On August 10, 2026, […]
7 Regulatory Changes Every Regulated Company Should Be Tracking
The first half of 2026 was anything but quiet at the U.S. Food and Drug Administration. While many companies expected a slower regulatory environment amid broader federal government changes, FDA instead continued advancing significant initiatives affecting foods, beverages, dietary supplements, cosmetics, OTC drugs, and medical devices. The agency’s focus has increasingly shifted toward data-driven oversight, […]
What Food Companies Should Know
The U.S. Department of Agriculture (USDA) has officially placed revisions to its National Bioengineered Food Disclosure Standard on the regulatory calendar, signaling that significant changes may be coming for food manufacturers, importers, retailers, and others throughout the food supply chain. According to USDA’s 2026 Unified Agenda, the agency is targeting August 2026 for publication of […]
Your Food Facility Registration (FFR) isn’t just another regulatory requirement—it may be one of your company’s most valuable compliance credentials. On July 20, 2026, the U.S. Food and Drug Administration (FDA) issued a new advisory reminding human and animal food facilities to protect their Food Facility Registration information from unauthorized access or misuse. The alert […]
What Food and Supplement Companies Should Be Watching
Every year, FDA publishes a document that receives far less attention than it deserves: the Human Foods Program Guidance Agenda. It is not a new regulation. It does not create new legal requirements. And it does not immediately change anyone’s compliance obligations. What it does provide is something many companies find even more valuable: a […]
FDA’s Revised General Wellness Policy Creates New Opportunities—and New Boundaries—for Digital Health Innovation
The latest generation of wellness technology is doing much more than counting steps. Today’s wearables can estimate blood pressure trends, analyze heart rate variability, monitor oxygen saturation, evaluate sleep quality, assess recovery, and use sophisticated algorithms to provide users with personalized insights. In short: your smartwatch may know you need a nap before you do. […]
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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.
