Tag: Current Affairs
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 […]
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, […]
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 […]
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. […]
First New Active Ingredient Added in 20+ Years
The FDA has added bemotrizinol to the OTC sunscreen monograph—the first new active ingredient permitted since the late 1990s—marking a significant step in modernizing the nonprescription drug framework and accelerating pathways for innovation. What Happened The FDA concluded an administrative order to add bemotrizinol as a permitted sunscreen active ingredient. The ingredient is considered generally […]
FDA’s New Inspection Playbook (and Why You Should Care)
The U.S. Food and Drug Administration has officially entered its “speed dating” era—at least when it comes to inspections. On May 6, 2026, FDA announced a pilot program for one-day inspectional assessments, a shorter, risk-based alternative designed to complement traditional, multi-day inspections. While the concept sounds deceptively simple—“we’ll be in and out in a day”—the […]
Power, Pitfalls, and the Non-Negotiable Role of Human Review
Artificial intelligence is rapidly transforming FDA-regulated industries—but it is also quietly reshaping regulatory risk. Companies across food, beverage, dietary supplements, OTC drugs, cosmetics, and medical devices are now using AI to draft submissions, generate SOPs, review labels, and analyze safety data. At the same time, FDA itself is deploying AI to accelerate review, inspections, and […]
FDA inspections don’t arrive with much ceremony. There’s no buildup—just a badge, a few introductions, and then a steady stream of questions about your documents, your systems, and your people. What has changed is everything around that moment. Inspections are happening more often, follow-ups are quicker, and tolerance for “we’ll fix it later” has narrowed […]
How FDA Is Implementing Its Expanded Cosmetics Authority—and What It Means for Industry
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents the most consequential update to U.S. cosmetics regulation since the Federal Food, Drug, and Cosmetic Act was enacted in 1938. In a recent FDA Voices article, the U.S. Food and Drug Administration explains how it is implementing this new authority and why these changes materially […]
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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.
