Category: FDA
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. […]
How to Avoid Escalation to a Warning Letter
An FDA Form 483 is not routine. It’s the moment your inspection outcome is decided. Across food, supplements, OTC drugs , cosmetics, and medical devices, recent enforcement shows a clear pattern: your response—not the inspection—often determines whether you escalate to a Warning Letter. What a 483 Really Means A Form 483 signals FDA believes your […]
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 […]
A Practical Enforcement Continuum
FDA import enforcement operates along a predictable—but unforgiving—continuum: detention, refusal, and, in repeat cases, import alert placement. Recent FDA data dashboards confirm sustained levels of import refusals and enforcement activity, reflecting the Agency’s continued reliance on data-driven screening and historical compliance patterns. For importers, the practical issue is not whether this framework exists—but whether entries […]
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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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.
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.
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.
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.
