Tag: FDA News
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 […]
What They Are, How to Avoid Them, and How to Mitigate Successfully
Importing FDA‑regulated products is a bit like going through airport security: most of the time it’s routine, but if something goes missing—or looks suspicious—you may be pulled aside, detained, and asked uncomfortable questions. In the import world, that “secondary screening” can result in liquidated damages (and potentially greater scrutiny) if an importer fails to comply […]
FDA Scrutiny on Honey Fraud Intensifies
The U.S. Food and Drug Administration (FDA) recently released findings from its latest honey sampling assignment, reaffirming a persistent issue in the food industry: economically motivated adulteration (EMA). Honey remains particularly vulnerable to this form of food fraud, where cheaper sweeteners—such as sugarcane or corn syrups—are added without disclosure. How the FDA Tests for Adulteration […]
Forever Chemicals, Federal Oversight, and the Changing Regulatory Landscape
The beauty industry has long been a proving ground for scientific innovation. But lately, it has also become a focal point for regulatory scrutiny—particularly when it comes to per- and polyfluoroalkyl substances (PFAS), the class of chemicals often referred to as “forever chemicals.” PFAS have drawn increasing attention from regulators, lawmakers, and consumer advocates due […]
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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.
