Tag: Imports
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, […]
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 […]
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 […]
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 […]
★★★★★
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.
