Category: Facility Registration
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 […]
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 […]
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 FDA’s Latest Cosmetic Data Means for the Beauty Biz
Hold onto your mascara wands, folks! The FDA recently dropped a bombshell of data on the registration and listing of cosmetic product facilities and products. While this might not seem as exciting as the latest contouring technique, it’s crucial for the safety, transparency, and regulation of the beauty industry. Think of it as the behind-the-scenes […]
A Consent Decree with a Side of Court-Ordered Chill
Hold on to your ice cream cones, folks! It looks like Totally Cool, Inc. has gotten a big ol’ spoonful of legal trouble. The United States District Court for the District of Maryland just handed down a consent decree of permanent injunction on March 18, barring the company (and its CEO, Michael J. Uhlfelder) from […]
Update on FDA Cosmetic Product Facility Registration and Cosmetic Product Listing Requirements
This week, FDA gave the cosmetic industry an early holiday gift when it issued a Compliance Policy on its intent to delay enforcement of the requirements for cosmetic product facility registration and cosmetic product listing requirements under MoCRA for 6 months after the December 29, 2023 statutory deadline, or until July 1, 2024. FDA advised […]
Last week, FDA provided a glossy update on ongoing activities related to the new cosmetic product facility registration and cosmetic product listing requirements that are now mandated under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). In our prior News & Insights articles here and here, we discussed cosmetic facility registration requirements, which includes […]
FDA’s 2023 device registration renewal period!
With the smell of pumpkin spice lattes in the air and the taste of warm apple cider doughnuts, comes another special time of year: FDA’s device registration renewal period! Beginning October 1 – December 31, 2023 , all foreign and domestic medical device establishments must register and renew their device establishment registration with FDA. This […]
On the Preventive Controls for Human Food Rule, Food Allergen Program and Acidified Foods
Staying true to its promise, the FDA announced the release of updated draft guidance this week to assist food facilities to comply with the requirements for current good manufacturing practices (cGMPs) and preventive controls for human food under the Food Safety Modernization Act (FSMA). Specifically, FDA’s draft guidance provides new chapters on ways manufacturers can […]
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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.
