Category: FDA
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 […]
Navigating USDA and FDA Regulations
Cue the scene : You have confirmed FDA/Customs compliance for an imported FDA-regulated product, riding high with not a compliance care in the world – all is set. Goods are imported and then comes the news…the goods have been placed on an “Agriculture Hold.” You think – “What in the world is that? They must […]
How to Handle Import Rejection Like a Pro
As FDA detentions and refusals continue to climb, whether it’s for missing nutrition facts information, or lack of required FDA registration, it reminds us that getting an FDA import rejection notice is about as fun as being stood up on a blind date! While the FDA isn’t exactly sending you a love letter when they […]
The beauty industry is experiencing a regulatory glow-up, thanks to the Modernization of Cosmetics Regulation Act (MoCRA). With the FDA tightening its grip on cosmetics oversight, the impact is being felt not just in the U.S. but across international borders. From import/export compliance to global harmonization efforts, brands navigating this evolving landscape must be prepared […]
What this Means for Regulated Industry
The U.S. Food and Drug Administration (FDA) announced the revocation of Red No. 3 (FD&C Red No. 3) for use in foods and dietary supplements. This decision, which has sparked significant discussion within the regulated industry, marks a pivotal moment in food additive regulation and consumer safety. What is Red No. 3? Red No. 3 […]
A Game Changer for Industry
The Food and Drug Administration (FDA) has officially redefined the term “healthy,” serving us a regulatory receipt that promises to transform the food industry. In a move designed to reflect the latest nutritional science and consumer expectations, the FDA’s new regulations are set to shake up how food manufacturers market their products. Spoiler alert: the […]
A Tighter Grip on Talc and Asbestos Testing
New Year, new regulations—(kind of)! As we step into 2025, the U.S. Food and Drug Administration (FDA) has decided that it’s time to give the talc industry a little more TLC—specifically when it comes to testing for the sneaky mineral asbestos. It’s a big deal because, as we all know, asbestos and talc are akin […]
FDA’s Photo Policy Snaps Back
When the U.S. Food and Drug Administration (FDA) comes knocking for an inspection, a company’s usual concerns revolve around compliance, spotless records, and a robust quality system. However, one detail that has increasingly drawn attention has been the FDA’s practice of taking photographs during inspections. This seemingly minor aspect recently became a flashpoint, as highlighted […]
Navigating FDA’s New Scombrotoxin Standards
The FDA recently set sail with a new Compliance Policy Guide (CPG) that brings updated standards to the often-complex world of scombrotoxin (histamine) management in fish and fishery products. This regulatory move impacts a wide range of seafood industry players—from fishermen and processors to distributors and retailers—by setting clear standards on how fish prone to […]
The Bewitching World of FDA-Approved Halloween Candy Colors
When you dive into a bucket of Halloween candy, you’re not just snagging sweet treats; you’re reaching into a cauldron of FDA-approved colors, flavors, and ingredients that make those goodies as vibrant as a witch’s wardrobe. Ever wondered why your candy corn is orange or your gummy worms are a little too green? Well, it’s […]
★★★★★
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.
