Tag: Foods
FDA Announces Expanded Use of Unannounced Foreign Inspections
In what can only be described as the regulatory equivalent of “We were in the neighborhood…”, the U.S. Food and Drug Administration (FDA) announced May 6, 2025, its expanded use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines and other medical products intended for American consumers and patients. Yes, you read […]
Strategic Guidance for FDA-Regulated Companies
The return of Trump-era “America First” trade policies in 2025 has reshaped the regulatory and economic environment for companies regulated by the U.S. Food and Drug Administration (FDA)—particularly those in the food, cosmetics, medical device, and over-the-counter (OTC) drug sectors. With the reimposition of tariffs on key imports, intensified scrutiny of foreign manufacturing, and a […]
What It Means for the Regulated Industry
In the world of food, there has been a colorful drama unfolding recently involving artificial food dyes, which are being dramatically shown the door. In recent years, a growing number of U.S. states have taken actions to ban or restrict the use of such dyes in consumer products. This movement, spearheaded by states like West […]
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 […]
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 […]
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 […]
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 […]
Navigating FDA’s Complex Regulation of Homeopathic and Ayurvedic Products
In an era where natural and alternative medicines continue to gain traction driven by a growing interest in holistic and natural health alternatives, the U.S. Food and Drug Administration (FDA) finds itself at the intersection of tradition and science. Homeopathic and ayurvedic products, rooted in centuries-old practices, have become a sizeable industry in the United […]
★★★★★
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.
