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Tag: Enforcement

Navigating FDA Regulations Amid 2025 Trump-Era Trade Policies

04/16/2025

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 […]

The Growing Trend of States to Ban Food Dyes

04/02/2025

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 […]

Totally Cool, Inc. Gets the Freeze-Out from the FDA Following Food Safety Violations

03/25/2025

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 […]

The Ultimate Permit Tag-Team

03/05/2025

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 […]

FDA Doesn’t Send Love Letters

02/18/2025

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 […]

FDA Revokes Approval for Red No. 3 in Foods and Dietary Supplements

01/16/2025

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 […]

The FDA’s New Year’s Resolution

01/06/2025

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 […]

Keeping Fish Fresh and Regulations Fresher

11/15/2024

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 […]

Witch’s Brew and Candy Hues

10/31/2024

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 […]

Warning Letters Ahoy!

10/15/2024

Navigating the FDA’s High Seas of Foreign Supplier Verification Program (FSVP) Inspections

Ahoy, mateys! Batten down the hatches and hold onto your manifests, because the FDA’s on the prowl, issuing Warning Letters like they’re going out of style! If you’re in the business of importing FDA-regulated products, particularly food, you’re probably well aware of the Foreign Supplier Verification Program (FSVP). And if you’re not—well, now’s the time […]

★★★★★

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.

R.G. Client

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.

Mike H. Client

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.

Dr. Sastry Client

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.

Claire P. Client