Category: Regulatory Law
In a move that has both nutritionists and food scientists raising their kale smoothies in approval, the FDA announced on May 9, 2025, the approval of three new natural food color additives. This decision marks a significant step in the Department of Health and Human Services’ (HHS) initiative to modernize the color additive regulations and […]
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 […]
A Closer Look at the Potential Inspection Shift, State Oversight and How to Stay Compliant
The Great Inspection Shake-Up: FDA’s New Recipe In the grand kitchen of U.S. food safety, the FDA has long played head chef—stirring up regulations, inspecting operations, and occasionally flipping a facility on its lid when things got unsanitary. But in 2025, the kitchen dynamics are shifting, with many wondering if the Agency is stepping away […]
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 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 […]
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 […]
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 […]
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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.
