Category: Regulatory Law
In a closely watched decision, the U.S. District Court for the District of Columbia on July 15, 2025, largely upheld the Food and Drug Administration’s (FDA) authority to regulate homeopathic drugs as “new drugs” under the Federal Food, Drug, and Cosmetic Act—effectively reinforcing the agency’s risk-based enforcement approach finalized in 2022. The lawsuit, brought […]
FDA Seeks Definition for Ultra-Processed Foods in Major Regulatory Shift
The FTC’s July 2025 Crackdown on “Made in USA” Claims Puts Industry on Notice
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
A Closer Look at the Potential Inspection Shift, State Oversight and How to Stay Compliant
Strategic Guidance for FDA-Regulated Companies
★★★★★
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.
