Category: FDA
A Transformative Shift for Regulated Imports
As of August 4, 2025, the FDA’s Office of Import Operations (OIO) has launched the Nationalized Entry Review (NER) program, a new system that aims to standardize and improve the review of imported products. Revolutionizing how the agency reviews imports of FDA‑regulated products, the NER replaces the old port-by-port processing model with a centralized, technology […]
FDA Seeks Definition for Ultra-Processed Foods in Major Regulatory Shift
If you’ve ever stared suspiciously at your pantry wondering whether that neon-orange cheese puff qualifies as dinner or some sort of science experiment, you’re not alone. The FDA, the same folks who once agonized over what “natural” means (spoiler: still no consensus), have now turned their regulatory magnifying glass on a new target: ultra-processed foods. […]
The FTC’s July 2025 Crackdown on “Made in USA” Claims Puts Industry on Notice
A Patriotic Primer Turned Compliance Crossfire As barbecues sizzled and flags fluttered this July 4th, the Federal Trade Commission (FTC) was busy preparing a fireworks display of its own—this one of the regulatory variety. Declaring July as “Made in USA Month,” the Commission followed up its symbolic gesture with real regulatory firepower: four warning letters […]
A Look at Audit Readiness in the Age of Expanded Inspections
The FDA is back in full swing, and inspections—both scheduled and surprise—are becoming more frequent, more detailed, and more critical than ever. As global regulators expand the scope, frequency, and depth of inspections, companies face increasing pressure to demonstrate compliance and transparency. Expanded inspections, whether triggered by legislative updates, whistleblower complaints, or routine agency policy, […]
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 […]
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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.
