Category: Regulatory Law
Mitigating Liquidated Damages
Wondering what liquidated damages actually are? They’re a predetermined sum written into your customs bond that CBP can assess when a bond condition isn’t met, with no need to prove actual harm. Here’s the twist for FDA-regulated importers: you may have already thought you dealt with the FDA problem, and the bill can still show […]
Documentation Alone Is Not Enough
The FDA continues to aggressively enforce the Foreign Supplier Verification Program (FSVP) , and its most recent Warning Letters reveal a common theme: importers are being cited not simply for lacking paperwork, but for failing to demonstrate meaningful oversight of their foreign suppliers. Recent Warning Letters issued to Datil Fresh Produce LLC, Moda Food LLC, […]
Registration Is Only the Beginning
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) significantly expanded FDA’s authority over cosmetics and created new obligations for many cosmetic companies. For businesses that entered the market after MoCRA’s enactment, one of the most common misconceptions is that facility registration and product listing equal FDA approval. They do not. FDA recently reiterated that […]
When Marketing Becomes Regulation
For many consumer brands, the package receives careful legal review while the website is treated as “marketing.” From an FDA perspective, that distinction can be dangerous. FDA evaluates representations made about regulated products when determining issues such as intended use, product classification, labeling , and whether a product is being marketed in violation of the […]
15 FDA Questions Every Consumer Brand Should Answer
Launching an FDA-regulated consumer product involves considerably more than creating a formula, designing packaging, and placing an order with a manufacturer. Food, beverage, dietary supplement , and cosmetic companies can encounter regulatory issues involving ingredients, product classification, labeling, claims, manufacturing, registration, safety substantiation, and post-market obligations. The most expensive regulatory problems are often those discovered […]
FDA’s Annual and Biennial Registration Season Is Here
As the leaves turn, pumpkin spice takes over, and inboxes become increasingly terrifying, FDA-regulated companies have another seasonal tradition to add to the calendar: registration renewals . Between October 1 and December 31, FDA’s registration systems become the regulatory equivalent of an annual physical. Some industries get called in every year. Others only every other […]
What Recent Enforcement Trends Are Really Telling Us
There are few phrases that ruin an importer’s morning as efficiently as: “FDA has refused admission.” One minute your shipment is crossing oceans, clearing customs, and heading toward your warehouse. The next, it is sitting at the port accumulating storage charges while everyone on the supply chain starts asking uncomfortable questions. FDA import refusals are […]
The End of the Self-GRAS Era?
For decades, the GRAS process has operated a bit like the honor system at a highway fruit stand: companies could determine that an ingredient was Generally Recognized as Safe (GRAS) and, if they chose, tell FDA about it. Many did. Some did not. FDA now wants everyone to show their work. On August 10, 2026, […]
What Food and Supplement Companies Should Be Watching
Every year, FDA publishes a document that receives far less attention than it deserves: the Human Foods Program Guidance Agenda. It is not a new regulation. It does not create new legal requirements. And it does not immediately change anyone’s compliance obligations. What it does provide is something many companies find even more valuable: a […]
How to Avoid Escalation to a Warning Letter
An FDA Form 483 is not routine. It’s the moment your inspection outcome is decided. Across food, supplements, OTC drugs , cosmetics, and medical devices, recent enforcement shows a clear pattern: your response—not the inspection—often determines whether you escalate to a Warning Letter. What a 483 Really Means A Form 483 signals FDA believes your […]
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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.
