Tag: Import Alerts
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, […]
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 […]
A Practical Enforcement Continuum
FDA import enforcement operates along a predictable—but unforgiving—continuum: detention, refusal, and, in repeat cases, import alert placement. Recent FDA data dashboards confirm sustained levels of import refusals and enforcement activity, reflecting the Agency’s continued reliance on data-driven screening and historical compliance patterns. For importers, the practical issue is not whether this framework exists—but whether entries […]
FDA Scrutiny on Honey Fraud Intensifies
The U.S. Food and Drug Administration (FDA) recently released findings from its latest honey sampling assignment, reaffirming a persistent issue in the food industry: economically motivated adulteration (EMA). Honey remains particularly vulnerable to this form of food fraud, where cheaper sweeteners—such as sugarcane or corn syrups—are added without disclosure. How the FDA Tests for Adulteration […]
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 […]
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 […]
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 […]
The Importance of Conducting a Regulatory “Check-Up”: Ensuring FSVP Compliance and Passing an FDA FSVP Inspection
FDA plays a critical role in safeguarding public health by enforcing regulations to ensure the safety of imported food products via routine inspections and other means. Recently, the FDA issued three warning letters to food companies for their failure to have a Foreign Supplier Verification Program (FSVP) in place. Specifically, FDA found that all three […]
Countdown to Cosmetics Compliance and the Upcoming Deadline
As the July 1 st deadline for compliance with the Modernization of Cosmetics Regulation Act (MoCRA) rapidly approaches, cosmetic companies are glamorously gearing up to meet the new regulatory requirements set forth by this landmark legislation. As a reminder, MoCRA represents a significant overhaul of the regulatory framework governing the cosmetics industry, ushering in a […]
Implications for Food Industry and Businesses
FDA’s recent step in issuing Import Alert 99-48 for food products containing chemical contaminants has sent ripples through the food industry and businesses engaged in food production. Particularly affected are companies involved in the production of products containing per- and polyfluoroalkyl substances (PFAS) or other chemical contaminants . PFAS are a group of man-made chemicals […]
★★★★★
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.
