Tag: Current Affairs
As we fire up the grills and get ready for fireworks this Independence Day, FDA is working to ensure that our food safety regulations are as American as apple pie and as dependable as Uncle Sam, providing a mid-year update on the Agency’s Food Program. Earlier in the year, FDA outlined the draft and final […]
Top 5 Violations in the Latest FDA Foreign Supplier Verification Warning Letters
It’s not just the temperatures that have been sizzling as of late! FDA’s recent flurry of FSVP Warning Letters continues to demonstrate that FSVP enforcement is hot, and high! As a reminder, FSVP mandates that importers verify that their foreign suppliers meet U.S. safety standards. We will take a look here at the top five […]
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 […]
A Paradigm Shift in the Regulation of Diagnostic Devices
In the realm of diagnostic testing, Laboratory Developed Tests (LDTs) have long occupied a unique position. Developed and performed within a single laboratory, these tests have been subject to varying degrees of regulatory oversight over the years. However, the FDA’s latest Final Rule on LDTs, issued on May 6, 2024, signifies a significant regulatory overhaul. […]
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 […]
An Endurance Test of Paperwork and Patience
Welcome to the FDA import detention merry-go-round, where we say, hold onto your paperwork! The FDA import detention process can be a daunting (and let’s be honest, derailing!) experience for businesses involved in importing goods, especially those in the realm of foods, cosmetics, dietary supplements, drugs or medical devices. However, with proper knowledge and strategic […]
Enhancing Safety and Efficiency
In a continuous effort to strengthen patient safety and streamline regulatory processes, FDA recently introduced significant updates to the 510(k) premarket notification process for medical devices which we previously reported on here . These revisions mark a pivotal shift in the regulatory landscape, aiming to enhance the efficiency of device clearance while maintaining stringent standards […]
FDA Intensifies Scrutiny on Honey Amid Rising Concerns of Economic Adulteration
The FDA announced this week that honey will undergo testing for economically motivated adulteration (EMA) via import sampling and a risk-based import entry screening program. Honey, the golden nectar cherished for its natural sweetness and numerous health benefits, has been on FDA’s radar over the last few years with Agency sampling assignments carried out in […]
Toxic Yellow Oleander in Certain Supplements Receives Updated FDA Warning
Late last week, FDA announced that it completed analytical testing of an additional dietary supplement product which has similarly tested positive for yellow oleander. This comes after FDA’s ongoing analysis has determined that certain dietary supplements labeled as tejocote ( Crataegus Mexicana ) root were tested and found to be substituted, and adulterated, with yellow […]
New Fiscal Year 2024 Rates and What You Need to Know
Last week, FDA announced the rates for over-the-counter (OTC) monograph drug facility fees for fiscal year (FY) 2024 with a noticeable 31% marked rate increase from FY 2023 rates: FY 2024 rates include $34,166 for a Monograph Drug Facility (MDF), and $22,777 for a Contract Manufacturing Organization (CMO). As a reminder, OTC monograph drug facility […]
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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.
