Category: FDA
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 […]
What This Means for the Regulated Industry
FDA announced this week that it will examine the potential harm to women of heavy metals exposure such as lead, cadmium and arsenic found in tampons, following the results of a July pilot study, growing consumer concern over product safety, ingredient transparency, and potential health risks associated with tampon use. FDA stated that while the […]
Navigating USDA Permits for FDA-Regulated Products
What do seeds imported for planting, chicken broth in an imported soup, or vitamins and minerals derived from animal origin materials intended for use in a dietary supplement have in common, you ask? They may all be jointly regulated by USDA and FDA! USDA (US Department of Agriculture) and FDA (Food and Drug Administration) regulations […]
Navigating FDA’s Complex Regulation of Homeopathic and Ayurvedic Products
In an era where natural and alternative medicines continue to gain traction driven by a growing interest in holistic and natural health alternatives, the U.S. Food and Drug Administration (FDA) finds itself at the intersection of tradition and science. Homeopathic and ayurvedic products, rooted in centuries-old practices, have become a sizeable industry in the United […]
The U.S. Food and Drug Administration (FDA) has announced its new medical device user fees for fiscal year 2025, effective October 1, 2024, highlighting significant updates aimed at strengthening regulatory oversight and ensuring the safety and efficacy of medical devices. The FDA’s user fee program is designed to generate necessary resources for the agency’s regulatory […]
The FDA and FTC recently issued warning letters to several companies involved in the sale of Delta-8 THC products in packaging mimicking popular national brands appealing to both children and adults, reflecting growing regulatory scrutiny over the rapidly expanding market for this cannabinoid. Delta-8 THC, a compound derived from hemp, gained popularity due to its […]
The Magic of FDA Export Certificates Including New Requirements for Dairy Exports to India
U.S. FDA compliance, marketing clearance, and being in general good standing with the Agency is oftentimes the secret sauce to international markets. Foreign governments and foreign purchasers are keen to understand whether and to what extent exported goods comply first with U.S. regulatory requirements, marking a glittery stamp of approval. To help in this effort, […]
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 Wild Waters of an FDA Recall
Recalls are critical for ensuring public safety when products pose health risks but for businesses, this also means reacting quickly to contain the bleeding, limit supply chain disruption and avoid business and reputation damage while simultaneously working alongside the FDA, which plays a pivotal role in managing and helping effectuate recalls – a juggle of […]
★★★★★
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.
