Category: Regulatory Law
A Tighter Grip on Talc and Asbestos Testing
New Year, new regulations—(kind of)! As we step into 2025, the U.S. Food and Drug Administration (FDA) has decided that it’s time to give the talc industry a little more TLC—specifically when it comes to testing for the sneaky mineral asbestos. It’s a big deal because, as we all know, asbestos and talc are akin […]
FDA’s Photo Policy Snaps Back
When the U.S. Food and Drug Administration (FDA) comes knocking for an inspection, a company’s usual concerns revolve around compliance, spotless records, and a robust quality system. However, one detail that has increasingly drawn attention has been the FDA’s practice of taking photographs during inspections. This seemingly minor aspect recently became a flashpoint, as highlighted […]
Navigating FDA’s New Scombrotoxin Standards
The FDA recently set sail with a new Compliance Policy Guide (CPG) that brings updated standards to the often-complex world of scombrotoxin (histamine) management in fish and fishery products. This regulatory move impacts a wide range of seafood industry players—from fishermen and processors to distributors and retailers—by setting clear standards on how fish prone to […]
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 […]
FDA’s Year-End Registration Reminder for Food and Medical Device Facilities
As the smell of pumpkin spice and nutmeg abounds during this special time of year, the U.S. Food and Drug Administration (FDA) reminds food and medical device facilities that it’s time to register or renew registrations between October 1 and December 31, 2024. This annual/bi-annual registration period is critical for facilities involved in the manufacturing, […]
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 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 […]
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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.
