Category: Foods & Beverages
How to Avoid and Mitigate U.S. Customs Liquidated Damages and Penalties Did you know that U.S. Customs can assess penalties up to 3x the value of goods if you fail to export or destroy FDA refused merchandise timely? On top of FDA compliance concerns associated with FDA detained and ultimately refused goods, numerous other costs […]
FDA and USDA Regulatory Updates on Lab Grown Meat Summer is synonymous with time at the beach, popsicles and grilling. But soon enough, you may be picking up cell-grown meat on your next grocery run. The U.S. Department of Agriculture (USDA) recently approved two companies, Good Meat and Upside Food, to sell lab-grown and cell-cultivated […]
Update to FDA’s 2023 Priorities for Foods FDA Releases Update of Priority Guidance Topics for the FDA Foods Program In efforts to provide continued transparency for stakeholders regarding foods program priorities, FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and the Office of Food Policy and Response (OFPR) released an updated list of draft […]
You import a product to the U.S. and then receive a notice from your customs broker that the shipment has been held by the FDA. Next, you receive a Notice of FDA Detention right when you are about to fulfill a huge Purchase Order. Now what? Is the shipment lost in FDA space or can […]
A Look at FDA’s Enforcement Policy on Major Food Allergen Labeling and Cross-Contact
How to Comply with USDA Requirements for Animal and Plant-Derived Products, and Avoid Import Holds and Enforcement Action Imported orchid extract in shampoos, chicken broth in pre-packaged soup, fish oil in supplements, seeds for planting, seeds for research use only, and vitamins and minerals derived from bovine and ovine origin surprisingly have a common thread. […]
Ongoing Scrutiny Over Kratom: Challenges as a Bulk Dietary Ingredient and as a Dietary Supplement FDA recently seized more than 250,000 units of dietary supplements and bulk dietary ingredients that are or contain kratom (also known as mitragyna speciosa, a tropical tree native to Southeast Asia, commonly used for its leaves). The dietary supplements, manufactured […]
Belgian authorities destroy American beer for failure to comply with Protected Designation of Champagne: A look at Parallel Market Imports and Food Standards and Labeling Last week, Belgian authorities destroyed more than 2,000 cans of Miller High Life at the request of the Comité Champagne, a trade organization that oversees use of the name Champagne, […]
Last week, FDA announced an Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market. The strategy is a result of shake-up caused by the recent infant formula shortage following unsanitary conditions at one of the country’s largest infant formula facilities, which led to stand-still production for several months and a significant voluntary recall. The […]
This week, FDA kicked-off a new resource about the Modernization of Cosmetics Regulation Act of 2002 (MoCRA) and a follow-up constituent advisory that FDA has stopped accepting and processing submissions to the Voluntary Cosmetic Registration Program (VCRP). FDA is developing a program for submission of the facility registrations and product listings required by MoCRA which […]
★★★★★
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.
