Tag: Foods
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 […]
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 […]
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 […]
Effective Implementation of USDA’s Strengthening Organic Enforcement (SOE) Final Rule Is Just around the Corner
Representing the largest and most comprehensive update to USDA’s organic regulations since the original Act in 1990, the “Strengthening Organic Enforcement” (SOE) final rule will impact all aspects of the organic supply chain and becomes effective just around the corner on March 19, 2024. The new SOE rule will require almost all producers, processors and […]
FDA Showcases New Regulation Portal for Food + Cosmetics Program
In efforts to increase transparency and support stakeholders with understanding the FDA’s regulatory agenda, the Agency unveiled its new website identifying regulations that the Agency plans to publish by October 2024, and longer-term regulations the FDA is prioritizing for publication at a later date. Aimed at informing industry on “what’s ahead”, the FDA Foods Program […]
FDA Screens Incoming Shipments of Cinnamon for Lead Contamination as a Result of Recalled Apple Cinnamon Fruit Pouches.
Following additional reports of illnesses potentially linked to lead in recalled fruit and applesauce pouches, the U.S. Food and Drug Administration (FDA) announced that it is screening shipments of cinnamon from multiple countries for possible lead contamination. So far, cinnamon rolls and other cinnamon-containing products can be still by joyfully had this Thanksgiving and holiday […]
On the Preventive Controls for Human Food Rule, Food Allergen Program and Acidified Foods
Staying true to its promise, the FDA announced the release of updated draft guidance this week to assist food facilities to comply with the requirements for current good manufacturing practices (cGMPs) and preventive controls for human food under the Food Safety Modernization Act (FSMA). Specifically, FDA’s draft guidance provides new chapters on ways manufacturers can […]
★★★★★
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.
