Tag: FDA News
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 […]
FDA completed its second pre-market consultation for human food made from cultured animal cells, and advised it had no further questions about the firm’s safety conclusions. The FDA’s premarket consultation with the submitter, GOOD Meat, Inc., involved an examination of the Company’s production process and the cultured cell material made by the production process. This […]
FDA Issues Draft Labeling Recommendations for Plant-Based Milk Alternatives
Use of the term “milk” in plant-based beverages over the years has been a nutty landscape for some and highly debated. However, with an increase in market availability and consumption, the types and varieties of alternative milk products has continued to expand from soy, almond and rice milk to cashew, coconut, hazelnut, hemp seed, oat, […]
Marketing Sunglasses, Bandages, Hospital Equipment, Pregnancy Test Kits, Cosmetic Devices, Personal Lubricants and More The U.S. leads the world in medical innovation and is the largest consumer of medical devices in the world. We use medical devices daily, whether it is throwing on a pair of sunglasses, hitting the ski slopes with a pair of […]
Closing Gaps, Protecting Organic Producers and Improving Transparency and Traceability of Organic Products As the “organic” section of many grocery stores continues to grow, with consumers wondering and hoping that their exchange of top dollar means safer food, USDA’s passage of a new rule aims to help deter and detect fraud and protect organic integrity […]
Protecting Consumers, Limiting Supply Chain Disruption and Avoiding Business and Reputation Damage Quickly and Effectively With product recalls consistently being in the news over undeclared allergens, bacterial contamination, physical hazards, potential of a product’s failure to conform to a performance standard, and many other reasons, consumer’s health and safety are naturally at stake. Companies also […]
With fresh snow and the start of a new year comes new FDA happenings. While most of the country was occupied by delayed flights and snowstorms, FDA and Congress made several noteworthy announcements that we flag here to bring you up to speed
While the year is winding down, FDA remains active in enforcement and issuing new guidance. Here’s a look at what has been happening at the Agency.
FDA’s Proposed Rule for Amending Color Certification Fees: Written Comments due by January 3, 2023
FDA’s Proposed Rule for Amending Color Certification Fees: Written Comments due by January 3, 2023 FDA recently issued a proposed rule to amend the color additive regulations, proposing to increase fees for certification services by 10 cents per pound. As the first proposed increase since 2005, the proposal is being made to cover increased operating […]
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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.
