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Tag: Foods

USDA VS Permits, PPQ Permits and EANs

05/12/2023

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. […]

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Ongoing Scrutiny Over Kratom

05/02/2023

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 […]

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No Cheers with the “The Champagne of Beers”

04/24/2023

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, […]

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FDA Regulation of Human Food Made from Cultured Animal Cells and Updates on FDA’s Imported Seafood Program

03/23/2023

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 […]

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USDA Ushers Organic Regulation Changes for the First Time in Over 30 Years

01/25/2023

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 […]

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How to Prepare and Execute an FDA Regulated Recall

01/19/2023

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 […]

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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.
R.G. Client
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.
Mike H. Client
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.
Dr. Sastry Client
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.
Claire P. Client

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