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Tag: Warning Letters
Using AI Tools in FDA Compliance
Power, Pitfalls, and the Non-Negotiable Role of Human Review
Love, Labels, and Selling Self-Care Without Selling an Unapproved Drug
FDA’s Valentine’s Day Reminder for OTC Drug Claims
Stars, Stripes, and Substantiation
The FTC’s July 2025 Crackdown on “Made in USA” Claims Puts Industry on Notice
When International Compliance Gets a Pop Quiz!
FDA Announces Expanded Use of Unannounced Foreign Inspections
Warning Letters Ahoy!
Navigating the FDA’s High Seas of Foreign Supplier Verification Program (FSVP) Inspections
Herbs, Hocus Pocus and the FDA
Navigating FDA’s Complex Regulation of Homeopathic and Ayurvedic Products
FDA Issues Warning Letters to Companies Selling Delta-8 THC Products in Kid-Friendly Packaging
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.