Tag: Dietary Supplements
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 […]
The Wild Waters of an FDA Recall
Recalls are critical for ensuring public safety when products pose health risks but for businesses, this also means reacting quickly to contain the bleeding, limit supply chain disruption and avoid business and reputation damage while simultaneously working alongside the FDA, which plays a pivotal role in managing and helping effectuate recalls – a juggle of […]
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 […]
Toxic Yellow Oleander in Certain Supplements Receives Updated FDA Warning
Late last week, FDA announced that it completed analytical testing of an additional dietary supplement product which has similarly tested positive for yellow oleander. This comes after FDA’s ongoing analysis has determined that certain dietary supplements labeled as tejocote ( Crataegus Mexicana ) root were tested and found to be substituted, and adulterated, with yellow […]
FDA Issues Final Guidance on Updated Procedures and Timeframes
This week, the FDA announced the availability of final guidance for the dietary supplement industry regarding procedures and timeframes for premarket safety notifications, commonly referred to as new dietary ingredient notifications (NDINs). Aimed at improving the rate of compliance with the new dietary ingredient (NDI) notification requirement, the quality of NDI notifications, and ensuring the […]
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 […]
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 […]
In Multi-Company Warning Letters Issued to Dietary Supplement Companies. FDA Issues Seven Warning Letters to Dietary Supplements Claiming to Treat Cardiovascular Disease.
It’s that time of year again
Every even-numbered year, food facilities that are required to register with the FDA, must renew their registrations during the period beginning October 1 and ending December 31. Failure to renew a registration by 11:59PM on December 31, 2022 will result in a different kind of excitement New Year’s Eve – your registration will be considered […]
★★★★★
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.
