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Category: FDA

FDA FSVP Inspections and Warning Letters on the Rise, oh my!

05/14/2024

The Importance of Conducting a Regulatory “Check-Up”: Ensuring FSVP Compliance and Passing an FDA FSVP Inspection

FDA plays a critical role in safeguarding public health by enforcing regulations to ensure the safety of imported food products via routine inspections and other means. Recently, the FDA issued three warning letters to food companies for their failure to have a Foreign Supplier Verification Program (FSVP) in place. Specifically, FDA found that all three […]

FDA’s New Final Rule on LDTs

05/08/2024

A Paradigm Shift in the Regulation of Diagnostic Devices

In the realm of diagnostic testing, Laboratory Developed Tests (LDTs) have long occupied a unique position. Developed and performed within a single laboratory, these tests have been subject to varying degrees of regulatory oversight over the years. However, the FDA’s latest Final Rule on LDTs, issued on May 6, 2024, signifies a significant regulatory overhaul. […]

Blush, Brush and MoCRA!

04/30/2024

Countdown to Cosmetics Compliance and the Upcoming Deadline

As the July 1 st deadline for compliance with the Modernization of Cosmetics Regulation Act (MoCRA) rapidly approaches, cosmetic companies are glamorously gearing up to meet the new regulatory requirements set forth by this landmark legislation. As a reminder, MoCRA represents a significant overhaul of the regulatory framework governing the cosmetics industry, ushering in a […]

The FDA Import Detention Marathon

04/23/2024

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’s Updated Approach to the 510(k) Premarket Notification Process for Medical Devices

04/15/2024

Enhancing Safety and Efficiency

In a continuous effort to strengthen patient safety and streamline regulatory processes, FDA recently introduced significant updates to the 510(k) premarket notification process for medical devices which we previously reported on here . These revisions mark a pivotal shift in the regulatory landscape, aiming to enhance the efficiency of device clearance while maintaining stringent standards […]

Show me the Honey!

04/10/2024

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 […]

Don’t Try to Beat this Yellow!

04/08/2024

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’s Import Alert for Chemical Contaminants Including PFAS

03/25/2024

Implications for Food Industry and Businesses

FDA’s recent step in issuing Import Alert 99-48 for food products containing chemical contaminants has sent ripples through the food industry and businesses engaged in food production. Particularly affected are companies involved in the production of products containing per- and polyfluoroalkyl substances (PFAS) or other chemical contaminants . PFAS are a group of man-made chemicals […]

Dietary Supplements and New Dietary Ingredient Notifications (NDINs)

03/06/2024

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 […]

Celebrating Valentine’s Day with Aromatherapy Products or “Love” as an Ingredient in your Granola?

02/13/2024

A Quick Look at FDA’s Regulation of Cosmetics vs. OTC Drugs and FDA-Approved Ingredients

As you lovingly purchase essential oils and aromatherapy products for your Valentine or add a sprinkle of “love” in their breakfast food this Valentine’s Day, you may want to double check that these products are FDA compliant! Under FDA regulations, fragrance products such as essential oils that are marketed with aromatherapy claims that they will […]

★★★★★

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