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Category: Foods & Beverages

FDA’s Proposal for Increasing Color Certification Fees

11/15/2022

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 […]

Checking it twice: FDA Facility Registration Renewals!

11/15/2022

A reminder to register or renew your food, dietary supplement, OTC drug, or medical device facility registration before December 31, 2022

FDA Welcomes 2022/2023 VQIP Participants

10/27/2022

Revisiting the Perks of FDA’s Voluntary Qualified Importer Program (VQIP)

FDA welcomed 2022/2023 Voluntary Qualified Importer Program (VQIP) Participants, as the benefit year begins October 1, 2022. FDA’s VQIP provides a unique badge of honor for importers, signifying that importers have obtained a high level of safety and security over their supply chains. While bearing conceptual similarities to CBP’s trusted trader programs, we also like […]

Factors Constituting FDA Refusal of Inspection

10/20/2022

Grace and Courtesy During an FDA Inspection: FDA’s New Guidance on What Constitutes Refusal of Inspection by a Foreign Food Establishment or Foreign Government

FSVP Warning Letters on the Rise

10/13/2022

Back at it Again: Uptick in FDA Warning Letters over FSVP Violations

This week, FDA publicly posted a handful of Warning Letters to importers over Foreign Supplier Verification Program (FSVP) violations. The FSVP regulation, part of the FDA Food Safety Modernization Act (FSMA), requires importers to perform certain risk-based activities to verify that human and/or animal foods that they import into the U.S. meet U.S. food safety […]

FDA’s modernized approach to nutrition

10/06/2022

Helping Clear up Mixed Messaging on what is “Healthy”: A look at FDA’s New Proposed Rule on Food Packages .

In an attempt to help consumers make better dietary decisions, to modernize FDA’s approach to nutrition, to tackle health disparities, and to reduce the burden of diet-related chronic diseases like Type 2 Diabetes and cardiovascular disease, the FDA recently revealed a proposal to change the criteria for which packaged foods are considered “healthy”. The definition, […]

Old Europe Cheese’s recall of Brie cheeses

10/05/2022

Update on Recent Food Recalls: Potential Contamination with Listeria monocytogenes, and undeclared allergens.

FDA has announced several recalls over the last two weeks due to potential contamination with Listeria monocytogenes, and patterned recalls based on undeclared allergens. On Wednesday, FDA announced an expansion of Old Europe Cheese’s voluntary recall of Brie cheeses, announced September 30, 2022, due to potential contamination with Listeria monocytogenes. The expanded recall includes baked […]

Three Cheers for FDA Food Facility Registration Renewal

09/22/2022

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 […]

A look at FDA’s Newly Issued Internal Report

09/21/2022

Will FDA’s Recognition of System Vulnerabilities in its Infant Formula Response Open the Door for Alternative Supply Sources and Regulatory Changes?

One, Two, Three Strikes, and you’re…on an FDA Import Alert!

09/19/2022

Over the years, FDA has issued a number of Import Alerts across various FDA product categories.

Over the years, FDA has issued a number of Import Alerts across various FDA product categories. No issue and no product is off limits. Import Alerts have targeted firms that have not met dietary supplement GMPs, firms that promote unapproved new drugs in the U.S., firms that distribute devices without FDA clearance or approval, and […]

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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