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Category: Foods & Beverages

FDA Releases Updated Draft Guidance

09/28/2023

On the Preventive Controls for Human Food Rule, Food Allergen Program and Acidified Foods

Staying true to its promise, the FDA announced the release of updated draft guidance this week to assist food facilities to comply with the requirements for current good manufacturing practices (cGMPs) and preventive controls for human food under the Food Safety Modernization Act (FSMA). Specifically, FDA’s draft guidance provides new chapters on ways manufacturers can […]

FDA Inspections on the Rise

09/07/2023

What to Expect and How to Prepare FDA’s renewed focus on foreign and domestic inspections via onsite routine surveillance inspections, unannounced inspections and remote regulatory assessments continues to climb across all FDA-regulated industries. Following a pandemic pause, foreign inspections are particularly on the rise with an estimated 1,636 facilities already investigated this year following a […]

Casting a Wider Net for Safer Seafood?

08/29/2023

FDA Announces Regulatory Partnership Arrangement with Ecuador Since 94% of the seafood consumed by volume in the U.S. is imported, the FDA has always been committed to ensuring that imported seafood meets the same food safety requirements as domestically produced foods. While the Agency has select equivalency agreements in place, the FDA announced the first […]

Open Sesame: Updates on Sesame Allergen Labeling

08/02/2023

In the story of “Ali Baba and the Forty Thieves” from The Arabian Nights, the phrase “Open Sesame” magically opens the mouth of a cave in which the Forty Thieves have hidden their plundered treasure. And now FDA is opening up discussion with industry regarding sesame regulations as the ninth major food allergen after observing practices involving […]

CBP Liquidated Damages, Penalties, & Fines…oh my!

07/21/2023

How to Avoid and Mitigate U.S. Customs Liquidated Damages and Penalties Did you know that U.S. Customs can assess penalties up to 3x the value of goods if you fail to export or destroy FDA refused merchandise timely? On top of FDA compliance concerns associated with FDA detained and ultimately refused goods, numerous other costs […]

Mid-Summer Grillin’! Fire up the…Cell Incubator?

07/13/2023

FDA and USDA Regulatory Updates on Lab Grown Meat Summer is synonymous with time at the beach, popsicles and grilling. But soon enough, you may be picking up cell-grown meat on your next grocery run. The U.S. Department of Agriculture (USDA) recently approved two companies, Good Meat and Upside Food, to sell lab-grown and cell-cultivated […]

FDA Releases Update for the FDA Foods Program

07/10/2023

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 […]

Summer is for Vacation, not Detention: A Guide to Avoiding FDA Import Refusal and Detention

06/14/2023

You import a product to the U.S. and then receive a notice from your customs broker that the shipment has been held by the FDA. Next, you receive a Notice of FDA Detention right when you are about to fulfill a huge Purchase Order. Now what? Is the shipment lost in FDA space or can […]

FDA Food Allergen Labeling and Cross-Contact

05/25/2023

A Look at FDA’s Enforcement Policy on Major Food Allergen Labeling and Cross-Contact

Update to FDA’s Enforcement Policy on Major Food Allergen Labeling and Cross-Contact As FDA recalls related to allergen labeling continue to abound, and as the agency continues to receive reports of consumers who experienced adverse reactions following exposure to an allergenic substance in foods, FDA provided a much-needed update with its issuance of an updated […]

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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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.

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