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Tag: Enforcement

FDA’s Annual Device Registration Renewal Is Back Online — and the Clock Is Ticking to December 31

11/14/2025

(Yes, it’s that time of year again — compliance season!)

The Compliance Countdown Resumes After a brief, unplanned intermission caused by the recent U.S. government shutdown, the FDA’s Device Establishment Registration and Listing system is officially back online and operational. For medical device manufacturers, importers, and other regulated establishments, this means it’s time to get back to business — and more importantly, back to compliance. […]

A Fine Line Between SPF and Soufflé

11/04/2025

Format Risk in the Era of Foodified Beauty

The consumer-beauty/personal‐care sector is operating in what one might call a “regulatory + innovation squeeze”-zone. On one hand, major regulatory enforcement activity is underway — particularly from the FDA’s Center for Drug Evaluation and Research (CDER) — which signals heightened agency focus on non-traditional dosage forms, claims and cross-category blur. On the other hand, brand […]

Regulatory Limbo

10/21/2025

The Ongoing Impact of the Government Shutdown on FDA and Regulated Industry — and What Companies Should Prioritize

The FDA’s Great Intermission In a world where pacemakers, peanut butter, wrinkle creams, and cold meds all depend on federal review or oversight, the government has — quite literally — left the chat. On October 1, 2025, at 12:01 a.m. ET, the United States federal government entered a funding lapse (a “shutdown”) due to the […]

Dashboard Confessional

09/29/2025

FDA Spills the Tea on Cosmetic Adverse Events

In a bold step toward greater public transparency, the U.S. Food and Drug Administration (FDA) has officially launched the FAERS Public Dashboard for Cosmetic Products. This new online tool provides real-time access to adverse event reports tied to cosmetic and personal care products, making it easier than ever for the public, regulators, and industry stakeholders […]

FDA Launches Nationalized Entry Review Program

09/04/2025

A Transformative Shift for Regulated Imports

As of August 4, 2025, the FDA’s Office of Import Operations (OIO) has launched the Nationalized Entry Review (NER) program, a new system that aims to standardize and improve the review of imported products. Revolutionizing how the agency reviews imports of FDA‑regulated products, the NER replaces the old port-by-port processing model with a centralized, technology […]

Stars, Stripes, and Substantiation

07/22/2025

The FTC’s July 2025 Crackdown on “Made in USA” Claims Puts Industry on Notice

A Patriotic Primer Turned Compliance Crossfire As barbecues sizzled and flags fluttered this July 4th, the Federal Trade Commission (FTC) was busy preparing a fireworks display of its own—this one of the regulatory variety. Declaring July as “Made in USA Month,” the Commission followed up its symbolic gesture with real regulatory firepower: four warning letters […]

Knock, Knock, It’s the FDA

06/03/2025

A Look at Audit Readiness in the Age of Expanded Inspections

The FDA is back in full swing, and inspections—both scheduled and surprise—are becoming more frequent, more detailed, and more critical than ever. As global regulators expand the scope, frequency, and depth of inspections, companies face increasing pressure to demonstrate compliance and transparency. Expanded inspections, whether triggered by legislative updates, whistleblower complaints, or routine agency policy, […]

Crayon Box Clean-Up: FDA Approves Three Natural Food Colors

05/10/2025

In a move that has both nutritionists and food scientists raising their kale smoothies in approval, the FDA announced on May 9, 2025, the approval of three new natural food color additives. This decision marks a significant step in the Department of Health and Human Services’ (HHS) initiative to modernize the color additive regulations and […]

When International Compliance Gets a Pop Quiz!

05/08/2025

FDA Announces Expanded Use of Unannounced Foreign Inspections

In what can only be described as the regulatory equivalent of “We were in the neighborhood…”, the U.S. Food and Drug Administration (FDA) announced May 6, 2025, its expanded use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines and other medical products intended for American consumers and patients. Yes, you read […]

FDA May Be Turning Down the Heat on Inspections, But Food Safety is Still on the Burner

04/22/2025

A Closer Look at the Potential Inspection Shift, State Oversight and How to Stay Compliant

The Great Inspection Shake-Up: FDA’s New Recipe In the grand kitchen of U.S. food safety, the FDA has long played head chef—stirring up regulations, inspecting operations, and occasionally flipping a facility on its lid when things got unsanitary. But in 2025, the kitchen dynamics are shifting, with many wondering if the Agency is stepping away […]

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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