Category: FDA
What They Are, How to Avoid Them, and How to Mitigate Successfully
Importing FDA‑regulated products is a bit like going through airport security: most of the time it’s routine, but if something goes missing—or looks suspicious—you may be pulled aside, detained, and asked uncomfortable questions. In the import world, that “secondary screening” can result in liquidated damages (and potentially greater scrutiny) if an importer fails to comply […]
Forever Chemicals, Federal Oversight, and the Changing Regulatory Landscape
The beauty industry has long been a proving ground for scientific innovation. But lately, it has also become a focal point for regulatory scrutiny—particularly when it comes to per- and polyfluoroalkyl substances (PFAS), the class of chemicals often referred to as “forever chemicals.” PFAS have drawn increasing attention from regulators, lawmakers, and consumer advocates due […]
When Voluntary Isn’t Exactly Optional
If your company makes, markets, manufactures food, beverages, or supplements, you’ve likely noticed that color is having a moment. Under the MAHA banner, Robert F. Kennedy Jr. and the U.S. Food and Drug Administration have set their sights on “petroleum-based synthetic dyes.” Yes, the usual suspects remain perfectly lawful and fully approved for use. But […]
What the Human Foods Agenda Means for Regulated Businesses
If you thought the FDA’s Human Foods Program (HFP) spent 2025 just rearranging labels and scolding salt shakers, think again. In 2026, the agency is showing up with a color-coded spreadsheet, a microscope, and a very strong opinion about what’s in America’s pantry. This is the year the FDA leans all the way into Making […]
What Brands Need to Know Now
By all appearances, the FDA just decided to use one of MoCRA’s sharpest tools—and sooner than expected. On December 18, 2025, the U.S. Food and Drug Administration (FDA) quietly (but significantly) released a draft guidance titled “Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry.” The document clarifies how the Agency intends to exercise […]
FDA Recalibrates Its Approach to General Wellness Devices
As the calendar flips and the industry collectively resolves to innovate smarter, faster, and with fewer regulatory headaches, FDA has offered an early New Year’s surprise. The Center for Devices and Radiological Health (CDRH) has issued an updated version of its General Wellness: Policy for Low Risk Devices guidance—an update that meaningfully reshapes the regulatory […]
(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. […]
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 […]
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 […]
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 […]
★★★★★
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.
