Tag: Imports
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 […]
FDA’s Valentine’s Day Reminder for OTC Drug Claims
Valentine’s Day is peak season for self-care. Consumers are encouraged to love themselves a little harder, sleep a little better, feel a little calmer, and look a little brighter—preferably by picking something up from the drugstore endcap wrapped in pink and red packaging. For OTC drug manufacturers, however, February also brings a familiar reminder from […]
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 […]
(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 […]
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 […]
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, […]
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 […]
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 […]
★★★★★
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.
