Category: OTC Drugs
FDA’s Annual and Biennial Registration Season Is Here
As the leaves turn, pumpkin spice takes over, and inboxes become increasingly terrifying, FDA-regulated companies have another seasonal tradition to add to the calendar: registration renewals . Between October 1 and December 31, FDA’s registration systems become the regulatory equivalent of an annual physical. Some industries get called in every year. Others only every other […]
7 Regulatory Changes Every Regulated Company Should Be Tracking
The first half of 2026 was anything but quiet at the U.S. Food and Drug Administration. While many companies expected a slower regulatory environment amid broader federal government changes, FDA instead continued advancing significant initiatives affecting foods, beverages, dietary supplements, cosmetics, OTC drugs, and medical devices. The agency’s focus has increasingly shifted toward data-driven oversight, […]
First New Active Ingredient Added in 20+ Years
The FDA has added bemotrizinol to the OTC sunscreen monograph—the first new active ingredient permitted since the late 1990s—marking a significant step in modernizing the nonprescription drug framework and accelerating pathways for innovation. What Happened The FDA concluded an administrative order to add bemotrizinol as a permitted sunscreen active ingredient. The ingredient is considered generally […]
FDA’s New Inspection Playbook (and Why You Should Care)
The U.S. Food and Drug Administration has officially entered its “speed dating” era—at least when it comes to inspections. On May 6, 2026, FDA announced a pilot program for one-day inspectional assessments, a shorter, risk-based alternative designed to complement traditional, multi-day inspections. While the concept sounds deceptively simple—“we’ll be in and out in a day”—the […]
FDA inspections don’t arrive with much ceremony. There’s no buildup—just a badge, a few introductions, and then a steady stream of questions about your documents, your systems, and your people. What has changed is everything around that moment. Inspections are happening more often, follow-ups are quicker, and tolerance for “we’ll fix it later” has narrowed […]
On March 11, 2026, the U.S. Food and Drug Administration (FDA) announced the launch of the Adverse Event Monitoring System (AEMS), a centralized, AI-driven platform that modernizes the agency’s post-market safety surveillance framework across all regulated product categories. These include medical products, vaccines, medical devices, tobacco products, food, cosmetics, and veterinary medicines. AEMS represents a […]
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 […]
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 […]
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 […]
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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.
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.
