Tag: Dietary Supplements
When Marketing Becomes Regulation
For many consumer brands, the package receives careful legal review while the website is treated as “marketing.” From an FDA perspective, that distinction can be dangerous. FDA evaluates representations made about regulated products when determining issues such as intended use, product classification, labeling , and whether a product is being marketed in violation of the […]
15 FDA Questions Every Consumer Brand Should Answer
Launching an FDA-regulated consumer product involves considerably more than creating a formula, designing packaging, and placing an order with a manufacturer. Food, beverage, dietary supplement , and cosmetic companies can encounter regulatory issues involving ingredients, product classification, labeling, claims, manufacturing, registration, safety substantiation, and post-market obligations. The most expensive regulatory problems are often those discovered […]
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, […]
A Practical Enforcement Continuum
FDA import enforcement operates along a predictable—but unforgiving—continuum: detention, refusal, and, in repeat cases, import alert placement. Recent FDA data dashboards confirm sustained levels of import refusals and enforcement activity, reflecting the Agency’s continued reliance on data-driven screening and historical compliance patterns. For importers, the practical issue is not whether this framework exists—but whether entries […]
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 […]
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 […]
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 […]
★★★★★
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.
