Tag: Labeling
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 […]
What Recent Enforcement Trends Are Really Telling Us
There are few phrases that ruin an importer’s morning as efficiently as: “FDA has refused admission.” One minute your shipment is crossing oceans, clearing customs, and heading toward your warehouse. The next, it is sitting at the port accumulating storage charges while everyone on the supply chain starts asking uncomfortable questions. FDA import refusals are […]
What Food Companies Should Know
The U.S. Department of Agriculture (USDA) has officially placed revisions to its National Bioengineered Food Disclosure Standard on the regulatory calendar, signaling that significant changes may be coming for food manufacturers, importers, retailers, and others throughout the food supply chain. According to USDA’s 2026 Unified Agenda, the agency is targeting August 2026 for publication of […]
FDA’s Revised General Wellness Policy Creates New Opportunities—and New Boundaries—for Digital Health Innovation
The latest generation of wellness technology is doing much more than counting steps. Today’s wearables can estimate blood pressure trends, analyze heart rate variability, monitor oxygen saturation, evaluate sleep quality, assess recovery, and use sophisticated algorithms to provide users with personalized insights. In short: your smartwatch may know you need a nap before you do. […]
FDA Scrutiny on Honey Fraud Intensifies
The U.S. Food and Drug Administration (FDA) recently released findings from its latest honey sampling assignment, reaffirming a persistent issue in the food industry: economically motivated adulteration (EMA). Honey remains particularly vulnerable to this form of food fraud, where cheaper sweeteners—such as sugarcane or corn syrups—are added without disclosure. How the FDA Tests for Adulteration […]
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 […]
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 […]
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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.
