Tag: Current Affairs
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 […]
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 […]
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 […]
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 […]
(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 […]
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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.
