Category: Regulatory Law
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 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 On December 18, 2025, the U.S. Food and Drug Administration (FDA) quietly (but significantly) released a draft guidance titled “Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry.”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 […]
FDA Recalibrates Its Approach to General Wellness Devices
As the calendar flips and the industry collectively resolves to innovate smarter, faster, and with fewer regulatory headaches, FDA has offered an early New Year’s surprise. The Center for Devices and Radiological Health (CDRH) has issued an updated version of its General Wellness: Policy for Low Risk Devices guidance—an update that meaningfully reshapes the regulatory […]
(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 […]
In a closely watched decision, the U.S. District Court for the District of Columbia on July 15, 2025, largely upheld the Food and Drug Administration’s (FDA) authority to regulate homeopathic drugs as “new drugs” under the Federal Food, Drug, and Cosmetic Act—effectively reinforcing the agency’s risk-based enforcement approach finalized in 2022. The lawsuit, brought […]
FDA Seeks Definition for Ultra-Processed Foods in Major Regulatory Shift
If you’ve ever stared suspiciously at your pantry wondering whether that neon-orange cheese puff qualifies as dinner or some sort of science experiment, you’re not alone. The FDA, the same folks who once agonized over what “natural” means (spoiler: still no consensus), have now turned their regulatory magnifying glass on a new target: ultra-processed foods. […]
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, […]
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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.
