Tag: Labeling
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 On December 18, 2025, the U.S. Food and Drug Administration (FDA) quietly (but significantly) released a draft guidance titled “Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry.”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 […]
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 […]
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. […]
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, […]
In a move that has both nutritionists and food scientists raising their kale smoothies in approval, the FDA announced on May 9, 2025, the approval of three new natural food color additives. This decision marks a significant step in the Department of Health and Human Services’ (HHS) initiative to modernize the color additive regulations and […]
What FDA’s Latest Cosmetic Data Means for the Beauty Biz
Hold onto your mascara wands, folks! The FDA recently dropped a bombshell of data on the registration and listing of cosmetic product facilities and products. While this might not seem as exciting as the latest contouring technique, it’s crucial for the safety, transparency, and regulation of the beauty industry. Think of it as the behind-the-scenes […]
How to Handle Import Rejection Like a Pro
As FDA detentions and refusals continue to climb, whether it’s for missing nutrition facts information, or lack of required FDA registration, it reminds us that getting an FDA import rejection notice is about as fun as being stood up on a blind date! While the FDA isn’t exactly sending you a love letter when they […]
A Game Changer for Industry
The Food and Drug Administration (FDA) has officially redefined the term “healthy,” serving us a regulatory receipt that promises to transform the food industry. In a move designed to reflect the latest nutritional science and consumer expectations, the FDA’s new regulations are set to shake up how food manufacturers market their products. Spoiler alert: the […]
The Bewitching World of FDA-Approved Halloween Candy Colors
When you dive into a bucket of Halloween candy, you’re not just snagging sweet treats; you’re reaching into a cauldron of FDA-approved colors, flavors, and ingredients that make those goodies as vibrant as a witch’s wardrobe. Ever wondered why your candy corn is orange or your gummy worms are a little too green? Well, it’s […]
Navigating FDA’s Complex Regulation of Homeopathic and Ayurvedic Products
In an era where natural and alternative medicines continue to gain traction driven by a growing interest in holistic and natural health alternatives, the U.S. Food and Drug Administration (FDA) finds itself at the intersection of tradition and science. Homeopathic and ayurvedic products, rooted in centuries-old practices, have become a sizeable industry in the United […]
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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.
