Tag: MoCRA
Registration Is Only the Beginning
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) significantly expanded FDA’s authority over cosmetics and created new obligations for many cosmetic companies. For businesses that entered the market after MoCRA’s enactment, one of the most common misconceptions is that facility registration and product listing equal FDA approval. They do not. FDA recently reiterated that […]
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 […]
How FDA Is Implementing Its Expanded Cosmetics Authority—and What It Means for Industry
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents the most consequential update to U.S. cosmetics regulation since the Federal Food, Drug, and Cosmetic Act was enacted in 1938. In a recent FDA Voices article, the U.S. Food and Drug Administration explains how it is implementing this new authority and why these changes materially […]
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 […]
FDA Spills the Tea on Cosmetic Adverse Events
In a bold step toward greater public transparency, the U.S. Food and Drug Administration (FDA) has officially launched the FAERS Public Dashboard for Cosmetic Products. This new online tool provides real-time access to adverse event reports tied to cosmetic and personal care products, making it easier than ever for the public, regulators, and industry stakeholders […]
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 […]
A Tighter Grip on Talc and Asbestos Testing
New Year, new regulations—(kind of)! As we step into 2025, the U.S. Food and Drug Administration (FDA) has decided that it’s time to give the talc industry a little more TLC—specifically when it comes to testing for the sneaky mineral asbestos. It’s a big deal because, as we all know, asbestos and talc are akin […]
As we fire up the grills and get ready for fireworks this Independence Day, FDA is working to ensure that our food safety regulations are as American as apple pie and as dependable as Uncle Sam, providing a mid-year update on the Agency’s Food Program. Earlier in the year, FDA outlined the draft and final […]
Countdown to Cosmetics Compliance and the Upcoming Deadline
As the July 1 st deadline for compliance with the Modernization of Cosmetics Regulation Act (MoCRA) rapidly approaches, cosmetic companies are glamorously gearing up to meet the new regulatory requirements set forth by this landmark legislation. As a reminder, MoCRA represents a significant overhaul of the regulatory framework governing the cosmetics industry, ushering in a […]
A Quick Look at FDA’s Regulation of Cosmetics vs. OTC Drugs and FDA-Approved Ingredients
As you lovingly purchase essential oils and aromatherapy products for your Valentine or add a sprinkle of “love” in their breakfast food this Valentine’s Day, you may want to double check that these products are FDA compliant! Under FDA regulations, fragrance products such as essential oils that are marketed with aromatherapy claims that they will […]
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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.
