Category: Cosmetics
FDA Announces New Medical Device User Fees for FY 2024 FDA announced its update on medical device user fees for FY 2024, which runs October 1, 2023 through September 30, 2024. The updated user fees affect everything from FDA medical device establishment registration to marketing submissions, and applies to all medical devices: beauty and cosmetic […]
What You Need to Have in Place Now for MoCRA Cosmetic Product Substantiation While FDA cosmetic product safety has always been required, MoCRA ups the ante and ensures that companies can no longer hide behind cover-up. As we discussed in our June 26 News and Insights issue, “Prep + Prime for MoCRA”, MoCRA’s new safety […]
Today, FDA issued long-awaited draft guidance on cosmetic facility registrations and product listings, as required under the Modernization of Cosmetics Act Regulation of 2022 (MoCRA). The draft guidance, when finalized, will assist cosmetic companies with cosmetic product facility registration and product listing submissions including ingredients, to FDA. Cosmetic facility registration and product listing will be […]
Are you considering starting your own cosmetic product manufacturing facility? To ensure successful production and compliance with industry standards, it’s crucial to understand the specific requirements for such facilities. From regulatory compliance and facility design to quality control and employee training, this blog post will guide you through the essential aspects of establishing a cosmetic […]
Cosmetic Facility Registration, Product Listing, Record-Keeping, Recall Readiness, and Labeling and Substantiation Compliance for Lasting Radiance Hear ye hear ye! Implementation deadlines and compliance dates for the new Modernization of Cosmetic Regulation Act (MoCRA) requirements, aimed at strengthening FDA’s regulation of cosmetic product safety in over 80 years, are around the corner. And we must […]
A Look at FDA’s Regulation of Sunscreen FDA has regulated sunscreen since the 1970s to ensure that consumers have access to safe and effective sun protection products, but not all sunscreens are created equally! As there have been several developments involving sunscreen regulation in the past few years, we’ll provide an update as to where […]
This week, FDA kicked-off a new resource about the Modernization of Cosmetics Regulation Act of 2002 (MoCRA) and a follow-up constituent advisory that FDA has stopped accepting and processing submissions to the Voluntary Cosmetic Registration Program (VCRP). FDA is developing a program for submission of the facility registrations and product listings required by MoCRA which […]
Marketing Sunglasses, Bandages, Hospital Equipment, Pregnancy Test Kits, Cosmetic Devices, Personal Lubricants and More The U.S. leads the world in medical innovation and is the largest consumer of medical devices in the world. We use medical devices daily, whether it is throwing on a pair of sunglasses, hitting the ski slopes with a pair of […]
Protecting Consumers, Limiting Supply Chain Disruption and Avoiding Business and Reputation Damage Quickly and Effectively With product recalls consistently being in the news over undeclared allergens, bacterial contamination, physical hazards, potential of a product’s failure to conform to a performance standard, and many other reasons, consumer’s health and safety are naturally at stake. Companies also […]
With fresh snow and the start of a new year comes new FDA happenings. While most of the country was occupied by delayed flights and snowstorms, FDA and Congress made several noteworthy announcements that we flag here to bring you up to speed
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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.
