Category: Cosmetics
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 […]
The Wild Waters of an FDA Recall
Recalls are critical for ensuring public safety when products pose health risks but for businesses, this also means reacting quickly to contain the bleeding, limit supply chain disruption and avoid business and reputation damage while simultaneously working alongside the FDA, which plays a pivotal role in managing and helping effectuate recalls – a juggle of […]
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 […]
An Endurance Test of Paperwork and Patience
Welcome to the FDA import detention merry-go-round, where we say, hold onto your paperwork! The FDA import detention process can be a daunting (and let’s be honest, derailing!) experience for businesses involved in importing goods, especially those in the realm of foods, cosmetics, dietary supplements, drugs or medical devices. However, with proper knowledge and strategic […]
FDA Makes Changes to Device GMPs to Align More Closely with International Consensus Standards.
On January 31, 2024, FDA issued a final rule, which will amend medical device current good manufacturing practice (cGMP) requirements of the Quality System (QS) Regulation under 21 CFR Part 820, to more closely align with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities around the […]
FDA Showcases New Regulation Portal for Food + Cosmetics Program
In efforts to increase transparency and support stakeholders with understanding the FDA’s regulatory agenda, the Agency unveiled its new website identifying regulations that the Agency plans to publish by October 2024, and longer-term regulations the FDA is prioritizing for publication at a later date. Aimed at informing industry on “what’s ahead”, the FDA Foods Program […]
What Should I Really Be Doing Now to Tone and Brighten for FDA Cosmetics Compliance?
While it may still seem off in the distance, cosmetic companies are required to comply with the new registration and listing requirements of the Modernization of Cosmetic Regulations Act (MoCRA) by July 1, 2024, and several other compliance requirements which are currently in effect. This includes labeling and substantiation compliance and recordkeeping, having an adverse […]
FDA (FINALLY) Announces Opening of Cosmetics Direct Portal for Electronic Registration and Listing of Cosmetic Product Facilities and Products
Update on FDA Cosmetic Product Facility Registration and Cosmetic Product Listing Requirements
This week, FDA gave the cosmetic industry an early holiday gift when it issued a Compliance Policy on its intent to delay enforcement of the requirements for cosmetic product facility registration and cosmetic product listing requirements under MoCRA for 6 months after the December 29, 2023 statutory deadline, or until July 1, 2024. FDA advised […]
Last week, FDA provided a glossy update on ongoing activities related to the new cosmetic product facility registration and cosmetic product listing requirements that are now mandated under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). In our prior News & Insights articles here and here, we discussed cosmetic facility registration requirements, which includes […]
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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.
