An Early FDA Holiday Present!
FDA (FINALLY) Announces Opening of Cosmetics Direct Portal for Electronic Registration and Listing of Cosmetic Product Facilities and Products
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Tag: FDA News
FDA Revisiting Classification of Wound Dressings and Liquid Wound Washes
Last week, FDA proposed two new rules to classify certain unclassified, wound dressings and liquid wound washes containing antimicrobials or other chemicals into three separate classification regulations: Solid wound dressings: this covers products intended to cover and protect a wound against external contamination, to absorb exudate and to maintain appropriate moisture balance within the wound […]
A Sprinkle of Holiday (Lead-Free) Cinnamon Spice?
FDA Screens Incoming Shipments of Cinnamon for Lead Contamination as a Result of Recalled Apple Cinnamon Fruit Pouches.
Following additional reports of illnesses potentially linked to lead in recalled fruit and applesauce pouches, the U.S. Food and Drug Administration (FDA) announced that it is screening shipments of cinnamon from multiple countries for possible lead contamination. So far, cinnamon rolls and other cinnamon-containing products can be still by joyfully had this Thanksgiving and holiday […]
Enforcement Delayed by 6 Months
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 […]
Tis the Season for Cosmetic Registration and Product Listing (with a Slight Delay)
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 […]
FDA Issues Eyedrops Products Warning
FDA Issues Warning to Avoid Purchase or Use of 26 Eyedrops Products from Several Major Brands due to Risk of Eye Infection
Celebrating Halloween With a Goulish Glow?
A Look at FDA’s Spooktacular Regulation of Decorative Contact Lenses and Makeup
As you step out this Halloween ready for a trick or a treat, you may wish to do a fit check and ensure that those decorative contact lenses, and Halloween makeup are FDA compliant! You may be surprised to learn that FDA regulates decorative contact lenses, also known as Halloween contact lenses, cosmetic contact lenses, […]
If it’s Not in Writing, it Doesn’t Exist!
MoCRA and Recordkeeping.
You’ve likely heard the term before in business and with FDA – if it’s not in writing, it doesn’t exist. But what is all the kerfuffle about with records under MoCRA, and why do cosmetic businesses really need to now make recordkeeping a priority? Well for starters, it is required under the law! The Modernization […]
It’s that Special Time of Year Again! FDA Device Registration Renewal
FDA’s 2023 device registration renewal period!
With the smell of pumpkin spice lattes in the air and the taste of warm apple cider doughnuts, comes another special time of year: FDA’s device registration renewal period! Beginning October 1 – December 31, 2023 , all foreign and domestic medical device establishments must register and renew their device establishment registration with FDA. This […]
FDA Releases Updated Draft Guidance
On the Preventive Controls for Human Food Rule, Food Allergen Program and Acidified Foods
Staying true to its promise, the FDA announced the release of updated draft guidance this week to assist food facilities to comply with the requirements for current good manufacturing practices (cGMPs) and preventive controls for human food under the Food Safety Modernization Act (FSMA). Specifically, FDA’s draft guidance provides new chapters on ways manufacturers can […]
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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.