Tag: Enforcement
Implications for Food Industry and Businesses
FDA’s recent step in issuing Import Alert 99-48 for food products containing chemical contaminants has sent ripples through the food industry and businesses engaged in food production. Particularly affected are companies involved in the production of products containing per- and polyfluoroalkyl substances (PFAS) or other chemical contaminants . PFAS are a group of man-made chemicals […]
The dreaded “Red List” and “Black List” (even the colors and short-form names spark fear!) commonly refer to FDA’s enforcement tool, “Import Alert”, an FDA-directive that is intended to inform the FDA’s field staff and the public that the FDA has enough evidence or other information to allow for “automatic detention” or “Detention Without Physical […]
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 […]
Quickly Remove Potentially Violative Product and Minimize Business Disruption and Loss
A pantry staple, granola bars and granola cereals faced a nationwide product recall just before the holidays by the Quaker Oats Company due to potential contamination with Salmonella, a high-risk bacteria that can cause fatal infections in vulnerable populations such as children, the elderly, and those with weakened immune systems. The recall affected Quaker Chewy […]
FDA (FINALLY) Announces Opening of Cosmetics Direct Portal for Electronic Registration and Listing of Cosmetic Product Facilities and Products
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 […]
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 […]
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 […]
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 […]
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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.
