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FDA Launches Real-Time Adverse Event Reporting Dashboard for Cosmetic Products

The U.S. Food and Drug Administration today announced the launch of the FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products, an interactive tool designed to facilitate the public’s ability to query real-time adverse event data on cosmetic products. The user-friendly platform allows users to download report listings or data sets, with reports being updated daily to include the most recent submissions.

Today’s launch marks another step in the FDA’s modernization strategy, which includes radical transparency. It follows the agency’s recent announcement on real-time reporting of adverse event and medication errors data for drugs and therapeutic biologics.

The dashboard is dedicated exclusively to reports of cosmetic product adverse events, making the data easier to search. It includes serious adverse event reports submitted by responsible persons for cosmetic products under requirements established by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), as well as voluntary adverse event reports submitted to the FDA by healthcare professionals, consumers, salon professionals, cosmetologists, and others. The FAERS dashboard contains adverse event reports for cosmetic products, such as moisturizers, shampoos, conditioners, hair dyes and tattoos.

FAERS cosmetic product adverse event data will no longer be available in the Human Foods Complaint System (HFCS) | FDA, formerly known as the CFSAN Adverse Event Reporting System (CAERS).

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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.
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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.
Mike H. Client
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.
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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.
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