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How FDA is Implementing Landmark Cosmetics Legislation to Positively Impact Public Health

Over the course of a single day, most Americans use multiple cosmetic products including face and body cleansers, shaving cream, and haircare products.

While cosmetic products were included in the landmark 1938 Federal Food, Drug, and Cosmetic (FD&C) Act that overhauled the U.S. Food and Drug Administration’s oversight of food and drugs and gave the agency authority over cosmetics, the FDA’s cosmetics authority saw limited expansion between 1938 and 2022, with the Fair Packaging and Labeling Act of 1967 being a notable exception.

This meant that the FDA had fewer tools to protect public health and help ensure safe cosmetic products than it did for other FDA-regulated products. For example, although cosmetic companies and individuals who market cosmetics are responsible for ensuring the safety of their products, there were no requirements to register cosmetic facilities with the FDA, to list cosmetic products, or to report serious adverse events as many other FDA-regulated companies did.

This changed on December 29, 2022. After more than a decade-long bipartisan effort, Congress enacted the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), significantly expanding the FDA’s authority over cosmetics and establishing substantial new requirements for cosmetic companies and individuals who market cosmetics in the United States.

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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.
R.G. Client
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.
Dr. Sastry Client
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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