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FDA Reopens Comment Period for Two Petitions Pertaining to the Use of Solvents

Today, the FDA announced that it is reopening the comment periods for two notifications of petitions published in the Federal Register on January 11, 2024, announcing that FDA filed:

  • food additive petition proposing to amend the food additive regulations to remove the use of the solvents benzene, ethylene dichloride, methylene chloride, and trichloroethylene; and
  • color additive petition proposing to amend the color additive regulations to remove the use of the solvents ethylene dichloride, methylene chloride, and trichloroethylene.

We are reopening the comment periods for 30 days to allow for the submission of any updated data and other information developed over the last two years.

Additional information, including instructions for submitting comments, is available in the Federal Register notices.

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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.
Claire P. Client

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