Distributors
Business clients
Compliance with U.S. FDA
The U.S. market remains the world’s leading economy with food, cosmetics and personal care products, medical devices, Over-the-Counter (OTC) drugs, and housewares and related products at the top of the list for products that are distributed in the U.S. With our legal expertise and regulatory compliance services, U.S. distributors have support in ensuring regulatory compliance, responding to enforcement issues, and finding new suppliers, importers and partners.
Distributing in the United States may require compliance with various federal, state and local regulations. For distributors of foods, dietary supplements, cosmetics and personal care products, medical devices, Over-the-Counter (OTC) drugs, animal and veterinary products, beverage alcohol, and more, this may include, depending on roles and responsibilities, compliance with U.S. Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA), Consumer Product Safety Commission (CPSC), Alcohol and Tobacco Tax and Trade Bureau (TTB), U.S. Environmental Protection Agency (EPA), California Proposition 65, U.S. Customs and Border Protection (CBP), and other agency and/or state regulation, as applicable. Distributors are also advised to have distribution agreements in place with supply chain parties to properly identify and allocate regulatory liability.
Compliance with U.S. distribution requirements may help reduce costs associated with import delays, testing, storage, frustration to ultimate purchasers caused by unpredictable trade flow, and reputational damage. By complying with requirements, distributors have a greater likelihood of fostering positive trade flow, a healthy relationship with regulatory agencies such as CBP and FDA, boosting consumer confidence and adding to their bottom line.
★★★★★
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.