Shelly Garg
Practices in the areas of cosmetics, over-the-counter drugs, food, beverage, dietary supplements, medical devices, homeopathic, and animal and veterinary products. She assists foreign and domestic businesses, manufacturers, distributors, and importers with regulatory compliance, trade and enforcement matters involving FDA, USDA, EPA, CPSC, TTB, CBP, and other federal and state authorities.
University of Florida Levin College of Law
University of Miami B.S., Economics and Political Science
Minor in Business Law
Florida
DC
Professional Bio
Noted for her creative leadership and personability, she provides counsel to clients in areas such as strategic business planning, regulatory strategy, product development, labeling and packaging compliance, testing and approval, import detentions, import alerts, FDA recalls, FDA inspections and related issues. Her keen insights into FDA and its inner workings have proved to be of significant value to her clients in successfully resolving matters before the agency.
A frequent speaker and author, Shelly has presented at conferences and seminars sponsored by the Food Drug Law Institute, the American Bar Association, the America’s Food and Beverage Show, the FIME Medical Device Expo, and many others. She was a regular contributor to FDLI’s Top 20 Food and Drug Cases published annually, and to FDLI’s Update Magazine where she sat on the Editorial Advisory Board.
Having worked at the world’s largest dedicated international trade law firm, Shelly offers a unique perspective to regulatory matters. She works closely with importers on addressing regulatory compliance and enforcement issues at the crossroads of FDA and CBP compliance.
Before beginning her legal career, Shelly worked in Washington, D.C. as an analyst in the Directorate of Intelligence at the U.S. Central Intelligence Agency. In that capacity she was granted a top-secret security clearance and produced intelligence briefs to support U.S. government foreign policy decision-makers on various homeland security concerns.
Shelly is training her kids to be martial artist grandmasters, pianists, and baking whizzes just like their mom. She has also self-published three children’s books. Shelly enjoys watching Laker games with her husband, reading a page-turner, travel, culture, fitness, and finding the best chocolate chip cookies around town – although the latter two are oftentimes a tug-of-war.
- Food Drug Law Institute Update Magazine, “Connecting the Dots: Reaffirming the Importance of the Produce Safety Rule and Tracing Technology with the Romaine Lettuce Outbreak,” August 2018.
- Food Drug Law Institute, Top 20 Food and Drug Cases 2015 & Cases to Watch 2016, Case Article “In Re: Incretin-Based Therapies Products Liability Litigation,” April 2016.
- 2016 Association of Food Industries U.S. Food Import Industry Annual Report, “Food Packaging: Supply-Chain Compliance, Innovation, Food Safety,” April 2016.
- Thomson Reuters, “Recent Developments in Food and Drug Law,” January 2016.
- 2015 Association of Food Industries U.S. Food Import Industry Annual Report, “Importer Food Safety Vulnerability Assessment: What It Is, and Why You Need It,” April 2015.
- Food Drug Law Institute, Update Magazine, “Proposed Federal GMO Legislation: Are Uniform National Standards on Their Way,” September/October 2014 Issue.
- Food Drug Law Institute, Top 20 Food and Drug Cases 2013 & Cases to Watch 2014, Case Article “Kane v. Chobani,” April 2014.
- Association of Food Industries U.S. Food Import Industry Annual Report, “FSMA in Review: Designating High-Risk Foods, and Proposed FSMA Sanitary Transport Rule,” April 2014.
- Food Drug Law Institute, Update Magazine, “Changes in Gluten-Free Labeling.” January 2013
- Various webinars and seminars to Foreign Exporters on US Market Entry Requirements, FDA Import Refusals and Removal from Import Alert (2023)
- Webinar, Complying with MoCRA: New FDA Cosmetics Regulation (September 2023)
- American Conference Institute (ACI), “An International Perspective on the Use of CBD Hemp Oil in the Cosmetics and Personal Care Space,” May 2021.
- American Conference Institute (ACI), “Plant-Based Food Trends in the Era of COVID-19: Legal and Regulatory and Economic Considerations,” May 2020
- ECTI, “Food, Supplements, Cosmetics, Devices…Oh My! How FDA Regulates More Thank You Think!”, 2019
- ECTI, “FDA’s Regulation of PPE and EUAs During COVID-19,” 2020.
- FIME Medical Devices International Trade Seminar, “U.S. Imports Compliance: FDA Regulation of Medical Devices”, Orlando and Miami, 2017, 2018
- America’s Food and Beverage Show, ongoing, “FDA Compliance of Foods”, Miami, 2016, 2015
- 30th Annual Conference on Transportation Innovation and Cost Savings, Speaker, “How the New U.S. Food Safety Modernization Act Regulations Impact Canadian Shippers and Carriers,” Toronto, CNSTR Webinar, November 2015.
- America’s Food and Beverage Show 2015, Speaker, “Top Ten Cutting Edge Tips to Successfully Import and Export Foods,” October 2015, Miami, FL.
- 15th TPM 2015 Annual Conference, Speaker, “Cold Chain Cargo Safety and Security from A to Z,” March 2015, Los Angeles, CA.
- Food Drug Law Institute, Food Week 2015, Speaker and Panelist “Claims: Advertising and Substantiation,” February 2015, Washington, DC.
- “What you Need to Know About FDA’s Food Facility Registration Mandates Before December 31,” STR Webinar, November 2014.
- FDLI Food Safety Conference 2014, Moderator and Presenter, “A Deep Dive into FSMA,” September 2014, Washington, DC.
- Association for Food Industries, Annual Convention 2014, “FDA: Updates to Nutrition Facts Labeling and GMO Labeling,” May 2014, Naples, FL.
- Council for Responsible Nutrition/Virgo, Spring 2014 Regulatory Roundup: INDs, FSMA, FTC Webinar, Speaker and Panelist, “FSMA Obligations for Finished Dietary Supplement Manufacturers,” April 2014, Washington, DC.
- ABA Section of International Law Spring 2014 Annual Meeting, “Are We Adequately Protecting Our Food Supplies? A Primer for those with Discriminating Taste,” May 2014, New York, NY.
- Japanese Trade Association, “California Proposition 65 and FSMA/FSVP Compliance”, Los Angeles, 2014
- Association of Food Industries Annual Town Hall Meeting, “What to Expect When FDA is Inspecting”, Newark, NJ, 2013
- ProChile Annual Meeting Speaker, “Importation of FDA Regulated Products – What Chilean Exporters Need to Know”, 2013 and 2014
- Various webinars:
- “FDA Import Alerts: How to Avoid Costs, Delays and Get Your Products Removed”
- “Import Permits for Animal and Plant Products”
- “Preparing for and Managing FDA Foreign Supplier Verification Program Inspections”
- “FDA Regulation: Cosmetic vs. Drug Product”
- “Changes to the FDA’s Nutrition Facts Label and Updated Guidance Documents”
- “FDA’s Voluntary Qualified Importer Program: Benefits + Requirements to Participate”
- “Preparing for and Managing FDA Foreign Supplier Verification Program Inspections”
- “What you Need to Know About Changes in Food Import Regulation Under FSMA”
- “Understanding Recent Changes to California’s Proposition 65 Rules”
- “FDA Regulation of Radiation-Emitting Products”
- “FSMA Update Including Discussion of New Foreign Supplier Verification Program and Third Party Auditor Rules”
- “FDA and Customs Regulations for Over-the-Counter Drugs”
- “Food and Dietary Supplements 101: Customs and FDA Compliance Issues for U.S. Importers”
- “FSMA Implementation: What to Expect from FDA, Analysis of Sections 103 and 105”
- “Medical Device Excise Tax & Establishment Registration Update”
- “What to Expect When FDA is Inspecting”
