Shelly Garg

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 Americaโs Food and Beverage Show, the FIME Medical Device Expo, and many others. She was a regular contributor to FDLIโs Top 20 Food and Drug Cases published annually, and to FDLIโs Update Magazine where she sat on the Editorial Advisory Board.
Having worked at the worldโs 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 son to be a future NBA star, and has self-published two childrenโs books. Her 3 year old is already a baking whiz just like her mom. Shelly also enjoys watching Laker games with her husband, reading a page-turner, travel, fitness, and finding the best chocolate chip cookies around town โ although the latter two are oftentimes a tug-of-war.
- Food Drug Law Institute Update Magazine, โConnecting the Dots: Reaffirming the Importance of the Produce Safety Rule and Tracing Technology with the Romaine Lettuce Outbreak,โ August 2018.
- Food Drug Law Institute, Top 20 Food and Drug Cases 2015 & Cases to Watch 2016, Case Article โIn Re: Incretin-Based Therapies Products Liability Litigation,โ April 2016.
- 2016 Association of Food Industries U.S. Food Import Industry Annual Report, โFood Packaging: Supply-Chain Compliance, Innovation, Food Safety,โ April 2016.
- Thomson Reuters, โRecent Developments in Food and Drug Law,โ January 2016.
- 2015 Association of Food Industries U.S. Food Import Industry Annual Report, โImporter Food Safety Vulnerability Assessment: What It Is, and Why You Need It,โ April 2015.
- Food Drug Law Institute, Update Magazine, โProposed Federal GMO Legislation: Are Uniform National Standards on Their Way,โ September/October 2014 Issue.
- Food Drug Law Institute, Top 20 Food and Drug Cases 2013 & Cases to Watch 2014, Case Article โKane v. Chobani,โ April 2014.
- Association of Food Industries U.S. Food Import Industry Annual Report, โFSMA in Review: Designating High-Risk Foods, and Proposed FSMA Sanitary Transport Rule,โ April 2014.
- Food Drug Law Institute, Update Magazine, โChanges in Gluten-Free Labeling.โ January 2013
- American Conference Institute (ACI), โAn International Perspective on the Use of CBD Hemp Oil in the Cosmetics and Personal Care Space,โ May 2021.
- American Conference Institute (ACI), โPlant-Based Food Trends in the Era of COVID-19: Legal and Regulatory and Economic Considerations,โ May 2020
- ECTI, โFood, Supplements, Cosmetics, DevicesโฆOh My! How FDA Regulates More Thank You Think!โ, 2019
- ECTI, โFDAโs Regulation of PPE and EUAs During COVID-19,โ 2020.
- FIME Medical Devices International Trade Seminar, โU.S. Imports Compliance: FDA Regulation of Medical Devicesโ, Orlando and Miami, 2017, 2018
- Americaโs Food and Beverage Show, ongoing, โFDA Compliance of Foodsโ, Miami, 2016, 2015
- 30th Annual Conference on Transportation Innovation and Cost Savings, Speaker, โHow the New U.S. Food Safety Modernization Act Regulations Impact Canadian Shippers and Carriers,โ Toronto, CNSTR Webinar, November 2015.
- Americaโs Food and Beverage Show 2015, Speaker, โTop Ten Cutting Edge Tips to Successfully Import and Export Foods,โ October 2015, Miami, FL.
- 15th TPM 2015 Annual Conference, Speaker, โCold Chain Cargo Safety and Security from A to Z,โ March 2015, Los Angeles, CA.
- Food Drug Law Institute, Food Week 2015, Speaker and Panelist โClaims: Advertising and Substantiation,โ February 2015, Washington, DC.
- โWhat you Need to Know About FDAโs Food Facility Registration Mandates Before December 31,โ STR Webinar, November 2014.
- FDLI Food Safety Conference 2014, Moderator and Presenter, โA Deep Dive into FSMA,โ September 2014, Washington, DC.
- Association for Food Industries, Annual Convention 2014, โFDA: Updates to Nutrition Facts Labeling and GMO Labeling,โ May 2014, Naples, FL.
- Council for Responsible Nutrition/Virgo, Spring 2014 Regulatory Roundup: INDs, FSMA, FTC Webinar, Speaker and Panelist, โFSMA Obligations for Finished Dietary Supplement Manufacturers,โ April 2014, Washington, DC.
- ABA Section of International Law Spring 2014 Annual Meeting, โAre We Adequately Protecting Our Food Supplies? A Primer for those with Discriminating Taste,โ May 2014, New York, NY.
- Japanese Trade Association, โCalifornia Proposition 65 and FSMA/FSVP Complianceโ, Los Angeles, 2014
- Association of Food Industries Annual Town Hall Meeting, โWhat to Expect When FDA is Inspectingโ, Newark, NJ, 2013
- ProChile Annual Meeting Speaker, โImportation of FDA Regulated Products โ What Chilean Exporters Need to Knowโ, 2013 and 2014
- Various webinars:
- โFDA Import Alerts: How to Avoid Costs, Delays and Get Your Products Removedโ
- โImport Permits for Animal and Plant Productsโ
- โPreparing for and Managing FDA Foreign Supplier Verification Program Inspectionsโ
- โFDA Regulation: Cosmetic vs. Drug Productโ
- โChanges to the FDAโs Nutrition Facts Label and Updated Guidance Documentsโ
- โFDAโs Voluntary Qualified Importer Program: Benefits + Requirements to Participateโ
- โPreparing for and Managing FDA Foreign Supplier Verification Program Inspectionsโ
- โWhat you Need to Know About Changes in Food Import Regulation Under FSMAโ
- โUnderstanding Recent Changes to Californiaโs Proposition 65 Rulesโ
- โFDA Regulation of Radiation-Emitting Productsโ
- โFSMA Update Including Discussion of New Foreign Supplier Verification Program and Third Party Auditor Rulesโ
- โFDA and Customs Regulations for Over-the-Counter Drugsโ
- โFood and Dietary Supplements 101: Customs and FDA Compliance Issues for U.S. Importersโ
- โFSMA Implementation: What to Expect from FDA, Analysis of Sections 103 and 105โ
- โMedical Device Excise Tax & Establishment Registration Updateโ
- โWhat to Expect When FDA is Inspectingโ