FDA regulatory attorney Seth Gitner counsels food, dietary supplement, OTC drug, cannabis, and medical device companies on the full spectrum of federal and state regulatory compliance, helping clients navigate the laws and regulations implemented by the Food and Drug Administration (FDA), Federal Trade Commission (FTC), United States Department of Agriculture (USDA), and Environmental Protection Agency (EPA) so they can bring innovative products to market with confidence and minimal enforcement risk. Seth serves clients at every stage of their regulatory lifecycle, from product development to initial public offering and beyond.
- Provided counsel regarding food and dietary supplement labels for national brand.
- Counseled client on promotional materials, including website and blog posts, to reduce regulatory enforcement and consumer class action risk.
- Prepared response to FDA inspectional findings and assisted client in revising internal policies and procedures, including with respect to the Foreign Supplier Verification Program and the Food Safety Modernization Act, to address the agency’s regulatory concerns.
- Assisted food and dietary supplement client in revising internal policies and procedures regarding ingredient suppliers and mandatory reporting requirements to ensure ongoing regulatory compliance.
- Responded to FDA Notice of Action regarding the detainment of the client’s product upon importation, leading to the release of the product.
- Helped client resolve issues identified during inspection by USDA-Organic certifying organization, resulting in maintenance of organic status for the client’s products.
- Responded to consumer class action notification letter regarding non-compliance with California’s Proposition 65, resulting in plaintiff not pursuing any charges.
- Prepared memorandum documenting permissible cannabis product forms for a top medical and recreational marijuana brand.
- Developed a comprehensive document detailing state-level regulatory requirements for various products, including CBD and tobacco, for a popular e-commerce marketplace.
- Preparing for Md. Adult-Use Cannabis: Operations and More, Law360, June 2023
- Preparing for Md. Adult-Use Cannabis: Licensing Provisions, Law360, June 2023
- The Fate of Hemp-Derived Products and the 2023 Farm Bill, The Legal Intelligencer, May 2023
- 2021 Cannabis Review and 2022 Outlook: States Will Continue to Lead the Charge, Possibility of Federal Landscape Shift, Plus Other Drugs, FDLI: Top Food and Drug Cases, 2021 and Cases to Watch, 2022, June 2022
- Cannabis M&A: How to Prepare for Regulatory Due Diligence, Law360, October 2021
- Presenter, Food and Drug Administration Inspections and Enforcement, FDLI Introduction to Tobacco and Nicotine Law and Regulation, October 2022
- Presenter, The Future of Federal Cannabis Policy, 2022 Public Health Law Summit, Baltimore, MD, September 2022
- Presenter, Tobacco and Nicotine Products: FDA Inspections and Enforcement, FDLI Introduction to Tobacco and Nicotine Law and Regulation, October 2021
Admissions
- District of Columbia
Education
- J.D., Georgetown University Law Center, 2018
- B.A., Philosophy, University of Colorado, Boulder, 2010