J. Mason Weeda
Principal
- Washington, DC
- mweeda@ofwlaw.com
- (202) 518-6362
Mason advises businesses on laws and regulations surrounding the manufacture, marketing and promotion of FDA regulated products. Mason also provides counsel to trade associations and commodity groups that include FDA regulated industry, and advises business on transactional matters concerning FDA regulations and related requirements.
Mason routinely provides advice surrounding FDA regulated products, including:
- FDA product applications and approvals
- FDA facility registration
- FDA and USDA enforcement and administrative matters (warning letters, complaints for injunctive relief and consent decrees, citizen petitions, and trade complaints)
- Promotion and advertising compliance
- Compliance with Federal Anti-kickback Statute, Sunshine Act, CAN-SPAM, HIPAA, and other laws that may apply to advertising and promotion of FDA-regulated products
- Legislative and regulatory policy strategy, including comments on relevant rule making and agency guidance
- Import and export requirements (import alerts, holds, detentions, and refusals, and other Customs and Border Protection requirements)
- Labeling, formulation and ingredients (food additives and GRAS petitions)
- Food Safety Modernization Act
- False Claims Act defense
Practice Areas
- National Organic Program
- Cannabis
- Trade Associations
- Enforcement & Litigation
- Inspections
- Food Recalls
- Feed and Pet Food
- Food Labeling & Advertisement
- Food Service, Restaurants & Retailers
- Customs & Import/Export Regulations
- Checkoff Programs
- FDA Food Law and Food Safety
- Facility Registrations
- Dietary Supplements
- Due Diligence
- Lobbying & Public Policy
- International Food Security
- Dietary Guidelines
- Coalition Building
- Medical Devices & Products
- Digital Health
Past Experience
- Biologics Sales Representative, Sanofi Pasteur, 2001-2004
- Neurogenetic Diagnostic Sales, Athena Diagnostics, 2004-2006
- Law Clerk to the Honorable Terrence J. McGann, Circuit Court for Montgomery County, Maryland, 2009-2010
Leadership & Community
Mason is a member of the Health and Agriculture Law Sections of the Maryland State Bar Association, the Food and Drug Law Institute, and the American Health Lawyers Association. Mason teaches food and drug law to new employees at FDA’s Center for Device and Radiological Health, and is a frequent presenter at local and national symposiums and trade events.
