An Import Alert allows FDA to detain, without physical examination, products that either have or potentially could violate the Food, Drug, and Cosmetic Act (“FDC Act”). Import Alerts lets FDA Field Staff know that the agency has enough evidence or other information to refuse admission of future shipments of an imported article. There are a variety of factors that could lead FDA to place a product, manufacturer, shipper, grower, geographical area, and/or country on Import Alert.
Once a shipment is refused admission to the U.S., the importer has an opportunity to introduce evidence, within 10 days, to overcome the appearance of a violation. During this time, the product is either held at a warehouse or at the importer’s premises and cannot be distributed. If the shipment is not proven to be safe, it must be destroyed or exported within 90 days.
The alert can be issued for an import from a manufacturer, shipper, grower, geographical area, or country. If the problem or condition exists on a wide scale, federal inspectors would be instructed to detain all products of a certain kind coming from that country.
An imported product, firm, region, or country may remain in this status until evidence or other information is provided that gives FDA confidence that the shipment is safe for consumers and that future shipments will be in compliance with the law. The conditions that the importer has to meet vary depending on the stipulations in the Import Alert.
This webinar will provide attendees with background about FDA Import Alerts, examine why they are issues, where to locate them, how to find whether a company or product is the subject of an Import Alert, and finally, provide a series of strategic recommendations for getting off of an Alert.
Learning Objective
- Understand the nature of Import Alerts: What are they? What purpose do they serve? What do they mean for a company?
- Become familiar with CBP and FDA’s shared jurisdiction at U.S. ports.
- Company or Products to be added to an Import Alert.
- Be able to find and search FDA’s Database of Import Alerts.
- Understand the potential and real impact of being named on an FDA Import Alert.
- Be able to identify the steps for removing a Company or Product from an Import Alert.
- What to do if you learn that your products are being detained by FDA at a port and your Company’s name is added to an Import Alert.
Webinar Takeaway
- Import Alerts
- The different types of Import Alert issued by FDA
- What Causes a Country, Company or Products to be added to an Import Alert
- What impact does being named on an Import Alert have on a Company
- What to do if your products are Held or Detained at the port by FDA.
- What to do if your Company or Products are named on an Import Alert.
- Strategic Recommendations for removing one’s Company and/or Products from an Import Alert.
Speakers
Mr Karl Nobert,
Senior Counsel ,
Michael Best & Friedrich LLPKarl focuses his practice on FDA Regulatory law, representing U.S. and international clients in the food and drug industries with regard to pharmaceuticals and OTC drugs, biologics, medical devices, food and beverages including dairy products, cosmetics, vitamins and dietary supplements, and veterinary products.
He has particular experience in the areas of prescription drugs and regenerative medicine and has counseled numerous clients seeking FDA approval for Rx drugs and cellular-based products to treat both humans and animals.
Ms Elizabeth Simonis,
FDA Regulatory Law Clerk ,
Michael Best & Friedrich LLPLiz Simonis is a law clerk for Michael Best & Friedrich working in the firm’s FDA Regulatory Practice group. While earning a B.S. in Dairy Science, she spent 5 months in Hangzhou, China, focusing on international trade and the Chinese dairy industry.
She then spent 5 years working in the animal feed industry where she encountered a variety or regulatory issues, from medicated feed labeling to FDA inspections. Liz has worked on several FDA Import Alert-related projects for the Firm’s clients including currently preparing a Petition for Removal from FDA’s Red List.
Who Should Attend
- Regulatory Affairs Professionals, Managers, Consultants, Scientists, Research Analysts, State Policy Officials, Insurers focusing on Representations & Warranties Insurance; Investment Analysts; Venture Capitalists.
- Pharmaceutical, Biologics, Animal Health, Food, Medical Device and other Biotech Companies
- Domestic and Foreign Corporations, Small Business, Start-Up Ventures, Manufacturers, Importers, Labelers and Product Distributors
- Importers, Customs Brokers, Distributors
- Financial analysts and investors watching the pharmaceutical, life sciences and biotech industries
