Understanding FDA Import Alerts: What Are They and Recommendations For Removing Your Company And Products From An Alert

Why Should You Attend:

Import Alerts can cause serious problems for a company including business disruptions, delayed distribution, contract breaches and financial losses. It can also present serious issues for downstream customers and contractors especially when orders are not being filled and product is not being delivered.

FDA maintains lists of Import Alerts naming companies or products that fail to comply with its regulations or that it suspects of being noncompliant. There does not need to be an actual showing of noncompliance but simply a belief that a product poses a safety risk.

The Federal Food, Drug, and Cosmetic Act and its regulations allow FDA to detain, without physical examination, products that either violate or potentially violate the law. Such products are added to an Import Alerts to notify FDA staff and the general public that the Agency has enough evidence or other information to refuse admission of future shipments from coming into the United States. Some of the factors influencing whether a company or product is added to an Import Alert include the product or manufacturer itself, geographical area, ingredients, labeling and/or country of origin.

When listed on an Import Alert, FDA field staff and customs agents are directed to detain all shipments of the particular product or all products from the company. Inspection of the product(s) is no longer needed to detain the product. Detention is now automatic.

A company or product will remain on an Import Alert until evidence or other information is provided to FDA giving it confidence that the problem has been resolved, the product in question is safe for consumers and that all future shipments will be in compliance with the law. The conditions for removal vary depending on the requirements of the particular Import Alert.

Once a company or its products are removed from an Import Alert, the company may resume shipping product into the United States without fear of automatic detention. At this point it is now business as usual again.

Learning objectives:

• Develop an understanding of Import Alerts and their potential impact on business and profitability.
• Reduce the risk of product detention or being added to an Import Alert
• How to avoid costly mistakes
• Understand what causes a company or product to be named on one
• Learn how to determine if your products or another company’s products are subject to detention
• Have procedures in place to act if your products are detained by FDA or customs are the port
• Learn steps for immediate action to be removed from an Import Alert

Areas Covered in the Webinar:

• What is an Import Alert
• The business and financial impact of being named on an Import Alert
• The applicable law including statutory and regulatory provisions
• The reasons for being added to an Import Alert
• The difference between the Red, Green and Yellow lists
• Examples of Ingredient, Labeling, Environmental and Geographic Violations
• FDA inspections at the port
• FDA’s cooperation with U.S. Customs and Border Protection (“CBP”)
• What to do when your products are seized, detained or held at the port
• What to do if your company or products are added to an Import Alert
• Methods for resolving regulatory violations
• Strategic Recommendations for removal from an Import Alert

Free Materials:

• Reference documents
• Rule documents or guidance
• Checklist
• SOP template
• Easy fill in forms
• Articles

Who Will Benefit:

• 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

Karl M. Nobert
President, ReCellerate, Inc.

Karl Nobert, Esq. is an FDA Regulatory Attorney with the law firm of Michael Best in their Washington, DC office.

Karl focuses his practice in 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.

Karl has significant experience in the areas of understanding FDA product detentions and developing strategic solutions for the removal of companies and products from Import Alerts. He has successfully assisted multiple clients with resolving costly detention issues including a large Canadian food company with multi-national operations, several Japanese drug and ingredient manufacturers, a European beverage maker, an Israel-based pharmaceutical distributor and a start-up pet product company.

Topic Background:

An Import Alert allows FDA to detain, without physical examination, products that may violate the Food, Drug, and Cosmetic Act and FDA’s regulations. Import Alerts make FDA staffers and the general public aware that the Agency has sufficient evidence or suspicions about the safety of a product to refuse admission of future shipments of the product. Once a manufacturer or product is added to the list all future imports will be prohibited until the issue is resolved.

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