FDA Issues

All those dietary supplements advertised on television and readily available on the Internet claim to do one thing or another.  Taking certain pills allegedly will make you smarter, give you a burst of energy, end problems with erectile dysfunction, or even cure cancer. The United States Food and Drug Administration (FDA) is the primary Federal agency responsible for protecting the American consumer from such false claims.  The FDA does this through its Office of Regulatory Affairs (ORA), and pursues criminal investigations through its Office of Criminal Investigations (OCI).

The mission of the Office of Criminal Investigations (OCI) is to conduct and coordinate investigations of suspected criminal violations of the Federal Food, Drug, and Cosmetic Act (FDCA). OCI has an office at FDA Headquarters in Rockville, Maryland, and field offices around the United States.  For example, the Miami Field Office is located in Ft. Lauderdale, Florida, and covers 8 Southeastern States, plus Puerto Rico and the U.S. Virgin Islands.  Special Agents of the OCI investigate street level distribution of counterfeit, unapproved, and designer drugs, major organized illicit diversion of prescription drugs, fraudulent schemes involving ineffective AIDS, cancer, and Alzheimer cures, large scale product substitution conspiracies, application and clinical investigator fraud, and health frauds involving harmful FDA-regulated drugs and medical devices.

In Miami, Florida, two importers were recently arrested for importing cheese contaminated with Staphylococcus aureus, making the food adulterated.  A conviction for introducing contaminated food into the United States may result in 3 years in prison and a fine of $250,000.

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FDA is proposing to expand disclosure of certain information which is currently not openly shared with the general public.  The twenty-one draft proposals are in response to comments received by FDA’s Transparency Task Force as a way to make the decision-making of the FDA more apparent to consumers and regulated industries.  The proposals are available on-line as a complete report or by specific topic area.

The report divides the draft proposal into the following eight general topic areas:

• Adverse Event Reports
• Docket Management Process
• Enforcement Priorities and Actions
• Import Procedures
• Inspections
• Product Applications (including Investigational applications)
• Recalls
• Warning and Untitled Letters

Ten of the twenty-one draft proposals are applicable to the food industry.  They are listed below with links provided to background information, summary of public comments, agency considerations and reasoning for the draft proposal.

Draft Proposal 2 [Docket Management Process]

FDA is accepting comments on the proposals through July 20, 2010.

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Co-authored with Dean Leaman, Director of Business Development

Import/Export – Miami, FL, ABC Research Corporation

The largest North American seafood event is the annual International Boston Seafood Show which next takes place March 20-22, 2011, in Boston, Massachusetts.  Not only will I be there, I welcome everyone to visit our exhibition booth!  This reflects the growth of our focus on FDA issues within the Customs and International Trade Department of my law firm.

With the U.S. Food and Drug Administration (FDA) holding, detaining, examining, testing, and refusing more imported food than ever before, our attorneys are constantly interacting with FDA Inspectors, Compliance Officers, and Investigators.  We typically represent the U.S. importer who has received a Notice of FDA Action, and is given 10 days to explain to the FDA that the food product  should enter the United States rather than be refused.  We also represent overseas suppliers who unfortunately find themselves listed on an FDA Import Alert, and want to get off that list.

For example, on May 20, 2010, the FDA issued Import Alert #16-18, which is “Detention Without Physical Examination of Fresh  and Frozen Shrimp from Bangladesh, Hong Kong, Indonesia, Taiwan, and Thailand” for filth, decomposition and Salmonella.  Shrimp from those countries will automatically be detained by the FDA until a United States laboratory provides sufficient documentation to the FDA that the product meets U.S. standards.  The secret is getting on what the FDA calls the “Green List” of approved shrimp suppliers from these countries so that the product proceeds through the FDA entry process without delay.

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