FDA Transparency Task Force

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.


Co-authored with Dean Leaman, Director of Business Development

Import/Export – Miami, FL, ABC Research Corporation

By |2015-12-01T01:35:10-05:00May 26, 2010|FDA Issues|0 Comments

U.S. Congressional Trade Committee Questions CBP and ICE

and the U.S. Immigration and Customs Enforcement (ICE) testified before the U.S. House of Representatives’ Committee on Ways and Means Subcommittee on Trade.   Chairman Tanner said the hearing was “to strike the right balance” between trade facilitation and security.  Unfortunately, the Committee heard all about the enforcement success of both ICE and CBP without hearing about the difficulties faced daily by importers and customs brokers.

Chairman Tanner accurately stated:

There has been a growing concern that, in particular, CBP’s modernization of trade functions, facilitation of trade, and enforcement of traditional customs laws have appeared to lag while the agency tightened security screening of passengers and cargo.

ICE was particularly proud of its accomplishments by its National Intellectual Property Rights Coordination Center.  In ongoing Operation Guardian, ICE has interdicted substandard, tainted, or counterfeit products, including food and medicine that pose health and safety risks to American consumers.  $26 million of such condoms, circuit breakers, toys, extension cords, honey, and shrimp were seized by ICE and CBP.

What was not revealed was how many unnecessary delays and expenses were caused by ICE and CBP for the legitimate merchandise that entered or transited the United States.  In order to determine the effectiveness of the targeting programs used by CBP, Congress needs to inquire about the number of detentions and examinations by CBP, and the consequential financial costs to importers.  The U.S. Government Accountability Office (GAO) is also concerned with properly targeted imported food shipments, as indicated in its May 6, 2010 report on “Food […]

See You at the Boston Seafood Show in 2011!

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.

Please comment on form below to let me know your experiences from […]

By |2015-12-01T01:33:45-05:00May 21, 2010|FDA Issues|0 Comments

Frequent Flyer Miles Getting Harder to Use

Are you also having a tough time turning in frequent flyer miles to travel internationally?  My wife and I will travel to the beautiful area of Tuscany, Italy, this summer. I wanted to fly non-stop on Delta or Continental, or their code-share partners, but their roundtrip frequent flyer mile minimum requirements were very high – 90,000 and 100,000 miles, respectively!   Instead, I turned in 60,00 frequent flier miles  on American Airlines to get each of the tickets, paid $80 in “taxes” for each, and am flying on American Airlines’ code-share partner, Iberia Airlines, through Madrid.

In years past, I had used only 50,000 frequent flyer miles on AA, Delta, and Continental to fly roundtrip from the United States to many countries in Europe.  Now, airlines want me to use double the miles, and charge me $20 per ticket for having to bother them by telephone to book the trip.  Since I live in South Florida, where American Airlines is the dominant carrier at Miami International Airport, I still have the AA Mastercard, of course, but charge on American Express whenever I can.

Fortunately, I have long had the Starwood American Express card, which allows me (for free) to move 20,000 Starpoints to get 25,000 frequent flyer miles on most airlines.  This is by far the best credit card I have ever used (yes, even better than the AMEX Platinum credit card).  After all,  I need to start saving for next year’s trip to Vienna, Austria.

By |2015-12-01T01:33:16-05:00May 16, 2010|International Travel|0 Comments

U.S. Consumer Product Safety Commission: Not Just Toys and Games

U.S. Consumer Product Safety Commission  (CPSC) officers will target more imported merchandise for safety risk assessments using information filed with U.S. Customs and Border Protection by importers or their customs brokers. The CPSC is an independent health and safety regulatory agency that is responsible for protecting the American public from unreasonable risks of injury and death from about 15,000 types of consumer products. Since the passage of the Consumer Product Safety Improvement Act (CPSIA) of 2008, CPSC increased the number of staff co-located with U.S. Customs at U.S. ports of entry.  Recently, U.S. Customs Commissioner Alan Bersin and CPSC Chairman Inez Tenenbaum signed a memorandum of understanding to create an Import Safety Commercial Targeting and Analysis Center (CTAC).

CTAC is the culmination of President Obama’s Food Safety Working Group  focused on (1) prevention, (2) surveillance, and (3) responding to the attempted importation into the United States of unsafe products.  The authority of CPSC officers is modeled after the authority and actions by the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS).

CPSC will soon issue its own Detention Notices, rather than having U.S. Customs do it, for imported cargo that is suspected of being unsafe.  CPSC will not only target and detain toys, games, and other children’s’ products, but also products previously screened only the FDA – food, cosmetic, medical devices, and dietary supplements.

The $600,000 penalty that Target Corp., of Minneapolis, Minn. has agreed to pay to CPSC for allegedly violating the federal lead paint […]

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