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FDA Import Alerts for Seafood

Americans are constantly bombarded with warnings that the seafood we eat is contaminated with salmonella, listeria, or some other antibiotic, fungicide, or microorganism that will make us sick. The U.S. Food and Drug Administration (FDA) is taking more samples of imported seafood, holding more seafood for laboratory analysis, and rejecting more seafood than in past years. That is true of basa from Vietnam, crabmeat from Indonesia, and a variety of seafood from countries as far away as China, or as close to the United States as the Bahamas.

The FDA issues ‘Import Alerts’ to attempt to prevent contaminated seafood (or specific products) from certain overseas suppliers from entering the food supply chain in the United States. Seafood importers should be very familiar with Import Alert 16-81 – “Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella”.

The Obama Administration’s Import Safety Working Group Food Protection Plan encourages the FDA to issue more Import Alerts. An Import Alert is an order to all FDA district officials to detain and examine imported seafood that is identified on an Import Alert, or to detain and examine any seafood shipped by an overseas company that is listed on the Import Alert (i.e. the “Red List”).

Import Alerts are issued on an almost daily basis by the FDA. For Import Alert 16-81, the “Charge” reads as follows:

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to contain salmonella, a poisonous and deleterious substance, which may render it […]

By Jennifer Diaz|2015-12-01T01:40:19-05:00August 23, 2010|Import, Import Alert|0 Comments

U.S. Customs Inflates Seizure Statistics

U.S. Customs and Border Protection is one of the leading Federal agencies responsible for stopping counterfeit products from entering the United States. U.S. Customs does a good job seizing counterfeit products at ports around the country on a daily basis. These counterfeit products vary from sunglasses to handbags to pharmaceuticals to footwear. But U.S. Customs’ press releases always use an unrealistic, inflated number when describing the value of the seized merchandise.

For example, last week in San Francisco, U.S. Customs allegedly seized $100 million counterfeit Gucci, Dooney & Bourke, and various other illegally trademarked merchandise from the Fisherman’s Wharf area. It was originally reported in the San Francisco Chronicle, then appeared on the Associated Press wire to the Chicago Tribune, the Washington Post, and other newspapers around the country. The Chronicle stated in part:

On Tuesday, they announced the seizure of more than 200,000 counterfeit retail items valued at $100 million – if they were genuine, that is – during what they called the largest-ever bust of retail counterfeiters on the West Coast.

Note the words, “if they were genuine, that is.” U.S. Customs uses the Manufacturer’s Suggested Retail Price (MSRP), which nobody pays, in reporting the value of the seized merchandise to the press. So, for example, a blatantly counterfeit Louis Vuitton handbag that would have been sold to a customer at Fisherman’s Wharf for $50 may be reported by U.S. Customs to be valued at $1,000, a multiple of 20 times the selling price.

Customs does a good job at identifying, […]

By Jennifer Diaz|2015-12-01T01:38:23-05:00August 10, 2010|Counterfeits|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 […]

By Jennifer Diaz|2015-12-01T01:34:49-05:00May 24, 2010|Food, Import, U.S Department of Homeland Security (DHS)|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 […]

By Jennifer Diaz|2015-12-01T01:32:47-05:00May 14, 2010|Import, U.S. Consumer Product Safety Commission (CPSC)|1 Comment

THE FDA IS FLEXING ITS ENFORCEMENT MUSCLES

At today’s Food and Drug Law Institute’s annual conference in Washington, D.C., FDA Commissioner Margaret Hamburg, M.D. said that one of her priorities is responding to the globalization of the food supply, and the increase in misbranded and adulterated food products imported into the United States. Dr. Hamburg stated that the FDA “cannot wait until the food arrives at our borders,” that “extending the FDA’s global reach is key to our success,” and that the FDA’s new PREDICT system will focus FDA Inspectors to select, stop, and examine high-risk shipments being imported into the United States.

Ralph Tyler, FDA’s new Chief Counsel, stated that the laws enforced by the FDA affect 25% of the American economy. The crowd in attendance applauded when Ralph stated that “FDA lawyers are not doing their jobs when they simply say ‘no'” to the food, drug, and cosmetic companies regulated by the FDA.

Michael Chappell, FDA’s Associate Commissioner for the Office of Regulatory Affairs (ORA), is the person responsible for managing the import, inspections and enforcement policy of the FDA. He stated that companies are now operating in “an age of heightened enforcement by the FDA.” He stated that “salmonella and listeria remain major problems in food manufacturing facilities.” He advised that there were 19 million customs entries in 2009, and the number is ever increasing. He stated that the FDA had in 2010 already issued a record number of Warning Letters to importers, producers, and distributors of FDA regulated products, especially dietary supplements and cosmetics.

In summary, my take away after hearing from the […]

By Jennifer Diaz|2015-12-01T01:32:04-05:00April 22, 2010|FDA Issues, Food, Import|0 Comments

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