U.S. Food and Drug Administration (FDA) Archives - Page 39 of 42

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

FDA To Inspect Foreign Food Facilities Starting October 1, 2010

The U.S. Food and Drug Administration has issued notices to all foreign food facilities registered with the FDA that it will conduct an inspection of those facilities between October 1, 2010 and September 30, 2011. Foreign food facilities that manufacturer, process, pack, hold, and ship food to the United States must have registered with the FDA pursuant to the Bioterrorism Act. Foreign food facilities that do not properly respond to the FDA notices may have their registrations automatically terminated. In effect, that will result in a detention of any food that arrives in the United States from those canceled facilities.

It is no secret why the FDA is visiting foreign food facilities shipping food to the United States. See blog post “The FDA is Flexing Its Enforcement Muscles”. The Foreign Food Inspection Team at the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) based in College Park, Maryland, is responsible for coordinating the foreign food inspections. The recent FDA notices state, in part:

The inspection will be conducted by an investigator of the FDA to determine if your facility is operating in accordance with U.S. Food, Drug, and Cosmetic Act and its regulations, including Title 21 CFR Part 110, Good Manufacturing Practices (GMP) regulations.

Any foreign food facilities not yet registered may register with the FDA using a website www.FDA-USA.com established and operated by my law firm for a fee. It is very easy to register on-line in English, Spanish, Portuguese, or German. Companies should properly prepare prior to the FDA inspection.

By Jennifer Diaz|2015-12-01T01:39:04-05:00August 11, 2010|FDA Issues, Food|0 Comments

Pills That Will Make You Smarter, Lose Weight, and Cure Cancer

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.

Whenever contacted by […]

By Jennifer Diaz|2015-12-01T01:37:46-05:00July 18, 2010|FDA Issues|0 Comments

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.

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Co-authored with Dean Leaman, Director of Business Development

Import/Export – Miami, FL, ABC Research Corporation

By Jennifer Diaz|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 […]

By Jennifer Diaz|2015-12-01T01:34:49-05:00May 24, 2010|Food, Import, U.S Department of Homeland Security (DHS)|0 Comments

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