Food

In 2010, Americans consumed almost 6 billions pounds of seafood.  The U.S. Food and Drug Administration (FDA) is responsible for ensuring that the nation’s food supply, including seafood, is safe, wholesome, and properly labeled. That is a tough task considering 80% of the seafood we eat is imported from countries all over the world.  Unfortunately, the reality is that seafood fraud is common. Moreover, it can have not only economic, but food safety, consequences.

According to a February 2009 GAO Report provided to the United States Congress which criticized the FDA for its lack of enforcement:

The most common types of seafood fraud are:

1.  shipping products through an intermediary country to avoid customs duties (transshipping),

2. adding excess amounts of water or ice to the seafood to increase its weight (over-treating),

3. substituting a different species of seafood for the species listed on the label (species substitution), and

4. including less seafood in a package than indicated by the label (short-weighting).

Read this typical January 20, 2011 Press Release from the U.S. Department of Justice regarding a company that pled guilty to false labeling of imported fish.  Read this typical Warning Letter from the FDA against a seafood company for misbranding its shrimp.

The Food Safety Modernization Act, signed into law in January 2011, is a step in the right direction to give the FDA the legal authority to prevent, not just respond to, seafood fraud. As FDA Commissioner Margaret Hamburg stated in a recent press release:

This law represents a sea change for food safety in America, bringing a new […]

On December 12, 2003, the U.S. Food and Drug Administration (FDA) implemented the Bioterrorism Act of 2002.  That Act basically required that companies shipping food to the United States must first be registered with the FDA, and that importers of food must provide “prior notice” to the FDA of any particular shipment before it physically arrives in the United States.  Over the past 7 years, has the Bioterrorism Act lived up to its expectations to protect the American consumer from eating dangerously contaminated food?

In an article entitled “Scrap the Bioterrorism Act” published in February 2004, I criticized the Act as not going far enough because it did not require (1) FDA Inspectors to be located in foreign countries sending us food,  (2) cooperation with foreign food inspection governmental authorities, and (3) mandatory recall authority to the FDA for contaminated foods.  In a May 6, 2010 report by the U.S. Government Accountability Office (GAO) entitled “Food Safety:  FDA Could Strengthen Oversight of Imported Food,” it came to exactly the same conclusions.

As stated in the GAO report:

The FDA physically examines approximately 1 percent of imported food.

Imported fish and other seafood is of particular interest to the FDA.  Obviously, FDA Inspectors cannot physically inspect every shipment of imported seafood, but every shipment that contains FDA-regulated products that enters the United States is electronically reviewed by the FDA  to determine if the shipment should be physically examined or a sample laboratory tested.   Hence, the prior notice information enables FDA, working closely with U.S. Customs and Border Protection, to more effectively target

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.