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Food Safety Modernization Act

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Here’s a Recap of Part II of our #WorldTradeMonth Seminar Series for Compliance Professionals on FDA FSMA and FSVP

posted by Jennifer Diaz May 19, 2017 0 comments

Yesterday, we at DTL, had the pleasure of hosting Part II of our #WorldTradeMonth Seminar Series for Compliance Professionals. The second seminar focused on FDA FSMA (Food Safety Modernization Act) Compliance for Importers with expert speakers from the U.S. Food and Drug Administration (FDA) and industry. We had a packed house with an array of attendees such as importers of food, beverages, and medical devices, along with customs brokers, freight forwarders / NVOCCs, lawyers, consultants, and others. We received requests for a re-cap from those who attended and industry members who were not able to attend. You asked and we deliver. Here is our recap:

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FoodFSMA

FDA Administrative Detention of Food… What can you do?

posted by Customs & International Trade Law Blog March 9, 2012 1 Comment

Just a few weeks ago, FDA investigators ordered an administrative detention of a Maine company’s cold-smoked salmon product, a ready-to-eat food, during an inspection. Once the food was detained, Mill Stream Corp. agreed to voluntarily destroy the cold-smoked salmon, under FDA supervision, after inspectors found Listeria monocytogenes within the company’s facility and on its processing equipment.

Similarly, in October 2011, U.S. Marshals seized food products held at the food storage and processing facility of Dominguez Foods of Washington, Inc., in Zillah, Wash., where the seized products had first been subject to a detention order issued by FDA, following an FDA inspection of the facility that found evidence of widespread and active rodent and insect infestation in the facility’s warehouse and processing area.

 

These administrative food detentions are becoming more and more widespread and this trend is not accidental. The January 2011 amendment to the FDA Food Safety Modernization Act (FSMA) granted the FDA a far broader authority than in years past to administratively detain foods suspected of adulteration or misbranding.    According to Dara Corrigan, the FDA’s Associate Commissioner for Regulatory Affairs:

The FDA will not hesitate to take immediate steps to protect the public’s health.  We will aggressively use our enforcement tools to prevent potentially adulterated food from reaching the public.

Previously, the FDA’s ability to administratively detain food products for humans or animals applied only when the agency had credible evidence that the food or feed presented a threat of serious adverse health consequences or death to humans or animals. With this expanded administrative detention authority, the FDA is now able to detain food and feed products that it has reason to believe are adulterated or misbranded. An administrative detention may last up to 30 calendar days, if needed, during which time the FDA determines whether an enforcement action is required, such as seizure of products or federal injunction against a firm.
 

Appealing an administrative detention is an option for claimants who act fast! After receiving the administrative detention order, an owner of perishable foods must file an appeal within two (2) calendar days and the owner of non-perishable foods has four days to file a notice of intent to file an appeal and to request a hearing with the actual appeal due within ten (10) calendar days of the receipt of the administrative detention order. A timely appeal filed correctly can result in a quicker termination of the administrative detention and thus, the return of the food article. Furthermore, it grants the owner of the food articles the opportunity to present evidence supporting the legitimacy of the detained food rather than to simply be at the mercy of the inspectors.

 

For more information, visit the recently published guide entitled “What You Need to Know About Administrative Detention of Foods, available at http://www.fda.gov/Food/guidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodDefenseandEmergencyResponse/ucm276871.htm

 

As always, if you are unsure, consult with a professional. Failure to appeal an administrative detention of food can result in seizure. Moreover, not only may you lose the food you intended to sell, but also get fined by the U.S. Government.

FDA IssuesFood

Seafood Fraud

posted by Customs & International Trade Law Blog March 9, 2011 0 comments

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 focus on prevention, and I expect that in the coming years it will have a dramatic and positive effect on the safety of the food supply.

The topics of seafood fraud and the Food Safety Modernization Act will be discussed in detail at the "Food Safety Reform Update" panel at the International Boston Seafood Show on Sunday, March 20, 1:30 to 3:00 p.m. Learn how to prevent seafood fraud, how to detect seafood fraud, and what to do if you or your company are under investigation by the FDA, U.S. Customs and Border Protection (CBP), or the National Marine Fisheries Service (NMFS) for seafood or other import fraud.