By: James Peacock

The FDA issued an announcement on June 20 that stated that the United States Marshal Service seized potentially adulterated food products on behalf of the FDA. The seizure took place on June 15 and affected Professional Warehouse and Distribution, Inc., based in St. Paul, Minnesota. The Marshals seized about $73,000 worth of products. Barley flour, spices, pasta, dried beans, tea, cookies, and other items were seized. The FDA had inspected the facility twice in 2015 and once in 2017. In an inspection that took place in February 2015, FDA officials uncovered unsanitary conditions in the facility that could potentially lead to adulterated products. The FDA told Professional Warehouse and Distribution, Inc. to correct the issues, and gave them advice on corrective actions that they could implement to prevent any adulteration. When the FDA returned to the facility in October 2015, not only had the warehouse not implemented the recommended corrective actions, but the FDA also discovered even more health violations. The company, who promised to correct the issues in February, once again issued a promise to implement corrective procedures.

In 2017, the FDA inspectors found additional problems. On May 26, 2017, food products held at the facility were detained by the FDA after widespread vermin activity was observed in the most recent inspection. The FDA’s Associate Commissioner for Regulatory Affairs Melinda K. Plaisier said, “The storage conditions in the warehouse were simply unacceptable, and the FDA took action to protect Americans.” After a period of about 20 days, the FDA made the decision to seize the products that were previously detained. Products that were not seized by the U.S. Marshal Service were embargoed by the state of Minnesota. There have not been any illnesses or adverse reactions connected to products stored and shipped from the Professional Warehouse and Distribution, Inc. facility in Minnesota.

The United States Department of Justice filed a complaint on behalf of the Food and Drug Administration for the seizure of the potentially adulterated foods. Citing the Federal Food, Drug, and Cosmetic Act, the FDA has the ability to order items to be detained if it is reasonable to believe, over the course of an inspection or investigation, that the items may be adulterated or misbranded. The FDA can hold the items in detention for up to 20 days, although in special circumstances this can be extended to 30 days. The FDA, in that 20 day time period, can decide to take further action if necessary including seizing the products, as they did in this instance. Melinda K. Plaisier, the Associate Commissioner for Regulatory Affairs, also stated, “The FDA plays a key role protecting public health and ensuring not only that food is properly manufactured and labeled, but that it is handled and stored correctly as well.”

The FDA and Legal Action

By and large, the FDA deals with voluntary recalls, which take place on an almost daily basis. It is far more uncommon for the FDA to take more action against a company. These other actions include, but are not limited to injunctions, warning letters, and seizures.  Recently, the FDA sent a warning letter to Aspen Hills, Inc. regarding Listeria monocytogenes found in their facility. The Iowa facility owned by Aspen Hills was inspected by FDA officials between September 27 and October 6, 2016. Listeria was found in locations throughout the facility, prompting the warning letter. Listeria was also found in finished products produced at the facility, namely raw cookie dough. The warning letter was accompanied by a recall. Aspen Hills eventually replied to the letter, announcing that they were closing their doors and ceasing operations at the Iowa facility.

The most recent seizure of products ordered by the FDA was announced on November 30, 2016. The U.S. Marshals were also involved in the seizure, which affected more than 4 million pounds of powder milk products. The dry nonfat milk powder and buttermilk powder seized were worth about $4 million. In a similar procedure to what occurred in the Minnesota seizure, the FDA inspected Valley Milk between July and September 2016, and a combination of poor sanitary practices and positive Salmonella tests led to the FDA requesting that a voluntary recall be made. When the company refused, the FDA took action.

On July 15, 2016, the Department of Justice, on behalf of the FDA, filed and injunction against Kwong Tung Foods, Inc. The company, doing business as Canton Foods, sold rice and wheat noodles, mung bean sprouts, and soy bean sprouts. The FDA cited a long history of violating health and safety violations, as well as operating in unsanitary conditions. FDA inspectors found rodent excrement that was “too numerous to count”, mold-like substances, improper cleaning practices, and a lack of procedures to prevent cross contamination. The injunction prohibited Kwong Tung Foods from processing, preparing, or distributing any items from their facility. The FDA required that the company fix its rampant issues before they would be allowed to resume operations.

Ten days prior to the injunction against Kwong Tung Foods, another injunction was filed, this time against BEK Catering LLC. The company operated as Floppers Foods, and sold ready-to-eat seafood products. Based in Daphne, Alabama, the company was flagged for multiple, repeated violations of the seafood Hazard Analysis and Critical Control Point (HACCP). These issues were found in inspections between September 2011 and April 2015. Citing the lack of adequate preventive controls regarding foodborne pathogen contamination, the company was told that they were no longer permitted to operate until regulatory standards were met.

Even though in most cases unsanitary practices and contaminations found by the FDA are cleared up by the companies involved, there are still instances that the FDA must get involved in. With the authority given to them by the Federal Food, Drug, and Cosmetic Act, the FDA can take necessary action to prevent potentially adulterated or contaminated products from reaching consumers. When the voluntary recall system fails, the FDA may file an injunction against the company. With proper cause, they may detain all potentially adulterated products for up to 30 days depending on the circumstances. From there, they may decide to take further action. In the case of Professional Warehouse and Distribution, the FDA chose to seize the products in order to prevent foodborne illnesses.

 

Sources:

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm563869.htm

https://www.law.cornell.edu/uscode/text/21/chapter-9

https://www.law.cornell.edu/uscode/text/21/334

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm531188.htm

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm511848.htm

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm510072.htm