FDA Exercises New Powers
The end of November marks a historic moment in the relationship between manufacturers, retailers, and regulatory agencies.
The Food and Drug Administration(FDA) has just suspended the food facility registration of Sunland Inc. due to a nationwide outbreak of Salmonella-related illnesses. Sunland Inc. was the sole manufacturer of the â€œTrader Joeâ€™s Valencia Creamy Salted Peanut Butterâ€ which was found to be the cause of 41 illnesses across 20 states. As of the suspension, Sunland is forbidden from selling their products nationally. Sunland is also forbidden from manufacturing, importing, or exporting products.
This suspension is the first ever of its kind. Through the Food Safety Modernization Act of 2011, the FDA was granted new powers to suspend the food registration license of manufacturers responsible for introducing dangerous or defective products into the market.
Prior to their Suspension, Sunland instituted a voluntary recall of almost all of their products sold over the last two years. A list of over 240 recalled products is available for viewing on the Sunland website http://www.sunlandinc.com/788/html/pdfs/SunlandRecall.pdf. The recall, which originally touched only a small selection of nut butters, has expanded to include shelled peanuts and raw peanuts from the processing facility.
Anatomy of a Recall
Â Â Â Â Â Â Â Â Â Â Â On September 20, Trader Joeâ€™s was alerted by the FDA and the Center for Disease Control(CDC) that a series of Salmonella Bredeney related-illnesses had been linked back to their Valencia Creamy Salted Peanut Butter. A recall notice to consumers was immediately posted on their website, and the products were immediately taken off of their shelves.
On September 23, FDA officials alerted Sunland Inc. of the contaminated peanut butter, and Sunland immediately initiated a voluntary recall of 100 different products.
On October 4th, Sunland added another 140 products to their recall list, bringing the total to 240.
On October 5th, the FDA released inspection results showing that strains of Salmonella Bredeney were found on the manufacturing equipment in the Sunland processing facility.
On November 14th, FDA released results of their Sunland Facility inspection to the public. The results showed that Sunland Inc. had cleared for distribution at least 8 lots of peanut butter that were confirmed to have traces of Salmonella according to internal company quality tests. The FDA reported many infractions in their review of the facility.
On November 20th, Sunland sends the FDA a letter detailing a schedule of reforms, and an anticipated re-opening of their production facility on the 26th of November.
On November 26th, the FDA officially suspends the food facility registration of Sunland Inc., citing a long history of infractions, and an insufficiently clear schedule or reforms.
Â Â Â Â Â Â Â Â Â Â Â The two separate processing plants of Sunland will be closed until Sunland can submit to the FDA a plan to â€œaddress the immediate problems and to implement a sustainable solution to those problems in a sound scientific mannerâ€. This closure represents a huge disruption to the supply chain, immense legal liability, and a potentially catastrophic loss of capital for Sunland.
For Trader Joeâ€™s, the recall has resulted in major labor costs surrounding the removal of the product from store shelves, and negative reactions from affected consumers.
The recall, andâ€”more specificallyâ€”the facility suspension, are indicative of an emerging trend within the consumer product industry towards tighter regulations. These tighter regulations and more severe penalties will not only effect manufacturers like Sunland, but will also have major repercussions for retailers like Trader Joeâ€™s and many others.
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-FDA Website: Food Section http://www.fda.gov/food/foodsafety/corenetwork/ucm320413.htm
Accessed Saturday, December 1st.
-Sunland Homepage: http://www.sunlandinc.com/788/html/index.htm