Del Monte Prepares for Suit Against Oregon

08/30/11

On August 29, 2011, Del Monte began taking steps to sue the State of Oregon’s Public Health Authority (PHA) and one of its senior officials. After suing the FDA last week, the company filed a notice to sue letter, alerting the State that it will be pursuing legal action in relation to allegations of tainted cantaloupes. According to Del Monte, Oregon’s PHA and its officials had insufficient evidence to link Del Monte cantaloupes to an outbreak of Salmonella Panama.

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FDA Issues Import Alert for Papayas from Mexico

08/30/11

On August 25, 2011, the U.S. Food and Drug Administration (FDA) issued an Import Alert aimed at stopping the introduction of contaminated papaya from entering the country. As announced here, the FDA and its Mexican counterparts have been closely monitoring the salmonella contamination that has been linked to papaya grown in Mexico.

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Violation of FDA Regulations Prompts Seizure by U.S. Marshals

08/30/11

On August 25, 2011, U.S. Marshals seized various seafood products from a manufacturing facility in California. Prompting the seizure, the U.S. Food and Drug Administration (FDA) requested the marshals take action against Meiko Food Co. after finding the company’s operations were not compliant with the federal Food, Drug, and Cosmetic Act (FDCA) and accompanying FDA regulations.

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Del Monte Brings Suit Challenging FDA Import Alert

08/25/11

On August 22, 2011, Del Monte Fresh Produce N.A., Inc. (Del Monte) brought suit against the U.S. Food and Drug Administration (FDA), seeking to invalidate an import alert the agency placed on cantaloupes imported from Guatemala. The challenged Import Alert, found here, was issued after the FDA concluded that cantaloupes being imported from Guatemala were the source of a Salmonella Panama outbreak that left several people ill. In its complaint, Del Monte alleges the FDA had insufficient evidence that Del Monte’s cantaloupes were the source of this outbreak.

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Five Tobacco Companies File Suit Challenging FDA’s New Warnings Rule

08/25/11

On August 16, 2011, five tobacco companies filed a complaint against the U.S. Food and Drug Administration (FDA) in the U.S. District Court for the District of Columbia challenging the Agency’s rule requiring new textual and graphic warning labels on cigarette packaging and advertisements. As we reported here earlier this year, the FDA issued a final rule pursuant to the Family Smoking Prevention and Tobacco Control Act (the “Act”) that requires each cigarette package and advertisement to bear one of nine new textual warning statements and an accompanying graphic image (see FDA’s approved images here). Learn More →

FDA Denies Requests for Reconsideration

08/23/11

Stemming from the recent crackdown on unapproved cough and cold drugs, the U.S. Food and Drug Administration (FDA) recently denied two citizen petitions for reconsideration of the Agency’s action. Submitted by the pharmaceutical companies ECR Pharmaceuticals (ECR) and Laser Pharmaceuticals, LLC (Laser), the requests sought review of the FDA’s decision to rid the market of these products without permitting the companies the opportunities for hearing and asked the Agency to stay future enforcement action, allowing their products to remain on the market until the issues were resolved. In what ultimately resulted in a dismissal based on procedural grounds, the FDA reaffirmed both its hard-line stance against these over-the-counter (OTC) unapproved medicines as well as the narrow grounds on which the Agency will allow an administrative appeal of its actions.

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