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Del Monte Fresh Sues FDA to Invalidate Cantaloupe Import Alert
August 23, 2011By Ricardo Carvajal –
Del Monte Fresh Produce N.A., Inc. ("Del Monte Fresh") sued to invalidate an FDA import alert on cantaloupe from Productos Agricolas de Oriente, S.A. ("PAO"), a Guatemalan producer that is one of Del Monte Fresh’s principal suppliers. FDA imposed the import alert as the result of a multi-state outbreak of Salmonella Panama that FDA attributed to PAO cantaloupes. The complaint alleges that FDA’s conclusion regarding the likely source of the outbreak “was not rationally supported by the evidence available to FDA,” and that “FDA also did not take into account evidence that did not support that conclusion.” In specific, the complaint alleges that all tests of PAO cantaloupes for Salmonella or other pathogens have been negative, that FDA inspections and other audits of PAO have been satisfactory, and that some evidence suggests that the outbreak may have been caused by cantaloupes from other sources or foods other than cantaloupe. Thus, if the case proceeds, it will likely focus on the sufficiency of the epidemiological evidence relied on by FDA. Given the increasing sophistication of (and reliance on) epidemiological investigations in responding to outbreaks of foodborne illness, that makes this a case to watch.
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- Senators to DEA: Consider Treaty Obligations In Marijuana Rescheduling April 23, 2024
- “Heigh-ho” Taiho! The PTO Says LYTGOBI Patent is Ineligible for PTE Because of Untimely Application . . . And a Corrected NDA Approval Letter is No Saving Grace April 22, 2024
- Clear that Cabinet Tour ‘24 April 18, 2024
- The Fourth Circuit Upholds CMS’ Definition of “Line-Extension Drug” and “New Formulation” April 17, 2024
- Does the Drug Shortage White Paper Fall Short? April 9, 2024
- Big Molecule Watch Blog
- Bloomberg BNA Health Care Blog
- Drug and Device Law Blog
- Eye on FDA
- FDA Matters
- Harvard Law Bill of Health
- IN VIVO Blog
- Internet Drug News.com
- Lachman Consultants Blog
- Medical Devices Today
- Orange Book Blog
- The Orange Book Insights Blog
- Pharma IQ
- Pharmalot
- SCOTUS Blog
- The Volokh Conspiracy
- WLF Legal Pulse
- Advertising and Promotion (Federal Trade Commission)
- Advertising and Promotion (OPDP)
- Animal Drugs and Feeds
- Biosimilars
- Cannabis
- cGMP Compliance
- Consumer Product Safety Commission
- Controlled Substances
- Cosmetics
- COVID19
- Current Affairs
- Dietary Supplements
- Drug Development
- Drug Enforcement Administration
- Enforcement
- FDA News
- Foods
- Foods and Dietary Supplements
- Fraud and Abuse
- Government Pricing
- Hatch-Waxman
- Health Care
- Health Privacy
- Import/Export
- In Vitro Diagnostic Devices
- Jobs
- Medical Devices
- Miscellaneous
- Orphan Drugs
- OTC Drugs and Cosmetics
- Prescription Drugs and Biologics
- Product Jurisdiction and Combination Products
- Reimbursement
- Tissue Products
- Tobacco
- Uncategorized