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First Fishery – Score for the Importer!
January 10, 2010By Dara Katcher Levy –
On December 23, 2009, FDA filed a Motion To Dismiss the First Fishery import matter that we previously blogged about back in late October. In short, First Fishery had filed suit seeking declaratory judgment and injunctive relief with regard to its product’s placement on Import Alert 99-08 – Detention Without Physical Examination of Processed Foods for Pesticides. First Fishery alleged that a finding of pesticide in its product was subject to an exemption under the Federal Food, Drug, and Cosmetic Act, and that there had been no final determination by FDA that the sampled product was violative before placing the product on Import Alert..
In its Motion to Dismiss, FDA acknowledges that in November, after correspondence with First Fishery and with the EPA (and after the First Fishery lawsuit was filed), FDA voluntarily released the detained entry and on December 3, 2009, removed the product from Import Alert. Because of these actions, FDA asserts there is no remaining case or controversy and moves to dismiss.
This case is a prime example that, although FDA may have broad discretion over imports, an appropriate legal challenge in the correct circumstance may force FDA to rein itself in.
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- Sarah Wicks Returns to HPM to Elevate Drug Development and Regulatory Practice May 2, 2024
- FDA’s Draft Guidance on the Q-Submission Program – A Step in the Wrong Direction May 1, 2024
- Democratic Lawmakers Advocate for Prompt Decontrol of Marijuana April 30, 2024
- FDA’s Revised Draft Guidance on Biological Product Promotion Provides Additional Recommendations/Clarifications April 26, 2024
- OMB Completes its Review of the Final LDT Rule—A Final Rule Coming Anytime Now April 25, 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