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FDA Sued For Not Acting on Nanotech Citizen Petition
December 29, 2011By Ricardo Carvajal –
Several nonprofit groups sued FDA for its failure to respond to a May 2006 citizen petition asking that products of nanotechnology be subject to specific regulatory requirements, and that FDA stop the marketing of sunscreens that contain nanoparticles. The complaint alleges that manufactured nanomaterials have properties that “create unique human health and environmental risks” that FDA has failed to address. Citing an inventory maintained by the Project on Emerging Nanotechnologies, plaintiffs contend that “nano-consumer products” are rapidly entering the marketplace with inadequate government oversight or research on their potential effects on human health and the environment. Plaintiffs single out personal care products (e.g., sunscreens) as a category of special concern because of their relative prevalence in the marketplace, “and their repeated, intimate use by consumers.” Plaintiffs request a court order declaring that FDA is in violation of the Administrative Procedure Act, and to compel FDA to respond to the 2006 citizen petition “as soon as reasonably practicable.”
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- Most Favored Nation Drug Pricing Rule on Hold Awaiting Changes January 22, 2021
- FDA Continues Discussion of AI/ML Software Medical Devices January 21, 2021
- Proposed Changes to Short-Form Version of Safe Harbor Proposition 65 Warning January 20, 2021
- AMG v. FTC: A Moot Court-Worthy Conflict at the Supreme Court January 15, 2021
- Orange Book Modernization Act: Congress Largely Codifies FDA’s Existing Orange Book Practices, But Also Brings PTAB Decisions Into the Fold January 14, 2021
- 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