- Getting Into the Weeds of USDA’s Hemp Production Program Regulations February 24, 2021
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FDA Seeks to Mow Down Lawsuit Over GRAS
May 27, 2014By Ricardo Carvajal –
FDA filed a motion to dismiss the lawsuit brought by the Center for Food Safety challenging the legality of FDA’s GRAS notification program (for background information on the lawsuit, see our prior posting here). In its supporting memorandum, FDA argues that plaintiff lacks standing and that the agency’s proposed rule on GRAS notification is not final agency action subject to judicial review. FDA further argues that plaintiff’s action is barred by the applicable statute of limitations.
FDA’s supporting memorandum points to the several advantages of the GRAS notification program as compared with the GRAS affirmation program it replaced, including increased efficiency and greater participation by industry. FDA notes that a return to GRAS affirmation would merely trade one voluntary mechanism for another, and would not achieve the gatekeeping function sought by plaintiff. FDA indicates that it intends to clear the final rule on GRAS notification by July 2016. We’ll continue to monitor and report on significant developments in this case.
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- Getting Into the Weeds of USDA’s Hemp Production Program Regulations February 24, 2021
- “Tongue and Done” – Just . . . No. February 18, 2021
- ACI’s 36th FDA Boot Camp (Virtual Conference) February 9, 2021
- HP&M’s Food, Beverage & Supplement Wrap Up: January 2021 February 8, 2021
- ACI’s Advanced Legal, Regulatory, and Compliance Forum on OTC Drugs (Virtual Conference) February 4, 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