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CSPI Sues FDA to Compel Action on Citizen Petition Challenging GRAS Status of Salt
October 9, 2015By Ricardo Carvajal –
The Center for Science in the Public Interested (CSPI) filed suit in the D.C. District Court to compel FDA to respond to CSPI’s 2005 citizen petition (Docket No. FDA-2005-P-0196) asking FDA to revoke the GRAS status of salt, require reduced levels of salt in processed foods, and require “health messages” on retail salt packages. The complaint alleges that FDA’s failure to act violates the Administrative Procedure Act (APA), and asks the court to order FDA to respond within 30 days of the court’s finding of an APA violation.
CSPI’s complaint is similar in substance to the complaint filed by Dr. Fred Kummerow in 2013 alleging that FDA violated the APA when it failed to respond to his citizen petition seeking a ban on partially hydrogenated oils (PHOs). FDA framed its recent declaratory order revoking the GRAS status of PHOs as a partial response to Dr. Kummerow’s citizen petition (see our previous post here). There has been no indication that FDA intends to take such an action with respect to salt. However, FDA has indicated its intent to seek gradual reduction of added sodium in the food supply. We’ll therefore be keeping a close eye on developments in this area.
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- FDA’s Revised Draft Guidance on Biological Product Promotion Provides Additional Recommendations/Clarifications April 26, 2024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
- 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
- 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
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- Miscellaneous
- Orphan Drugs
- OTC Drugs and Cosmetics
- Prescription Drugs and Biologics
- Product Jurisdiction and Combination Products
- Reimbursement
- Tissue Products
- Tobacco
- Uncategorized