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FDA Sued for Failure to Ban Partially Hydrogenated Oils
August 13, 2013By Ricardo Carvajal –
Fred Kummerow, a Professor Emeritus at University of Illinois, sued FDA for failing to respond to his citizen petition (Docket No. FDA-2009-P-0382) asking the agency to ban partially hydrogenated oils containing artificial trans fat. The citizen petition was submitted in August 2009, and the complaint contends that FDA has neither issued a substantive response nor taken the actions requested by the petition, in violation of the Administrative Procedure Act ("APA").
The complaint contends that there is no safe level of artificial trans fat, and that such fat causes a number of diseases and damages vital organs. The complaint further contends that “there is a clear difference between natural trans fat, which appears in dairy products and some meats from ruminant animals in the form of vaccenic acid, and artificial trans fat, which appears in partially hydrogenated oils.” The former purportedly has no adverse health effects and therefore need not be regulated, while the latter is associated with adverse health effects and therefore should be banned as a poisonous or deleterious substance.
In addition to asking that the court declare FDA in violation of the APA, the complaint asks the court to compel FDA “to recognize partially hydrogenated oils as unsafe and ban their use in food by a Court-ordered deadline.”
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- FTC Continues to Rage Against Device Patent Listings in the Orange Book March 27, 2024
- FDA Approval of New Therapy, Duvyzat, for Duchenne Muscular Dystrophy Represents Several Meaningful Firsts March 26, 2024
- Arkansas Law Prohibiting Manufacturer 340B Contract Pharmacy Restrictions Upheld by 8th Circuit March 25, 2024
- Conference Notebook: ACI’s Cosmetics and Personal Care Products Conference March 22, 2024
- HP&M Director, Allyson Mullen, Appointed to the Association of Medical Diagnostic Manufacturers 2024-2026 Board of Directors March 20, 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