Judge deals blow to FDA with ruling that Cholestin is a dietary supplement

Article Abstract:

A turning point in the federal judge's decision to rule Cholestin as a dietary supplement instead of a drug was when it was decided that the FDA clears a whole product, not just the active ingredient(s). U.S. District Judge Dale A. Kimball ruled in favor of Pharmanex Inc. that sued the FDA in 1998. Merck & Co. is accused of encouraging the FDA to review the product as a drug because it makes Mevacor, also for cholesterol control.

Comment:

Cholestin found to not be a drug in need of FDA approval

Legal issues & crime, Vitamin, Nutrient & Hematinic Preps, Cases, Pharmaceutical industry, Dietary supplements industry, Dietary supplements, Pharmanex Inc.

---

J&J's cholesterol-lowering spread to be sold as food, not supplement

Article Abstract:

Johnson & Johnson got word from the FDA that its cholesterol-lowering Benecol will receive fast-track review as a food. J&J's McNeil Consumer Healthcare originally wanted to market the spread as a dietary supplement. Now the product is expected to hit store shelves in early April 1999, about the same time as Take Control, a cholesterol-lowering margarine from Unilever PLC.

Comment:

Benecol could be in stores by April

Product standards, safety, & recalls, Lipotropics & Cholesterol Reducers, Safety and security measures, Investigations, Johnson & Johnson, Anticholesteremic agents, JNJ

---

Similar abstracts:

• Abstracts: Look-alike names lead to drug mix-ups. Parkinson's drug will carry strict safety warning
• Abstracts: Judge rejects two separate drug mergers. Medtronic set to buy Arterial for $3.7 billion
• Abstracts: Goodyear moves to cut capacity, jobs; U.S. tire-making factory will close as alliance with Sumitomo is set. GM files IPO for Delphi Automotive stake
• Abstracts: Some reasons Lycos was such a willing bride. Defining the on-line chief; Ebay's Meg Whitman explroes management, Web style
• Abstracts: Advertising: the extremely creative Kaplan Thaler Group agrees to be acquired by MacManus Group

This website is not affiliated with document authors or copyright owners. This page is provided for informational purposes only. Unintentional errors are possible.