Legal & Regulatory Briefs

Six companies that together account for about 80% of bulk sales of the most popular vitamins have agreed to pay more than $1.1 billion to settle price-fixing claims outlined in an antitrust lawsuit, The Washington Post reported in September. In addition to F. Hoffman La Roche & Co. of Switzerland, BASF AG of Germany and Rhone-Poulenc SA of France, which together paid a $750 million fine in May to end a U.S. Justice Dept. investigation, three Japanese firms, Eisai Co., Daiichi Pharmaceutical Co. and Takeda Chemical Industries Ltd., joined the tentative civil settlement. But some of the major corporate plaintiffs in the lawsuit say they will opt out of the proposed settlement and press cases against companies on their own. Little Rock, AR-based Tyson Foods (TSN) and Chicago-based Quaker Oats Co. (OAT), among others, told The Wall Street Journal that they believe the proposed settlement would let vitamin makers off too cheaply. The amount represents about $.20 per $1 plaintiffs spent on vitamins since the conspiracy began nine years ago, some say.

Scientific data on four potential health claims for dietary supplements are solicited by FDA in a Sept. 8 Federal Register notice. The request is the agency’s first public effort in response to the DC federal appeals court decision in the Pearson vs. Shalala case in which the court ordered FDA to reconsider denial of the four claims reviewed under FDA’s implementation of the Nutrition Labeling & Education Act of 1990. The agency determined at that time that there was “insufficient scientific agreement regarding the scientific validity” of the claims. The claims are: “Consumption of antioxidant vitamins may reduce the risk of certain kinds of cancer”; “Consumption of fiber may reduce the risk of colorectal cancer”; “Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease”; and “.8 mg of folic acid in a dietary supplement is more effective in reducing the risk of neural tube defects than a lower amount in foods in common form.”

The SEC settled charges with three officials at a defunct NJ brokerage that allegedly raised more than $33 million by fraudulently underwriting public offerings and manipulating market prices. The offerings included one for Superior Supplements Inc. (SPSU). The U.S. attorney for the Southern district of NY is filing criminal charges against the three officials from Investors Associates for securities fraud and perjury. The SEC agreed to waive a return of some $33.1 million in illegal profits because of a “demonstrated inability to pay.”