In Brief
This article was originally published in The Tan Sheet
Executive Summary
FDA encourages disclosures at public hearings
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FDA encourages disclosures at public hearings FDA's final guidance for speakers in open public hearings at advisory committee meetings encourages but does not require disclosure of financial relationships linked to a meeting's topic. While the Dec. 9 guidance advises committee members to question speakers "to discover more information that might be useful to the committee's deliberations," it says no questions on financial information should be asked. Public Citizen said a 2005 draft guidance failed to ensure transparent meetings because it "merely encourages" financial disclosures (Also see "Open Public Hearing Speakers Should Disclose Financial Conflict – Comments" - Pink Sheet, 18 Jul, 2005.). FDA will implement the guidance at advisory committee meetings beginning in March 2011. E-cigarette marketers prevail over ban A federal appeals court upholds an injunction against FDA's seizure of electronic cigarettes. The U.S. Court of Appeals for the District of Columbia Circuit ruled Dec. 7 that e-cigarettes are tobacco products subject to FDA's authority under the Family Smoking Prevention and Tobacco Control Act, and the agency cannot regulate them as drugs or medical devices except when they are marketed for therapeutic purposes. FDA argued the products are unauthorized drugs because they contain nicotine and require approval through new drug applications. After FDA seized shipments in mid-2009, marketers sued, saying e-cigarettes are tobacco products and the agency's authority over them is limited. In January, a U.S. district court judge agreed, saying FDA lacked authority to ban imports of the products ("Federal court lifts import ban on e-cigarettes," "The Tan Sheet" Jan. 28, 2010, In Brief). Vitacost financial woes deepen The online supplement retailer considers a Chapter 11 bankruptcy reorganization after an audit revealed "potential deficits" in documents and transactions linked to Vitacost.com's 2009 initial public offering. Certain stock issuance transactions may not have been authorized under applicable corporate law, Vitacost said Dec. 7, and financial statements issued since 1994 "cannot and should not be relied upon" due to uncertainty about the firm's equity capitalization. Boca Raton, Fla.-based Vitacost recently replaced several upper-level executives, including its CEO and CFO ( (Also see "People In Brief" - Pink Sheet, 1 Nov, 2010.), In Brief). Martek restructuring yields Q4 net loss The sale of most assets at Martek Biosciences' Winchester, Ky., manufacturing plant led to $30.7 million in restructuring charges during the fourth quarter, and Martek had a net loss of $6.1 million, compared to year-ago income of $11 million ("Martek trims Kentucky operations," "The Tan Sheet" July 5, 2010, In Brief). The nutritional oils company increased product sales 43.6% to $117.6 million in the August-October period, and 32.1% to $434.8 million in fiscal 2010. Martek executives said Dec. 8 the Columbia, Md., firm discontinued its small contract manufacturing business in 2010 to focus on higher-margin Amerifit branded supplements. Martek also extended supply agreements with infant formula customers. Hi-Tech OTC sales down, income jumps Sales in the specialty pharmaceutical company's Health Care Products division dropped 7% to $3.4 million for the quarter ended Oct. 31. The decrease was due largely to lower sales of diabetic products, but was offset partially by the Mag-Ox line of magnesium supplements, the Amityville, N.Y., firm said Dec. 9. Hi-Tech Pharmacal reported overall net sales of $44.9 million, up 10% from the year-ago quarter. The figures are opposite from the previous quarter, when overall sales dropped but the OTC sector grew ("Hi-Tech sales down despite OTC growth," "The Tan Sheet" Sept. 13, 2010, In Brief). Net income for the period was $10 million. SunOpta buys nutrition bar firm SunOpta Fruit Group acquires Edner of Nevada Inc., a nutrition bar manufacturer, for $4 million. The Toronto-based SunOpta subsidiary said Dec. 6 that Edner has about $10 million in annual revenues and sufficient equipment and capacity at its Carson City, Nev., facility to increase revenues to $50 million. SunOpta intends to use Edner to grow its offerings in the healthy convenience foods category. EC approves BASF-Cognis Deal The European Commission and Chinese authorities approve German chemical company BASF's acquisition of Cognis Holding GmbH pending divestments worth less than 3% of Cognis' total sales. BASF says Nov. 30 it will sell Cognis hydroxy methacrylates, Cognis multifunctional methacrylates and adducts and manufacturing plants for polyalkylene glycols and PAG-based lubricants. BASF expects to close the $3.8 billion deal in December ("BASF splits divisions," "The Tan Sheet" Aug. 9, 2010, In Brief). |