Chattem Shipments Of Dexatrim With Bitter Orange To Halt In May
This article was originally published in The Tan Sheet
Executive Summary
Chattem's impending exit from the bitter orange weight-loss market may be a bellwether for industry, as was the firm's departure from the ephedra business
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Chattem's impending exit from the bitter orange weight-loss market may be a bellwether for industry, as was the firm's departure from the ephedra business. As of May 31, Chattem will cease shipments of Dexatrim products containing synephrine in the form of bitter orange (Citrus aurantium). Chattem is in the process of reformulating the line for a third time. Prior to discontinuing sales of ephedra-containing products, the company developed "ephedrine-free" SKUs with bitter orange peel extract, caffeine and other ingredients. The firm introduced ephedra-containing Dexatrim Natural in 1999. The ingredient replaced phenylpropanolamine in the Dexatrim brand when FDA asked for a voluntary recall of PPA-containing products in 2000. Three SKUs, representing about 50% of total Dexatrim sales, currently contain synephrine. One will be discontinued, while the other two will be reworked with a green tea-based formula. The firm cited the legal challenges it has faced as a result of ephedra and PPA as reasons behind the decision to drop synephrine. The PPA product liability litigation is ongoing, but the firm hopes to settle by mid-year (1 (Also see "Chattem Optimistic On 2004 Line Extensions, Litigation Settlement" - Pink Sheet, 26 Jan, 2004.), p. 10). Recent court wins for Novartis over PPA liability claims may be a good sign for Chattem. As with ephedra, liability insurance may begin to play a role in other marketers' decisions to stop selling synephrine-containing products. Chattem noted that as early as last year, insurers were inquiring on application forms whether or not firms carried bitter orange products. While Chattem maintains synephrine is safe, several recent events suggest it may cause headaches for marketers. Based on the chemical similarity of bitter orange and ephedra, FDA recently announced it is reviewing the safety of the supplement ingredient (2 (Also see "FDA’s McClellan Touts Scientific Analysis As Part Of Ephedra Ban" - Pink Sheet, 26 Jan, 2004.), p. 12.). In addition, several members of Congress have contacted FDA in support of a ban or further investigation into the ingredient's safety (3 (Also see "Bitter Orange Safety Concerns Raised By Sen. Schumer, Rep. Waxman" - Pink Sheet, 9 Feb, 2004.), p 11). |