Twinlab Corporation Issues Statement in Response to FDA Warning Letter Concerning Androstenedione.
Twinlab Corporation respectfully disagrees with the conclusions drawn in the FDA warning letter and is in the process of preparing an appropriate response that will be submitted within the allowable response period. We believe that Twinlab androstenedione products are safe and effective if used as directed. When IdeaSphere, Inc. acquired the Twinlab assets in December 2003, the decision was made in view of the declining market for androstenediol/androstenedione products and the availability of new ingredients not to offer these products on a go-forward basis. In support of that decision, IdeaSphere Inc. did not acquire any assets related to androstenediol products. It did acquire pre-existing inventory of Twinlab's Andro Fuel product, which contains androstenedione, however this is residual inventory that is being phased out of the market. Twinlab is currently manufacturing and will commence selling a new performance product, Andro Nitrate 4 Fuel, in April 2004. This product contains no androstenediol and no androstenedione. "Andro" is a longstanding Twinlab brand name drawing its identity from the Greek root meaning "male" or "masculine," and will be retained for that reason. IdeaSphere Inc. and Twinlab Corporation share the FDA's commitment to science and safety - we are science-focused and research-driven. Notwithstanding this disagreement, Twinlab remains committed to the principle that by working hand in hand with the FDA on this and other matters, Twinlab, the industry, and ultimately the consumer all win. About Twinlab
Twinlab, based in Hauppauge, NY, is the leading manufacturer and marketer of high quality, science-based, nutritional supplements, including a robust line of vitamins, minerals, specialty supplements, herbs, teas and sports nutrition products.
About IdeaSphere, Inc.
IdeaSphere, Inc., with offices in New York, NY, Hauppauge, NY, Grand Rapids, Michigan, and American Fork, Utah, is the champion of the Wellness Revolution. A purpose-built, vertically integrated health and wellness company, it provides total wellness solutions through its holdings, which include leaders in wellness products, content and services. IdeaSphere's family of companies includes Twinlab Corporation; Rebus LLC, and iVillage Solutions.
Contact: Ross A. Anderson, IdeaSphere, Inc. 631-467-3140 ext. 8324 email@example.com Alan Ampolsk, PR21 212-299-8953 firstname.lastname@example.org
CONTACT: Ross A. Anderson, of IdeaSphere, Inc., +1-631-467-3140 ext. 8324, email@example.com; or Alan Ampolsk of PR21, +1-212-299-8953, firstname.lastname@example.org, for Twinlab Corporation
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|Date:||Mar 12, 2004|
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