...the Company had made a business decision to reformulate its PWR to remove DMAA for marketing and distribution reasons...
Golden, CO (PRWEB) April 27, 2012
iSatori Technologies, Inc. (OTCBB:IZZI) of Golden (metropolitan Denver) Colorado, today announced its recent receipt of a warning letter from the U.S. Food and Drug Administration (“FDA”) relating to its dietary supplement product, PWR™. The warning letter concerns an ingredient in that product, dimethylpentylamine, commonly known as “DMAA.” DMAA is a substance widely used in the dietary supplements industry, and FDA issued comparable letters to a number of dietary supplement companies marketing products containing this ingredient. The warning letter asserts that DMAA does not satisfy FDA requirements for a dietary ingredient in a dietary supplement.
iSatori believes firmly that DMAA is a lawful and safe dietary ingredient in its PWR™ product and will respond to the warning letter with a detailed legal and scientific rationale. Four months prior to receiving this letter, however, the Company had made a business decision to reformulate its PWR to remove DMAA for marketing and distribution reasons, and steps toward manufacturing and labeling of the reformulated products already have been underway. iSatori therefore intends to continue its plans to reformulate its PWR product to remove DMAA and to have the new product on the market on and after June 30, 2012. iSatori has informed its distributors of this action.
For the year ended December 31, 2011, iSatori sales of the affected product, PWR, constituted approximately $330,000 of revenues, contributing less than $178,000 of gross profit to the firm. As a result of these financial measures, 2011 annual sales of PWR comprised less than 3/10ths of 1% market share of sports nutritional products.
This news release contains statements made about future events and expectations, or “forward-looking statements.” Forward-looking statements include statements regarding our expectations, beliefs, intentions, plans, projections, objectives, goals, strategies, future events or similar statements which generally are not historical in nature. Actual results may differ materially from those expressed or implied by the forward-looking statements contained in this release. Forward-looking statements are subject to numerous risks, uncertainties and assumptions about us and our business. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. We do not undertake to release publicly any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.