Statement Regarding FDA Regulation of Electronic Cigarettes

The United States Food & Drug Administration (“FDA”) has recently taken an interest in electronic cigarettes.  The FDA has taken the position that electronic cigarettes which have not gone through and subsequently received FDA approval, appear to violate the Food Drug and Cosmetic Act and has detained several shipments of electronic cigarettes.

Since the fall of last year, Smokefree Innotec, through its counsel Troutman Sanders LLP has been working with the FDA to address the manner in which Smokefree Innotec’s products can lawfully be sold in the United States.  Although we have not yet received a formal response from the FDA, we are hopeful that we can reach a mutually-agreeable resolution soon.

As a company along with our counsel, we continue to explore the best manner in which to obtain approval or consent from the FDA for our product to enter the stream of commerce.  The area of tobacco regulation, e-cigarettes and related products is new to the FDA and we believe, as a company, it is in our best interest to work through these new regulatory issues along with the FDA and we will continue to do so.

A number of statements referenced in this statement are forward-looking statements, which are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995, and within the meaning of Section 27A of the Securities Act of 1933 and Section 21B of the Exchange Act of 1934. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, and goals, assumption of future events or performance are not statements of historical fact and may be “forward-looking statements.” Forward looking statements are based on expectations, estimates and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward-looking statements in this statement may be identified through the use of words such as “expects,” “will,” “anticipates,” “estimates,” “believes,” or statements indicating certain actions “may,” “could,” or “might” occur. Such statements reflect the current views of Smokefree Innotec, Inc. with respect to future events and are subject to certain assumptions, including those described in this statement. These forward-looking statements involve a number of risks and uncertainties, including the timely development and market acceptance of products, services, and technologies, competitive market conditions, successful integration of acquisitions, the ability to secure additional sources of financing, the ability to reduce operating expenses, and other factors. The actual results that the Company achieves may differ materially from any forward-looking statements due to such risks and uncertainties. Smokefree Innotec, Inc. does not undertake any responsibility to update the “forward-looking” statements contained in this statement.

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