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While 22nd Century owns or controls the intellectual property that makes VLN tobacco possible, the company has reiterated its willingness and expectation to license the technology to strategic partners to help ensure availability to the maximum number of adult smokers in the U.S

So without guidance we don't know how to comply, but yet the deadline is still the deadline

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In addition, the safety and efficacy of these medications in pregnant smokers have not been determined, and the use of medications to aid smoking cessation in this population has been delegated to the discretion of the physician

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