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The company is a niche player among tobacco stocks, focusing on high-growth accessories and specialty tobacco

69 Following this, a manufacturer must submit a report detailing the minor modification and establishing that FDA has determined that the product is exempt from demonstrating substantial equivalence to a predicate product

In our review of TCPs efforts to analyze progress reports, we saw evidence that TCP staff members had appropriately contacted contractors to identify corrective actions, although we did not identify any instances that would have required the TCP to implement additional corrective actions beyond this first step

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