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Supreme Court upheld a lower courts decision that the FDA could not regulate tobacco as a drug.) Previous Slide Next Slide Intended use and broad review To establish a products intended use, FDA declared no limits, saying it is not bound by the manufacturer or distributors subjective claims of intent, but rather can consider objective evidence, which may include a variety of direct and circumstantial evidence. Previous Slide Next Slide Top 5 Tobacco Stories of 2016 Mitigated risk Much of the revised rules underscore the importance of clarity around mitigated risk products, and how consumer confusion may result with products claiming to be health-focused but only achieve reduced risk