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131 Through such regulations, FDA can also require manufacturers and importers to report if a tobacco product may have caused or contributed to a "serious unexpected adverse experience or any significant increase in the frequency of a serious, expected adverse product experience." 132 Required reports cannot be overly burdensome and cannot disclose the identity of a patient, except under certain circumstances

In 2023, the adult daily tobacco smoking prevalence was reported to be 7.7%, with approximately 362,845 daily smokers