§387i Records and Reports on Tobacco Products

Summary

Companies that make or import tobacco products must keep records, make reports, and give information that the Secretary reasonably requires by regulation to help ensure products are not tainted or mislabeled and to protect public health. The rules can make a company report when it learns a product may have caused or helped cause a serious unexpected harm, or when there is a big rise in a serious expected harm. The Secretary will also require other important adverse-event reports as needed. Requests and required reports must explain why the information is needed and say what is being requested. Rules must not be unduly burdensome and generally cannot force companies to give a patient’s or user’s name unless it is needed for medical care, to assess public‑health risk, or to check the report. A company must also promptly report to the Secretary any fixes or product removals done to reduce a health risk or to correct a violation that could be a health risk, unless that same action was already reported under the earlier reporting rule.