21 U.S.C. § 387i — Records and reports on tobacco products

(a) In general: Every tobacco product manufacturer^* or importer must establish and maintain records, make reports, and provide information the Secretary^* reasonably requires by regulation, to make sure a tobacco product^* isn't adulterated or misbranded and to otherwise protect public health. The Secretary's regulations on this: (1) may require a manufacturer or importer to report to the Secretary whenever it learns of information reasonably suggesting a marketed product may have caused or contributed to a serious, unexpected adverse health experience, or a significant increase in a known, expected one; (2) must require reporting of other significant adverse tobacco product experiences the Secretary determines need reporting; (3) must not impose requirements that are unduly burdensome, weighing compliance cost against the need to protect public health and carry out this subchapter; (4) must, whenever the Secretary requests a report or information, require that the request state the reason or purpose and identify what's being asked for as specifically as practicable; (5) must do the same — state the reason and identify the material as specifically as practicable — whenever a report or information is required generally rather than requested individually; and (6) may not require disclosing a patient's or user's identity in required records, reports, or information, unless disclosure is needed for that person's medical welfare, to determine a product's public health risk, or to verify a submitted record, report, or piece of information. In writing these regulations, the Secretary must show due regard for medical-profession ethics and patients' interests. The ban on disclosing a patient's identity keeps applying even after that person^* stops being a patient.

(b) Reports of removals and corrections: (1) In general — Except as paragraph (2) provides, the Secretary must, by regulation, require a manufacturer or importer to promptly report any corrective action it takes or any removal from the market it undertakes for a tobacco product, if that action was taken (A) to reduce a health risk posed by the product, or (B) to fix a violation of this subchapter that could pose a health risk. If a correction or removal doesn't have to be reported under this paragraph, the manufacturer or importer must still keep a record of it. (2) Exception — No report of a corrective action or removal is required under paragraph (1) if a report covering that same action is already required, and has been submitted, under subsection (a).