§387i — Title 21 Food and Drugs | U.S. Code

Summary

Tobacco product makers and importers must keep records, send reports, and give information that the Secretary requires by rule. These rules are to help make sure products are not contaminated or mislabeled and to protect public health. Companies may be required to tell the Secretary when they learn something that reasonably suggests a product may have caused a serious, unexpected health problem or when there is a big rise in serious health problems that were expected. The Secretary can also require reports about other important harmful events. Requests for reports must say why the information is needed and describe what to send. Companies generally do not have to give a patient’s name unless it is needed for medical care, to check public health risks, or to verify a report. The Secretary must also make rules requiring companies to quickly report any corrective action or product removal done to reduce a health risk or to fix a violation of this part of the law that could affect health. If that corrective action or removal was already reported under the earlier reporting rules, the company does not have to report it again.

Title 21, §387i

Food and Drugs — Source: USLM XML via OLRC

(a)Every person who is a tobacco product manufacturer or importer of a tobacco product shall establish and maintain such records, make such reports, and provide such information, as the Secretary may by regulation reasonably require to assure that such tobacco product is not adulterated or misbranded and to otherwise protect public health. Regulations prescribed under the preceding sentence—

(1)may require a tobacco product manufacturer or importer to report to the Secretary whenever the manufacturer or importer receives or otherwise becomes aware of information that reasonably suggests that one of its marketed tobacco products may have caused or contributed to a serious unexpected adverse experience associated with the use of the product or any significant increase in the frequency of a serious, expected adverse product experience;

(2)shall require reporting of other significant adverse tobacco product experiences as determined by the Secretary to be necessary to be reported;

(3)shall not impose requirements unduly burdensome to a tobacco product manufacturer or importer, taking into account the cost of complying with such requirements and the need for the protection of the public health and the implementation of this subchapter;

(4)when prescribing the procedure for making requests for reports or information, shall require that each request made under such regulations for submission of a report or information to the Secretary state the reason or purpose for such request and identify to the fullest extent practicable such report or information;

(5)when requiring submission of a report or information to the Secretary, shall state the reason or purpose for the submission of such report or information and identify to the fullest extent practicable such report or information; and

(6)may not require that the identity of any patient or user be disclosed in records, reports, or information required under this subsection unless required for the medical welfare of an individual, to determine risks to public health of a tobacco product, or to verify a record, report, or information submitted under this subchapter.

(b)(1)Except as provided in paragraph (2), the Secretary shall by regulation require a tobacco product manufacturer or importer of a tobacco product to report promptly to the Secretary any corrective action taken or removal from the market of a tobacco product undertaken by such manufacturer or importer if the removal or correction was undertaken—

(A)to reduce a risk to health posed by the tobacco product; or

(B)to remedy a violation of this subchapter caused by the tobacco product which may present a risk to health.

(2)No report of the corrective action or removal of a tobacco product may be required under paragraph (1) if a report of the corrective action or removal is required and has been submitted under subsection (a).

Editorial Notes

Prior Provisions

A prior section 909 of act June 25, 1938, was renumbered section 1009 and is classified to section 399 of this title.

§387i Records and reports on tobacco products

Summary

Title 21, §387i

Notes & Related Subsidiaries

Editorial Notes

Prior Provisions

Citations & Metadata