PRIA, Government Policy, Made Personal

Summary

Tobacco product makers and importers must keep records, make reports, and give information that the Secretary (a government official in charge) reasonably requires to make sure products are not unsafe or labeled wrongly and to protect public health. Rules can make companies report when they learn something that suggests a product may have caused a serious unexpected health problem or when there is a big rise in a serious expected problem. The Secretary can also require reports of other important bad experiences. Requests for reports must say why the information is needed and identify what is wanted. Rules must not be overly burdensome. Companies do not have to give a patient’s identity unless it is needed for that person’s medical care, to find public-health risks from the product, or to check a submitted report. The Secretary must respect medical ethics and patient interests, and the privacy rule stays even after someone stops being a patient. If a maker or importer removes a tobacco product from the market or corrects it to reduce a health risk or to fix a violation that might threaten health, they must report that promptly to the Secretary. If the action was already reported under the adverse-event reporting rules above, they do not need to report it again. If an action is not required to be reported, the company must keep a record of it.

Title 21, §387i

Food and Drugs, Source: USLM XML via OLRC

(a)In general

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.

In prescribing regulations under this subsection, the Secretary shall have due regard for the professional ethics of the medical profession and the interests of patients. The prohibitions of paragraph (6) continue to apply to records, reports, and information concerning any individual who has been a patient, irrespective of whether or when he ceases to be a patient.

(b)Reports of removals and corrections

(1)In general

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.

A tobacco product manufacturer or importer of a tobacco product who undertakes a corrective action or removal from the market of a tobacco product which is not required to be reported under this subsection shall keep a record of such correction or removal.

(2)Exception

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