123STA T . 1 806PUBLIC LA W 111 – 31 —J U NE 22 , 200 9tha t suc ht ob acco pr o d uct i s n ot adu l t e rated or m isbranded and to other w ise protect public health .R e g ulations prescribed under the preceding sentence —‘ ‘ (1) ma y re q uire a tobacco product manu f acturer or importer to report to the S ecretary whene v er the manufacturer or importer receives or otherwise becomes aware of information that reasonably suggests that one of its mar k eted tobacco prod - ucts may have caused or contributed to a serious une x pected 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 chapter; ‘‘( 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 chapter. I n prescribing regulations under this subsection, the Secretary shall have due regard for the professional ethics of the medical profession and the interests of patients. T he 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) R EPORTS O F RE M O VAL SA NDC ORRE C T I ONS.— ‘‘(1) IN G ENERAL.— E xcept 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 chapter 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 Ap p licab ili ty.
