U.S. Code
»
Title 15
» Chapter CHAPTER 70— COMPREHENSIVE SMOKELESS TOBACCO HEALTH EDUCATION
15 U.S.C. § 4403
Ingredient reporting
(a) In general(1) Each person who manufactures, packages, or imports smokeless tobacco products shall annually provide the Secretary with—(A) a list of the ingredients added to tobacco in the manufacture of smokeless tobacco products which does not identify the company which uses the ingredients or the brand of smokeless tobacco which contains the ingredients; and(B) a specification of the quantity of nicotine contained in each such product.(2) A person or group of persons required to provide information by this subsection may designate an individual or entity to provide the information required by this subsection.(b) Report(1) At such times as the Secretary considers appropriate, the Secretary shall transmit to the Congress a report, based on the information provided under subsection (a), respecting—(A) a summary of research activities and proposed research activities on the health effects of ingredients added to tobacco in the manufacture of smokeless tobacco products and the findings of such research;(B) information pertaining to any such ingredient which in the judgment of the Secretary poses a health risk to users of smokeless tobacco; and(C) any other information which the Secretary determines to be in the public interest.(2)(A) Any information provided to the Secretary under subsection (a) shall be treated as a trade secret or confidential information subject to section 552(b)(4) of title 5 and shall not be revealed, except as provided in paragraph (1), to any person other than those authorized by the Secretary in carrying out their official duties under this section.(B) Subparagraph (A) does not authorize the withholding of information provided under subsection (a) of this section from any duly authorized subcommittee or committee of the Congress. If a subcommittee or committee of the Congress requests the Secretary to provide it such information, the Secretary shall make the information available to the subcommittee or committee and shall, at the same time, notify in writing the person who provided the information of such request.(C) The Secretary shall establish written procedures to assure the confidentiality of information provided under subsection (a) of this section. Such procedures shall include the designation of a duly authorized agent to serve as custodian of such information. The agent—(i) shall take physical possession of the information and, when not in use by any person authorized to have access to such information, shall store it in a locked cabinet or file; and(ii) shall maintain a complete record of any person who inspects or uses the information.Such procedures shall require that any person permitted access to the information shall be instructed in writing not to disclose the information to anyone who is not entitled to have access to the information.(Pub. L. 99–252, § 4, Feb. 27, 1986, 100 Stat. 32.)Statutory Notes and Related SubsidiariesEffective DateSubsec. (a) effective one year after Feb. 27, 1986, and subsec. (b) effective Feb. 27, 1986, see section 11 of Pub. L. 99–252, set out as a note under section 4401 of this title.
Notes of Decisions
Pub. Citizen v. Fed. Trade Comm'n, 869 F.2d 1541 (D.C. Cir. 1989).
“§ 4401 , and ingredient reporting, see 15 U.S.C. § 4403 . The Act’s most striking component, however, is its comprehensive warning scheme.”
Philip Morris Inc. v. Harshbarger, 122 F.3d 58 (1st Cir. 1997).
“§ 1335 (b)(2)(A) with 15 U.S.C. § 4403 (b)(2). The statute also requires the Secretary to transmit informative and advisory reports to Congress.”
Phillip Morris Inc. v. Reilly, 113 F. Supp. 2d 129 (D. Mass. 2000).
“§ 1905 ); 15 U.S.C. § 4403 (b)(2)(A) (composite ingredient disclosures "shall be treated as a trade secret or confidential information”).”
Phillip Morris, Inc. v. Harshbarger, 159 F.3d 670 (1st Cir. 1998).
“The Comprehensive Smokeless Tobacco Health and Education Act, 15 U.S.C. § 4403 (1994), constrains smokeless tobacco purveyors to furnish similar composite ingredient information.”
Brown & Williamson v. FDA (4th Cir. 2000).
“§ 4402 (f); and required annual ingredi- ent and nicotine-level reporting to the HHS Secretary, 15 U.S.C. § 4403 . In addition, the Smokeless Tobacco Act authorized the Secre- tary of HHS to develop a program for informing the public of the health hazards caused by use of…”
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