15 U.S.C. § 1335a

List of cigarette ingredients; annual submission to Secretary; transmittal to Congress; confidentiality

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(a) Each person who manufactures, packages, or imports cigarettes shall annually provide the Secretary with a list of the ingredients added to tobacco in the manufacture of cigarettes which does not identify the company which uses the ingredients or the brand of cigarettes which contain the ingredients. A person or group of persons required to provide a list by this subsection may designate an individual or entity to provide the list required by this subsection.(b)(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 cigarettes and the findings of such research;(B) information pertaining to any such ingredient which in the judgement of the Secretary poses a health risk to cigarette smokers; 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 trade secret or confidential information subject to section 552(b)(4) of title 5 and section 1905 of title 18 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 a list provided under subsection (a) 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 a list, the Secretary shall make the list available to the subcommittee or committee and shall, at the same time, notify in writing the person who provided the list of such request.(C) The Secretary shall establish written procedures to assure the confidentiality of information provided under subsection (a). 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 a 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. 89–92, § 7, as added Pub. L. 98–474, § 5(a), Oct. 12, 1984, 98 Stat. 2203.)Editorial NotesPrior Provisions

A prior section 7 of Pub. L. 89–92 was renumbered section 8 and is classified to section 1336 of this title.

Statutory Notes and Related SubsidiariesEffective Date of 1984 Amendment

Pub. L. 98–474, § 5(b), Oct. 12, 1984, 98 Stat. 2204, provided that: “Section 7 of the Federal Cigarette Labeling and Advertising Act [this section] added by subsection (a) shall take effect upon the expiration of the one-year period beginning on the date of the enactment of this Act [Oct. 12, 1984].”

Notes of Decisions

Cited in 6 cases, 1997–2004 · leading case: Philip Morris Inc. v. Harshbarger, 122 F.3d 58 (1st Cir. 1997).

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Philip Morris Inc. v. Harshbarger, 122 F.3d 58 (1st Cir. 1997). · cites it 4× “See 15 U.S.C. §§ 1335a(a), 4403(a). Under both statutes, the information provided is “treated as a trade secret or confidential information,” and its unauthorized disclosure is forbidden.”

Omaha Tribe of Nebraska v. Miller, 311 F. Supp. 2d 816 (S.D. Iowa 2004). “§§ 290aa-l — 290bb-23 (2003) (requiring the Secretary of Health and Human Services to report every three years to Congress on research findings concerning tobacco’s addictive properties); Comprehensive Smoking Education Act, 15 U.S.C. § 1335a (2003) (Secretary of Health and…”

Phillip Morris Inc. v. Reilly, 113 F. Supp. 2d 129 (D. Mass. 2000). “See 15 U.S.C. § 1335a(b)(2)(A) (composite list of cigarette ingredient information submitted to the U.”

Phillip Morris, Inc. v. Harshbarger, 159 F.3d 670 (1st Cir. 1998). “The Federal Cigarette Labeling and Advertising Act, 15 U.S.C. § 1335a (1994) (the Labeling Act), mandates that “[e]ach person who manufactures, packages, or imports cigarettes shall annually provide the Secretary [of Health and Human Services] with a list of the ingredients…”

The Filling Station, Inc. v. Vilsack, 174 F. Supp. 2d 942 (S.D. Iowa 2001). “15 U.S.C. § 1335a. In another system of reporting, it requires the Federal Trade Commission (FTC) to report to Congress on “(1) current practices and methods of cigarette advertising and promotion, and (2) such recommendations for legislation as it may deem appropriate.”

Brown & Williamson v. FDA (4th Cir. 2000). “§ 1341 (b); and required annual disclosure of tobacco ingredients to the Secretary of HHS, 15 U.S.C. § 1335a. Quoting U.S. Surgeon General Dr.”

— 15 U.S.C. § 1335a(a) — 1 case

Philip Morris Inc. v. Harshbarger, 122 F.3d 58 (1st Cir. 1997). “See 15 U.S.C. §§ 1335a(a), 4403(a). Under both statutes, the information provided is “treated as a trade secret or confidential information,” and its unauthorized disclosure is forbidden.”

— 15 U.S.C. § 1335a(b)(2)(A) — 2 cases

Phillip Morris Inc. v. Reilly, 113 F. Supp. 2d 129 (D. Mass. 2000). “See 15 U.S.C. § 1335a(b)(2)(A) (composite list of cigarette ingredient information submitted to the U.”

— 15 U.S.C. § 1335a(b)(2)(B) — 1 case

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