S.Amdt. 1227

SA 1227. Mr. COBURN submitted an amendment intended to be proposed by him to the bill H.R. 1256, to protect the public health by providing the Food and Drug Administration with certain authority to regulate tobacco products, to amend title 5, United States Code, to make certain modifications in the Thrift Savings Plan, the Civil Service Retirement System, and the Federal Employees' Retirement System, and for other purposes; which was ordered to lie on the table; as follows:

Beginning in section 102(a) of division A, strike paragraph (5) and all that follows through section 103(g) of such division and insert the following:

(5) Enforcement.--

(A) In general.--The Secretary of Health and Human Services shall ensure that the provisions of this Act, the amendments made by this Act, and the implementing regulations (including such provisions, amendments, and regulations relating to the retail sale of tobacco products) are enforced with respect to the United States.

(B) Indian tribes.--The Secretary of Health and Human Services shall ensure that the provisions of this Act, the amendments made by this Act, and the implementing regulations (including such provisions, amendments, and regulations relating to the retail sale of tobacco products) apply to, and are enforced with respect to, Indian tribes.

(6) Qualified adult-only facility.--A qualified adult-only facility (as such term is defined in section 897.16(d) of the final rule published under paragraph (1)) that is also a retailer and that commits a violation as a retailer shall not be subject to the limitations in section 103(q) and shall be subject to penalties applicable to a qualified adult-only facility.

(7) Congressional review provisions.--Section 801 of title 5, United States Code, shall not apply to the final rule published under paragraph (1).

(b) Limitation on Advisory Opinions.--As of the date of enactment of this Act, the following documents issued by the Food and Drug Administration shall not constitute advisory opinions under section 10.85(d)(1) of title 21, Code of Federal Regulations, except as they apply to tobacco products, and shall not be cited by the Secretary of Health and Human Services or the Food and Drug Administration as binding precedent:

(1) The preamble to the proposed rule in the document titled “Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco Products to Protect Children and Adolescents” (60 Fed. Reg. 41314-41372 (August 11, 1995)).

(2) The document titled “Nicotine in Cigarettes and Smokeless Tobacco Products is a Drug and These Products Are Nicotine Delivery Devices Under the Federal Food, Drug, and Cosmetic Act” (60 Fed. Reg. 41453-41787 (August 11, 1995)).

(3) The preamble to the final rule in the document titled “Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents” (61 Fed. Reg. 44396-44615 (August 28, 1996)).

(4) The document titled “Nicotine in Cigarettes and Smokeless Tobacco is a Drug and These Products are Nicotine Delivery Devices Under the Federal Food, Drug, and Cosmetic Act; Jurisdictional Determination” (61 Fed. Reg. 44619-45318 (August 28, 1996)).

SEC. 103. CONFORMING AND OTHER AMENDMENTS TO GENERAL PROVISIONS.

(a) Amendment of Federal Food, Drug, and Cosmetic Act.--Except as otherwise expressly provided, whenever in this section an amendment is expressed in terms of an amendment to, or repeal of, a section or other provision, the reference is to a section or other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).

(b) Section 301.--Section 301 (21 U.S.C. 331) is amended--

(1) in subsection (a), by inserting “tobacco product,” after “device,”;

(2) in subsection (b), by inserting “tobacco product,” after “device,”;

(3) in subsection (c), by inserting “tobacco product,” after “device,”;

(4) in subsection (e)--

(A) by striking the period after “572(i)”; and

(B) by striking “or 761 or the refusal to permit access to” and inserting “761, 909, or 920 or the refusal to permit access to”;

(5) in subsection (g), by inserting “tobacco product,” after “device,”;

(6) in subsection (h), by inserting “tobacco product,” after “device,”;

(7) in subsection (j)--

(A) by striking the period after “573”; and

(B) by striking “708, or 721” and inserting “708, 721, 904, 905, 906, 907, 908, 909, or 920(b)”;

(8) in subsection (k), by inserting “tobacco product,” after “device,”;

(9) by striking subsection (p) and inserting the following:

“(p) The failure to register in accordance with section 510 or 905, the failure to provide any information required by section 510(j), 510(k), 905(i), or 905(j), or the failure to provide a notice required by section 510(j)(2) or 905(i)(3).”;

(10) by striking subsection (q)(1) and inserting the following:

“(q)(1) The failure or refusal--

“(A) to comply with any requirement prescribed under section 518, 520(g), 903(b), 907, 908, or 915;

“(B) to furnish any notification or other material or information required by or under section 519, 520(g), 904, 909, or 920; or

“(C) to comply with a requirement under section 522 or 913.”;

(11) in subsection (q)(2), by striking “device,” and inserting “device or tobacco product,”;

(12) in subsection (r), by inserting “or tobacco product” after the term “device” each time that such term appears; and

(13) by adding at the end the following:

“(oo) The sale of tobacco products in violation of a no-tobacco-sale order issued under section 303(f).

“(pp) The introduction or delivery for introduction into interstate commerce of a tobacco product in violation of section 911.

“(qq)(1) Forging, counterfeiting, simulating, or falsely representing, or without proper authority using any mark, stamp (including tax stamp), tag, label, or other identification device upon any tobacco product or container or labeling thereof so as to render such tobacco product a counterfeit tobacco product.

“(2) Making, selling, disposing of, or keeping in possession, control, or custody, or concealing any punch, die, plate, stone, or other item that is designed to print, imprint, or reproduce the trademark, trade name, or other identifying mark, imprint, or device of another or any likeness of any of the foregoing upon any tobacco product or container or labeling thereof so as to render such tobacco product a counterfeit tobacco product.

“(3) The doing of any act that causes a tobacco product to be a counterfeit tobacco product, or the sale or dispensing, or the holding for sale or dispensing, of a counterfeit tobacco product.

“(rr) The charitable distribution of tobacco products.

“(ss) The failure of a manufacturer or distributor to notify the Attorney General and the Secretary of the Treasury of their knowledge of tobacco products used in illicit trade.

“(tt) Making any express or implied statement or representation directed to consumers with respect to a tobacco product, in a label or labeling or through the media or advertising, that either conveys, or misleads or would mislead consumers into believing, that--

“(1) the product is approved by the Food and Drug Administration;

“(2) the Food and Drug Administration deems the product to be safe for use by consumers;

“(3) the product is endorsed by the Food and Drug Administration for use by consumers; or

“(4) the product is safe or less harmful by virtue of--

“(A) its regulation or inspection by the Food and Drug Administration; or

“(B) its compliance with regulatory requirements set by the Food and Drug Administration;

including any such statement or representation rendering the product misbranded under section 903.”.

(c) Section 303.--Section 303(f) (21 U.S.C. 333(f)) is amended--

(1) in paragraph (1)(A), by inserting “or tobacco products” after the term “devices” each place such term appears;

(2) in paragraph (5)--

(A) in subparagraph (A)--

(i) by striking “assessed” the first time it appears and inserting “assessed, or a no-tobacco-sale order may be imposed,”; and

(ii) by striking “penalty” the second time it appears and inserting “penalty, or upon whom a no-tobacco-sale order is to be imposed,”;

(B) in subparagraph (B)--

(i) by inserting after “penalty,” the following: “or the period to be covered by a no-tobacco-sale order,”; and

(ii) by adding at the end the following: “A no-tobacco-sale order permanently prohibiting an individual retail outlet from selling tobacco products shall include provisions that allow the outlet, after a specified period of time, to request that the Secretary compromise, modify, or terminate the order.”; and

(C) by adding at the end the following:

“(D) The Secretary may compromise, modify, or terminate, with or without conditions, any no-tobacco-sale order.”;

(3) in paragraph (6)--

(A) by inserting “or the imposition of a no-tobacco-sale order” after the term “penalty” each place such term appears; and

(B) by striking “issued.” and inserting “issued, or on which the no-tobacco-sale order was imposed, as the case may be.”; and

(4) by adding at the end the following:

“(8) If the Secretary finds that a person has committed repeated violations of restrictions promulgated under section 906(d) at a particular retail outlet then the Secretary may impose a no-tobacco-sale order on that person prohibiting the sale of tobacco products in that outlet. A no-tobacco-sale order may be imposed with a civil penalty under paragraph (1). Prior to the entry of a no-sale order under this paragraph, a person shall be entitled to a hearing pursuant to the procedures established through regulations of the Food and Drug Administration for assessing civil money penalties, including at a retailer's request a hearing by telephone, or at the nearest regional or field office of the Food and Drug Administration, or at a Federal, State, or county facility within 100 miles from the location of the retail outlet, if such a facility is available.”.

(d) Section 304.--Section 304 (21 U.S.C. 334) is amended--

(1) in subsection (a)(2)--

(A) by striking “and” before “(D)”; and

(B) by striking “device.” and inserting the following: “device, and (E) Any adulterated or misbranded tobacco product.”;

(2) in subsection (d)(1), by inserting “tobacco product,” after “device,”;

(3) in subsection (g)(1), by inserting “or tobacco product” after the term “device” each place such term appears; and

(4) in subsection (g)(2)(A), by inserting “or tobacco product” after “device”.

(e) Section 505.--Section 505(n)(2) (21 U.S.C. 355(n)(2)) is amended by striking “section 904” and inserting “section 1004”.

(f) Section 523.--Section 523(b)(2)(D) (21 U.S.C. 360m(b)(2)(D)) is amended by striking “section 903(g)” and inserting “section 1003(g)”.

(g) Section 702.--Section 702(a)(1) (U.S.C. 372(a)(1)) is amended--

(1) by striking “(a)(1)” and inserting “(a)(1)(A)”; and

(2) by adding at the end the following:

“(B) For a tobacco product, to the extent feasible, the Secretary shall contract with the States in accordance with this paragraph to carry out inspections of retailers within that State in connection with the enforcement of this Act.”.