Title III — S. 39 (Introduced in Senate)

Sec. 301 Guidelines for reduction in sodium content in certain foods

(a)

In general— Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Services shall promulgate regulations establishing guidelines for the mandatory reduction, over a 2-year period, in the sodium content of processed food and restaurant food following, as appropriate, the recommendations made by the Institute of Medicine report entitled “Strategies to Reduce Sodium Intake in the United States”.

(b)

Definitions— For purposes of this section—

(1)

the term processed food has the meaning given such term in section 201(gg) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(gg)); and

(2)

the term restaurant food means food subject to the requirements of section 403(q)(5)(H) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)(5)(H)).

Sec. 302 Nutrition labeling for food products sold principally for use in restaurants or other retail food establishments

Section 403(q)(5) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)(5)) is amended by striking clause (G).

Sec. 303 Front-label food guidance systems

(a)

In general— Not later than 6 months after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall begin soliciting public comments regarding—

(1)

the use of retail front-label food guidance systems to convey nutrition information to the public using logos, symbols, signs, emblems, insignia, or other graphic representations on the labeling of food intended for human consumption that are intended to provide simple, standardized, and understandable nutrition information to the public in graphic form;

(2)

appropriate nutrition standards by which a retail front-label food guidance system may convey the relative nutritional value of different foods in simple graphic form; and

(3)

whether American consumers would be better served by establishing a single, standardized retail front-label food guidance system regulated by the Food and Drug Administration, or by allowing individual food companies, trade associations, nonprofit organizations, and others to continue to develop their own retail front-label food guidance systems.

(b)

Effect on nutrition facts panel— In soliciting public comments under subsection (a), the Secretary shall inform the public that any retail front-label food guidance system is intended to supplement, not replace, the Nutrition Facts Panel that appears on food labels pursuant to section 403(q) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)).

(c)

Proposed regulation— Not later than 12 months following the closure of the public comment solicitation period under subsection (a), the Secretary shall—

(1)

publish a notice in the Federal Register that summarizes the public comments and describes the suggested retail front-label food guidance systems received through such solicitation; and

(2)

publish proposed regulations that—

(A)

establish a single, standardized retail front-label food guidance system; or

(B)

establish the conditions under which individual food companies, trade associations, nonprofit organizations, and other entities may continue to develop their own retail front-label food guidance systems.

Sec. 304 Rulemaking authority for advertising to children

(a)

Purpose— The purpose of this section is to restore the authority of the Federal Trade Commission to issue regulations that restrict the marketing or advertising of foods and beverages to children under the age of 18 years if the Federal Trade Commission determines that there is evidence that consumption of certain foods and beverages is detrimental to the health of children.

(b)

Authority— Section 18 of the Federal Trade Commission Act (15 U.S.C. 57a) is amended—

(1)

in subsection (a), by striking “Except as provided in subsection (h), the” and inserting “The”;

(2)

by amending subsection (b) to read as follows:

“(b) Procedure applicable—When prescribing a rule under subsection (a)(1)(B) of this section, the Commission shall proceed in accordance with section 553 of title 5 (without regard to any reference in such section to sections 556 and 557 of such title).”

(3)

by striking subsections (c), (f), (h), (i), and (j);

(4)

by striking subsection (d) and inserting the following:

“(c) When any rule under subsection (a)(1)(B) takes effect a subsequent violation thereof shall constitute an unfair or deceptive act or practice in violation of section 5(a)(1) of this Act, unless the Commission otherwise expressly provides in such rule.”

(5)

by redesignating subsections (e) and (g) as subsections (d) and (e), respectively; and

(6)

in subsection (d), as redesignated—

(A)

in paragraph (1)(B), by striking “the transcript required by subsection (c)(5),”;

(B)

in paragraph (3), by striking “error)” and all that follows through the period at the end and inserting “error).”; and

(C)

in paragraph (5), by striking subparagraph (C).

Sec. 305 Health literacy: research, coordination and dissemination

(a)

In general— Part A of title IX of the Public Health Service Act (42 U.S.C. 299 et seq.) is amended by adding at the end the following:

“904. Health literacy: research, coordination and dissemination

“(a) Definition—In this section, the term health literacy means a consumer’s ability to obtain, process, and understand basic health information and services needed to make appropriate health care decisions and the adaptation of services to enhance a consumer’s understanding and navigation of applicable health care services.

“(b) Health literacy program

“(1) Establishment—The Director shall establish within the Agency a program (referred to in this section as the “program”) to strengthen health literacy by improving measurement, research, development, and information dissemination.

“(2) Duties—In carrying out the program, the Director shall—

“(A) gather health literacy resources from public and private sources and make such resources available to researchers, health care providers, and the general public;

“(B) identify and fill research gaps relating to health literacy that have direct applicability to—

“(i) prevention;

“(ii) self-management of chronic disease;

“(iii) quality improvement;

“(iv) the barriers to health literacy;

“(v) relationships between health literacy and health disparities, particularly with respect to language and cultural competency; and

“(vi) the utilization of information on comparative effectiveness of health treatments;

“(C) sponsor demonstration and evaluation projects with respect to interventions and tools designed to strengthen health literacy, including projects focused on—

“(i) the provision of simplified, patient-centered written materials;

“(ii) technology-based communication techniques;

“(iii) consumer navigation services; and

“(iv) the training of health professional providers;

“(D) give preference to health literacy initiatives that—

“(i) focus on the particular needs of vulnerable populations such as the elderly, racial and ethnic minorities, children, individuals with limited English proficiency, and individuals with disabilities; and

“(ii) partner with institutions in the community such as schools, libraries, senior centers, literacy groups, recreation centers, early childhood education centers, area health education centers, and public assistance programs;

“(E) assist appropriate Federal agencies in establishing specific objectives and strategies for carrying out the program, in monitoring the programs of such agencies, and incorporating health literacy into research design, human subjects protections, and informed consent in clinical research;

“(F) seek to enter into implementation partnerships with organizations and agencies, including other agencies within the Department of Health and Human Services, such as the Centers for Medicare & Medicaid Services and the Health Resources and Services Administration, the Office of the Surgeon General, the Joint Commission on the Accreditation of Healthcare Organizations, the Office of the National Coordinator for Health Information Technology, and the National Committee for Quality Assurance, to promote the adoption of interventions and tools developed under this section, particularly in the training of health professionals; and

“(G) coordinate with other agencies within the Department of Health and Human Services to collect data that monitors national trends in health literacy by including relevant items in surveys such as the Medical Expenditure Panel Survey, the National Health Interview Survey, and the National Hospital Discharge Survey.

“(3) Report—The Agency for Healthcare Research and Quality shall annually submit to Congress a report that includes—

“(A) a comprehensive and detailed description of the operations, activities, financial condition, and accomplishments of the Agency in the field of health literacy; and

“(B) a description of how plans for the operation of the program for the succeeding fiscal year will facilitate achievement of the goals of the program.

“(4) Authorization of appropriations—There are authorized to be appropriated to carry out this subsection such sums as may be necessary for each of fiscal years 2014 through 2018.

“(c) State health literacy grants

“(1) Grants—The Director of the Agency shall award grants to eligible entities to facilitate State and community efforts to strengthen health literacy.

“(2) Use of funds—An entity receiving a grant under this subsection shall use amounts received under such grant to—

“(A) support efforts to monitor and strengthen health literacy within a State or community;

“(B) assist public and private efforts in the State or community in coordinating and delivering health literacy services;

“(C) encourage partnerships among State and local governments, community organizations, non-profit entities, academic institutions, and businesses to coordinate efforts to strengthen health literacy;

“(D) provide technical and policy assistance to State and local governments and service providers; and

“(E) monitor and evaluate programs conducted under this grant.

“(3) Report—Not later than September 30 of each fiscal year for which a grant is received by an entity under this section, the entity shall submit to the Director a report that describes the programs supported by the grant and the results of monitoring and evaluation of those programs.

“(4) Authorization of appropriations—There are authorized to be appropriated such sums as may be necessary to carry out this subsection for each of fiscal years 2014 through 2018.”

(b)

Institute of Medicine study and report—

(1)

Study— The Secretary of Health and Human Services shall seek to enter into a contract with the Institute of Medicine to conduct a study identifying opportunities within the Department of Health and Human Services to strengthen the health literacy of health care providers and health care consumers in accordance with the Patient Protection and Affordable Care Act (Public Law 111–148).

(2)

Report— A contract entered into under paragraph (1) shall include a provision requiring the Institute of Medicine, not later than 1 year after the date of enactment of this Act, to submit a report concerning the results of the study conducted under paragraph (1) to the Secretary of Health and Human Services and the appropriate committees of Congress.”.

Sec. 306 Disallowance of deductions for advertising and marketing expenses relating to tobacco product use

(a)

In general— Part IX of subchapter B of chapter 1 of subtitle A of the Internal Revenue Code of 1986 (relating to items not deductible) is amended by adding at the end the following new section:

“280I. Disallowance of deduction for advertising and marketing expenses relating to tobacco product use

“No deduction shall be allowed under this chapter for expenses relating to advertising or marketing cigars, cigarettes, smokeless tobacco, pipe tobacco, or any other tobacco product. For purposes of this section, any term used in this section which is also used in section 5702 shall have the same meaning given such term by section 5702.”

(b)

Conforming amendment— The table of sections for such part IX is amended by adding after the item relating to section 280H the following new item:

(c)

Effective date— The amendments made by this section shall apply to taxable years beginning after the date of the enactment of this Act.

Sec. 307 Incentives to reduce tobacco use

(a)

Child tobacco use surveys—

(1)

Annual performance survey—

(A)

In general— Not later than August 31, 2014, and annually thereafter, the Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall publish the results of an annual tobacco use survey, to be carried out not later than 18 months after the date of enactment of this Act and completed on an annual basis thereafter, to determine—

(i)

the percentage of all young individuals who used tobacco products within the 30-day period prior to the conduct of the survey involved; and

(ii)

the percentage of young individuals who identify each brand of each type of tobacco product as the usual brand used within such 30-day period.

(B)

Young individuals— For the purposes of this section, the term young individuals means individuals who are under 18 years of age.

(2)

Size and methodology—

(A)

In general— The survey referred to in paragraph (1) may be the National Survey on Drug Use and Health or shall at least be comparable in size and methodology to the NSDUH that was completed in 2009 to measure the use of cigarettes (by brand) by youths under 18 years of age within the 30-day period prior to the conduct of the study. Such survey may be conducted as a component of the National Health and Nutrition Examination Survey or the National Health Interview Survey, if all other requirements provided for in this section are complied with.

(B)

Conclusive accurateness— A survey using the methodology described in subparagraph (A) shall be deemed conclusively proper, correct, and accurate for purposes of this section.

(C)

Definition— In this section, the term National Survey on Drug Use and Health or NSDUH means the annual nationwide survey of randomly selected individuals, aged 12 and older, conducted by the Substance Abuse and Mental Health Services Administration.

(3)

Reduction— The Secretary, based on a comparison of the results of the first annual tobacco product survey referred to in paragraph (1) and the most recent survey data referred to in paragraph (2)(A) completed prior to the date of enactment of this Act, shall determine the percentage reduction (if any) in youth tobacco use for each manufacturer of tobacco products.

(4)

Participation in survey— Notwithstanding any other provision of law, the Secretary may conduct a survey under this subsection involving minors if the results of such survey with respect to such minors are kept confidential and not disclosed.

(5)

Nonapplicability— Chapter 35 of title 44, United States Code, shall not apply to information required for the purposes of carrying out this section.

(b)

Tobacco use reduction goal and noncompliance—

(1)

Goal— It shall be the tobacco use reduction goal that youth tobacco use be reduced by at least 5 percent or a level determined significantly sufficient by the Secretary between the most recent NSDUH referred to in subsection (a)(2)(A) and the completion of the first annual cigarette survey (and such subsequent surveys as compared to the previous year's survey) referred to in subsection (a)(1).

(2)

Noncompliance—

(A)

Industry-wide penalty— If the Secretary determines that the tobacco use reduction goal under paragraph (1) has not been achieved, the Secretary shall, not later than September 10, 2014, and September 10 of each year thereafter, impose an industry-wide penalty on the manufacturers of cigarettes in an amount that is in the aggregate equal to $3,000,000,000.

(B)

Payment— The industry-wide penalty imposed under this subsection shall be paid by each manufacturer based on the brand share among youth ages 12–17 (as determined by the survey described in subsection (a)(1)) as such percentage relates to the total amount to be paid by all manufacturers.

(C)

Final determination— The determination of the Secretary as to the amount and allocation of a surcharge under this section shall be final and the manufacturer shall pay such surcharge within 10 days of the date on which the manufacturer is assessed. Such payment shall be retained by the Secretary pending final judicial review of what, if any, change in the surcharge is appropriate.

(D)

Limitation— With respect to cigarettes, a manufacturer with a market share of 1 percent or less of youth tobacco use shall not be liable for the payment of a surcharge under this paragraph.

(E)

Use of amounts— Amounts collected under subparagraph (A) shall be deposited into the Prevention and Public Health Fund established under section 4002 of the Patient Protection and Affordable Care Act (42 U.S.C. 300u–11). Such funds shall remain available for transfer through September 30th of the fifth fiscal year following their collection, subject to the terms and conditions of such section 4002.

(3)

Penalties nondeductible— The payment of penalties under this section shall not be considered to be an ordinary and necessary expense in carrying on a trade or business for purposes of the Internal Revenue Code of 1986 and shall not be deductible.

(4)

Judicial review—

(A)

After payment— A manufacturer of cigarettes may seek judicial review of any action under this section only after the assessment involved has been paid by the manufacturer to the Department of the Treasury and only in the United States District Court for the District of Columbia.

(B)

Review by attorney general— Prior to the filing of an action by a manufacturer seeking judicial review of an action under this section, the manufacturer shall notify the Attorney General of such intent to file and the Attorney General shall have 30 days in which to respond to the action.

(C)

Review— The amount of any surcharge paid under this section shall be subject to judicial review by the United States Court of Appeals for the District of Columbia Circuit, based on the arbitrary and capricious standard of section 706 of title 5, United States Code. Notwithstanding any other provision of law, no court shall have the authority to stay any surcharge payment due to the Secretary under this section pending judicial review until the Secretary has made or failed to make a compliance determination, as described under this section, that has adversely affected the person seeking the review.

(c)

Enforcement—

(1)

Initial penalty— There is hereby imposed an initial penalty on the failure of any manufacturer to make any payment required under this section not later than a period determined sufficient by the Secretary after the date on which such payment is due.

(2)

Amount of penalty— The amount of the penalty imposed by paragraph (1) on any failure with respect to a manufacturer shall be an amount equal to 2 percent of the penalty owed under subsection (b) for each day during the noncompliance period.

(3)

Noncompliance period— For purposes of this subsection, the term noncompliance period means, with respect to any failure to make the surcharge payment required under this section, the period—

(A)

beginning on the due date for such payment; and

(B)

ending on the date on which such payment is paid in full.

(4)

Limitations— No penalty shall be imposed by paragraph (1) on—

(A)

any failure to make a surcharge payment under this section during any period for which it is established to the satisfaction of the Secretary that none of the persons responsible for such failure knew or, exercising reasonable diligence, would have known, that such failure existed; or

(B)

any manufacturer that produces less than 1 percent of cigarettes used by youth in that year (as determined by the annual survey).

Sec. 308 Voluntary standards on food marketing to children

(a)

In general— The Interagency Working Group on Food Marketed to Children (as established by the Omnibus Appropriations Act, 2009 (Public Law 109–8)) and constituted by the Commisioner of the Federal Trade Commission, together with the Commissioner of the Food and Drug Administration, the Director of the Centers for Disease Control and Prevention, and the Secretary of Agriculture, shall develop recommendations for standards for the marketing of food when such marketing targets children who are 17 years of age or younger or when such food represents a significant component of the diets of children.

(b)

Considerations— In developing standards under subsection (a), the Working Group shall consider—

(1)

positive and negative contributions of nutrients, ingredients, and food (including calories, portion size, saturated fat, trans fat, sodium, added sugars, and the presence of nutrients, fruits, vegetables, and whole grains) to the diets of such children; and

(2)

evidence concerning the role of the consumption of nutrients, ingredients, and foods in preventing or promoting the development of obesity among such children.

(c)

Scope— The Working Group shall determine the scope of the media to which the standards developed under subsection (a) should apply.

(d)

Submission to Congress— Not later than July 15, 2014, the Working Group shall submit to the relevant Committees of Congress a report containing the findings and recommendations of the Working Group under this section.

Title III — Responsible marketing and consumer awareness

III Responsible marketing and consumer awareness