,,ii #aaeth ,,congress #b;d ,session ,s4 #bfdg ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,april #aa1 #bjah ,mr4 ,blumenthal 7for himself1 ,mr4 ,whitehouse1 and ,mr4 ,markey7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act to strengthen requirements related to nutrient information on food labels1 and for other purposes4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,food ,labeling ,modernization ,act of #bjah4 7b7 ,table of contents ,the table of contents of this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4 ,sec4 #b4 ,additional requirements for front-of-packaging 7,,fop7 labeling for processed foods4 ,sec4 #c4 ,claims for conventional foods4 ,sec4 #d4 ,use of specific terms4 ,sec4 #e4 ,nutrition facts panel compliance date4 ,sec4 #f4 ,ingredient labels4 ,sec4 #g4 ,caffeine content on information panel4 ,sec4 #h4 ,food allergen labeling for sesame4 ,sec4 #i4 ,information about major food allergens in nonprepackaged foods4 ,sec4 #aj4 ,submission and availability of food label information4 ,sec4 #aa4 ,definitions4 ,sec4 #ab4 ,applicability2 regulations4 #b4 ,additional requirements for front-of-packaging 7,,fop7 labeling for processed foods 7a7 ,summary nutrition labeling information ,section #djc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdc7 is amended by adding at the end the following3 7z7 7#a7 ,summary nutrition information ,except as provided in subparagraphs 7#c71 7#d71 and 7#e7 of paragraph 7q71 if it is food 7other than a dietary supplement7 intended for human consumption and is offered for sale and otherwise required to bear nutrition labeling1 unless its principal display panel bears summary nutrition information that reflects the overall nutritional value of the food or specified ingredients1 as specified in accordance with regulations of the ,secretary1 and does not contain any summary nutritional information which is in addition to or inconsistent with the information required under this subparagraph4 7#b7 ,required criteria for implementing regulations ,final regulations regarding the summary nutrition information required under subparagraph 7#a7 shall meet the following criteria3 7,a7 ,there shall be a single1 simple1 standard symbol system that displays calorie information related to the serving size determined under paragraph 7q77#a77;,a71 and information related to the content of saturated and trans fats1 sodium1 added sugars1 and any other nutrients that the ,secretary determines are strongly associated with public health concerns4 7,b7 ,the system shall employ an approach that clearly distinguishes between products of greater or lesser nutritional value4 ,this system may include-- 7i7 a warning symbol or symbols for products high in saturated or trans fats1 sodium1 added sugars1 or other nutrients the consumption of which should be limited or discouraged2 or 7ii7 a stop-light1 points1 star1 or other commonly recognized signaling system to scale or rank foods according to their overall health value4 7,c7 ,the information shall appear on all products that are required to bear nutrition labeling4 7,d7 ,the information shall-- 7i7 appear in a consistent location on the principal display panels across products2 7ii7 have a prominent design that visually contrasts with existing packaging design2 and 7iii7 be sufficiently large to be easily legible4 7#c7 ,principles for implementing regulations ,in promulgating regulations regarding the summary nutrition information required under subparagraph 7#a71 the ,secretary shall take into account published reports by the ,health and ,medicine ,division of the ,national ,academy of ,sciences regarding such information1 and base regulations on the following principles3 7,a7 ,consumers should be able to quickly and easily comprehend the meaning of the symbol system as an indicator of a product's contribution to a healthy diet without requiring specific or sophisticated nutritional knowledge4 7,b7 ,the nutrition information should be consistent with the ,nutrition ,facts ,panel and with the recommendations of the ,dietary ,guidelines for ,americans4 7,c7 ,the information should aim to facilitate consumer selection of healthy product options1 including among nutritionally at-risk subpopulations4 7,d7 ,the ,secretary should periodically evaluate the front-of-package information to assess its ability to help facilitate consumer selection of healthy product options and the extent to which manufacturers are offering healthier products as a result of the disclosure4 7,e7 ,the implementation of the information disclosure should be accompanied by appropriate consumer education and promotion campaigns determined by the ,secretary4 4 7b7 ,percentage of wheat and grains in grain-,based products ,section #djc of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as amended1 is further amended by adding at the end the following3 7aa7 ,percentage of wheat and grains in grain-,based products ,if1 in the case of food other than a dietary supplement1 the principal display panel bears-- 7#a7 the terms whole wheat1 whole grain1 made with whole grain1 or multigrain2 7#b7 a declaration of the whole grain content by weight2 7#c7 the term wheat on a wheat bread1 pasta1 or similar product that is typically made from wheat2 or 7#d7 any similar descriptive phrases1 terms1 or representations suggesting the product contains whole grains1 unless the amount of whole grains1 expressed as a percentage of total grains1 is conspicuously disclosed in immediate proximity to the descriptive phrase1 term1 or representation1 using a font1 color1 and formatting of equivalent prominence to the descriptive phrase1 term1 or representation with respect to whole grain content4 4 7c7 ,sweeteners1 coloring1 and flavoring ,section #djc of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as amended1 is further amended by adding at the end the following3 7bb7 ,sweeteners1 coloring1 and flavoring ,if1 in the case of food other than a dietary supplement1 it bears or contains any added artificial or natural coloring1 any added artificial or natural non-caloric sweetener1 or any added artificial or natural flavoring1 unless such fact is prominently stated on the principal display panel of a package or container of the food4 4 7d7 ,conforming amendment ,the second sentence of section #djc7k7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdc7k77 is amended by striking and 7i7 and inserting 1 7i71 7z71 7aa71 and 7bb74 7e7 ,construction ,nothing in this section shall be construed as affecting any requirement in regulation in effect as of the date of the enactment of this ,act with respect to matters that are required to be stated on the principal display panel of a package or container of food that is not required by an amendment made by this section or as restricting the authority of the ,secretary of ,health and ,human ,services to require additional information be disclosed on such a principal display panel4 #c4 ,claims for conventional foods 7a7 ,health-,related claims 7#a7 ,in general ,section #djc7r77#a77;,b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdc7r77#a77;,b77 is amended by inserting after health-related condition the following3 1 describes the effect that a nutrient may have on the structure or function of the human body1 characterizes the documented mechanism by which that nutrient acts to maintain such structure or function1 or describes general well-being from consumption of that nutrient14 7#b7 ,substantiation of claim ,section #djc7r7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdc7r77 is amended-- 7,a7 by redesignating subparagraph 7#g7 as subparagraph 7#h72 and 7,b7 by inserting after subparagraph 7#f7 the following3 7#g7 ,if the ,secretary requests that a claim under subparagraph 7#a77;,b7 for food 7other than a dietary supplement7 be substantiated1 then not later than #ij days after the date on which the ,secretary makes such request1 the manufacturer shall provide to the ,secretary all documentation in the manufacturer's possession relating to the claim4 4 7b7 ,trans fats ,section #djc7r77#b77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdc7r77#b77;,a77 is amended-- 7#a7 in subclause 7iii7-- 7,a7 in the matter before item 7,i71 by striking fat or saturated fat and inserting fat1 saturated fat1 or trans fats2 and 7,b7 in item 7,,ii71 by striking fat or saturated fat and inserting fat1 saturated fat1 or trans fats2 7#b7 in subclause 7iv71 by striking saturated fat and inserting saturated fat or trans fats each place it appears2 7#c7 by redesignating subclauses 7v7 and 7vi7 as subclauses 7vi7 and 7vii71 respectively2 and 7#d7 by inserting after subclause 7iv7 the following new subclause3 7v7 may not be made with respect to the level of trans fats in the food unless the food contains less than one gram of saturated fat per serving or1 if the food contains more than one gram of saturated fat per serving1 unless the label or labeling of the food discloses the level of saturated fat in the food in immediate proximity to such claim and with appropriate prominence which shall be no less than one-half the size of the claim with respect to the level of trans fats1 4 7c7 ,added sugars ,not more than #b years after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall promulgate a final rule revising section #aja4ad of title #ba1 ,code of ,federal ,regulations1 to include a disqualifying nutrient level for added sugars4 #d4 ,use of specific terms 7a7 ,use of the term natural 7#a7 ,in general ,not later than #b years after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall promulgate a final rule-- 7,a7 relating to use of the term natural on the labeling of food 7other than a dietary supplement72 and 7,b7 including provisions to specifically address the use of such term on the principal display panel and the information panel4 7#b7 ,definition ,the rule promulgated pursuant to paragraph 7#a7 shall define the term natural-- 7,a7 to exclude1 at a minimum1 the use of any artificial food or ingredient 7including any artificial flavor or added color72 and 7,b7 based on data1 including data on consumers' understanding of the term as used in connection with food4 7#c7 ,process ,in promulgating the rule required by paragraph 7#a71 the ,secretary of ,health and ,human ,services shall-- 7,a7 conduct consumer surveys and studies and issue a timely call for relevant public submissions regarding relevant consumer research1 including with respect to consumer understanding of the term natural in relation to the term organic2 and 7,b7 fully consider the results of such surveys and studies1 as well as such public submissions4 7b7 ,use of term healthy 7#a7 ,added sugars and whole grains ,the ,secretary of ,health and ,human ,services shall revise the regulations under the ,federal ,food1 ,drug1 and ,cosmetic ,act relating to the use of the term healthy on the labeling of a food 7other than a dietary supplement7 to take into account the extent to which such food contains added sugars or whole grains4 7#b7 ,requirements ,in making the revisions to regulations required by paragraph 7#a7-- 7,a7 in the case of a food 7other than a dietary supplement7 that contains grains1 the ,secretary shall not consider the food to be healthy unless at least half of those grains1 by weight1 are whole grains2 and 7,b7 the ,secretary shall not allow a food to be labeled healthy if the food contains more than #aj percent of the daily value of added sugar per serving4 #e4 ,nutrition facts panel compliance date ,the ,secretary of ,health and ,human ,services shall not extend the compliance dates in the final rule entitled ,food ,labeling3 ,revision of the ,nutrition and ,supplement ,facts ,labels published by the ,food and ,drug ,administration in the ,federal ,register on ,may #bg1 #bjaf 7or any successor rule71 beyond the compliance dates proposed in the proposed rule entitled ,food ,labeling3 ,revision of the ,nutrition and ,supplement ,facts ,labels and ,serving ,sizes of ,foods ,that ,can ,reasonably ,be ,consumed at ,one ,eating ,occasion2 ,dual-,column ,labeling2 ,updating1 ,modifying1 and ,establishing ,certain ,reference ,amounts ,customarily ,consumed2 ,serving ,size for ,breath ,mints2 and ,technical ,amendments2 ,proposed ,extension of ,compliance ,dates published by the ,food and ,drug ,administration in the ,federal ,register on ,october #b1 #bjag4 #f4 ,ingredient labels 7a7 ,format of ingredient labels 7#a7 ,in general ,the ,secretary of ,health and ,human ,services shall include requirements for the format of the information required under section #djc7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdc7;i77-- 7,a7 for the purpose of improving the readability of such information on the label of the food 7other than a dietary supplement72 and 7,b7 that are1 as determined by the ,secretary1 necessary to assist consumers in maintaining healthy dietary practices4 7#b7 ,format requirements ,the format requirements referred to in paragraph 7#a7 shall include requirements for upper- and lower-case characters1 serif and noncondensed font types1 high-contrast between text and background1 and bullet points between adjacent ingredients with appropriate exemptions for small packages or other considerations4 7b7 ,characterizing ingredients in name or primary display panel 7#a7 ,in general ,section #djc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdc71 as amended1 is further amended by adding at the end the following3 7cc7 ,if the name or primary display panel of the food 7other than a dietary supplement7 refers to any characterizing ingredient or component of the food1 unless-- 7#a7 the characterizing ingredient or component is a predominant ingredient in the food2 or 7#b7 the primary display panel of the food includes1 in letters not less than one-half the height of the letters used in the name of the food1 the percentage of each characterizing ingredient or component contained in the food4 4 7#b7 ,enforcement of characterizing ingredients ,not later than #b years after the date of enactment of this ,act and every #b years thereafter1 the ,secretary of ,health and ,human ,services shall submit a report to the ,congress on the ,secretary's enforcement of-- 7,a7 section #djc7;cc7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by paragraph 7#a72 and 7,b7 regulations of the ,food and ,drug ,administration on characterizing ingredients and components1 including section #ajb4e of title #ba1 ,code of ,federal ,regulations 7and any successor regulations74 7c7 ,declaration of phosphorus on the ingredient label ,section #djc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdc71 as amended1 is further amended by adding at the end the following3 7dd7 ,if it is a food intended for human consumption that is offered for sale and contains phosphorus1 unless-- 7#a7 the phrase contains phosphorus1 along with the quantity of phosphorus in the product1 reported in milligrams per serving1 is printed immediately after or is adjacent to the list of ingredients required under paragraphs 7g7 and 7i71 in a type size no smaller than the type size used in the list of ingredients2 or 7#b7 the quantity of phosphorus contained in the product1 in milligrams1 is reported in the ,nutrition ,facts ,panel4 4 #g4 ,caffeine content on information panel ,section #djc7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdc7;i77 is amended-- 7#a7 by striking and 7#b7 and inserting 7#b72 7#b7 by striking and if the food purports and inserting 1 7#c7 if the food purports2 and 7#c7 by inserting 1 and 7#d7 if the food is food other than a dietary supplement and contains at least #aj milligrams of caffeine from all sources per serving1 a statement 7with appropriate prominence near the statement of ingredients required by this paragraph7 of the number of milligrams of caffeine contained in one serving of the food and the size of such serving after vegetable juice contained in the food4 #h4 ,food allergen labeling for sesame ,section #bja7qq77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7qq77#a77 is amended by striking and soybeans and inserting soybeans1 and sesame4 #i4 ,information about major food allergens in nonprepackaged foods ,section #djc7w7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdc7w77 is amended-- 7#a7 in subparagraph 7#a77;,a71 by striking is printed immediately after or is adjacent to the list of ingredients 7in a type size no smaller than the type size used in the list of ingredients7 required under subsections 7g7 and 7i7 and inserting is printed as specified in subparagraph 7#h72 7#b7 in subparagraph 7#a77;,b71 by striking in the list of ingredients required under subsections 7g7 and 7i7 and inserting as so printed2 7#c7 in subparagraph 7#c71 by striking ,the information and inserting ,subject to subparagraph 7#h77;,b71 the information2 and 7#d7 by adding at the end the following3 7#h7 ,the information required by subparagraph 7#a7 to be conveyed to the consumer shall be-- 7,a7 printed immediately after or adjacent to the list of ingredients 7in a type size no smaller than the type size used in the list of ingredients7 required under paragraphs 7g7 and 7i72 or 7,b7 in the case of a nonpackaged food being offered for sale at retail1 and not subject to the requirements of paragraphs 7g7 and 7i71 placed on a sign adjacent to the food 7in a type size no smaller than the name of the food item74 4 #aj4 ,submission and availability of food label information ,the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended by inserting after section #djc;,c of such ,act 7#ba ,u4,s4,c4 #cdc-c7 the following3 #djc;,d4 ,submission and availability of food label information 7a7 ,submissions 7#a7 ,requirement ,the ,secretary shall require the manufacturer or importer of any food that is introduced or delivered for introduction into interstate commerce in package form to submit to the ,secretary all information to be included in the label of the food1 including-- 7,a7 the nutrition facts panel2 7,b7 ingredients2 7,c7 an image of the primary display panel2 7,d7 allergy warnings or information2 7,e7 claims under section #djc7r77#a77;,a7 7popularly referred to as nutrient-content claims72 7,f7 claims under section #djc7r77#a77;,b7 7popularly referred to as health-related claims72 and 7,g7 other relevant information required by law to be published in the labeling of the food4 7#b7 ,updates ,the ,secretary shall require the manufacturer or importer of food to update or supplement the information submitted under paragraph 7#a7 with respect to the food in order to keep the information up-to-date and complete4 7#c7 ,civil penalty ,whoever knowingly violates paragraph 7#a7 with respect to any food shall be liable to the ,united ,states for a civil penalty in an amount not to exceed #aj1jjj for each day on which such violation continues with respect to such food4 7b7 ,public database ,the ,secretary shall establish and maintain a public database containing the information submitted under this section that-- 7#a7 is available to the public through the website of the ,food and ,drug ,administration2 and 7#b7 allows members of the public to easily search and sort information4 4 #aa4 ,definitions 7a7 ,definitions applicable in this ,act ,in this ,act1 the terms food and dietary supplement have the meanings given to such terms in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba74 7b7 ,definitions applicable in the ,federal ,food1 ,drug1 and ,cosmetic ,act ,section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7 is amended by adding at the end the following3 7ss7 ,the term artificial1 with respect to food or any ingredient of food1 means-- 7#a7 food or an ingredient that is synthetically produced whether or not it has the same chemical structure as a naturally occurring food or ingredient2 7#b7 food or an ingredient that has undergone chemical changes through the introduction of synthetic chemicals or processing aids 7such as corn syrup1 high-fructose corn syrup1 high-maltose corn syrup1 maltodextrin1 chemically modified starch1 and cocoa processed with alkali71 excluding-- 7,a7 food or an ingredient that has undergone traditional processes used to make food edible1 to preserve food1 or to make food safe for human consumption 7such as smoking1 roasting1 freezing1 drying1 and fermenting processes72 or 7,b7 food or an ingredient that has undergone traditional physical processes that do not fundamentally alter the raw product or which only separate a whole intact food into component parts 7such as grinding grains1 separating eggs into albumen and yolk1 or pressing fruits to produce juice72 or 7#c7 any food or ingredient that the ,secretary specifies by regulation to be artificial for purposes of this ,act4 7tt7 ,the term synthetic1 with respect to a substance1 means a substance that is formulated or manufactured by a chemical process or by a process that chemically changes a substance extracted from a naturally occurring plant1 animal1 or mineral source1 except that such term does not apply to a substance created by naturally occurring biological processes4 4 #ab4 ,applicability2 regulations 7a7 ,applicability ,the amendments made by-- 7#a7 subsections 7a7 and 7b7 of section #c1 subsections 7b77#a7 and 7c7 of section #f1 and sections #g1 #h1 #aj1 and #aa7;b7 shall apply beginning on the date that is #b years after the date of enactment of this ,act2 and 7#b7 sections #b and #i shall apply beginning on the date that is #c years after such date of enactment4 7b7 ,regulations 7#a7 ,proposed regulations ,the ,secretary of ,health and ,human ,services shall propose regulations-- 7,a7 not later than #a year after the date of enactment of this ,act1 to implement the amendments made by subsections 7a7 and 7b7 of section #c1 subsections 7b77#a7 and 7c7 of section #f1 and sections #g1 #h1 #i1 #aj1 and #aa7;b72 and 7,b7 not later than #b years after such date of enactment1 to implement the amendments made by section #b4 7#b7 ,final regulations ,the ,secretary of ,health and ,human ,services shall promulgate final regulations-- 7,a7 not later than #b years after the date of enactment of this ,act1 to implement the amendments made by subsections 7a7 and 7b7 of section #c1 subsections 7b77#a7 and 7c7 of section #f1 and sections #g1 #h1 #i1 #aj1 and #aa7;b72 and 7,b7 not later than #c years after such date of enactment to implement the amendments made by section #b4 7#c7 ,deadline ,if the ,secretary of ,health and ,human ,services does not issue a final regulation by the deadline specified in subparagraph 7,a7 or 7,b7 of paragraph 7#b71 the corresponding proposed regulation under subparagraph 7,a7 or 7,b7 of paragraph 7#a7 shall become final on the respective deadline4