,,ii #aadth ,,congress #ast ,session ,s4 #bcja ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,november #ah1 #bjae ,mr4 ,blumenthal 7for himself 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 #bjae4 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 ,modernization of the ,nutrition ,facts ,panel4 ,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 ,effective date2 regulations4 #b4 ,additional requirements for front-of-packaging 7,,fop7 labeling for processed foods 7a7 ,summary nutrition labeling information 7#a7 ,in general ,section #djc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdc7 is amended by adding at the end the following new paragraph3 7z7 7#a7 ,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 4 7#b7 ,principles for implementing regulations ,in promulgating regulations regarding the summary nutrition information required under the amendment made by paragraph 7#a71 the ,secretary of ,health and ,human ,services shall take into account published reports of the ,institute of ,medicine of the ,national ,academy of ,sciences regarding such information and base regulations on the following principles3 7,a7 ,there should be a single simple1 standard symbol system that displays calorie information related to a common serving size1 and information related to nutrients strongly associated with public health concerns4 7,b7 ,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 diet4 7,c7 ,the information should appear on all products that are required to bear nutrition labeling4 7,d7 ,the information should-- 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,e7 ,the nutrition information should be consistent with the ,nutrition ,facts ,panel and with the recommendations of the ,dietary ,guidelines of ,americans4 7,f7 ,the information should aim to facilitate consumer selection of healthy product options1 including among nutritionally at-risk subpopulations4 7,g7 ,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,h7 ,the implementation of the information disclosure should be accompanied by appropriate consumer education and promotion campaigns determined by the ,secretary4 7b7 ,percentage of wheat and grains in grain-,based products ,section #djc7z7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdc7z771 as added by subsection 7a77#a71 is further amended by adding at the end the following new subparagraph3 7#b7 ,if1 in the case of food other than a dietary supplement1 the principal display panel bears-- 7,a7 the phrase made with whole grain1 the term multigrain1 or similar descriptive phrases1 terms1 or representations with respect to whole grain content1 unless the amount of whole grains1 expressed as a percentage of total grains1 is conspicuously disclosed in immediate proximity to such descriptive phrase1 term1 or representation2 or 7,b7 the terms wheat or whole wheat on breads1 pasta1 crackers1 or similar wheat-based products1 unless the percentage of whole wheat by weight contained in the food is conspicuously declared in immediate proximity to that term or there is a conspicuous declaration that the food contains no whole wheat in immediate proximity to that term4 4 7c7 ,sweeteners1 coloring1 and flavoring ,section #djc7z7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdc7z771 as amended1 is further amended by adding at the end the following new subparagraph3 7#c7 ,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 and 7z74 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 ,regulations and guidance ,not later than #c years after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall-- 7,a7 promulgate a final rule clarifying the application of section #djc7r7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdc7r77 with respect to the mechanisms by which a nutrient in food 7other than a dietary supplement7 is intended to affect the structure or any function of the human body1 or characterize the documented mechanism by which a nutrient in such food acts to maintain such structure or function2 and 7,b7 issue guidance clarifying the application of such section #djc7r7 with respect to the substantiation of claims pursuant to a request under section #djc7r77#g7 of such ,act1 as added by paragraph 7#b74 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 #c 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 color7 or any synthetic substance2 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 serving as determined by the ,secretary under section #djc7q77#a77;,f77i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #e7;c7 of this ,act4 #e4 ,modernization of the ,nutrition ,facts ,panel 7a7 ,disclosure of calorie information ,section #djc7q77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdc7q77#a77 is amended-- 7#a7 by striking the period at the end of clause 7,e7 and inserting a comma2 7#b7 by inserting after clause 7,e7 the following new clause3 7,f7 in the case of food other than a dietary supplement-- 7i7 the percent of recommended daily calories that are provided by one serving of the product1 based on a recommended daily consumption of calories determined by the ,secretary to be appropriate for members of the general population2 and 7ii7 at the discretion of the ,secretary1 the percent of recommended daily calories that are provided by one serving of the product-- 7,i7 for members of any subpopulation identified by the ,secretary2 and 7,,ii7 based on a recommended daily consumption of calories determined by the ,secretary to be appropriate for members of such subpopulation1 and 2 and 7#c7 by adding1 after the flush text following clause 7,f71 as added by paragraph 7#b71 the following3 ,the information required under clause 7,c77i7 shall1 in the case of food other than a dietary supplement1 appear in a typeface and design which is more prominent and conspicuous than that used for other information required under this subparagraph44 7b7 ,serving size ,section #djc7q77#a77;,a77i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdc7q77#a77;,a77i77 is amended by inserting 1 or1 in the case of a food 7other than a dietary supplement7 that is packaged in an amount that could reasonably be consumed in a single-eating occasion1 which is an amount equal to the amount of food contained in the package before 1 or4 7c7 ,disclosure of information relating to sugar on nutrition fact panel 7#a7 ,in general ,section #djc7q77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdc7q77#a771 as amended by subsection 7a71 is amended-- 7,a7 in subparagraph 7,d71 by striking sugars and inserting sugars 7and1 in the case of food other than a dietary supplement1 total sugars1 and of that1 added sugars1 disclosed in teaspoons as well as grams72 and 7,b7 by inserting after clause 7,f71 as added by subsection 7a77#b71 the following new clause3 7,g7 in the case of food other than a dietary supplement-- 7i7 the percent of added sugars recommended for daily consumption that are provided by one serving of the product1 based on a recommended daily consumption of calories determined by the ,secretary to be appropriate for members of the general population2 and 7ii7 at the discretion of the ,secretary1 the percent of added sugars recommended for daily consumption that are provided by one serving of the product-- 7,i7 for members of any subpopulation identified by the ,secretary2 and 7,,ii7 based on a recommended daily consumption of calories determined by the ,secretary to be appropriate for members of such subpopulation4 4 #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 amended by section #b7;a77#a71 is further amended by adding at the end the following new paragraph3 7aa7 ,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 the characterizing ingredient or component contained in each serving of 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 ,congress on the ,secretary's enforcement of-- 7,a7 section #djc7;aa7 of the ,federal ,food1 ,drug1 and ,cosmetic1 as added by paragraph 7#a72 and 7,b7 regulations of the ,food and ,drug ,administration on characterizing ingredients and components including section #ajb4e of title #ba1 ,code of ,federal ,regulations 7and any successor regulations74 #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 7a7 ,definition of major food allergen ,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 7b7 ,regulation ,not later than #c years after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall promulgate a final regulation under section #djc7w7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdc7w77 determining the manner in which sesame must be disclosed4 #i4 ,information about major food allergens in nonprepackaged foods 7a7 ,in general ,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 subsections 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 subsections 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 7b7 ,applicability ,the amendments made by subsection 7a7 apply beginning on the date that is #c years after the date of enactment of this ,act4 #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 any natural or artificial flavoring2 7,d7 an image of the primary display panel2 7,e7 allergy warnings or information2 7,f7 claims under section #djc7r77#a77;,a7 7popularly referred to as nutrient-content claims72 7,g7 claims under section #djc7r77#a77;,b7 7popularly referred to as health-related claims72 and 7,h7 other relevant information as determined by the ,secretary4 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 ,internet website of the ,food and ,drug ,administration2 and 7#b7 is for a public database of searchable1 sortable 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 but 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 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 ,effective date2 regulations 7a7 ,effective date ,the amendments made by-- 7#a7 sections #c1 #d1 #e1 #f1 #g1 #aj1 and #aa7;b7 shall take effect on the date that is #b years after the date of enactment of this ,act2 and 7#b7 sections #b and #i shall take effect 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 sections #c1 #d1 #e1 #f1 #g1 #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 such date of enactment1 to implement the amendments made by sections #c1 #d1 #e1 #f1 #g1 #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