From: [c--a--g] at [microunity.com] (Craig Hansen) Newsgroups: sci.med.nutrition Subject: Official Summaries of Supplement Legislation Date: 19 Oct 93 02:30:53 GMT There seems to be a great number of messages discussing the effects the NLEA may or may not have on the availability of nutritional supplements. In the interest of keeping the discussion focused on the facts of the legislation, I have retrieved summaries of the NLEA itself, Senate Amendment 3045 that delayed enforcement of the NLEA with respect to supplements, and the pending legislation: HR-509, HR-1709, and S-784. These have been retrieved from the Library of Congress on-line data. I do not have the list of cosponsors and detailed status of HR-509 and HR-1709, as the Library of Congress server became unavailable after I retrieved the information enclosed. I'll put them into another post when I can retrieve them. I note that S-784 has enough sponsors to pass the Senate if it makes its way out of the committee. It is also notable that Senators Glenn and Wofford have taken the unusual step of withdrawing an earlier co-sponsorship of the bill. Regards, Craig Hansen [c--a--g] at [microunity.com] ******* NLEA (Public Law 101-535) ******** OFFICIAL TITLE(S): AS INTRODUCED: (DATA FURNISHED BY THE HOUSE) A bill to amend the Federal Food, Drug, and Cosmetic act to prescribe nutrition labeling for foods, and for other purposes. SHORT TITLES: AS INTRODUCED: Nutrition Labeling and Education Act of 1989 REPORTED TO HOUSE: Nutrition Labeling and Education Act of 1990 AS PASSED HOUSE: Nutrition Labeling and Education Act of 1990 AS PASSED SENATE: Nutrition Labeling and Education Act of 1990 AS ENACTED: Nutrition Labeling and Education Act of 1990 COMMITTEE(S) OF REFERRAL: House Energy and Commerce COMMITTEE(S) REPORTING: House Energy and Commerce ABSTRACT AS INTRODUCED: Amends the Federal Food, Drug, and Cosmetic Act to provide for nutrition information and claims on food labels. DETAILED STATUS STEPS (IN REVERSE CHRONOLOGY): *EXECUTIVE ACTIONS* Nov 8, 90 Became Public Law No: 101-535. Nov 8, 90 Signed by President. Oct 31, 90 Presented to President. Oct 26, 90 Cleared for White House. *CONFERENCE ACTIONS* Oct 26, 90 House Agreed to Senate Amendments by Voice Vote. *SENATE ACTIONS* Oct 25, 90 Message on Senate action sent to the House. Oct 24, 90 Passed Senate with amendments by Voice Vote. Oct 24, 90 Amendment SP 3126 agreed to in Senate by Voice Vote. Oct 24, 90 Amendment SP 3126 proposed by Senator Byrd for Senator Jeffords. Oct 24, 90 Amendment SP 3125 agreed to in Senate by Voice Vote. Oct 24, 90 Amendment SP 3125 proposed by Senator Byrd for Senator Metzenbaum. Oct 24, 90 Measure laid before Senate by unanimous consent. Aug 4, 90 Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 784. Aug 2, 90 Received in the Senate. *HOUSE ACTIONS* Jul 30, 90 Passed House (Amended) by Voice Vote. Jul 30, 90 Called up by House Under Suspension of Rules. Jun 13, 90 Placed on Union Calendar No: 331. Jun 13, 90 Reported to House (Amended) by House Committee on Energy and Commerce. Report No: 101-538. May 16, 90 Ordered to be Reported (Amended). May 16, 90 Committee Consideration and Mark-up Session Held. Oct 31, 89 For Previous Action See H.R.3028. Oct 31, 89 Referred to House Committee on Energy and Commerce. SIMILAR BILLS: (DATA SUPPLIED BY HOUSE) S.1425 REVISED DIGEST: (AS OF 10/24/90) Measure passed Senate, amended Nutrition Labeling and Education Act of 1990 - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to deem a food misbranded unless its label bears nutrition information that provides: (1) the serving size or other common household unit of measure customarily used; (2) the number of servings or other units per container; (3) the number of calories per serving and derived from total fat and saturated fat; (4) the amount of total fat, saturated fat, cholesterol, sodium, total carbohydrates, complex carbohydrates, sugars, total protein, and dietary fiber per serving or other unit; and (5) subject to conditions, vitamins, minerals or other nutrients. Authorizes the Secretary of Health and Human Services to: (1) require certain information to be highlighted; (2) require additional nutrients to be included in the labeling; or (3) exempt nutrients from the labeling requirement. Allows nutrition information on food received in bulk containers at a retail establishment to be displayed at the location in the establishment at which the food is offered for sale. Directs the Secretary to provide, for raw agricultural commodities and raw fish (defining "fish" to mean aquatic animal life), for furnishing the nutrition information by issuing voluntary nutrition guidelines. Applies the voluntary guidelines only to the 20 varieties most frequently consumed of each of vegetables, fruit, and raw fish. Allows the Secretary to apply the guidelines regionally. Directs the Secretary, if the Secretary finds after 30 months that there is not substantial compliance with the voluntary guidelines, to issue regulations requiring the nutrition information to be provided for frequently consumed varieties of vegetables, fruit, and raw fish. Regulates the location, content, and manner of presentation of the information. Prohibits prosecution for minor violations if there has been substantial compliance. Exempts from the labeling requirements food: (1) sold for immediate consumption in restaurants, or sold to restaurants for sale or use in restaurants; (2) processed and prepared primarily in a retail establishment and not for immediate consumption in the establishment; (3) including certain infant formulas; (4) which is a medical food; (5) which is customarily processed, labeled, or repacked in substantial quantities at establishments other than those where it was originally processed or packed; (6) in small packages containing no nutrition information; (7) which contains insignificant amounts of all the nutrients and does not make any claim with respect to the nutritional value of the food; (8) sold by certain small businesses, unless the label provides nutrition information or makes a nutrition claim; and (9) sold by a distributor to restaurants or certain other establishments. Allows the Secretary to require, if a food contains insignificant amounts of more than half the nutrients required to be included in the labeling, that the amounts of such nutrients be stated in a simplified form. Requires certain vitamins and minerals to include nutrient information in their labeling as appropriate and as specified by the Secretary. Directs the Secretary to issue regulations which: (1) require the nutrition information on labels to be conveyed in a manner which enables the public to readily observe and comprehend it and to understand its relative significance in the context of a total daily diet; (2) establish standards to define serving size or other unit of measure; (3) permit the inclusion of certain information beyond that which is required; and (4) permit single statements or ranges when there are minor variations in the nutritional value or the food is comprised of an assortment of similar foods which have variations in nutritional value. Directs the Secretary to carry out consumer education regarding nutrition labeling. Sets forth the circumstances under which nutrition and health claims may and may not be made for foods. Regulates the presentation of claims, including claims involving cholesterol, saturated fat, or fiber. Authorizes the Secretary to prohibit claims that are misleading in light of another nutrient in the food. Exempts from certain regulations: (1) terms contained in the brand name of a food, if the name was in use on that food before October 25, 1989; (2) the term "diet," when used in the brand name of a soft drink and subject to other requirements; (3) a statement regarding the percentage of vitamins and minerals in the food in relation to recommended daily consumption; and (4) infant formulas subject to specified provisions of the FDCA and medical foods as defined in the Orphan Drug Act. Allows proceedings for the enforcement, or to restrain violations, of the amendments made by this Act to be brought in the name of a State in which the food that is the subject of the proceedings is located (in addition to the existing authorization to bring such actions to enforce the FDCA in the name of the United States). Declares that a food which makes a claim which characterizes the relationship of its constituents to a disease or a condition, or makes a claim with respect to a dietary supplement of vitamins, minerals, herbs, or similar nutritional substances, in accordance with the requirements of this Act, is not, solely because of such claim, a drug under specified provisions of FDCA. Prohibits, subject to exception, a State or its subdivision from establishing or continuing in effect any requirement for a food that is the subject of a standard of identity, or any labeling requirement that is not identical to the requirements of this Act. Provides for exemption petitions by States if a State or local requirement would not cause any food to be in violation of Federal law, would not unduly burden interstate commerce, and is designed to address a particular need for nutrition information which is not met by the requirements of this Act. Deems any food (currently, any food without a prescribed definition and standard of identity) misbranded unless it bears any common or usual name of the food and lists optional ingredients. Requires a beverage containing vegetable or fruit juice to bear a statement of the percentage of the vegetable or fruit juice in the food. Provides exceptions for spices, flavorings, and colors not required to be certified under specified provisions. Modifies provisions relating to the procedures for the establishment of regulations concerning definitions and standards of identity. COSPONSOR COSPONSORED ON WITHDRAWN ON Rep Madigan 10/31/89 Rep Moakley 10/31/89 Rep Cooper 10/31/89 Rep Scheuer 10/31/89 Rep Walgren 10/31/89 Rep Sikorski 10/31/89 Rep Sharp 10/31/89 Rep Levine 10/31/89 Rep Smith, N. 10/31/89 Rep Faleomavaega 10/31/89 Rep Pallone 10/31/89 Rep Pease 10/31/89 Rep Studds 10/31/89 Rep Stark 10/31/89 Rep Boxer 10/31/89 Rep Solarz 10/31/89 Rep Wheat 10/31/89 Rep Pelosi 10/31/89 Rep Smith, P. 11/07/89 Rep Bates 11/08/89 Rep Collins 11/15/89 Rep Unsoeld 01/29/90 Rep Gejdenson 01/29/90 Rep Markey 04/24/90 **************** S.AMDT.3045 ********* S.AMDT.3045 AMENDMENT TO H.R.5677 (C102) 09/18/92 Sen Hatch, (Acosp=7) CONG REC S14128 DETAILED STATUS STEPS: *SENATE ACTIONS* Sep 18, 92 Proposed by Senator Hatch. Sep 18, 92 Amendment SP 3045 agreed to in Senate by Yea-Nay Vote. 94-1. Record Vote No: 218. AMENDMENT DIGEST: FROM HOUSE OR SENATE To delay implementation of regulations on P.L. 101-535 with respect to the dietary supplement of vitamins, minerals, herbs and other similar nutritional substances. COSPONSOR COSPONSORED ON WITHDRAWN ON Sen Dole 09/18/92 Sen Nickles 09/18/92 Sen D'Amato 09/18/92 Sen Stevens 09/18/92 Sen McCain 09/18/92 Sen Symms 09/18/92 Sen Bond 09/18/92 *************** hr 509 **************** H.R.509 (C103) 01/21/93 Rep Gallegly, (Cosp=57) House Energy and Commerce DIGEST AS INTRODUCED: Health Freedom Act of 1993 - Amends the Federal Food, Drug, and Cosmetic Act to define "dietary supplement" as an article that: (1) includes, and is intended to supplement the diet with, a vitamin, mineral, or herb; or (2) is intended for ingestion. Prohibits considering a dietary supplement a drug solely because: (1) of the potency of a substance in such supplement; or (2) the labeling or advertising for the supplement contains a claim concerning potency or a health claim permitted under this Act. Specifies that a supplement is not a food additive if it is identified in the labeling of the dietary supplement as a substance provided by the product to supplement the diet. Allows a supplement to be described as a dietary supplement in labeling or advertising. Permits labeling or advertising for such a supplement to include a claim characterizing the relationship of the supplement to a disease or health-related condition, if certain conditions are met. Prohibits any requirement that a claim that meets the requirements of this Act be approved or conform to a regulation before the claim may be used. Allows a declaratory judgment on the validity of an assertion that a claim fails to comply with this Act. ***************** HR 1709 *************** H.R.1709: SPON=Rep Richardson, (Cosp=148); OFFICIAL TITLE: A bill to amend the Federal Food, Drug, and Cosmetic Act to establish provisions regarding the composition and labeling of dietary supplements. ***************** S 784 ***************** S.784 (C103) 04/07/93 Sen Hatch, (Cosp=58) Senate Labor and Human Resources OFFICIAL TITLE(S): AS INTRODUCED: (DATA FURNISHED BY THE SENATE) A bill to amend the Federal Food, Drug, and Cosmetic Act to establish standards with respect to dietary supplements, and for other purposes. POPULAR TITLE(S): Health Freedom Act SHORT TITLE(S): AS INTRODUCED: Dietary Supplement Health and Education Act of 1993 COMMITTEE(S) OF REFERRAL: Senate Labor and Human Resources DETAILED STATUS STEPS: *SENATE ACTIONS* Apr 7, 93 Read twice and referred to the Committee on Labor and Human Resources. DIGEST AS INTRODUCED: Dietary Supplement Health and Education Act of 1993 - Amends the Federal Food, Drug, and Cosmetic Act to define a "dietary supplement" as a food for special dietary use that includes a vitamin, a mineral, an herb, an amino acid, or another ingredient used to supplement the diet by increasing total dietary intake. Excludes a dietary supplement from the definition of the term "drug" and the term "food additive". Deems a dietary supplement adulterated if it presents a substantial and unreasonable risk of illness or injury. Deems a food misbranded unless the label lists the daily value of specified nutrients which shall reflect the daily intake of each nutrient that will promote optiomal health. Prohibits such value from being less than the U.S. Recommended Daily Allowance. Deems a dietary supplement misbranded unless it meets specified guidelines. Establishes an Office of Dietary Supplements within the National Institutes of Health. Authorizes appropriations. COSPONSOR COSPONSORED ON WITHDRAWN ON Sen Reid 04/07/93 Sen Murkowski 04/07/93 Sen Craig 04/28/93 Sen Durenberger 04/28/93 Sen Gorton 04/28/93 Sen Wallop 04/28/93 Sen Grassley 04/29/93 Sen Thurmond 04/29/93 Sen D'Amato 04/29/93 Sen Coats 04/29/93 Sen Simpson 05/06/93 Sen Kempthorne 05/11/93 Sen Bennett 05/11/93 Sen Domenici 05/26/93 Sen Smith 06/09/93 Sen Jeffords 06/10/93 Sen Gregg 06/22/93 Sen Burns 06/22/93 Sen Nickles 07/20/93 Sen Pell 07/27/93 Sen McCain 07/28/93 Sen Faircloth 07/28/93 Sen Mikulski 08/06/93 Sen Helms 08/06/93 Sen Dole 09/08/93 Sen Gramm 09/08/93 Sen Bingaman 09/08/93 Sen Campbell 09/08/93 Sen Daschle 09/10/93 Sen Inouye 09/10/93 Sen Mack 09/10/93 Sen Coverdell 09/10/93 Sen Simon 09/10/93 Sen Moseley-Braun 09/10/93 Sen Hatfield 09/10/93 Sen Hollings 09/10/93 Sen Pressler 09/10/93 Sen Hutchison 09/10/93 Sen Dorgan 09/10/93 Sen McConnell 09/10/93 Sen Bond 09/10/93 Sen Stevens 09/10/93 Sen Specter 09/10/93 Sen Heflin 09/10/93 Sen Mathews 09/10/93 Sen Lott 09/10/93 Sen Brown 09/10/93 Sen DeConcini 09/14/93 Sen Johnston 09/15/93 Sen Akaka 09/15/93 Sen Boren 09/20/93 Sen Chafee 09/21/93 Sen Boxer 09/23/93 Sen Exon 09/23/93 Sen Glenn 09/23/93 10/07/93 Sen Wofford 09/23/93 10/05/93 Sen Shelby 09/29/93 Sen Ford 09/30/93 Sen Sasser 10/06/93 Sen Leahy 10/06/93 ****************** END *************** -- Craig Hansen, Chief Architect Tel: (408) 734-8100 MicroUnity Systems Engineering, Inc. 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