21 U.S. Code § 343–2 - Dietary supplement labeling exemptions

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(a) In general
A publication, including an article, a chapter in a book, or an official abstract of a peer-reviewed scientific publication that appears in an article and was prepared by the author or the editors of the publication, which is reprinted in its entirety, shall not be defined as labeling when used in connection with the sale of a dietary supplement to consumers when it—
(1) is not false or misleading;
(2) does not promote a particular manufacturer or brand of a dietary supplement;
(3) is displayed or presented, or is displayed or presented with other such items on the same subject matter, so as to present a balanced view of the available scientific information on a dietary supplement;
(4) if displayed in an establishment, is physically separate from the dietary supplements; and
(5) does not have appended to it any information by sticker or any other method.
(b) Application
Subsection (a) of this section shall not apply to or restrict a retailer or wholesaler of dietary supplements in any way whatsoever in the sale of books or other publications as a part of the business of such retailer or wholesaler.
(c) Burden of proof
In any proceeding brought under subsection (a) of this section, the burden of proof shall be on the United States to establish that an article or other such matter is false or misleading.

Source

(June 25, 1938, ch. 675, § 403B, as added Pub. L. 103–417, § 5,Oct. 25, 1994, 108 Stat. 4328.)

This is a list of parts within the Code of Federal Regulations for which this US Code section provides rulemaking authority.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


21 CFR - Food and Drugs

21 CFR Part 1 - GENERAL ENFORCEMENT REGULATIONS

21 CFR Part 2 - GENERAL ADMINISTRATIVE RULINGS AND DECISIONS

21 CFR Part 5 - ORGANIZATION

21 CFR Part 7 - ENFORCEMENT POLICY

21 CFR Part 10 - ADMINISTRATIVE PRACTICES AND PROCEDURES

21 CFR Part 11 - ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

21 CFR Part 12 - FORMAL EVIDENTIARY PUBLIC HEARING

21 CFR Part 13 - PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY

21 CFR Part 14 - PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

21 CFR Part 15 - PUBLIC HEARING BEFORE THE COMMISSIONER

21 CFR Part 16 - REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

21 CFR Part 20 - PUBLIC INFORMATION

21 CFR Part 25 - ENVIRONMENTAL IMPACT CONSIDERATIONS

21 CFR Part 50 - PROTECTION OF HUMAN SUBJECTS

21 CFR Part 56 - INSTITUTIONAL REVIEW BOARDS

21 CFR Part 70 - COLOR ADDITIVES

21 CFR Part 73 - LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION

21 CFR Part 74 - LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION

21 CFR Part 100 - GENERAL

21 CFR Part 101 - FOOD LABELING

21 CFR Part 102 - COMMON OR USUAL NAME FOR NONSTANDARDIZED FOODS

21 CFR Part 104 - NUTRITIONAL QUALITY GUIDELINES FOR FOODS

21 CFR Part 105 - FOODS FOR SPECIAL DIETARY USE

21 CFR Part 107 - INFANT FORMULA

21 CFR Part 111 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS

21 CFR Part 119 - DIETARY SUPPLEMENTS THAT PRESENT A SIGNIFICANT OR UNREASONABLE RISK

21 CFR Part 120 - HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS

21 CFR Part 123 - FISH AND FISHERY PRODUCTS

21 CFR Part 130 - FOOD STANDARDS: GENERAL

21 CFR Part 131 - MILK AND CREAM

21 CFR Part 133 - CHEESES AND RELATED CHEESE PRODUCTS

21 CFR Part 135 - FROZEN DESSERTS

21 CFR Part 136 - BAKERY PRODUCTS

21 CFR Part 137 - CEREAL FLOURS AND RELATED PRODUCTS

21 CFR Part 139 - MACARONI AND NOODLE PRODUCTS

21 CFR Part 145 - CANNED FRUITS

21 CFR Part 146 - CANNED FRUIT JUICES

21 CFR Part 152 - FRUIT PIES

21 CFR Part 155 - CANNED VEGETABLES

21 CFR Part 156 - VEGETABLE JUICES

21 CFR Part 158 - FROZEN VEGETABLES

21 CFR Part 160 - EGGS AND EGG PRODUCTS

21 CFR Part 161 - FISH AND SHELLFISH

21 CFR Part 163 - CACAO PRODUCTS

21 CFR Part 164 - TREE NUT AND PEANUT PRODUCTS

21 CFR Part 165 - BEVERAGES

21 CFR Part 166 - MARGARINE

21 CFR Part 168 - SWEETENERS AND TABLE SIRUPS

21 CFR Part 169 - FOOD DRESSINGS AND FLAVORINGS

21 CFR Part 179 - IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF FOOD

21 CFR Part 180 - FOOD ADDITIVES PERMITTED IN FOOD OR IN CONTACT WITH FOOD ON AN INTERIM BASIS PENDING ADDITIONAL STUDY

21 CFR Part 500 - GENERAL

21 CFR Part 501 - ANIMAL FOOD LABELING

21 CFR Part 502 - COMMON OR USUAL NAMES FOR NONSTANDARDIZED ANIMAL FOODS

21 CFR Part 800 - GENERAL

21 CFR Part 801 - LABELING

 

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