LEADER 05321nam 22006374a 450 001 9910823906703321 005 20230617005225.0 010 $a1-281-45015-4 010 $a9786611450151 010 $a0-470-38493-X 010 $a0-470-38471-9 035 $a(CKB)1000000000535844 035 $a(EBL)353494 035 $a(OCoLC)437219622 035 $a(SSID)ssj0000138799 035 $a(PQKBManifestationID)11954246 035 $a(PQKBTitleCode)TC0000138799 035 $a(PQKBWorkID)10124036 035 $a(PQKB)11582242 035 $a(MiAaPQ)EBC353494 035 $a(Au-PeEL)EBL353494 035 $a(CaPaEBR)ebr10296386 035 $a(CaONFJC)MIL145015 035 $a(EXLCZ)991000000000535844 100 $a20040331d2004 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 10$aDietary supplement labeling compliance review$b[electronic resource] /$fJames L. Summers with contributions by Elizabeth J. Campbell 205 $a3rd ed. 210 $aAmes, Iowa $cBlackwell Publishing Professional$dc2004 215 $a1 online resource (246 p.) 300 $aDescription based upon print version of record. 311 $a0-8138-0426-4 320 $aIncludes bibliographical references (p. 231-232) and index. 327 $aDIETMY SUPPLEMENT LABELING COMPLIANCE REVIEW; Contents; I. Introduction; II. Overview of Dietary Supplements Labeling; Ill. Definitions; IV. Need for Specific Regulations Governing Dietary Supplements; A. Safety of Dietary Supplements; B. New Dietary Ingredients; 1. New Dietary Ingredients; 2. Premarket Notification for a New Dietary Ingredient; V. Outline for Compliance Review of Dietary Supplement Labels; A . Establish Jurisdiction; 1. Dietary Supplement is Subject to the Requirements of the Federal Food, Drug, and Cosmetic Act, as Amended (FD&CA) 327 $a2. On Requests for Information on a Label Review and Certificate of Free SaleB. Determine the Completeness and Accuracy of the Required Label Information; C. Determine the Degree of Compliance with Applicable Regulations; D. Advise Responsible Firm of Label(s) Needing Corrections; 1. Untitled Letter; 2. Product Recall; 3. Warning Letter; 4. Seizure; 5. Citation; 6. Prosecution; 7. Injunction; 8. Release with Comment Notices (Import); 9. Detention (Import); VI. Compliance Label Review; A. Identity Statement; 1. Summary of the Requirements for Dietary Supplements; 2. Questions and Responses 327 $a3. Illustrations of the Principal Display Panel4. Identity Labeling Regulations; 5. Flavor Labeling Regulations; B. Designation of Ingredients; 1. Summary of the Requirements for Dietary Supplements; 2. Questions and Responses; 3. Illustrations of the Information Panel; 4. Food: Exemptions from Labeling; C. Name and Place of Business; 1. Summary of the Requirements for Dietary Supplements; 2. Questions and Responses; D. Net Quantity of Contents Statement; 1. Summary of the Requirements for Dietary Supplements; 2. Questions and Responses; E. Nutrition Labeling for Dietary Supplements 327 $a1. Summary of the Nutrition Labeling Requirements2. Questions and Responses; 3. Illustrations of Supplement Facts Boxes; (i) Multiple Vitamins; (ii) Multiple Vitamins for Children and Adults; (iii) Multiple Vitamins in Packets; (iv) Dietary Supplement Containing Dietary Ingredients with and without RDls and DRVs; (v) A Proprietary Blend of Dietary Ingredients; (vi) Dietary Supplement of an Herb; (vii) Dietary Supplement of Amino Acids; (viii) Format Split and Continued to the Right; 4. Daily Values for Nutrition Labeling; 5. Illustration of Format Using Dots 327 $a6. Reference Amounts Customarily Consumed Per Eating Occasion for Dietary Supplements7. Rounding Rule Table for Serving Sizes; 8. Nutrition Labeling Exemptions/Special Labeling Provisions; (i) Exemptions under 21 CFR 101.9(j); (ii) Exemptions under 21 CFR 101.36(h); (iii) Special Labeling Provisions under 21 CFR 101.36(i); 9. Type Size Requirements for Nutrition Labeling; 9.1 Illustration of Supplement Facts Box with Arrows Showing Type Size; 10. Rounding Rule Table for Declaring Nutrients; 11. Guidelines for Determining Metric Equivalence of Household Measures; F. Nutrient Content Claims 327 $a1. Summary Statements 330 $aConsultant and long-time FDA food and dietary supplement labeling expert James Summers offers a comprehensive guide to understanding and complying with the dietary supplement labeling requirements of the Food and Drug Administration (FDA) in Dietary Supplement Labeling Compliance Review, Third Edition. Available in book or searchable CD-ROM (view CD-ROM version) formats, this updated review is composed of three essential parts: Sections I through V consist of the introduction and how-to information. Sections VI through IX consist of the compliance step-by- 606 $aFood$xLabeling$zUnited States 615 0$aFood$xLabeling 676 $a363.19/2 700 $aSummers$b James L$g(James Lee),$f1936-$0845629 701 $aCampbell$b Elizabeth J$0845630 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910823906703321 996 $aDietary supplement labeling compliance review$91887801 997 $aUNINA