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| Dockets Entered
On April 2, 2004
Table of Contents
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| Docket #
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| Title
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| 1990N-0309
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| Drug Labeling; Sodium Labeling For OTC Drugs
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| 1995N-0254
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| Labeling of Orally Ingested OTC Products Containing Calcium,
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| 1995N-0304
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| Ephedrine Alkaloids: Reports of Adverse Events; Availability
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 1999F-4372
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| National Fisheries Institute and the Louisiana Dep of Agricu
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| 1999F-5321
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| Food Safety & Inspection service safe use of ionizing radiai
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| 1999F-5322
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| Ionizing Radiation for the Treatment of Food
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| 1999F-5522
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| Ionizing radiation /control of Food-borne pathogens safe use
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 1999P-2630
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| Establish a Daily Value for "added sugars"
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| 1999P-5106
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| Identify Sources of Natural Flavorings
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| 2000N-1484
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| Safety Reporting Requirements Human Drug/Biological Products
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| 2000P-1211
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| Establish Mandatory Pre-Market Safety Testing for GE Foods
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| 2000P-1322
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| Food Labeling and Allergen Contamination Control
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| 2001D-0064
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| Encapsulated Amalgam,Amalgam Alloy & Dental Mercury Labeling
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| 2001F-0047
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| Foodborne pathogens in raw-frozen-cooked-partially cooked
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| 2001N-0067
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| Reclassification of Dental Mercury
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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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| 2002N-0277
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| Bioterrorism; Establishment & Maintenance of Records
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| 2003N-0338
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| Obesity
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| 2003N-0400
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| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
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| 2003P-0362
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| Over-the-counter Hearing Aids
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| 2003P-0555
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| Maintain the Electroconvulsive Therapy Device in Class III for All Indications
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| 2004D-0028
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| Draft Consumer Advisory regarding Advice for Subgroups of a Population regarding Mercury in Fish and Shellfish
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| 2004D-0041
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| Guidance for Industry on Providing Regulatory Submissions in Electronic Format--Content of Labeling
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| 2004N-0115
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| Prescription Drug Importation Study
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| 2004P-0075
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| Prohibit the marketing and distribution of Authorized Generics until the expiraration of the first generic applicant's exclusivity period.
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| 2004P-0091
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| To premarket approval (PMA) for the gastric electrical stimulation ( GES), level III device, enterra therapy, for the treatment of severe nausea and vomiting from gastroparesis
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| 1990N-0309
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| Drug Labeling; Sodium Labeling For OTC Drugs
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| BKG 1
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| References 1-3 found in 69FR13717
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| Vol #:
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| 6
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| 1995N-0254
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| Labeling of Orally Ingested OTC Products Containing Calcium,
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| | | | | | | | |
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| BKG 1
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| References 1 and 2 found in 69FR13725
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| Vol #:
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| 1
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| 1995N-0304
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| Ephedrine Alkaloids: Reports of Adverse Events; Availability
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| EMC 1276
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| G. Haring
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| Vol #:
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| 394
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| EMC
1277
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| Acupuncture and Oriental Medicine Alliance (AOMALLIANCE)
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| Vol #:
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| 394
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| EMC 1278
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| C. Gardner
|
| Vol #:
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| 394
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|
| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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|
| LET
13486
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 112
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| LET
13487
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| Dr. Smith Get Thin Program
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| Vol #:
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| 112
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| LET
13488
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| Food Science of Vermont
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| Vol #:
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| 112
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| LET
13489
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| Food Science of Vermont
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| Vol #:
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| 112
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| LET
13490
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| Food Science of Vermont
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| Vol #:
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| 112
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| LET
13491
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| Food Science of Vermont
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| Vol #:
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| 112
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| LET
13492
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| Food Science of Vermont
|
| Vol #:
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| 112
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| LET
13493
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| MT Sales (U.S.), Inc.
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| Vol #:
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| 112
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| LET
13494
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| Solgar Vitamin and Herb
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| Vol #:
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| 112
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| LET
13495
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| Weleda, Inc.
|
| Vol #:
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| 112
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| LET
13496
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| Now Foods
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| Vol #:
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| 112
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| LET
13497
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| Now Foods
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| Vol #:
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| 112
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| LET
13498
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| Now Foods
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| Vol #:
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| 112
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| LET
13499
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| Now Foods
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| Vol #:
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| 112
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| LET
13500
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| Now Foods
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| Vol #:
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| 112
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| LET
13501
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| Gaia Herbs
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| Vol #:
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| 112
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| LET
13502
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| Health Direct
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| Vol #:
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| 112
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| LET
13503
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| Health Direct
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| Vol #:
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| 112
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| LET
13504
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| Market America, Inc.
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| Vol #:
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| 112
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| LET
13505
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| Nature's Way Products, Inc.
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| Vol #:
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| 112
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| LET
13506
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| Natural Organics, Inc.
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| Vol #:
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| 112
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| LET
13507
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| Solstice Medicine Company
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| Vol #:
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| 112
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| LET
13508
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| Solstice Medicine Company
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| Vol #:
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| 112
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| LET
13509
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 112
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| LET
13510
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| Perrigo Company of South Carolina
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| Vol #:
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| 112
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| LET
13511
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| Awareness Corporation
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| Vol #:
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| 112
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| LET
13512
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| Perrigo Company of South Carolina
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| Vol #:
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| 112
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| LET
13513
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| Metagenics, Inc.
|
| Vol #:
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| 112
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| LET
13514
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| Enzymatic Therapy Natural Medicines
|
| Vol #:
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| 112
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|
| | | | | | | | |
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| LET
13515
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| Enzymatic Therapy Natural Medicines
|
| Vol #:
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| 112
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| LET
13516
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| Michael's Naturopathic Programs
|
| Vol #:
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| 112
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|
|
|
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| LET
13517
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| Nature's Sunshine Products, Inc.
|
| Vol #:
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| 112
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|
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|
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| LET
13518
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| Pharmavite LLC
|
| Vol #:
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| 112
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| LET
13519
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| pH Sciences
|
| Vol #:
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| 112
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| LET
13520
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| Integrative Therapeutics Inc.
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| Vol #:
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| 112
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| LET
13521
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| Perrigo Company of South Carolina
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| Vol #:
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| 112
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| LET
13522
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| Perrigo Company of South Carolina
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| Vol #:
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| 112
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| LET
13523
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| EuroPharma, Inc.
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| Vol #:
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| 112
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|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
|
|
|
|
| EMC 4167
|
| R. Srivastava
|
| Vol #:
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| 304
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|
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|
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| EMC 4168
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| D. Saxena
|
| Vol #:
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| 304
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|
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|
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| EMC 4169
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| S. Sen
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| Vol #:
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| 304
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|
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| EMC 4170
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| L. Bernhard
|
| Vol #:
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| 304
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|
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| EMC 4171
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| N. Mathur
|
| Vol #:
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| 304
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|
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| EMC 4172
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| J. Bell
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| Vol #:
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| 304
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| EMC 4173
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| S. Eaves
|
| Vol #:
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| 304
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|
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| EMC 4174
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| K. Bradford
|
| Vol #:
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| 304
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|
|
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| EMC 4175
|
| J and M Denman
|
| Vol #:
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| 304
|
|
|
|
|
| 1999F-4372
|
| National Fisheries Institute and the Louisiana Dep of Agricu
|
|
|
|
|
| EMC 468
|
| L. Lynn
|
| Vol #:
|
| 8
|
|
|
|
|
| 1999F-5321
|
| Food Safety & Inspection service safe use of ionizing radiai
|
|
|
|
|
| EMC 371
|
| L. Lynn
|
| Vol #:
|
| 8
|
|
|
|
|
| 1999F-5322
|
| Ionizing Radiation for the Treatment of Food
|
|
|
|
|
| EMC 370
|
| L. Lynn
|
| Vol #:
|
| 6
|
|
|
|
|
| 1999F-5522
|
| Ionizing radiation /control of Food-borne pathogens safe use
|
|
|
|
|
| EMC 373
|
| L. Lynn
|
| Vol #:
|
| 6
|
|
|
|
|
| 1999N-4282
|
| Biotechnology in the Year 2000 and Beyond; Public Meetings
|
|
|
|
|
| EMC 4181
|
| N. Reygers
|
| Vol #:
|
| 515
|
|
|
|
|
| EMC 4182
|
| L. Dutton
|
| Vol #:
|
| 515
|
|
|
|
|
| EMC 4183
|
| L. Lynn
|
| Vol #:
|
| 515
|
|
|
|
|
| EMC 4184
|
| M Talpur
|
| Vol #:
|
| 515
|
|
|
|
|
| EMC 4185
|
| N. Shaul
|
| Vol #:
|
| 515
|
|
| | | | | | | | |
|
|
|
|
| EMC 4186
|
| A. Bayer
|
| Vol #:
|
| 515
|
|
|
|
|
| EMC 4187
|
| M. Velardi
|
| Vol #:
|
| 515
|
|
|
|
|
| EMC 4188
|
| M. Velardi
|
| Vol #:
|
| 515
|
|
|
|
|
| EMC 4189
|
| M. Velardi
|
| Vol #:
|
| 515
|
|
|
|
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
|
|
|
|
|
| EMC 529
|
| A. Warner
|
| Vol #:
|
| 24
|
|
|
|
|
| 1999P-2630
|
| Establish a Daily Value for "added sugars"
|
|
|
|
|
| EMC 766
|
| L. Johnson
|
| Vol #:
|
| 33
|
|
|
|
|
| EMC 767
|
| B. O'Neall
|
| Vol #:
|
| 33
|
|
|
|
|
| EMC 768
|
| T. Heinmiller
|
| Vol #:
|
| 33
|
|
|
|
|
| EMC 769
|
| S. Massena
|
| Vol #:
|
| 33
|
|
|
|
|
| EMC 770
|
| B. Insley
|
| Vol #:
|
| 33
|
|
|
|
|
| 1999P-5106
|
| Identify Sources of Natural Flavorings
|
|
|
|
|
| EMC 156
|
| E. Waters
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC 157
|
| R. Long
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC 158
|
| H. Lowery
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC 159
|
| M. George
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC 160
|
| C. Silvernail
|
| Vol #:
|
| 2
|
|
|
|
|
| 2000N-1484
|
| Safety Reporting Requirements Human Drug/Biological Products
|
|
|
|
|
| EMC
68
|
| PPD Medical Communications
|
| Vol #:
|
| 5
|
|
|
|
|
| 2000P-1211
|
| Establish Mandatory Pre-Market Safety Testing for GE Foods
|
|
|
|
|
| EMC 5805
|
| Natalie Reygers
|
| Vol #:
|
| 789
|
|
|
|
|
| EMC 5806
|
| Lea Dutton
|
| Vol #:
|
| 789
|
|
|
|
|
| EMC 5807
|
| Lorna Lynn
|
| Vol #:
|
| 789
|
|
|
|
|
| EMC 5808
|
| Mir Haider Ali Talpur
|
| Vol #:
|
| 789
|
|
|
|
|
| EMC 5809
|
| Nellie Shaul
|
| Vol #:
|
| 789
|
|
|
|
|
| EMC 5810
|
| Alicia Bayer
|
| Vol #:
|
| 789
|
|
|
|
|
| EMC 5811
|
| Marie McCabe-Velardi
|
| Vol #:
|
| 789
|
|
|
|
|
| EMC 5812
|
| Marie McCabe-Velardi
|
| Vol #:
|
| 789
|
|
|
|
|
| EMC 5813
|
| Marie McCabe-Velardi
|
| Vol #:
|
| 789
|
|
|
|
|
| 2000P-1322
|
| Food Labeling and Allergen Contamination Control
|
|
|
|
|
| EMC 538
|
| L. Harris
|
| Vol #:
|
| 20
|
|
|
|
|
| 2001D-0064
|
| Encapsulated Amalgam,Amalgam Alloy & Dental Mercury Labeling
|
|
| | | | | | | | |
|
|
|
|
| EMC
7
|
| Consumers for Dental Choice, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
8
|
| Consumers for Dental Choice, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
9
|
| Consumers for Dental Choice, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2001F-0047
|
| Foodborne pathogens in raw-frozen-cooked-partially cooked
|
|
|
|
|
| EMC 475
|
| L. Lynn
|
| Vol #:
|
| 8
|
|
|
|
|
| 2001N-0067
|
| Reclassification of Dental Mercury
|
|
|
|
|
| EMC
654
|
| Consumers for Dental Choice
|
| Vol #:
|
| 17
|
|
|
|
|
| EMC
655
|
| Consumers for Dental Choice
|
| Vol #:
|
| 17
|
|
|
|
|
| EMC
656
|
| Consumers for Dental Choice
|
| Vol #:
|
| 17
|
|
|
|
|
| EMC
657
|
| Consumers for Dental Choice
|
| Vol #:
|
| 17
|
|
|
|
|
| EMC
658
|
| Consumers for Dental Choice
|
| Vol #:
|
| 17
|
|
|
|
|
| EMC
659
|
| Consumers for Dental Choice
|
| Vol #:
|
| 17
|
|
|
|
|
| EMC
660
|
| Consumers for Dental Choice
|
| Vol #:
|
| 17
|
|
|
|
|
| 2001P-0345
|
| Listing the color additive yellow #5 for use in food/Drug
|
|
|
|
|
| EMC 1221
|
| L. Alba
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 1222
|
| J. Stephenson
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 1223
|
| J. Stephenson
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 1224
|
| N. Showalter
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 1225
|
| D. Ouimet
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 1226
|
| No signature
|
| Vol #:
|
| 5
|
|
|
|
|
| 2002N-0277
|
| Bioterrorism; Establishment & Maintenance of Records
|
|
|
|
|
| EMC 161
|
| J. Crafts
|
| Vol #:
|
| 16
|
|
|
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
|
|
|
|
| EMC 319
|
| Dr. B. Martini
|
| Vol #:
|
| 6
|
|
|
|
|
| EMC 320
|
| Dr. B. Martini
|
| Vol #:
|
| 6
|
|
|
|
|
| EMC 321
|
| Dr. B. Martini
|
| Vol #:
|
| 6
|
|
|
|
|
| EMC 322
|
| Dr. B. Martini
|
| Vol #:
|
| 6
|
|
|
|
|
| EMC 323
|
| Dr. B. Martini
|
| Vol #:
|
| 6
|
|
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
|
|
| EMC 145
|
| B. Rude
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC 146
|
| C. Langgood
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC 147
|
| No signature
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC 148
|
| L. Zeiner
|
| Vol #:
|
| 3
|
|
