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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Details as Recorded in OASIS by FDA

for Refusal 580-2905613-0/2/1

Manufacturer FEI3003681967
Manufacturer NameVitamin Broker  
Manufacturer Address line 1201 Commercial Rd  
Manufacturer Address line 2  
Manufacturer's CitySouth Yarra  
Manufacturer Province/StateVIC  
Manufacturer Country/AreaAustralia  
Product Code54FCF99  
FDA Product DescriptionHERBALS & BOTANICALS (NOT TEAS), N.E.C.  
Refusal Date20-Aug-2002  
FDA DistrictSEA-DO  
Entry/doc/line/sfx 580-2905613-0/2/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
DIETARYLBL   403(s)(2)(B), 801(a)(3), misbranded   The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term ?dietary supplement,? which term may be modified with the name of such an ingredient. [Misbranding, Section 403(s)(2)(B)].  
LABELING   Section 4(a); 801(a)(3) Misbranding   The article appears in violation of FPLA because of its placement, form and/or contents statement.  
NUTRIT LBL   403(q); 801(a)(3); Misbranding   The article appears to be misbranded in that the label or labeling fails to bear the required nutrition information.