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  • 1.  Dietary supplements export

    Posted 11-Sep-2015 10:42

    Hello All,

    We are looking into exporting certain dietary supplements and I see that we would have to apply for a free sale certificate on FDA's FURLS system via CFSAN. What I want is an example of what this certificate would look like so that we can confirm that it would be acceptable by the foreign government. I've not been successful in finding this and I would appreciate any guidance on this.

     

    Thanks,

    Mehul


    ------------------------------
    Mehul Govani
    Regulatory Specialist
    PL Developments
    Westbury NY
    United States
    ------------------------------



  • 2.  RE: Dietary supplements export

    Posted 14-Sep-2015 08:28

    Hi Mehul.

    Honestly, in 20+ years in FDA-regulated industry (12+ in regulatory) I have never seen a foreign government refuse to accept an FDA-issued Certificate of Free Sales.  More often you have foreign governments who may misunderstand the use of free sales certificates from "third parties" such as trade associations and believe the trade association to be in some way connected to the regulator or more often the third party certificate being "invalid" because they do not specifically represent the regulator.

    I have far more often come into issues with explaining to foreign governments (through our foreign representative) the latter situation.  I have never had to explain to the foreign government what or why a particular free sales certificate reads in the way it does.

    ------------------------------
    Victor Mencarelli
    Sr. Manager - Regulatory Affairs
    Hain Celestial Group
    United States
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    Original Message


  • 3.  RE: Dietary supplements export

    Posted 14-Sep-2015 09:29

    Thank you Victor. I had the same impression that a FDA issued free sale certificate should be widely accepted. 

    ------------------------------
    Mehul Govani
    Regulatory Specialist
    PL Developments
    Westbury NY
    United States
    ------------------------------


    Original Message


  • 4.  RE: Dietary supplements export

    Posted 14-Sep-2015 09:37
    Mehul,

    There is some more info useful once you are aware of. Please refer to FDA's Compliance Policy Guides for Exports or here.   

    For example, in CA, there are five options you can go around after you communicate with the health authority.  

    s/ David
    ____________________________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    President and CEO | REGULATORY DOCTOR and GCS
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    Original Message