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  • 1.  Fish Oil: PC rule or HACCP

    Posted 19-Aug-2017 12:29
    Hello,
    I am curious, does fish oil manufacturing fall under FSMA Preventive Controls for Human Food (part 117) or Seafood HACCP (21 CFR Part 123). What do you think?  

    The fish trimmings or livers from cod or squid are received from the primary processor of the fish. Let's say, it is received frozen. The oil is processed on-site from these trimmings or livers and is marketed as a dietary ingredient for a dietary supplement use.
      
    Thank you for your thoughts.

    Best,


    Larisa Pavlick
    V.P. Global Regulatory and Compliance

    United Natural Products Alliance

    1075 E Hollywood Ave, Salt Lake City, UT 84105  lunpa.com 
    Office phone 801.474.2572 

    Direct: 801.738.2975  

    fax 801.474.2571  info@unpa.com

    --
    Best,


    Larisa Pavlick
    V.P. Global Regulatory and Compliance

    United Natural Products Alliance

    1075 E Hollywood Ave, Salt Lake City, UT 84105  lunpa.com 
    Office phone 801.474.2572 

    Direct: 801.738.2975  

    fax 801.474.2571  info@unpa.com



  • 2.  RE: Fish Oil: PC rule or HACCP

    Posted 19-Aug-2017 13:06
    Larisa,

    Good Day!

    Your description of activity falls under the definition of "manufacturing and processing." See 21 CFR 117.3 

    Accordingly, 21 CFR Part 117 applies.

    Thank you.

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    REGULATORY DOCTOR
    Phone (Toll-Free): 1-(800) 321-8567

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.





    Original Message


  • 3.  RE: Fish Oil: PC rule or HACCP

    Posted 20-Aug-2017 01:54

    In addition to Dr. Lim's  suggestion, it is also required to comply with  HACCP regulations.  The link to FDA compliance is attached

    https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Seafood/ucm2018426.htm




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    Nehru Gaddipati
    New York NY
    United States
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    Original Message


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