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  • 1.  Dietary supplements Allergen statement question

    Posted 02-Feb-2016 11:25

    Hello Community members,

    FALCPA (Food allergen labeling and consumer protection act) requires that the label of a food that contains an ingredient that is or contains protein from a "major food allergen" declare the presence of the allergen in the manner described by the law. 

    My question: If a dietary supplement contains starch as one of the ingredients and if the source of starch is Wheat. Is it still necessary to mention starch as an allergen? Starch is not a protein, it's just a carbohydrate. 

    Please note: Wheat is one of the 8 major food allergen.

    Thanks,

    Mehul

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    Mehul Govani RAC
    Regulatory Specialist
    PL Developments
    Westbury NY
    United States
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  • 2.  RE: Dietary supplements Allergen statement question

    Posted 02-Feb-2016 12:03
    Mehul,

    Yes.  That is how I interpret per the Act (FALCPA) of 2004. 

    Ingredients (e.g., food additives, colors and flavors) are subject to the allergen labeling requirements. Thus, wheat starch should be included.   

    Thank you.  

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



    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

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  • 3.  RE: Dietary supplements Allergen statement question

    Posted 03-Feb-2016 10:29

    Hi Mehul,

     

    Should you search Ovid or PubMed:

    Ø  Hypersensitivity (not – Anaphylactic) reactions - remain actively studied.

    Albeit, more focused to your question, please see two paragraphs (from 2006) via the following link:

    www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Allergens/ucm106108.htm

    Ø   "E. Allergenic Foods of Concern"

    o   "2. Food Ingredients (Please see the fourth paragraph)

    Furthermore, via the same link:

    Ø  G. Exposure

    o   2. Processing Effects (Please see the last paragraph)

     

    I hope this provides some additional insight to your question.

     

    Best regards,

     

    David Goldstein

    Scientific/Medical Writing and Research

    Office: (201-868-5952)

    Cell: (917-836-9818)

    E-mail: dx354@pipeline.com

     

    http://www.linkedin.com/pub/david-goldstein/13/b00/19b

     

    Confidentiality notice: This communication and any files transmitted with it may contain information that is confidential, privileged and exempt from disclosure. It is intended solely for the individual or entity to which it is addressed. If you are not the intended recipient, you are hereby notified that any use, dissemination or copying of this communication is not permitted and may be unlawful. If you have received this communication in error, please notify the sender immediately by replying to the message and deleting the material from your computer.

     




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  • 4.  RE: Dietary supplements Allergen statement question

    Posted 09-Feb-2016 09:15

    Dear Mehul,

    We agree that yes, it is necessary to add to your product label, because the FDA has not established a threshold for wheat allergen. It is possible that the starch may contain a small amount wheat protein. If a threshold has been established for wheat protein and the level of protein in the starch is underneath this level (by a valid method), however, then you would no need to declare. Please contact me directly if you would like additional information from our experts at aroche@burdockgroup.com or (407) 802-1400.

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    Amanda Roche
    Marketing Coordinator
    Burdock Group
    Orlando FL
    United States

    Original Message