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SPECIAL TALK BY FIRN



            1. Obtain a good understanding of the end     c. Reduction-of-disease-risk claims – similarly to Other function claims required
              product claim and market positioning as     documentation. There have been some such claims allowed in the US, for
              well as how to navigate and prepare for     example calcium for risk reduction of osteoporosis, omega-3 fatty acids for
              regulatory requirements up front. If the     reducing risk of cardiovascular disease or lycopene for risk reduction
              product has a history of consumption for     of prostate cancer.
              less than 15 years, it must go through a   Thai Example “In take of calcium of X mg from
              Novel Food safety approval. Otherwise,   Food Y together with suitable exercise at least Z
              the product will go through a regular food   hrs per day consistently help build strong bones
              labelling petition and Health Claim petition   in women and helps reduce the risk
                                                 of osteoporosis upon aging.”
            2. Understand different claim categories
              a. Nutrient function claims require
                 scientific  documentation  namely
                 systematic review (s) and Meta-analysis
                 that  have  been  published  in  highly
                 respectable journal or scientific reviews
                 and opinions that are well accepted and
                 wildly acknowledged from organization
                 or committee that are well accepted or
                 respected  internationally  or well-
                 designed human intervention study
                 that have been published in a well-
                 respected journal.

            For example of claim in this category
          “Calcium partly helps build strong bone and teeth.
          Product A is a source of calcium.” (based on FDA
          announcement 182) Thai FDA has issued a
          positive list for nutrients that can be used for
          health claims.

              b. Other function claims – supportive
               scientific  documents  include  reports
               that  are  well-designed human
               intervention  studies  in full  and have
               been published  in  well-respected
               scientific  journals  and  one  of  the
               following
               (1)  Systematic review and Meta-
               analysis  that  have  been  published  in
               well-respected journals or
               (2)  Scientific  opinions  that  have  been
              well  accepted  and  respected  from
               organization or officials or expert group
               that are respected internationally.


            Currently, Thailand has not issued a Positive
          List for Other functional claim where as some
          other ASEAN countries have such as Malaysia
          and Singapore.


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